Ultime notizie per Novartis (NYSE:NVS) Azioni

Novartis

Novartis develops and manufactures innovative drugs. Key areas of drug development include oncology, rare diseases, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. The company sells its products globally, with the United States comprising close to one third of total revenue.

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The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">CAR T cell immunotherapies</a>.&nbsp;
These products are gene therapies currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma.
&#8220;The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies. REMS is a useful safety system, but reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,&#8221;&nbsp;said FDA Vinay Prasad, Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/news/fda/25/06/46144447/fda-eases-rules-for-bristol-myers-cell-therapies-for-blood-cancers" rel="noreferrer noopener">FDA Eases Rules For Bristol Myers&#8217; Cell Therapies For Blood Cancers</a>
&#8220;Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces the burden on providers,&#8221; he added.
A REMS is a safety <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor" rel="noreferrer noopener">program</a> that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
The FDA determined that the approved REMS for the f<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36760938/gileads-tecartus-dropped-from-fda-list-of-car-t-therapy-with-updated-label-warning-of-risks-of-se" rel="noreferrer noopener">ollowing products should be eliminated</a> because a REMS is no longer necessary to ensure that the benefits of the autologous CAR T cell immunotherapies outweigh their risks.&nbsp;
The products affected by this change include Bristol Myers Squibb &amp; Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel), Johnson &amp; Johnson&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Carvykti (ciltacabtagene autoleucel), Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Kymriah (tisagenlecleucel), and Gilead Science Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).
The elimination of REMS for the above products removes the requirements that hospitals and their associated clinics that dispense products must be specially certified and have on-site, immediate access to tocilizumab.
&#8220;Continuous monitoring and assessment of the safety of all biological products, including the CAR T cell immunotherapies, is an FDA priority and we remain committed to informing the public when we learn new information about these products,&#8221; the FDA said in a press release.
As per a <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor" rel="noreferrer noopener">safety</a> statement on Thursday, the regulator also reduced its requirement that patients remain near the facility where they received treatment to two weeks. The agency also removed its advice to patients to avoid driving for two weeks following product administration.
Commenting on the development and accessibility of CAR T-cell therapies, William Blair said, &#8220;Overall, we view the removal of the REMS program for CAR-T cell therapies as a positive development for the space, as it supports the notion that the FDA is working to minimize red tape and increase access to potentially curative treatments for patients. We also believe the removal of the REMS requirements could increase access and use of these therapies in the community settings.&#8221;
Analyst Sami Corwin said the update also suggests there will likely be no REMS requirements for CD19 and BCMA autologous CAR-T cell therapies approved in the future, such as Arcellx, Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACLX#NASDAQ">ACLX</a>) anito-cel.
Moreover, Corwin highlighted the positive implications for companies developing CAR T-cell therapies for autoimmune diseases, such as Autolus Therapeutics plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AUTL#NASDAQ">AUTL</a>), Bristol-Myers, and Cabaletta Bio, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CABA#NASDAQ">CABA</a>), &#8220;given that the safety profile is more tolerable than in oncology.&#8221;
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ACLX

AUTL

CABA

GILD

FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers

Analyst Ratings

AMZN

iShares Dow Jones US Financial Sector Index Fund

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Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) on Wednesday announced<a href="https://www.globenewswire.com/news-release/2025/06/25/3104985/0/en/Biogen-to-Advance-Investigational-Spinal-Muscular-Atrophy-Asset-to-Registrational-Studies-Based-on-Positive-Interim-Phase-1-Results.html"> in</a> a press release the topline results from the Phase 1 study of salanersen (BIIB115/ION306), an antisense oligonucleotide (ASO) being developed for <a href="https://www.benzinga.com/general/biotech" target="_blank" rel="noreferrer noopener">spinal muscular atrophy (SMA)</a>.
Biogen licensed the global development, manufacturing and commercialization rights for salanersen from Ionis Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IONS#NASDAQ">IONS</a>). Salanersen was discovered by Ionis.
Leveraging the same mechanism of action as Spinraza (nusinersen) but designed to achieve greater potency, salanersen can achieve high efficacy and enable once-a-year dose.
Also Read: <a target="_blank" href="https://www.benzinga.com/m-a/25/06/45949485/supernus-pharma-acquires-maker-of-postpartum-depression-drug-zurzuvae-in-795-million-deal" rel="noreferrer noopener">Supernus Pharma Acquires Maker Of Postpartum Depression Drug Zurzuvae In $795 Million Deal</a>
An interim analysis of the phase one study in participants with SMA who were previously treated with Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) gene therapy, Zolgensma (onasemnogene abeparvovec), was conducted to inform the decision on whether to move salanersen forward <a href="https://www.benzinga.com/pressreleases/25/06/g46091748/biogen-to-advance-investigational-spinal-muscular-atrophy-asset-to-registrational-studies-based-on" target="_blank" rel="noreferrer noopener">into registrational studies</a>.
Both dose levels tested, 40 mg and 80 mg, given once a year, were generally well-tolerated and led to substantial slowing of neurodegeneration, as shown by reductions in neurofilament.
Exploratory clinical outcome data show clinically meaningful improvements in function and attainment of new World Health Organization (WHO) milestones over one year.
Interim results are from part B (n=24) in individuals who received either 40 mg or 80 mg salanersen once a year.
In participants with elevated baseline concentrations of neurofilament light chain (NfL), indicating ongoing neurodegeneration, initiation of salanersen led to mean reductions in NfL of 70% at six months, which were sustained through the one-year dosing interval.
Exploratory clinical outcome data were evaluated for the subgroup of participants with at least one year of follow-up during the interim analysis (n=8 participants aged 2-12 who received 40 mg of salanersen). Half (four out of eight) of these participants achieved new WHO motor milestones they could not previously achieve on their own or required assistance, such as walking, crawling, standing or sitting.
Furthermore, these participants experienced clinically meaningful improvements in motor function from baseline to one year, including a 3.3-point (SD 4.46) mean improvement from baseline on the Hammersmith Functional Motor Scale – Expanded (HFMSE) and a 5.3 point (SD 4.75) improvement on the Revised Upper Limb Module (RULM).
Biogen is currently engaging with global health authorities regarding the design of the phase 3 studies.
Earlier in June, Biogen initiated dosing in the BRAVE phase 3 study to evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between <a href="https://www.benzinga.com/pressreleases/25/06/g45992415/biogen-initiates-phase-3-pediatric-study-of-omaveloxolone-for-the-treatment-of-friedreich-ataxia" target="_blank" rel="noreferrer noopener">the ages of 2 to &lt;16</a>.
Both non-ambulatory and ambulatory participants may qualify for the study.
Currently, omaveloxolone is commercialized under the brand name Skyclarys in over 40 countries, including the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.
BIIB Price Action: Biogen stock is up 0.58% at $127.04 at publication on Wednesday.
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BIIB

IONS

Biogen-Ionis Partnered Drug Shows Benefit In Children With Spinal Muscular Atrophy Previously Treated With Novartis' Zolgensma

On Monday, HC Wainwright initiated coverage on Septerna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEPN#NASDAQ">SEPN</a>), citing a next-generation drug design platform aimed at <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">hitherto-undruggable targets</a>.
Septerna is working on G protein-coupled receptor (GPCR) drug discovery powered by its proprietary Native Complex Platform. Its industrial-scale platform aims to unlock the full <a href="https://www.benzinga.com/pressreleases/25/05/g45450781/septerna-highlights-business-progress-and-reports-first-quarter-2025-financial-results" target="_blank" rel="noreferrer noopener">potential of GPCR therapies</a>.
It has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a>
Analyst Raghuram Selvaraju, in his report, highlighted several compelling factors for investors.
He pointed out that &#8220;Septerna trades at a discount to its most recently reported cash position and upfront cash from a recently-inked partnership.&#8221; 
This, he argues, makes Septerna &#8220;a risk-mitigated opportunity with multiple shots on goal and catalysts constituting key value inflection points slated to accrue over the next six to 12 months.&#8221;
HC Wainwright has initiated coverage on the biotechnology firm with a Buy rating and a <a href="https://www.benzinga.com/quote/SEPN/analyst-ratings">price forecast of $26</a>.
The company&#8217;s most advanced drug candidate, SEP-631, is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) in development for mast cell diseases, including chronic spontaneous urticaria (CSU).
Wainwright believes SEP-631 could offer a distinct treatment option for CSU patients. This is due to its selective inhibition of mast cells, convenient oral administration, and potential for combination therapy. 
Selvaraju further noted that if SEP-631 can replicate the efficacy of Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>)/Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Xolair (omalizumab) – an anti-IgE monoclonal antibody that generated nearly $3.9 billion in sales in 2023, it &#8220;could readily achieve blockbuster status based on an enhanced convenience profile.
Further solidifying its position, Septerna recently announced an exclusive global collaboration and license agreement with Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) in May. 
This <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs">significant pact</a> covers the discovery, development, and commercialization of oral small-molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases, with<a href="https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916006"> four development programs</a> initially commencing. 
HC Wainwright underscored the financial implications of this partnership, stating, &#8220;given the size of the upfront and near-term milestone payments, we feel that Septerna&#8217;s implied enterprise value is either negligible or actually negative, further mitigating risk and underscoring the extent to which the company appears undervalued.&#8221;
Price Action: SEPN stock is trading higher by 0.38% to $10.51 at last check Monday.
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RHHBY

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Analyst Flags Septerna As Undervalued Biotech Play With Significant Upside

Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced Thursday that it will advance subcutaneous and oral amycretin into phase 3 development <a href="https://www.benzinga.com/topic/weight-loss" target="_blank" rel="noreferrer noopener">in weight management</a>.
Amycretin is developed for subcutaneous and oral administration.
The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management.
Novo Nordisk <a target="_blank" href="https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916348" rel="noreferrer noopener">plans</a> to initiate a phase 3 development program with amycretin for adults with overweight or obesity during the first quarter of 2026.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45885869/novo-nordisk-deep-apple-launch-drug-discovery-alliance-for-weight-loss-oral-therapies" rel="noreferrer noopener">Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies</a>
Oral Amycretin Phase 1 trial evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.
The Subcutaneous Amycretin Phase 1b/2a trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in overweight or obese people.
The trial was a combined single ascending dose, multiple ascending dose, and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
When evaluating the effects of treatment if all people adhered to treatment&nbsp;from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43187095/novo-nordisks-weekly-amycretin-delivers-up-to-22-weight-loss-in-study-stock-soars" rel="noreferrer noopener">on 20mg (36 weeks)</a>.
People treated with a placebo experienced an estimated 1.9%, 2.3%, and 2.0% body weight gain, respectively.
After the update, Novo Nordisk again became the largest European company by market capitalization.
According <a target="_blank" href="https://www.benzinga.com/pro/feature/newsfeed" rel="noreferrer noopener">to Benzinga Pro</a>, Novo Nordisk&#8217;s market capitalization was $360.14 billion, compared with $351.9 billion for SAP SE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SAP#NYSE">SAP</a>).
Since reaching a record high in June 2024, Novo has suffered a series of setbacks, including <a target="_blank" href="https://www.benzinga.com/24/12/42613036/novo-nordisks-hybrid-weight-loss-drug-falls-short-on-expectations-stock-plunges" rel="noreferrer noopener">disappointing clinical trial results</a> for its experimental obesity treatments and mounting competition from its U.S. rival, Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>).
In May, the drugmaker <a href="https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916008" target="_blank" rel="noreferrer noopener">decided</a> to replace chief executive officer Lars Fruergaard Jorgensen. A search for a new CEO is ongoing.
Year to date, Novo Nordisk stock has fallen around 5.5%. In the past year, the stock has plunged approximately 43%.
Price Action: NVO stock is down 0.57% at $80.59&nbsp;at the last check on Friday.
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Photo: Shutterstock

Novo Nordisk Moves Amycretin Into Phase 3 Trials For Weight Management, Becomes Europe's Largest Company

Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) on Thursday released results from APPULSE-PNH, a Phase 3B study evaluating the efficacy and safety of twice-daily oral monotherapy Fabhalta (iptacopan) in adult patients with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">paroxysmal nocturnal hemoglobinuria (PNH)</a> with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab).
The company released topline <a target="_blank" href="https://www.benzinga.com/24/12/42370119/novartis-touts-encouraging-data-from-late-stage-study-for-fabhalta-in-rare-type-of-blood-disorder" rel="noreferrer noopener">data in December 2024</a>.
What Happened: PNH is a rare complement-mediated blood disorder. People with PNH have an acquired mutation in some of their hematopoietic stem cells that causes them to produce RBCs susceptible to premature destruction.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/45075714/novartis-q1-earnings-beat-street-view-ceo-confident-to-deliver-upgraded-2025-guidance" rel="noreferrer noopener">Novartis Q1 Earnings Beat Street View, CEO &#8216;Confident&#8217; In Delivering Upgraded Guidance</a>
This leads to intravascular hemolysis (destruction of RBCs within blood vessels) and extravascular hemolysis (destruction of RBCs mostly in the spleen and liver).
After 24 <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-fabhalta-shows-statistically-significant-and-clinically-meaningful-improvements-hemoglobin-new-population-patients-pnh" rel="noreferrer noopener">weeks</a> of treatment with Fabhalta, the Hb level improved&nbsp;on average by 2.01 g/dL, with most patients achieving normal or near-normal levels.
Data will be presented at the European Hematology Association (EHA) Congress 2025.
No patients required transfusion during the study, and the vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels. Patients treated with Fabhalta also reported clinically meaningful improvements in fatigue (as measured by FACIT-Fatigue score) through Day 168, reaching absolute levels similar to those reported in the general population.
Furthermore, patients treated with Fabhalta maintained intravascular hemolysis control and resolved extravascular hemolysis control, as demonstrated by lactate dehydrogenase levels (&lt;1.5 upper limit of normal) and a reduction in absolute reticulocyte count.
Alongside APPULSE-PNH, longer-term data from patients initially included in the APPLY-PNH and APPOINT-PNH Phase 3 studies will be presented at EHA.
Why It Matters: Novartis says Anti-C5 therapies, including AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Soliris (eculizumab) or Ultomiris (ravulizumab), are commonly administered every two to eight weeks as intravenous infusions, and treatment visits (including journey, waiting, infusion and recovery time) can take approximately four to five hours.
Despite treatment with anti-C5 therapies, a large proportion of people with PNH remain anemic, and some are dependent on blood transfusions.
NVS Price Action: NVS stock is up 2.17% at $120.54 at publication on Thursday.
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Photo: Shutterstock

Novartis' Fabhalta Delivers Hemoglobin Gains, Reduces Fatigue In Patients With Rare Blood Disorder

Novartis's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) short percent of float has fallen 26.09% since its last report. The company recently reported that it has 3.35 million shares sold short, which is 0.17% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.74 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Novartis Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1749045633_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Novartis has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing Novartis's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Novartis's peer group average for short interest as a percentage of float is 3.72%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

Short Sellers

Short Ideas

Is Novartis Gaining or Losing Market Support?

<ul>
<li>Thoma Bravo may retain minority stake in Apryse</li>
<li>Company generates over $100 million in EBITDA, growing over 20% annually</li>
<li>Apryse completed over a dozen acquisitions to expand functionality</li>
</ul>
May 29 (Reuters) - Buyout firm Thoma Bravo is exploring a $3 billion-plus sale of Apryse, after receiving interest from potential buyers of the document processing software provider, people familiar with the matter said on Thursday.
Thoma Bravo is working with investment bankers at Lazard <a href="https://workspace.refinitiv.com/web/apps/quotewebapi?RIC=LAZ.N">LAZ.N</a> on the sale process, said the sources, noting interest had already come from other private equity firms.
As part of any deal, Thoma Bravo may decide to retain a minority stake in Apryse, the sources said. They also cautioned that no sale was guaranteed and spoke on condition of anonymity to discuss confidential deliberations.
Thoma Bravo declined to comment, while Apryse and Lazard did not respond to Reuters' requests for comment.
Denver, Colorado-based Apryse provides document processing technology for developers of mobile and computer applications, allowing them to create, edit, and convert digital documents, as well as integrate such capabilities into their own applications.
Its customers include Novartis <a href="https://workspace.refinitiv.com/web/apps/quotewebapi?RIC=NOVN.S">NOVN.S</a>, Wells Fargo <a href="https://workspace.refinitiv.com/web/apps/quotewebapi?RIC=WFC.N">WFC.N</a> and DocuSign <a href="https://workspace.refinitiv.com/web/apps/quotewebapi?RIC=DOCU.O">DOCU.O</a>, according to its website.
Apryse generates more than $100 million in earnings before interest, taxes, depreciation, and amortization (EBITDA) and is growing more than 20 percent annually, the sources said.
Any deal is expected to value the company at 30x its EBITDA or higher, the sources added.
PDFTron, the previous name of Apryse, was founded in 1998 as a document processing technology platform. It was acquired by Thoma Bravo in 2021, with the investment led by the co-head of Thoma's Discover platform, Hudson Smith. The company was renamed as Apryse two years later. Silversmith Capital Partners and the company's management team have remained minority shareholders in the business.
Apryse has completed nine add-on acquisitions to expand its functionality and global reach since Thoma Bravo acquired the company. These include Netherlands-based digital document processor TallComponents, which was announced earlier this week, and AI-powered software maker Lead Technologies, completed last year.

Asset Sales

DOCU

'Thoma Bravo Exploring $3 Billion-Plus Sale Of Software Firm Apryse After Receiving Inbound Interest, Sources Say' - Reuters Exclusive

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders will search for circumstances when the market estimation of an option diverges heavily from its normal worth. High amounts of trading activity could push option prices to exaggerated or underestimated levels. 
Here's the list of options activity happening in today's session: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>TEM</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>07/18/25</td>
<td>$55.00</td>
<td>$71.1K</td>
<td>2.1K</td>
<td>1.3K</td>
</tr>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>06/06/25</td>
<td>$25.00</td>
<td>$68.0K</td>
<td>2.2K</td>
<td>1.0K</td>
</tr>
<tr>
<td>GILD</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>06/06/25</td>
<td>$100.00</td>
<td>$44.0K</td>
<td>1.1K</td>
<td>960</td>
</tr>
<tr>
<td>REGN</td>
<td>CALL</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>07/18/25</td>
<td>$630.00</td>
<td>$119.6K</td>
<td>6</td>
<td>705</td>
</tr>
<tr>
<td>VEEV</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>06/20/25</td>
<td>$210.00</td>
<td>$65.7K</td>
<td>534</td>
<td>589</td>
</tr>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$115.00</td>
<td>$28.0K</td>
<td>1.8K</td>
<td>379</td>
</tr>
<tr>
<td>MDT</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>08/15/25</td>
<td>$80.00</td>
<td>$42.5K</td>
<td>883</td>
<td>372</td>
</tr>
<tr>
<td>AMGN</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$295.00</td>
<td>$40.2K</td>
<td>985</td>
<td>344</td>
</tr>
<tr>
<td>ABBV</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$195.00</td>
<td>$25.8K</td>
<td>5.0K</td>
<td>319</td>
</tr>
<tr>
<td>COR</td>
<td>PUT</td>
<td>SWEEP</td>
<td>NEUTRAL</td>
<td>06/20/25</td>
<td>$280.00</td>
<td>$36.4K</td>
<td>762</td>
<td>200</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These bullet-by-bullet explanations have been constructed using the accompanying table. 
• For TEM (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEM#NASDAQ">TEM</a>), we notice a put option sweep that happens to be bearish, expiring in 51 day(s) on July 18, 2025. This event was a transfer of 89 contract(s) at a $55.00 strike. This particular put needed to be split into 3 different trades to become filled. The total cost received by the writing party (or parties) was $71.1K, with a price of $799.0 per contract. There were 2196 open contracts at this strike prior to today, and today 1320 contract(s) were bought and sold. 
• For MRNA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), we notice a put option sweep that happens to be bearish, expiring in 9 day(s) on June 6, 2025. This event was a transfer of 1000 contract(s) at a $25.00 strike. This particular put needed to be split into 7 different trades to become filled. The total cost received by the writing party (or parties) was $68.0K, with a price of $68.0 per contract. There were 2289 open contracts at this strike prior to today, and today 1083 contract(s) were bought and sold. 
• For GILD (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), we notice a put option trade that happens to be bearish, expiring in 9 day(s) on June 6, 2025. This event was a transfer of 958 contract(s) at a $100.00 strike. The total cost received by the writing party (or parties) was $44.0K, with a price of $46.0 per contract. There were 1139 open contracts at this strike prior to today, and today 960 contract(s) were bought and sold. 
• Regarding REGN (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>), we observe a call option trade with neutral sentiment. It expires in 51 day(s) on July 18, 2025. Parties traded 46 contract(s) at a $630.00 strike. The total cost received by the writing party (or parties) was $119.6K, with a price of $2600.0 per contract. There were 6 open contracts at this strike prior to today, and today 705 contract(s) were bought and sold. 
• Regarding VEEV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VEEV#NYSE">VEEV</a>), we observe a put option sweep with bearish sentiment. It expires in 23 day(s) on June 20, 2025. Parties traded 212 contract(s) at a $210.00 strike. This particular put needed to be split into 45 different trades to become filled. The total cost received by the writing party (or parties) was $65.7K, with a price of $310.0 per contract. There were 534 open contracts at this strike prior to today, and today 589 contract(s) were bought and sold. 
• For NVS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), we notice a call option sweep that happens to be bullish, expiring in 23 day(s) on June 20, 2025. This event was a transfer of 224 contract(s) at a $115.00 strike. This particular call needed to be split into 9 different trades to become filled. The total cost received by the writing party (or parties) was $28.0K, with a price of $125.0 per contract. There were 1879 open contracts at this strike prior to today, and today 379 contract(s) were bought and sold. 
• For MDT (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MDT#NYSE">MDT</a>), we notice a call option trade that happens to be bearish, expiring in 79 day(s) on August 15, 2025. This event was a transfer of 100 contract(s) at a $80.00 strike. The total cost received by the writing party (or parties) was $42.5K, with a price of $425.0 per contract. There were 883 open contracts at this strike prior to today, and today 372 contract(s) were bought and sold. 
• Regarding AMGN (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), we observe a call option trade with bullish sentiment. It expires in 23 day(s) on June 20, 2025. Parties traded 134 contract(s) at a $295.00 strike. The total cost received by the writing party (or parties) was $40.2K, with a price of $300.0 per contract. There were 985 open contracts at this strike prior to today, and today 344 contract(s) were bought and sold. 
• For ABBV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), we notice a call option trade that happens to be bullish, expiring in 23 day(s) on June 20, 2025. This event was a transfer of 137 contract(s) at a $195.00 strike. The total cost received by the writing party (or parties) was $25.8K, with a price of $189.0 per contract. There were 5038 open contracts at this strike prior to today, and today 319 contract(s) were bought and sold. 
• Regarding COR (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COR#NYSE">COR</a>), we observe a put option sweep with neutral sentiment. It expires in 23 day(s) on June 20, 2025. Parties traded 135 contract(s) at a $280.00 strike. This particular put needed to be split into 27 different trades to become filled. The total cost received by the writing party (or parties) was $36.4K, with a price of $270.0 per contract. There were 762 open contracts at this strike prior to today, and today 200 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

ABBV

AMGN

MRNA

REGN

VEEV

10 Health Care Stocks Whale Activity In Today's Session

Novartis Subsidiary Launches Offer to Acquire All Outstanding Shares of Regulus Therapeutics for $7.00 in Cash Plus Additional $7.00 Contingent Value Right Per Share, with Offer Expiring at 12:01 A.M. ET on June 25, 2025, Unless Extended or Terminated

<a href="https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease">https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease</a>.

ACIU

ANVS

DNLI

PRTA

RHHBF

SAVA

'FDA Clears First Blood Test Used In Diagnosing Alzheimer's Disease; New Test Provides Less Invasive Option, Reduces Reliance On Pet Scans And Increases Diagnosis Accessibility' - FDA

In a move that indicates faith in the resurgence of global equities, Lazard Asset Management has transformed its International Equity Advantage mutual fund into<a href="https://www.benzinga.com/etfs"> actively managed ETF</a>, the Lazard International Dynamic Equity Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IEQ#NYSE">IEQ</a>). With this, IEQ joins Lazard&#8217;s theme- and region-based ETF suite that includes the Equity Megatrends ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THMZ#NASDAQ">THMZ</a>), Japanese Equity ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JPY#NASDAQ">JPY</a>), and Next Gen Technologies ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEKY#NASDAQ">TEKY</a>).
Also Read:<a href="https://www.benzinga.com/etfs/specialty-etfs/25/05/45297474/imtm-etf-tanks-then-soars-why-global-momentum-is-making-a-comeback"> IMTM ETF Tanks, Then Soars: Why Global Momentum Is Making A Comeback</a>
Launched on Monday, IEQ is not starting from zero. It inherits both the history and portfolio DNA of its mutual fund ancestor, now in the slick, low-cost, and tax-efficient wrapper increasingly favored by investors. The ETF launched with $31.1 million in assets and an expense ratio of 0.40%.
IEQ follows the MSCI All Country World ex-US Index (ACWI ex-US) as its benchmark but seeks to outperform it, not merely replicate it. The fund uses a quantitatively oriented process that combines machine intelligence with fundamental research to create a concentrated, high-conviction portfolio of non-U.S. stocks.
The fund&#8217;s strategy resists temptation to lean too heavily in any one direction of investment. Rather, Lazard&#8217;s team regularly assesses companies on the basis of valuation, growth, quality, and the way markets are thinking about them.
Rob Forsyth, Lazard's Global Head of ETFs, sees the &#8220;pendulum swing back toward international equities,&#8221; and investors are taking notice.
Additionally, Lazard Chief Market Strategist Ronald Temple sees a &#8220;world of opportunity&#8221; outside of the U.S., according to Bloomberg.
IEQ's portfolio includes global powerhouses such as TSMC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TSM#NYSE">TSM</a>), Iberdrola (OTCPK: IBDRY), Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Alibaba (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BABA#NYSE">BABA</a>), and Tencent (OTCPK: TCEHY), offering exposure across key regions and sectors.
As the ETF market starts to sizzle and international shares return to favour with investors, Lazard is betting that an experienced international strategy with a technology-driven twist is precisely what the market needed. IEQ might be a new ticker tape name, but the strategy playbook that underlies it has been rigorously stress-tested through market cycles — and now it&#8217;s taking it global.
Read Next: 
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<li><a href="https://www.benzinga.com/etfs/new-etfs/25/05/45446558/new-innovator-etf-targets-rolling-downside-protection-with-up-to-50-equity-upside">New Innovator ETF Targets Rolling Downside Protection With Up To 50% Equity Upside</a></li>
</ul>
Image: Shutterstock

New ETFs

ETFs

BABA

IBDRY

TCEHY

TEKY

THMZ

Lazard Transforms Mutual Fund Into IEQ ETF Amid Rising Demand For International Stocks

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced on Wednesday that it will invest at least $20 billion in the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">U.S. through 2030</a>.
Research and development, plus U.S. manufacturing, will receive the bulk of the spending.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help <a href="https://www.benzinga.com/pressreleases/25/05/n45414947/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-exp" target="_blank" rel="noreferrer noopener">enhance the U.S. supply chain</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44981281/french-drugmaker-sanofi-clocks-20-q1-profit-growth-forecasts-strong-rebound-in-annual-profit" rel="noreferrer noopener">French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit</a>
Sanofi has 13,000 US-based employees, according to CEO Paul Hudson.
&#8220;Our expected investments in the US will be substantial and will help ensure the production of key medicines in the U.S.,&#8221; he added.
Sanofi also expects to partner with other domestic manufacturers to help ensure the production of medicines in the U.S.  
Earlier in May, U.S. President&nbsp;Donald Trump's&nbsp;signed an executive order to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The White House wants facilities to come on board at a faster rate. It <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">estimates</a> that it can currently take five to 10 years to build new pharmaceutical manufacturing capacity, which it calls "unacceptable from a national-security standpoint.&#8221;
It&#8217;s not just Sanofi. <a href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufacturing-oversight" target="_blank" rel="noreferrer noopener">Amid tariff uncertainty</a>, many drug companies are investing to boost production within the U.S.:
<ul class="wp-block-list">
<li>Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled&nbsp;<a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm&nbsp;Becton, Dickinson, and Company&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest&nbsp;$2.5 billion&nbsp;in U.S. manufacturing capacity&nbsp;<a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)  seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a $23 billion investment plan to expand in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>.</li>
<li>Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;announced that it will invest $50 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Bristol-Myers Squibb &amp; Co.'s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Christopher Boerner, chair and chief executive officer,&nbsp;<a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">shared</a>&nbsp;plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Statnews.</li>
</ul>
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is one pharma company that did not highlight investments in new manufacturing plants. The company noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">products in the U.S</a>.
Price Action: Sanofi stock is down 1.53% at $49.20 at the last check on Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a></li>
</ul>
Image: Shutterstock

Sanofi To Navigate Tariff Impact With $20 Billion In Spending Through 2030

On May 11, 2025, Incyte Corporation (the "Company") and Novartis Pharma AG ("Novartis") entered into a settlement agreement (the "Settlement Agreement") with respect to litigation initiated by Novartis and relating to the duration of royalty payments owed by the Company to Novartis under the Collaboration and License Agreement dated November 24, 2009, as amended, between the Company and Novartis. As of March 31, 2025, the Company had approximately $537.1 million of accrued royalties relating to the dispute with Novartis included in accrued and other current liabilities on the Company's condensed consolidated balance sheet. Under the Settlement Agreement, the Company has agreed to pay to Novartis $280.0 million as the settlement of disputed royalties on net sales of JAKAFI in the United States through December 31, 2024, and the parties agreed to reduce by 50% the royalty rate payable by the Company on future net sales of JAKAFI in the United States beginning January 1, 2025 for a period defined in the Settlement Agreement. The reduced royalty payable for the quarter ended March 31, 2025, is approximately $14.9 million. The difference of $242.2 million between the total accrued royalties and the total amount to be paid by the Company to Novartis as disclosed above will be recorded in the Company's condensed consolidated statement of operations for the quarter ending June 30, 2025.

Contracts

Legal

INCY

Incyte And Novartis Settle Royalty Dispute With $280M Payment And 50% Reduction In Future JAKAFI U.S. Royalties, Resolving Litigation Over 2009 Collaboration Agreement And Releasing $242.2M In Accrued Liabilities

Protagonist Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTGX#NASDAQ">PTGX</a>), in collaboration with Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), released new clinical data from the Phase 3 ICONIC-TOTAL&nbsp;study investigating icotrokinra for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">scalp and genital psoriasis</a>.
Key findings from the high-impact skin sites cohort:
<ul class="wp-block-list">
<li>At week 16, 57% of patients treated with once daily icotrokinra achieved the study&#8217;s primary endpoint with an Investigator&#8217;s Global Assessment (IGA)&nbsp;b&nbsp;score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of <a href="https://www.benzinga.com/pressreleases/25/05/ac45315482/protagonist-announces-icotrokinra-phase-3-data-on-difficult-to-treat-scalp-and-genital-psoriasis-" target="_blank" rel="noreferrer noopener">patients receiving placebo</a>.</li>
<li>66% of patients with scalp psoriasis achieved a scalp-specific Investigator&#8217;s Global Assessment (ss-IGA)&nbsp;c&nbsp;score of 0/1 compared to 11% receiving placebo at 16 weeks.</li>
<li>77% of patients with genital psoriasis achieved a static Physician&#8217;s Global Assessment of Genitalia (sPGA-G)&nbsp;d&nbsp;score of 0/1 at 16 weeks, compared to 21% receiving placebo.</li>
<li>In the smaller subset of patients with hand/foot psoriasis, patients showed a numerically higher rate of skin clearance at Week 16, with 42% achieving a hand and/or foot Physician&#8217;s Global Assessment (hf-PGA)&nbsp;e&nbsp;score of 0/1 compared to 26% receiving placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44737545/johnson-johnson-protagonist-partnered-investigational-psoriasis-oral-pill-shows-75-of-adolescents-achieved-completely-clear-skin" rel="noreferrer noopener">Johnson &amp; Johnson, Protagonist Tout Positive Results For Psoriasis Oral Pill Study</a>
In March, the companies announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44220449/why-is-protagonist-therapeutics-stock-trading-higher-on-monday" rel="noreferrer noopener">ulcerative colitis (UC)</a>.
The study met its primary endpoint of clinical response&nbsp;in all icotrokinra dose groups evaluated.
Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/ac44217207/protagonist-reports-positive-top-line-results-from-phase-2b-study-of-icotrokinra-showing-potentia" rel="noreferrer noopener">improvement at Week 12</a>.
The company also shared preclinical characterization of PN-881, the first-in-class oral peptide antagonist blocking the three dimeric forms of IL-17 (AA, AF and FF), at the Society for Investigative Dermatology (SID) Annual Meeting.
PN-881 represents Protagonist&#8217;s next generation of oral peptides for psoriasis. Key takeaways:
<ul class="wp-block-list">
<li>Exhibited nanomolar to picomolar in vitro potency comparable to UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) Bimzelx (bimekizumab) and superior (70-fold) to Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Consentyx secukinumab.</li>
<li>Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.</li>
<li>Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing.</li>
<li>Demonstrated dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.</li>
</ul>
Price Action: PTGX stock is up 1.87% at $44.74 at the last check on Friday.
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</ul>
Image: Shutterstock

PTGX

UCBJF

UCBJY

Protagonist/Johnson & Johnson Partnered Drug Shows Significant Skin Clearance In Pivotal Psoriasis Study

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">American consumers and patients</a>.
This change builds upon the agency&#8217;s Office of Inspection and Investigations&#8217; Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.&nbsp;
&#8220;For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning,&#8221; said FDA Commissioner Martin Makary. &nbsp;
On Tuesday, the FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities?utm_medium=email&amp;utm_source=govdelivery" rel="noreferrer noopener">said</a> it plans to review and improve its foreign inspection program to ensure it meets the highest standards for oversight. Part of this effort includes making it clear that FDA inspectors should not accept travel-related perks like hotel stays or transportation from the companies they inspect.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/05/45225204/iqvia-beats-q1-earnings-expectations-despite-sector-uncertainty-company-navigating-market-conditions-effectively-says-ceo" rel="noreferrer noopener">IQVIA Beats Q1 Earnings Expectations Despite Sector Uncertainty, Company Navigating Market Conditions &#8216;Effectively&#8217; Says CEO</a>
The FDA conducts about 12,000 inspections annually in the U.S. and 3,000 in other countries. While U.S. companies often get surprise inspections, foreign companies usually receive advanced notice, giving them time to prepare and potentially hide problems.
Still, foreign inspections often reveal serious issues, more than twice as often as domestic ones.
In the U.S., inspections are usually unannounced unless specific programs require advance notice to ensure staff and records are available.
Even then, companies can&#8217;t pick the date or time. The FDA says foreign companies shouldn&#8217;t have that option either.
By shifting to more surprise inspections abroad, the FDA aims to better protect American consumers by catching dishonest practices, like falsifying records or hiding violations, before they cause harm.
The agency can take action against any company that tries to delay, block, or refuse an unannounced inspection.
The update follows President&nbsp;Donald Trump&#8217;s signed executive order on Monday to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The order directs the FDA to reduce the amount of time it takes to approve manufacturing plants in the U.S. by eliminating unnecessary requirements, streamlining reviews, and working with domestic drugmakers to &#8220;provide early support before facilities come online,&#8221; <a target="_blank" href="https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-announces-actions-to-reduce-regulatory-barriers-to-domestic-pharmaceutical-manufacturing/" rel="noreferrer noopener">according</a> to&nbsp;a White House fact sheet.
It also directs the agency to raise inspection fees for foreign manufacturing plants, improve the enforcement of active-ingredient source reporting by overseas producers, and consider publicly listing facilities that don&#8217;t comply.
The White House <a target="_blank" href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/" rel="noreferrer noopener">estimates</a> that it can currently take five to ten years to build new pharmaceutical manufacturing capacity, which it calls &#8220;unacceptable from a national-security standpoint.&#8221;
<a target="_blank" href="https://www.benzinga.com/markets/25/02/43906811/trump-reportedly-warns-big-pharma-move-manufacturing-to-us-or-face-tariffs" rel="noreferrer noopener">Amid tariff uncertainty</a>, many companies have disclosed a wave of investments in recent months to boost production in the U.S.
<ul>
<li>Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled <a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over <a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm Becton, Dickinson, and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest $2.5 billion in U.S. manufacturing capacity <a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) did not highlight investments in new manufacturing plants; it noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">their products in the U.S</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a sweeping $23 billion investment plan to expand its manufacturing and research infrastructure in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced its plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>.</li>
<li>Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced that it will invest $50 billion in the U.S. over <a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Most recently, Bristol-Myers Squibb &amp; Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Christopher Boerner, chair and chief executive officer, <a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/" target="_blank" rel="noreferrer noopener">shared</a> plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Stat this week.</li>
</ul>
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</ul>
Photo by Tada Images via Shutterstock

Government

Regulations

FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight

BioNTech SE&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>)&nbsp;on Monday reported a first-quarter per-share loss of $1.82 (1.73 euros), up from 1.31 euros reported a year ago compared to beating <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">the consensus of $2.02</a>.
The COVID-19 vaccine maker reported sales of $192.23 million (182 million euros), compared to 187 million euros, beating&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45190192/biontech-announces-first-quarter-2025-financial-results-and-corporate-update" rel="noreferrer noopener">the consensus of $177.40 million</a>.
Revenues during the first quarter of 2025 were mainly driven by revenues derived from BioNTech&#8217;s COVID-19 vaccine collaboration.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44535393/european-patent-office-rules-vaccine-developer-curevacs-amended-patent-valid-stock-jumps" rel="noreferrer noopener">European Patent Office Rules Vaccine Developer CureVac&#8217;s Amended Patent Valid, Stock Jumps</a>
&#8220;Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations,&#8221;&nbsp;said Jens Holstein, CFO of BioNTech. &#8220;BioNTech&#8217;s robust financial position empowers us to pursue our strategic goal of evolving into a leading biotech company with multiple oncology products by 2030.&#8221;
Cost of sales was 83.8&nbsp;million euros compared to 59.1&nbsp;million&nbsp;a year ago, mainly due to a positive impact of an inventory revaluation in the first quarter of 2024.
Research and development expenses were 525.6&nbsp;million euros compared to 507.5&nbsp;million euros a year ago. The increase was mainly driven by progressing late-stage clinical studies for candidates in BioNTech&#8217;s ADC and antibody portfolio.
Cash and cash equivalents plus security investments&nbsp;as of March&nbsp;31, 2025, reached 15.85 billion euros.
<h2 class="wp-block-heading">CFO Appointment</h2>
BioNTech appointed Ramón Zapata-Gomez to the Management Board on Monday as Chief Financial Officer, effective July 1, 2025. He will join BioNTech from Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) global biomedical research organization, where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45189869/biontech-announces-appointment-of-ram-n-zapata-to-management-board-as-chief-financial-officer" rel="noreferrer noopener">on June 30, 2025</a>.
<h2 class="wp-block-heading">Guidance For 2025</h2>
BioNTech <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44220746/pfizers-covid-19-shot-partner-biontech-reports-q4-profit-but-2025-guidance-falls-short-on-expectations" rel="noreferrer noopener">reaffirmed its fiscal year 2025</a> guidance of 1.7 billion-2.2 billion euros compared to the consensus of 2.08 billion euros and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full-year revenue figure. The revenue guidance assumes:
<ul>
<li>Relatively stable vaccination rates, pricing levels, and market share compared to 2024.</li>
<li>Estimated inventory write-downs and other charges by BioNTech&#8217;s collaboration partner Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) that negatively influence BioNTech&#8217;s revenues.</li>
<li>Anticipated revenues from a pandemic preparedness contract with the German government.</li>
<li>Anticipated revenues from the BioNTech Group service businesses.</li>
<li>Potential changes to the law or governmental policy, including tariffs, public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses.</li>
</ul>
BioNTech expects to focus investments on R&amp;D and scaling the business for late-stage development and commercial readiness in oncology while remaining cost-disciplined.
As part of BioNTech&#8217;s strategy, the Company may continue to evaluate appropriate corporate development opportunities to drive sustainable long-term growth and create future value.
Price Action: BNTX stock is down 3.65% at $101.11 at the last check Monday.
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</ul>
Photo Marcus Krauss via Shutterstock

Earnings

Guidance

Management

BNTX

BioNTech Appoints Novartis Executive As Finance Chief, Reaffirms 2025 Outlook Focusing on Oncology Expansion

Humana Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>) on Wednesday posted a first-quarter adjusted EPS of $11.58, up from $7.23 a year ago,&nbsp;beating the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $10.07</a>.
Humana sales increased from $29.6 billion to $32.11 billion, slightly missing the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b45093637/humana-reports-first-quarter-2025-financial-results-affirms-full-year-2025-adjusted-financial-guid" rel="noreferrer noopener">consensus of $32.22 billion</a>.
The revenue was driven by higher per-member Medicare and state-based contract premiums. The Medicare increase was primarily driven by an increased direct subsidy due to the Inflation Reduction Act (IRA) and membership growth in the company&#8217;s stand-alone PDP and state-based contracts businesses.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44927473/despite-medicaid-pressure-elevance-health-delivers-strong-q1-performance-reiterates-profit-outlook" rel="noreferrer noopener">Despite Medicaid Pressure, Elevance Health Delivers Strong Q1 Performance, Reiterates Profit Outlook</a>
Humana&nbsp;ended the first quarter with 14.84 million in total medical membership, down from 16.35 million in December 2024 and 16.17 million in March 2024. Individual Medicare Advantage membership&nbsp;<a target="_blank" href="https://humana.gcs-web.com/static-files/ef339ddf-83f9-4333-8f2d-4f97fe1e4bcb" rel="noreferrer noopener">reached</a> 5.22 million, down from 5.55 million a year ago.
1Q25 Insurance segment benefit ratio of 87.4% aligns with the previously disclosed expectation of approximately 87.5%.
In its prepared remarks, the company <a target="_blank" href="https://humana.gcs-web.com/static-files/04e1ec5b-ef37-44fc-bf21-0b5d2d6ac304" rel="noreferrer noopener">said</a>, &#8220;We are pleased with a solid start to 2025. Our first quarter Insurance segment benefit ratio of 87.4% reflects medical cost trends that developed in line with our expectations.&#8221;
The company states, &#8220;We remain committed to achieving an individual Medicare Advantage (MA) pretax margin of &#8216;at least 3%&#8217; over time and remain confident in our expectation that our 2025 MA pricing will drive the intended underlying margin improvement.&#8221;
Guidance: Humana expects 2025 GAAP sales of $126 billion-$128 billion versus the <a target="_blank" href="https://www.benzinga.com/25/02/43621782/insurance-giant-humanas-q4-earnings-at-par-with-estimates-2025-profit-outlook-falls-below-street-view" rel="noreferrer noopener">consensus of $126.21 billion</a>.
Sales guidance includes insurance segment sales of $121 billion—$123 billion and center-well segment sales of $20.5 billion—$21.5 billion.
The company said CenterWell Pharmacy was selected as the fulfillment pharmacy for NovoCare Pharmacy, operated by Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) weight loss medication for cash-pay customers.
The insurer expects an annual membership decline of approximately 550,000 for individual Medicare Advantage, including the company&#8217;s decision to exit certain unprofitable plans and counties. Group Medicare Advantage will remain relatively flat, and Medicare stand-alone PDP growth will be approximately 200,000.
Humana reaffirms the 2025 adjusted EPS outlook of $16.25 versus the consensus of $16.35.
For 2025, Humana expects its insurance segment&#8217;s benefit ratio guidance of approximately 90.1-90.5%.
The company added, &#8220;Looking ahead, the 2026 final MA rate notice better reflects the medical cost trend environment and should enable greater stability within the industry as it serves the 34 million seniors who rely on the MA program.&#8221;
Price Action: HUM stock is down 0.80% at $257.28 at the last check on Wednesday.
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Photo by T. Schneider via Shutterstock

Humana Does Not Alter 2025 Outlook Despite Sales Miss And Medicare Membership Decline

Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) agreed to acquire Regulus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGLS#NASDAQ">RGLS</a>) on Wednesday for an initial payment of $7.00 per share in <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">cash or $0.8 billion</a>.
The upfront cash portion of the consideration represents a premium of 274% to Regulus&#8217; 60-day volume-weighted average stock price and 108% to Regulus&#8217; closing <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n45095629/regulus-therapeutics-enters-into-agreement-to-be-acquired-by-novartis-ag" rel="noreferrer noopener">price on&nbsp;April 29, 2025</a>.
Regulus is a clinical-stage biopharmaceutical company developing microRNA therapeutics for severe renal disease and autosomal dominant polycystic kidney disease (ADPKD).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/45075714/novartis-q1-earnings-beat-street-view-ceo-confident-to-deliver-upgraded-2025-guidance" rel="noreferrer noopener">Novartis Q1 Earnings Beat Street View, CEO &#8216;Confident&#8217; In Delivering Upgraded Guidance</a>
The lead asset for ADPKD, farabursen, is a novel, next-generation oligonucleotide targeting miR-17 that recently completed a Phase 1b multiple-ascending dose clinical trial.
In addition, Regulus shareholders will receive a contingent value right (CVR) providing for payment of&nbsp;$7.00&nbsp;per share, contingent upon the achievement of a milestone regarding the regulatory approval of Regulus&#8217; lead product candidate, farabursen.
If the milestone is achieved, total consideration, including the CVR, would be approximately&nbsp;$1.7 billion.
The transaction is expected to close in the second half of 2025. Regulus will continue to operate as a separate and independent company.
In March, Regulus Therapeutics released topline results from all patients in the fourth cohort in its Phase&nbsp;1b&nbsp;MAD study of farabursen <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44519887/regulus-therapeutics-stock-shoots-higher-after-positive-results-from-investigational-drug-for-rare-type-of-kidney-disease" rel="noreferrer noopener">(RGLS8429) for ADPKD</a>.
Cohort 4 data highlights:
<ul>
<li>Increases in urinary PC1 and PC2 levels were similar to cohort 3 and reached a similar level of statistical significance compared to placebo (PC1 p=0.026; PC2 p=0.014).</li>
<li>The mean htTKV growth rate over 4 months was 0.05%, while placebo subjects in the trial experienced a mean growth rate of 2.58%.</li>
<li>Changes in htTKV were highly correlated with changes in renal cyst volume, suggesting farabursen directly impacts disease progression by limiting abnormal cyst growth.</li>
</ul>
Novartis strengthened its kidney disease portfolio after the U.S. Food and Drug Administration (FDA) granted accelerated approval for&nbsp;Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44631273/novartis-secures-third-fda-approval-for-its-kidney-disease-portfolio-in-one-year" rel="noreferrer noopener">rapid disease progression</a>.
This is Novartis' third U.S. approval for its kidney disease portfolio in the last year. Fabhalta&nbsp;was granted FDA approval in&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44544720/fda-oks-novartis-prostate-cancer-treatment-triples-eligible-patient-pool" rel="noreferrer noopener">C3 glomerulopathy in&nbsp;March 2025</a>&nbsp;and accelerated approval in&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40254535/fda-approves-expanded-use-of-novartis-rare-disease-drug-fabhalta-for-kidney-disease" rel="noreferrer noopener">IgAN in&nbsp;August 2024</a>.
Price Action: RGLS stock is up 132.9% at $7.85 during the premarket session at the last check Wednesday.
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Novartis To Buy US Kidney Drug Developer Regulus Therapeutics For Around $800 Million

Regulus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGLS#NASDAQ">RGLS</a>), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that it has entered into an agreement and plan of merger with Novartis AG ("Novartis") and an indirectly wholly owned subsidiary of Novartis, pursuant to which Novartis will acquire Regulus for an initial payment of $7.00 per share in cash at closing, or $0.8 billion. The upfront cash portion of the consideration represents a premium of 274 percent to Regulus' 60-day volume-weighted average stock price and 108 percent to Regulus' closing price on April 29, 2025. In addition, Regulus shareholders will receive a contingent value right (CVR) providing for payment of $7.00 per share, contingent upon the achievement of a milestone with respect to regulatory approval of Regulus' lead product candidate, farabursen. Total consideration including the CVR, if the milestone is achieved, would be approximately $1.7 billion. The transaction has been unanimously approved by the Boards of Directors of both companies.
Completion of the transaction is expected in the second half of 2025, subject to the satisfaction or waiver of customary closing conditions, including the tender of shares representing at least a majority of the total number of Regulus' outstanding shares, and other customary closing conditions and regulatory clearance. Until that time, Regulus will continue to operate as a separate and independent company.
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Novartis To Buy Regulus Therapeutics For $7.00/Shr In Cash, With Potential To Receive Addl $7.00/Shr In Cash Through Contingent Value Right, For Total Equity Value Of Up To About $1.7B

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