Ultime notizie per Roche Holding (OTC:RHHBY) Azioni

Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and 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>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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</ul>
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Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

On Wednesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to &lt;18 years with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">spinal muscular atrophy (SMA)</a>.
In the Phase 3 STEER study, <a target="_blank" href="https://www.novartis.com/news/media-releases/new-novartis-phase-iii-data-demonstrate-meaningful-efficacy-and-safety-results-intrathecal-onasemnogene-abeparvovec-broad-patient-population-sma" rel="noreferrer noopener">treatment</a> with OAV101 IT led to a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded (HFMSE), an assessment of motor ability and disease progression, vs. 0.51 points in the sham control arm.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43629559/novartis-to-beef-up-heart-disease-offering-with-3-billion-blackstone-backed-anthos-therapeutics-deal" rel="noreferrer noopener">Novartis To Beef Up Heart Disease Offering With $3 Billion Blackstone-Backed Anthos Therapeutics Deal</a>
Novartis <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-intrathecal-onasemnogene-abeparvovec-phase-iii-study-meets-primary-endpoint-children-and-young-adults-sma" rel="noreferrer noopener">released</a> topline data from the Phase 3 STEER study in December 2024.
In the Phase 3b STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Spinraza (nusinersen) or Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Evrysdi (risdiplam) demonstrated stabilization of motor function over 52 weeks of follow-up.
The results add to the growing body of evidence within the OAV101 IT development program, which has evaluated a broad population of over 170 patients with SMA, spanning a total of over 6.4 years across the STEER, STRENGTH, and Phase 1/2 STRONG studies.
OAV101 IT is an investigational gene replacement therapy designed to directly address the genetic root cause of the disease by replacing the nonworking&nbsp;SMN1 gene with a single dose.
In the registrational STEER study, efficacy and safety were studied in treatment naïve patients with SMA Type 2, aged two to less than 18 years, who could sit but had never walked independently. Key findings:
<ul>
<li>The trial met its primary endpoint of change from baseline to 52 weeks in HFMSE score, with OAV101 IT demonstrating a statistically significant 2.39-point improvement on the HFMSE vs 0.51 points in the sham group.</li>
<li>All secondary endpoints consistently favor OAV101 IT, despite not achieving statistical significance due to the pre-planned multiple testing procedure.</li>
</ul>
The open-label Phase 3b STRENGTH study evaluated the safety, tolerability and efficacy of OAV101 IT in patients with SMA aged two to less than 18 years who had discontinued treatment with nusinersen or risdiplam.&nbsp;Key findings:
<ul>
<li>OAV101 IT demonstrated a favorable safety profile that was consistent with the STEER study.</li>
<li>The motor endpoint of efficacy, HFMSE, demonstrated stabilization for the overall study population over 52 weeks. The increase from baseline to 52 weeks in HFMSE least squares (LS) total score was 1.05.</li>
</ul>
Price Action: NVS stock is down 0.75% at $111.38 at the last check Wednesday.
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Novartis New Data From Single-Dose Gene Therapy Shows Meaningful Efficacy, Safety In Patients With Spinal Muscular Atrophy

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) confirmed a licensing agreement with Zealand Pharma on Wednesday that will see the two companies <a href="https://www.benzinga.com/topic/weight-loss">co-develop petrelintide</a>.
Petrelintide is Zealand Pharma's amylin analog. It&#8217;s currently in phase 2 clinical development.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41097630/roche-fast-tracks-obesity-drug-development-eyes-over-3b-sales-potential" rel="noreferrer noopener">Roche Fast-Tracks Obesity Drug Development, Eyes Over $3B Sales Potential</a>
Combining petrelintide with Roche's dual GLP-1/GIP receptor agonist CT-388 will further strengthen Roche's pipeline in cardiovascular, renal, and metabolic (CVRM) diseases.
As a part of the <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2025-03-12" rel="noreferrer noopener">agreement</a>, Zealand Pharma and Roche will co-commercialize petrelintide in the U.S. and Europe.
Roche will obtain exclusive rights to commercialization in the rest of the world and be responsible for commercial manufacturing and supply.
Zealand Pharma will receive upfront cash payments of $1.65 billion. This includes $1.4 billion due upon closing, and $250 million over the first two anniversaries of the collaboration.
Zealand Pharma is also eligible for development milestones of $1.2 billion primarily linked to initiation of Phase 3 trials with petrelintide monotherapy and sales-based milestones of $2.4 billion, for a total consideration of up to $5.3 billion to Zealand Pharma.
Profits and losses for petrelintide and petrelintide/CT-388 will be shared on a 50/50 basis in the U.S. and Europe, and Zealand Pharma is eligible to receive tiered double-digit royalties up to high teens % royalties on net sales in the rest of the world.
Zealand Pharma will pay Roche $350 million, offsettable against milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products being pursued under the collaboration agreement.
The transaction is expected to close in the second quarter. 
In December 2023, Roche acquired a privately held obesity company, Carmot Therapeutics, for $2.7 billion in cash. Additionally, Carmot's equity holders are entitled to receive payments of up to $400 million depending on <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36064233/roche-joins-bandwagon-to-challenge-novo-nordisk-eli-lilly-for-weight-loss-drugs" rel="noreferrer noopener">achieving certain milestones</a>.&nbsp;
Price Action: RHHBY stock is up 5.55% at $44.33 during the premarket session at the last check Wednesday.
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Contracts

Roche Further Boosts Obesity Pipeline With Zealand Pharma Deal Worth $5.3 Billion For Weight Loss Drugs

Zealand Pharma and Roche enter collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity
<ul>
<li>The companies will co-develop and co-commercialize petrelintide monotherapy and potential combination products, including petrelintide/CT-388, in the U.S. and Europe</li>
<li>Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due at closing and USD 250 million in anniversary payments over two years, as well as potential milestone payments, for a total consideration of up to USD 5.3 billion</li>
<li>Profits and losses will be shared on a 50/50 basis for petrelintide and petrelintide/CT-388 in the U.S. and Europe, and Zealand Pharma is eligible to royalties on net sales in the rest of the world</li>
<li>Zealand Pharma will pay Roche USD 350 million for the contribution of CT-388 in the first combination product arising from the collaboration</li>
<li>Collaboration and license agreement aims to unlock the full value of petrelintide, redefining the standard of care for people with overweight and obesity by establishing the leading amylin-based franchise</li>
<li>Zealand Pharma will host a conference call today March 12 at 1pm CET / 8am ET to discuss the agreement</li>
</ul>

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RHHVF

Zealand Pharma Secures $1.65B Upfront In Strategic Collaboration With Roche To Advance Petrelintide For Obesity And Metabolic Disorders

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva&#xAE; (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard therapy alone.The FDA is expected to make a decision on approval by October 2025.

Regulations

Genentech's Gazyva Moves Closer to FDA Approval for Lupus Nephritis After Positive Phase III Trial

– TNKase&#xAE; (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years –
– Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care –
– Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase&#xAE; (alteplase)–
Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase&#xAE; (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech's second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase&#xAE; (alteplase).
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.

FDA Approves Genentech's TNKase In Acute Ischemic Stroke In Adults

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) released data Sunday on its Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH study for Xolair (omalizumab) for one or more food allergies.
Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.
<ul>
<li>In the first head-to-head trial comparing Xolair to OIT, the <a href="https://www.roche.com/media/releases/med-cor-2025-03-02" target="_blank" rel="noreferrer noopener">study</a> met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group.</li>
<li>These findings were largely driven by the high rates of adverse events (AEs) in the OIT group.</li>
<li>Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%), and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient&#8217;s diet after stopping Xolair.
Stage 3 is ongoing, and study investigators continue to analyze data from additional patients who completed Stage 2 and then entered Stage 3.
In the US, Genentech, a member of the Roche Group, and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) are co-developing and co-promoting Xolair.
Last February, the FDA approved Xolair for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older <a target="_blank" href="https://www.benzinga.com/pressreleases/24/02/b37182116/fda-approves-xolair-as-first-and-only-medicine-for-children-and-adults-with-one-or-more-food-aller" rel="noreferrer noopener">with IgE-mediated food allergy</a>.
Price Action: RHHBY stock closed at $41.74 on Friday.
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Roche Touts Food Allergy Drug As Superior Than Oral Immunotherapy

– First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) –
– Results were featured as late-breakers at the 2025 AAAAI Annual Meeting –
– Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies –

Reported Sunday, Roche's Genentech Phase III Study Finds Xolair More Effective And Safer Than Oral Immunotherapy For Food Allergies

DRIO

Hims & Hers Health, Inc. Class A Common Stock

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FDA Says Novo Nordisk's Ozempic Injection .68 mg/1 ml, Injection 1.34 mg/1 ml, Injection 2.68 Mg/1 ml Available As Of Feb 21; Novo Nordisk's Wegovy, Injection, 1.7 mg/.75 ml , Wegovy, Injection, 2.4 mg/.75 ml Now Available; FDA Says Semaglutide Injection Shortage Is Resolved As Of Feb 21

Roche Group Announced Detailed Analysis Of Its Phase III Regency Trial Of Gazyva (Obinutuzumab) In People With Active Lupus Nephritis - Company Says Trial Demonstrated Statistically Significant Improvement In Primary Endpoint Of Complete Renal Response

<ul>
<li>As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.</li>
<li>The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022,&nbsp; is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.</li>
<li>HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment.</li>
</ul>
Basel, 31 January 2025 - Roche ((SIX: RO, ROG, OTCQX:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY&#xAE; anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody&#x2A; to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU&#xAE;. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
Until the introduction of HER2-low status in 2022, HER2 status was categorised as either "positive" or "negative" based on the level of HER2 expression. The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as "HER2-ultralow." HER2-ultralow refers to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category.

Roche Receives FDA Approval For The First Companion Diagnostic To Identify Patients With Her2-Ultralow Metastatic Breast Cancer Eligible For ENHERTU

For 2025, the company expects mid-single-digit sales growth and high-single-digit core EPS growth, with a further increase in dividends in Swiss francs.

Earnings

Guidance

Roche For 2025 Expects Mid-Single-Digit Sales Growth And High-Single-Digit Core EPS Growth

Roche's Q4 Adj. EPS CHF18.80 Up From CHF18.57 YoY, Sales CHF60.49B Up From CHF58.72B YoY

Piper Sandler analyst David Amsellem reiterated the Overweight rating on Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) <a href="https://www.benzinga.com/quote/TEVA/analyst-ratings">with a price forecast of $30.</a>
Amsellem writes that he hosted a call with a top gastroenterologist who treats many ulcerative colitis and Crohn&#8217;s disease patients. The doctor specializes in managing treatment-experienced and refractory cases at a major referral center.
From the call, the analyst notes that feedback on Teva's/Sanofi's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) anti-TL1A antagonist duvakitug, along with the broader anti-TL1A class, suggests these agents could play a significant role in treating both ulcerative colitis and Crohn&#8217;s disease, which is supported by competitive data.
Amsellem highlights that according to the featured expert, biomarkers are crucial, and they are particularly interested in studies/data stratified by biomarkers.
The analyst will closely follow what Teva shares on this at the upcoming ECCO meeting.
Both Merck &amp; Company, Inc. and Roche Holding Ltd are also stratifying their anti-TL1A studies by biomarkers.
The expert considers that biomarkers could greatly benefit the broader inflammatory bowel disease (IBD) field if they are easy to assess and help predict clinical response.
While Teva/Sanofi&#8217;s all-comers Phase III program for duvakitug is commercially reasonable, the goal is to address a wide ulcerative colitis and Crohn&#8217;s disease patient audience.
Price Action: TEVA shares are trading lower by 1.47% to $21.46 at last check Tuesday.
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TEVA

Teva's Duvakitug Set To Shake Up IBD Treatment, Analyst Highlights Competitive Data

– Updated overall survival (OS) results – a key secondary endpoint – reinforce the significant benefit of the ItovebiTM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting –
– Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population –
– Full OS results from the Phase III INAVO120 study will be presented at an upcoming medical meeting –

Roche's Genentech Reports Significant Survival Benefit With Itovebi In Advanced HR-Positive Breast Cancer Patients

On Monday, Sarepta Therapeutics Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) released topline results from Part 2 of EMBARK (Study SRP-9001-301) Phase 3 clinical study of Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with <a target="_blank" href="https://www.benzinga.com/quote/SRPT" rel="noreferrer noopener">Duchenne muscular dystrophy</a>.
Crossover-treated patients who received a placebo in Part 1, crossed over at 52 weeks and were treated with Elevidys in Part 2 improved 2.34 points from baseline compared to matched external controls on the North Star Ambulatory Assessment (NSAA) 52 weeks after treatment. NSAA measures functional motor abilities in <a href="https://www.benzinga.com/pressreleases/25/01/b43220537/sarepta-therapeutics-announces-results-from-part-2-of-the-embark-study-demonstrating-sustained-ben" target="_blank" rel="noreferrer noopener">children with Duchenne</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42883730/solid-biosciences-outpaces-competitors-in-duchenne-gene-therapy-development" rel="noreferrer noopener">Solid Biosciences Outpaces Competitors In Duchenne Gene Therapy Development</a>
Despite being one year older (average age 7.18 years) than those treated in Part 1 (average age 5.98 years), crossover-treated patients showed clinically meaningful and statistically significant functional benefit for NSAA, Time to Rise (TTR) and 10-meter walk/run (10MWR) function tests compared with a pre-specified, propensity-weighted external control group (EC).
Individuals treated in part one of EMBARK (n=63) showed clinically meaningful and statistically significant improvements on the NSAA sustained two years after treatment with Elevidys. Functional motor improvements include:
<ul>
<li>+2.88 points (improvement) on NSAA.</li>
<li>-2.06 seconds (improvement) on Time to Rise.</li>
<li>-1.36 seconds (improvement) on 10MWR.</li>
</ul>
Muscle biopsies from a subset of patients taken 64 weeks after dosing in part one showed consistent and sustained expression of micro-dystrophin. Muscle pathology on MRI continues to show minimal progression in underlying muscle pathology and remains highly consistent with the functional benefits shown.
No new safety signals were observed.
As part of a collaboration agreement signed in 2019, Sarepta is working with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>). Sarepta is responsible for regulatory approval and commercializing Elevidys in the U.S. and manufacturing.
Roche is responsible for regulatory approvals and bringing Elevidys to patients across the rest of the world.
Price Action: SRPT stock closed at $116.46 on Friday.
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SRPT

Sarepta Therapeutics' Duchenne Gene Therapy Shows Sustained Benefits And Disease Stabilization At Two Years

In states where both medical and recreational marijuana are legal, patients are filling fewer prescriptions for medications commonly used <a href="https://www.benzinga.com/topic/anxiety">to treat anxiety</a>, according to a recent study published in JAMA Network Open.
The findings consistently showed that increased access to marijuana correlates with reductions in benzodiazepine prescription fills, which refer to the number of prescriptions picked up by patients, not the number written by doctors. 
Lead <a href="https://spp.gatech.edu/people/person/ashley-bradford">author</a> Ashley Bradford, PhD, of the Georgia Institute of Technology, <a href="https://www.painnewsnetwork.org/stories/2025/1/19/prescriptions-for-anti-anxiety-meds-decline-in-states-where-marijuana-is-legal#google_vignette">noted</a> that the research is particularly relevant given that nearly 23% of U.S. adults reported having a diagnosable mental health disorder in 2021, but only 65% of them received treatment.
Expanding cannabis access offers an alternative treatment avenue, especially as many <a href="https://www.benzinga.com/cannabis/laws">state medical marijuana laws</a> allow patients with mental health conditions like post-traumatic stress disorder (PTSD) to use medical cannabis. The Food and Drug Administration <a href="https://www.benzinga.com/24/11/42100354/fda-approves-cannabis-trial-for-veterans-with-ptsd-after-years-of-delays">approved a clinical trial in November 2024</a> to assess the efficacy of smoked medical marijuana in treating PTSD among military veterans.
The <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2823248?resultClick=3">findings</a> have significant implications for insurance providers, prescribers, patients and pharmaceutical companies that produce benzodiazepines, which, like opioids, carry risks. In 2020, benzodiazepines contributed to 14% of total opioid overdose deaths, said Bradford, who added that the substitution of marijuana for medications with high misuse potential could also have far-reaching public health benefits.
<h2 class="wp-block-heading">Could Cannabis For Anxiety Cut Into Big Pharma's Bottom Line?</h2>
Bradford&#8217;s research focused on medications like Valium, Xanax and Ativan, which are brand names for diazepam, alprazolam and lorazepam, respectively. Xanax and Lorazepam are produced by Pfizer, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Wyeth Pharmaceuticals, which <a href="https://www.investopedia.com/companies-owned-by-pfizer-5211303">Pfizer acquired in 2009</a>.
The most common drug, Valium, produced by the Hoffmann-La Roche pharmaceutical company – now <a href="https://www.benzinga.com/24/12/42721437/roche-ceo-reassures-no-job-cuts-despite-drug-development-challenges-reports">Roche Holdings</a> (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) &nbsp;&#8211; was introduced in 1963 and gained popularity as a sedative almost immediately. Between 1969 and 1982, "Mother's Little Helper" as the Rolling Stones called it in their 1966 hit song, Valium was the <a href="https://drugabuse.com/benzodiazepines/valium/history-and-statistics/">most prescribed drug in the US</a>. Sales peaked in 1978 with more than 2.3 billion pills sold that year. 
Roche, with a market value of $244.27 billion, is among the <a href="https://www.visualcapitalist.com/cp/worlds-50-largest-pharmaceutical-companies/">largest pharmaceutical companies</a> in the world.
According to <a href="https://my.clevelandclinic.org/health/treatments/24570-benzodiazepines-benzos">the</a> Cleveland Clinic, benzodiazepines are still among the most commonly prescribed medications and are notably &#8220;habit-forming.&#8221; 
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Photo: Shutterstock

Cannabis

Legal Marijuana Linked To Drop In Anxiety Medications: What It Means For Pharma Giants

On Thursday, Outlook Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g43023003/outlook-therapeutics-announces-complete-twelve-week-efficacy-and-safety-results-of-norse-eight-cli" rel="noreferrer noopener">degeneration (wet AMD) patients</a>.
ONS-5010 demonstrated non-inferiority to 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>) Lucentis (ranibizumab) at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.
The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37893076/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-higher-on-friday" rel="noreferrer noopener">Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?</a>
BCVA measures how well a person can see after wearing corrective lenses, such as glasses or contact lenses.
In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. <a target="_blank" href="https://www.benzinga.com/24/11/42214804/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Food and Drug Administration (FDA)</a>.
However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.
Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab.
ONS-5010/LYTENAVA (bevacizumab gamma) has been approved in the European Union and the United Kingdom. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.
The company also entered into agreements for warrant inducement transactions expected to result in up to $20.4 million in gross proceeds.
The company will use the proceeds to fund its ONS-5010 clinical development programs, the European commercial launch of LYTENAVA, and working capital and general corporate purposes.
Price Action: OTLK stock is down 9.78% at $2.06 at last check Thursday.
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Financing

Offerings

OTLK

Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug

<ul>
<li>The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2</li>
<li>The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients.</li>
<li>B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.3</li>
</ul>

Roche's VENTANA ISH Test Secures FDA Clearance For Accurate B-Cell Lymphoma Diagnosis

<ul>
<li>The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. &nbsp;</li>
<li>This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. &nbsp;</li>
<li>Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.</li>
</ul>

Roche's Digital Pathology Dx System Expands With FDA Approval Of High-Capacity VENTANA DP 600 Scanner

Small Cap

Press Releases

Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma

Dyno Therapeutics Announces Exercise of Option by Roche for Next-Generation AAV Vector for Neurological Gene Therapy

Genentech's Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer

FDA Approves Genentech's Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness

New England Journal of Medicine Publishes New Data for Genentech's Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis

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