Dr Reddy's Laboratories Azioni (NYSE: RDY)

Ultime notizie per Dr Reddy's Laboratories (NYSE:RDY) Azioni

Dr Reddy's Laboratories

Dr. Reddy's is one of the largest generic drug manufacturers in the world. It has a significant presence in North America, a region that makes up roughly half of its generics sales, and it services India (about 20% of its generics sales), Russia (10%), and certain European and Latin American countries. Beyond simple generics, Dr. Reddy's also has a solid portfolio of injectables which make up 25% of its North America sales. In branded generic markets like India, Dr. Reddy's has established a compelling presence with its strong brand name and earned a top five spot in key therapeutic areas including oncology and gastroenterology. Dr. Reddy's also has an active pharmaceutical ingredient business that manufactures over 150 APIs and sells in over 75 countries.

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories Ltd

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Dr. Reddy's Laboratories shares are trading hgher on possible continued strength after reporting better-than-expected Q4 financial results on Friday.

Dr Reddy's Laboratories (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) reported quarterly earnings of $0.22 per share which beat the analyst consensus estimate of $0.20 by 10 percent. This is a 22.22 percent increase over earnings of $0.18 per share from the same period last year. The company reported quarterly sales of $996.00 million which beat the analyst consensus estimate of $866.51 million by 14.94 percent. This is a 20.14 percent increase over sales of $829.00 million the same period last year.

Earnings

Earnings Beats

News

Dr Reddy's Laboratories Q4 EPS $0.22 Beats $0.20 Estimate, Sales $996.00M Beat $866.51M Estimate

Date: April 14, 2025&nbsp; National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)&nbsp; BSE Limited (Scrip Code: 500124)&nbsp; New York Stock Exchange Inc. (Stock Code: RDY)&nbsp; NSE IFSC Ltd (Stock Code: DRREDDY)&nbsp; Dear Sirs,&nbsp; Sub: Disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure&nbsp; Requirements) Regulations, 2015 – information on reported news item&nbsp; This is in reference to Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements)&nbsp; Regulations, 2015 ("SEBI Listing Regulations") regarding a news item published in Business Standard&nbsp; (newspaper/ media) on April 13, 2025, with the heading "DRL trims workforce costs by 25% amid&nbsp; Revlimid-linked margin strain".&nbsp; We wish to clarify that the said news is factually incorrect. We categorically deny the claim of a 25%&nbsp; workforce cost reduction and the other claims mentioned in the said news article.&nbsp; In this regard, please note that the Company does not comment on market speculations and there is&nbsp; currently no such event or information which requires a disclosure under Regulation 30 of the SEBI&nbsp; Listing Regulations.&nbsp; In compliance with Regulation 30 of the SEBI Listing Regulations, the Company makes prompt&nbsp; disclosure of any event or information, as and when any event or information is considered material or&nbsp; warrants such disclosure under the said Regulation.&nbsp; This is for your information.&nbsp; Thanking you.&nbsp; Yours faithfully,&nbsp; For Dr. Reddy's Laboratories Limited&nbsp; K Randhir Singh&nbsp; Company Secretary, Compliance Officer and Head-CSR&nbsp; Dr. Reddy's Laboratories Ltd.&nbsp; 8-2-337, Road No. 3, Banjara Hills&nbsp; Hyderabad – 500 034, Telangana, India&nbsp; &nbsp;

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Dr. Reddy's Denies Report Of 25% Workforce Cost Cut, Calls News Factually Incorrect And Confirms No Disclosure-Worthy Event Under SEBI Regulations

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;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>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
Read Next:
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Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy's&nbsp;will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy's will also receive the exclusive commercial rights to BAT2206 in Colombia.

Contracts

Bio-Thera And Dr. Reddy's Reach Exclusive Commercialization Agreement For BAT2206

ALVO

Alvotech And Dr. Reddy's Announce FDA Acceptance Of Biologic License Application For AVT03

Dr. Reddy's Laboratories Subsidiary Announced That It Has Entered Into A License Agreement With Shanghai Henlius Biotech, Inc. Related To The Development And Commercialization Of HLX15, Henlius's Investigational Daratumumab Biosimilar Candidate To Darzalex & Darzalex Faspro

Shanghai Henlius Biotech Enters License Agreement With Dr. Reddy's Laboratories  For HLX15 Expansion In Europe And US

On Thursday, Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) stock is trading lower after the company released third-quarter 2025 earnings.
The pharma company clocked a net income of $165 million, marginally up from $161 million a year ago. Revenue increased from $843 million to $977 million — almost a 16% jump.
The <a target="_blank" href="https://www.drreddys.com/cms/cms/sites/default/files/2025-01/Earnings%20Release_Q3FY25_230125_Final_1.pdf" rel="noreferrer noopener">growth</a> was largely driven by revenues from the recently acquired Nicotine Replacement Therapy (NRT) portfolio, as well as revenues from India and Emerging Markets.
Last year, Haleon plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>) sold its&nbsp;nicotine replacement therapy&nbsp;business outside of the U.S. to&nbsp;Dr. Reddy's Laboratories SA, a wholly owned subsidiary of&nbsp;Dr. Reddy's Laboratories Limited for 500 million pounds (<a target="_blank" href="https://www.benzinga.com/news/large-cap/24/06/39506878/haleon-to-offload-non-core-nicotine-therapy-business-to-dr-reddys-for-over-600m" rel="noreferrer noopener">around $632 million</a>).
The NRT portfolio consists of brands such as Nicotinell, Nicabate, Habitrol, and Thrive, which are available in gum, lozenge, and patch forms across over 30 markets.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/01/42819611/cvs-health-aetna-files-lawsuit-against-drugmakers-for-alleged-inflated-generic-drug-prices" rel="noreferrer noopener">CVS Health's Aetna Files Lawsuit Against Drugmakers For Alleged Inflated Generic Drug Prices</a>
"We delivered double-digit growth aided by our newly acquired NRT business, new launches, and improved operational efficiencies," Co-Chairman &amp; MD, G V Prasad, said.
Global generics revenues reached $850 million (73.75 billion rupees), showing a 17% year-over-year growth; underlying growth excluding NRT is 7%. Revenues from the acquired NRT portfolio, higher volumes and new product launches largely drove growth.
North American sales increased 1% (a sequential decline of 9%) to 33.8 billion rupees. Volume growth coupled with new product launches and favorable forex was offset by price erosion on a YoY basis. The sequential decline was largely due to lower sales of certain products, including Lenalidomide.
Gross Margin at 58.7% (GG: 61.3%, PSAI: 28.6%), a YoY increase of 20 basis points (bps), and a QoQ decline of 91 bps. The YoY increase was primarily due to a favorable product mix and manufacturing overhead leverage, which was partly offset by price erosion. Sequentially, the decline was primarily due to an unfavorable product mix.
Price Action:&nbsp;RDY stock is down 5.80% at $14.22 at the last check on Thursday.
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Photo by David Pimborough via Shutterstock

Dr Reddy's Laboratories Q3 Earnings: Double-Digit Growth Aided By Newly Acquired Nicotine Replacement Business

Dr. Reddy's Laboratories shares are trading lower. The company reported Q3 financial results.

Dr Reddy's Laboratories Q3 2025 GAAP EPS $0.20 Versus $0.19 YoY, Sales $977.00M Compared To $843M YoY

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This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Earnings Scheduled For January 23, 2025

CVS Health Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) subsidiary, Aetna Inc., has filed a lawsuit against more than 20 generic drug manufacturers. The lawsuit alleges a coordinated scheme to fix prices, <a href="https://www.benzinga.com/topic/drug-prices">allocate markets, and stifle competition</a>.
The result was a significant overcharge for essential medications.
Defendants include Teva Pharmaceutical Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>), Amneal Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMRX#NASDAQ">AMRX</a>), Dr. Reddy&#8217;s Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</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>), Viatris, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTRS#NASDAQ">VTRS</a>), among others.
The <a target="_blank" href="https://civilinquiry.jud.ct.gov/DocumentInquiry/DocumentInquiry.aspx?DocumentNo=29056426" rel="noreferrer noopener">lawsuit</a> accuses the defendants of orchestrating one of the largest price-fixing conspiracies in U.S. history, causing inflated drug prices and widespread harm to consumers, insurers, and the healthcare system.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42600472/your-healthcare-costs-are-soaring-us-spending-reached-5-trillion-in-2023-with-major-increase-in-obesity-and-diabetes-drugs-hospital-services" rel="noreferrer noopener">Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services</a>
The lawsuit claims that these pharmaceutical companies colluded to artificially raise generic drug prices by as much as 2,762%.
Examples include clomipramine (2,600% increase), nadolol (+2,762%), and oxybutynin chloride (up to 1,500%).
Aetna alleges this conspiracy exploited market conditions, fostered cronyism, and suppressed competition, while depriving third-party payers like Aetna of expected cost savings.
According to the complaint, the defendants utilized secretive methods to implement their price-fixing strategies. These included in-person meetings, private phone calls, and strategic coordination during trade association events. Evidence of collusion was deliberately minimized, with written communications often destroyed to evade detection.
Central to the allegations is the so-called &#8220;fair share&#8221; system, which allocated market share and dictated price increases among competitors. This strategy, referred to as the &#8220;rules of engagement,&#8221; ensured that generic drugmakers avoided undercutting one another, thereby maintaining inflated prices. In some cases, competitors allegedly submitted cover bids to maintain an artificial equilibrium in the market.
The lawsuit highlights Teva Pharmaceuticals as an example of this practice, alleging the company collaborated with select &#8220;high-quality&#8221; competitors to lead and follow each other&#8217;s price hikes.
This agreement reportedly extended to various drugs, enabling the companies to dominate the market and secure extraordinary profits.
Aetna contends that the defendants&#8217; actions have severely impacted the U.S. healthcare system, driving up costs for insurers, consumers, and government programs like Medicare Part D.
The insurer is seeking treble damages and injunctive relief under state antitrust and unfair competition laws to recover losses and prevent future anticompetitive practices.
Price Action: CVS stock is up 2.31% at $46.85 at last check Monday.
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CVS Health's Aetna Files Lawsuit Against Drugmakers For Alleged Inflated Generic Drug Prices

<a href="https://www.bseindia.com/xml-data/corpfiling/AttachLive/79ff5f5f-81a0-4bb0-a2f0-b93541f1164e.pdf" title="https://www.bseindia.com/xml-data/corpfiling/AttachLive/79ff5f5f-81a0-4bb0-a2f0-b93541f1164e.pdf">https://www.bseindia.com/xml-data/corpfiling/AttachLive/79ff5f5f-81a0-4bb0-a2f0-b93541f1164e.pdf</a>

Dr. Reddy's Laboratories Forms New Subsidiary In Finland, 'Dr. Reddy's Finland Oy', As Step-Down Wholly-Owned Entity

These ten large-cap stocks were the best performers in the last week. Are they in your portfolio?
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<li>Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) stock escalated 33.88% after the company and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced that primary endpoints were met in the Phase 2b trial of Duvakitug for <a href="https://www.benzinga.com//node/42531132" target="_blank" rel="noreferrer noopener">ulcerative colitis and Crohn&#8217;s disease</a>.</li>
<li>Klaviyo, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KVYO#NYSE">KVYO</a>) shares surged 12.85%.</li>
<li>Olive Garden parent Darden Restaurants, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DRI#NYSE">DRI</a>) stock rose 12.54% after the company reported better-than-expected second-quarter EPS and <a href="https://www.benzinga.com//node/42585797" target="_blank" rel="noreferrer noopener">issued an FY25 revenue outlook</a>. Several analysts raised the <a href="https://www.benzinga.com/quote/dri/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast on the stock</a>.</li>
<li>Doximity, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DOCS#NYSE">DOCS</a>) shares upped 10.91%. Stephens &amp; Co. initiated coverage with an Equal-Weight rating and <a href="https://www.benzinga.com/quote/docs/analyst-ratings" target="_blank" rel="noreferrer noopener">a price forecast of $55</a>.</li>
<li>Birkenstock Holding plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIRK#NYSE">BIRK</a>) shares increased 9.70% after the company reported better-than-expected fourth-quarter financial results and issued FY25 guidance. Several analysts raised <a href="https://www.benzinga.com//node/42599431" target="_blank" rel="noreferrer noopener">the price forecast on the stock</a>.</li>
<li>Jabil Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JBL#NYSE">JBL</a>) stock upped 7.30% after the company reported better-than-expected <a href="https://www.benzinga.com//node/42553094" target="_blank" rel="noreferrer noopener">first-quarter EPS and revenues</a>. Several analysts raised <a href="https://www.benzinga.com/quote/jbl/analyst-ratings" target="_blank" rel="noreferrer noopener">the price forecast on the stock</a>.</li>
<li>Neurocrine Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NBIX#NASDAQ">NBIX</a>) stock rose 6.88%. The FDA approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with <a href="https://www.benzinga.com//node/42508449" target="_blank" rel="noreferrer noopener">classic congenital adrenal hyperplasia (CAH).</a></li>
<li>GameStop Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GME#NYSE">GME</a>) stock was up 6.54% last week, continuing strength from Q3 earnings.</li>
<li>Dr. Reddy&#8217;s Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) stock increased 6.29%.</li>
<li>Li Auto Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LI#NASDAQ">LI</a>) shares upped 6.13% last week.</li>
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Photo by Sundry Photography via Shutterstock

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Teva Pharmaceutical, Li Auto, And Darden Restaurants Are Among Top Large Cap Gainers Last Week (December 16-20): Are The Others In Your Portfolio?

<ul>
<li>Only immuno-oncology drug approved by various regulatory authorities around the world such as the USFDA, DCGI, EMA, MHRA, NMPA and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC)</li>
<li>Combination of Toripalimab and standard of care chemotherapy has shown a 48% reduction in risk of progression or death</li>
<li>Launched in India in the same year as its launch in the U.S., making India the third country in the world to receive access to this New Biological Entity (NBE)</li>
</ul>

Reported Thursday, Dr. Reddy's Introduces Toripalimab In India, Immuno-Oncology Drug Approved For The Treatment Of Nasopharyngeal Carcinoma

Dr. Reddy's Laboratories, Inc. and Senores Pharmaceuticals, Inc. today announced the launch of Ivermectin Tablets USP, 3 mg, which is bioequivalent and therapeutically equivalent to STROMECTOL&#xAE; Tablets of Merck Sharp and Dohme LLC in the U.S. market. The product will be marketed by Dr. Reddy's.

Dr. Reddy's Laboratories, Senores Pharmaceuticals Launch Ivermectin Tablets USP, 3 mg In US Market

Dear Fellow Stockholder,
Given my recent transition to the role of CEO, I wanted to share my thoughts on Coya and our future and to express my gratitude to our founder and Executive Chair, Dr. Howard Berman, whose bold vision has instilled the "innovation and get-it-done" culture in Coya's DNA. We have made tremendous strides in 2024, repeatedly executing on our promises. As I look to 2025, I am confident that our nimble and highly experienced team will continue to exceed expectations.
I have spent my entire 25-year career in the biotech space, and I believe that Coya has the most promise of any company that I have represented. I truly believe our novel science, strong clinical proof of concept data, pharmaceutical partnership validation, cash runway, and clear path to a commercial drug differentiates us. Prior to serving at Coya, I helped spearhead and lead pharmaceutical transactions worth billions of dollars that led to significant value creation. I believe the opportunities ahead of us in 2025 and beyond are what investors, stockholders, and patients should be most excited about. Our science and approach of regulating Tregs is now validated in multiple trials across multiple neurodegenerative diseases, we have a track record of executing value-creating non-dilutive deals, and our strong cash position allows us to be prudent in our decisions.
Year Ahead
We expect our activities in 2025 to be focused on the following indications:
ALS (Amyotrophic Lateral Sclerosis) Program: We have alignment with the FDA on the data required to initiate our potentially pivotal COYA 302 Phase 2 double-blind randomized study in patients with ALS. We are targeting the submission of the requested data package by 2Q 2025 and initiation of the clinical trial upon FDA clearance. The roadmap to topline results is now clear with reduced uncertainty. In late 2023, we partnered with Dr. Reddy's Laboratories, a multi-billion-dollar drug developer, to license COYA 302 in ALS in a deal that is worth up to $700 million. We still retain the rights to COYA 302 in ALS in Japan and South/Central America and Mexico, thus providing us direct upside and optionality in this indication alone.
FTD (Frontotemporal Dementia) Program: We expect to see topline results in 2H 2025 from the investigator-initiated, open-label study of Low Dose IL-2 (LD IL-2) + CTLA4-Ig in FTD. Study endpoints will measure safety, peripheral and central inflammation, FTD progression, and pharmacodynamic effects on Treg cell populations. The data are expected to guide our planned COYA 302 Phase 2 double-blind randomized study (which will be funded by the Alzheimer's Drug Discovery Foundation) and further optimize the design for success. The guidance from the FDA on the ALS IND reduces uncertainty on the planned IND filing for FTD in 2H of 2025. We have retained full commercial rights on this program thus far, providing us optionality to develop the program to BLA approval ourselves and capture the full potential upside or partner at a later stage once we obtain additional clinical data.
AD (Alzheimer's disease) Program: Complementing the promising data that was presented at CTAD in Madrid for LD IL-2 in mild to moderate AD, the investigators will disclose additional data in 1H 2025 that summarizes the changes in inflammation in the peripheral system (blood) and central nervous system (CSF and brain) and other molecular measurements for the two IL-2 dosing arms vs. placebo. These important data will help to further address the basic science associated with the promising clinical response observed in the lower dose IL-2 arm and its association with better Treg enhancement. We retain full rights to the AD indication for COYA 302 and are already in the process of exploring non-dilutive and strategic partnering opportunities. While the CTAD data was based on LD IL-2 alone and proved highly promising in and of itself, COYA 302, which is a proprietary combination of LD IL-2 and CTLA4-Ig, targets multiple pathways and is developed to more significantly and durably enhance Treg function, which we believe will be highly attractive to potential partners.
Strategic Partnerships
Dr. Reddy's Partnership: Our partnership with Dr. Reddy's Laboratories is approaching its one-year anniversary, and our collaboration could not be stronger. We have a reliable partner for ALS, and leveraging its resources and expertise has created value beyond the milestone payments. In 2025, we anticipate receiving $8.4 million upon initiation of the Phase 2 ALS clinical trial and will continue to evaluate opportunities to further deepen the relationship.
Other Strategic Possibilities: As I have described, my background is one of deal-making, and I intend to leverage my network and capabilities to maximize opportunities for Coya in 2025. We have only partnered COYA 302 in ALS, and the optionality to partner, co-develop, or license the asset in other indications exists. Any potential transaction will be evaluated based on maximizing stockholder value. The positive data from the investigator-initiated trial of LD IL-2 in patients with Alzheimer's disease increases our confidence in obtaining value-creating pharma partnerships that combine our proprietary LD IL-2, COYA 301, with other modalities. I can envision multiple opportunities with LD IL-2 serving as a backbone adjuvant with standard of care agents and other novel pathways.
Moreover, the opportunity for grant funding and financial support from foundations exists and will be vigorously pursued. We believe the data emerging on Tregs in autoimmune disease (such as lupus, rheumatoid arthritis, and scleroderma) and, in particular, treatment with LD IL-2 is compelling and may strengthen the role of COYA 302 and LD IL-2 combinations in this space. I intend to actively pursue partnerships in this arena that would further place us in a strong position to pursue value-creating deals.
Value-Creating Pipeline
Like many experts in the scientific community, we believe combination strategies are the future to address devastating neurodegenerative diseases. We believe targeting one mechanism or pathway is likely insufficient to achieve maximal effect - hence our approach with COYA 302. COYA 302 is a "Pipeline within a Product" and has strong potential in ALS, FTD, AD, Parkinson's disease, and other indications.
We are continuously building our intellectual property to further enhance the value of Coya. One recent development is the combination of COYA 301 and GLP-1 agonists. Data suggests that the mechanism of action appears additive and/or synergistic in ameliorating inflammation. This is yet another opportunity for value-creating strategic partnerships. We intend to publish more detailed data in 1Q 2025.
Conclusion
As you can see from our past performance, our entire management team is committed to the success of Coya. We expect to recognize a number of clinical, regulatory, and/or commercial milestones in 2025 that will help us advance the treatment of neurodegenerative diseases.
On behalf of the entire Coya team, please accept our sincere gratitude for both your support and belief in our science, our story, and our team. We look forward to presenting additional clinical data and updating you on our additional corporate developments as they unfold. Onwards and upwards!

COYA

Coya Therapeutics Highlights Strategic Vision Under New CEO, With Key 2025 Milestones Including ALS Trial With Dr. Reddy's Partnership Worth Up To $700M, Emerging Opportunities In Parkinson's And Autoimmune Conditions, And Focus On Non-Dilutive Funding To Advance Treg-Enhancing Biologics For Neurodegenerative And Autoimmune Diseases

Dr. Reddy&#8217;s Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) reported Tuesday a second-quarter 2025 net income of $160 million, down from $177 million a year ago.
Revenue increased from $821 million to $957 million — almost a 16.6% jump.
The strong revenue growth during the quarter was <a target="_blank" href="https://www.drreddys.com/cms/cms/sites/default/files/2024-11/Q2%20FY25%20Results%20.pdf" rel="noreferrer noopener">primarily</a> driven by growth in global generics revenues. The sequential growth was led by global generics revenues in Emerging Markets, India, Europe and Pharmaceutical Services and Active Ingredients (PSAI).
EBITDA for the quarter rose from $260 million to $272 million.
&#8220;We delivered another good quarter and maintained the growth momentum across businesses. We made progress on our future growth drivers, operationalized our venture with Nestle and completed the acquisition of Nicotinell and related brands,&#8221; said co-chair GV Prasad.
Global generics revenues during the second quarter reached 71.6 billion rupees, showing a 17% year-over-year growth, driven by improved sales volumes and new product launches.
North American sales increased 17% (a sequential decline of 3%) to 37.3 billion rupees. YoY growth was largely due to increased sales volumes, partly offset by price erosion. The sequential decline was due to a decrease in sales volumes.
Gross Margin at 59.6% (GG: 63.1 %, PSAI: 30.0%), a YoY increase of 92 basis points (bps) and a QoQ decline of 81 bps. The YoY increase was due to an improvement in product mix and overhead leverage, partly offset by price erosion. On a sequential basis, the decline was primarily due to changes in the mix.
Price Action: Dr. Reddy&#8217;s Laboratories is up 4.81% at $15.51 during the premarket session at last check Tuesday.
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Dr. Reddy's Lab Delivers 'Another Good Quarter,' CEO Says As Revenue Jumps 17%

Dr. Reddy's Laboratories shares are trading higher after the company reported a year-over-year increase in Q2 sales results.

Press Releases

Dr. Reddy's Laboratories and Senores Pharmaceuticals, Inc. Announce the Launch of Ivermectin Tablets USP, 3 mg in US Market

Dr. Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma

Dr. Reddy's Q3 & 9MFY25 Financial Results

Henlius and Dr. Reddy's Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S.

Dr. Reddy's enters into collaboration with Henlius for commercialization of HLX15 (daratumumab), a biosimilar candidate to Darzalex® & Darzalex Faspro® in the U.S., and Europe

Dr. Reddy's Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., due to Mislabeling of Infusion Bag

Alvotech and Dr. Reddy's Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

Alvotech and Dr. Reddy's Announce FDA Acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

Bio-Thera and Dr. Reddy's Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia

Dr. Reddy's Q4 & Full Year FY25 Financial Results

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