Key Takeaways Regeneron reported positive data from the CHORD study on its investigational gene therapy DB-OTO.DB-OTO improved hearing in 11 of 12 participants, with 3 achieving normal hearing levels.The therapy was well tolerated and met its primary endpoint; U.S. filings are planned later this year.Regeneron Pharmaceuticals, Inc. (REGN) announced updated data on its investigational gene therapy DB-OTO from the CHORD study.This gene therapy is being evaluated for profound genetic hearing loss due to varian ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the top stocks to buy in Michael Burry’s stock portfolio. On October 6, the company announced it is poised to incur an $83 million in-process research and development (IPR&D) charge. Regeneron Pharmaceuticals, Inc. (REGN) Prepares for $83M Charge Copyright: nexusplexus / 123RF Stock Photo The charge is related to an $80 million up-front payment made to Hansoh Pharmaceuticals Group Company Limited as part of a 2025 license agreement. In addition to ...

Core Insights - Regeneron Pharmaceuticals announced significant progress in their investigational gene therapy DB-OTO for profound genetic hearing loss, with 11 out of 12 participants in the CHORD trial experiencing clinically meaningful hearing improvements, including three achieving normal hearing levels [1][2][3] Group 1: Clinical Trial Results - The CHORD trial involved pediatric participants with profound hearing loss due to variants of the OTOF gene, with 12 participants aged 10 months to 16 years receiving DB-OTO via intracochlear infusion [2][9] - The primary endpoint was met, with 9 participants showing hearing improvements at a threshold of ≤70 decibels (dBHL) at week 24, indicating a level that typically does not require cochlear implantation [3][11] - Among participants with longer follow-up, eight showed stability or continued improvement in hearing, and all three who completed speech assessments demonstrated significant improvements in speech recognition [4][5] Group 2: Safety and Regulatory Status - The surgical procedure and DB-OTO were well tolerated, with no adverse findings related to DB-OTO reported; however, two serious adverse events were noted, unrelated to the therapy [5][6] - A U.S. regulatory submission for DB-OTO is planned for later this year, pending discussions with the FDA, which has granted multiple designations to the therapy, including Orphan Drug and Fast Track [6][7] Group 3: Background on Hearing Loss - OTOF-related hearing loss is a rare condition affecting approximately 20-50 newborns per year in the U.S., caused by variants in the OTOF gene, leading to a lack of functional otoferlin protein critical for auditory nerve communication [8][13] - The CHORD trial is a Phase 1/2 multicenter, open-label study evaluating the safety and efficacy of DB-OTO in children with OTOF-related hearing loss, currently enrolling participants across multiple countries [9][10]

Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty ImagesSOPA Images/LightRocket via Getty ImagesHere’s why we believe Regeneron Pharmaceuticals (REGN) stock merits attention as a value addition. Currently, it is trading almost 44% lower than its 1-year peak and is also priced at a PS multiple below its average from the last 3 years. Nonetheless, it possesses solid fundamentals relative to its valuation.Sound Revenue Growth: 5.4% LTM and 0.3% average over the last 3 years.Cash Generative: ...

Key Takeaways Regeneron gained FDA approval to expand Libtayo as adjuvant therapy for high-risk CSCC.Libtayo cut disease recurrence or death risk by 68% in the late-stage C-POST study.Strong Libtayo sales and new oncology drugs help offset Eylea's competition-driven decline.Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA has approved the label expansion of PD-1 inhibitor Libtayo (cemiplimab-rwlc).Libtayo is now approved as an adjuvant treatment for adult patients with cutaneous squamous cell c ...

The U.S. Food and Drug Administration on Wednesday cleared Regeneron Pharmaceuticals' immunotherapy, Libtayo, as an add-on treatment for skin cancer patients at high risk of their disease returning after surgery and radiation, the drugmaker said. ...

Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today ...

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Looking into the current session, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) shares are trading at $603.61, after a 0.60% increase. Moreover, over the past month, the stock increased by 5.27%, but in the past year, fell by 39.40%. Shareholders might be interested in knowing whether the stock is undervalued, even if the company is performing up to par in the current session. Regeneron Pharmaceuticals P/E Ratio Analysis in Relation to Industry PeersThe P/E ratio is used by long-term shareholders to assess t ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is among the most promising biotech stocks to buy according to hedge funds. During the second quarter, Generate Investment Management Ltd acquired a new stake in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) through the purchase of 12,000 shares of the company’s stock. According to a recent disclosure with the SEC, the firm’s investment in the company is approximately $6,300,000 now. While the company’s returns don’t seem quite compelling, Regeneron Pharmaceut ...