Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (Nasdaq: REGN) and Alnylam Pharmaceuticals (Nasdaq: ALNY) announced positive interim results from the Phase 1 clinical study of ALN-APP, an RNAi therapeutic targeting amyloid precursor protein for Alzheimer’s disease and cerebral amyloid angiopathy. The study enrolled 20 patients, revealing that single doses of ALN-APP achieved dose-dependent reductions of soluble APPα and APPβ in cerebrospinal fluid, with decreases of up to 90%. Safety and tolerability were encouraging, with only mild to moderate adverse events reported. This marks the first demonstration of RNAi gene silencing in the human brain, utilizing Alnylam's C16 platform. Further data will be disclosed at an upcoming scientific conference, and the trial continues to explore longer-term effects.

On April 17, 2023, Regeneron Pharmaceuticals (NASDAQ: REGN) announced significant leadership changes. P. Roy Vagelos, M.D., the Chair of the Board since 1995, will retire and not seek reelection at the 2023 Annual Meeting on June 9. Following his departure, Leonard S. Schleifer, M.D., Ph.D., and George D. Yancopoulos, M.D., Ph.D., will serve as Co-Chairs of the Board while maintaining their executive roles. Additionally, Christine A. Poon will become the Lead Independent Director. Dr. Vagelos expressed pride in Regeneron's transformation into a leading biopharmaceutical company, confident in the new leadership's ability to enhance shareholder value.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Bayer announced that their aflibercept 8 mg and EYLEA (aflibercept) injections will be featured in 18 presentations at the upcoming ARVO 2023 Annual Meeting, scheduled for April 23-27.

Key highlights include results from pivotal trials, PULSAR and PHOTON, on the efficacy and safety of aflibercept 8 mg for treating wAMD and DME. Notably, the FDA accepted a Biologics License Application for aflibercept 8 mg, targeting a decision by June 27, 2023. The drug is currently investigational and has not been fully evaluated by regulatory bodies.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced it will release its first quarter 2023 financial results on May 4, 2023, before U.S. markets open. The company will hold a conference call and webcast at 8:30 AM ET to discuss these results. Participants can access the call via the ‘Investors and Media’ section on Regeneron's website. Registration is required for telephone participation, where attendees will receive a confirmation email with access details. Regeneron is renowned for its biotechnology innovations and has developed multiple FDA-approved treatments for severe diseases.

Regeneron Pharmaceuticals announced that the European Commission approved Libtayo (cemiplimab) in combination with chemotherapy for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) showing ≥1% PD-L1 expression. This marks Libtayo's second first-line indication and fifth overall approval in the EU. The decision is based on the successful Phase 3 EMPOWER-Lung 3 trial, which demonstrated significant survival benefits, including a 45% reduction in the risk of death compared to chemotherapy alone. Patients receiving Libtayo had a median overall survival of 22 months versus 13 months for those on chemotherapy alone.

Regeneron Pharmaceuticals (NASDAQ: REGN) has entered a collaboration with Sonoma Biotherapeutics to develop novel regulatory T cell (T_reg) therapies for autoimmune diseases. The agreement includes an upfront payment of $75 million, consisting of $45 million in cash and a $30 million equity investment, as well as a potential development milestone payment of $45 million. Both companies will jointly research therapies targeting conditions such as ulcerative colitis and Crohn's disease, sharing R&D costs and profits. Regeneron retains the option to lead late-stage development globally, while Sonoma will co-promote products in the U.S.

Regeneron Pharmaceuticals and Sanofi announced positive results from a Phase 3 trial of Dupixent for chronic obstructive pulmonary disease (COPD). The trial demonstrated a 30% reduction in exacerbations compared to placebo, alongside a significant improvement in lung function (160 mL in FEV1) and quality of life. This makes Dupixent the first biologic to achieve these results in COPD patients with type 2 inflammation. COPD, the third leading cause of death globally, has seen no new treatment approaches in over a decade, highlighting the importance of these findings. The study included 939 participants and met all primary and secondary endpoints.