Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) announced FDA review extensions for two EYLEA HD® (aflibercept) 8 mg regulatory submissions to Q4 2025. The extensions affect the prefilled syringe CMC Prior-Approval Supplement and a supplemental Biologics License Application for RVO treatment and expanded dosing options.

The delay stems from a recent FDA inspection of Catalent Indiana LLC, a third-party manufacturer acquired by Novo Nordisk. Novo Nordisk submitted a comprehensive response in August 2025 to address FDA observations. EYLEA HD remains available in vial form, with approved dosing intervals of 8-16 weeks for wAMD and DME patients, and 8-12 weeks for DR patients after initial monthly doses.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its participation in four major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference (Sept 3), Wells Fargo Healthcare Conference (Sept 4), Morgan Stanley Global Healthcare Conference (Sept 8), and Bernstein Healthcare Forum (Sept 24).

All presentations will be accessible via webcast through Regeneron's investor relations website, with replays and transcripts available for at least 30 days after the events.

Regeneron (NASDAQ:REGN) reported strong Q2 2025 financial results with total revenues increasing 4% to $3.68 billion. Key highlights include Dupixent global sales growth of 22% to $4.34 billion and EYLEA HD U.S. sales growth of 29% to $393 million, though total EYLEA franchise sales decreased 25% to $1.15 billion.

The quarter saw significant regulatory achievements, including FDA approvals for Lynozyfic in multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria. The company reported GAAP EPS of $12.81 (up 3%) and non-GAAP EPS of $12.89 (up 12%).

Notable pipeline progress includes positive obesity trial results, manufacturing challenges affecting EYLEA HD approvals, and a strategic in-licensing deal for a late-stage GLP-1/GIP receptor agonist. The company returned over $2.3 billion to shareholders through share repurchases and dividends.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the winners of its 13th annual Regeneron Prize for Creative Innovation. The 2025 recipients are Dr. Alissandra L. Hillis from MIT and Sreekar Mantena from Harvard Medical School-MIT, each receiving $50,000 awards plus $5,000 institutional grants.

Dr. Hillis's research focuses on cancer cell metabolism and proposed studying endometriosis, while Mr. Mantena's work involves investigating thymus cell competence decline with age. Seven other finalists received $5,000 awards. Since 2013, the program has provided nearly $2 million in awards to early-career scientists, with Regeneron's STEM initiatives reaching over 3.25 million students since 2020.

Regeneron Pharmaceuticals (NASDAQ: REGN) has received FDA accelerated approval for Lynozyfic™ (linvoseltamab-gcpt), the first BCMAxCD3 bispecific antibody for treating relapsed or refractory multiple myeloma in adults who have received at least four prior therapies.

The approval is based on the LINKER-MM1 trial results, where patients (n=80) achieved a 70% objective response rate, with 45% reaching complete response or better. The median duration of response was not reached, with an estimated 89% duration of response at 9 months.

Lynozyfic features a unique dosing schedule, allowing administration every two weeks starting at week 14, and potentially every four weeks with good response. The treatment includes mandatory hospitalization during initial dosing for safety monitoring.

Regeneron Pharmaceuticals (NASDAQ: REGN) has scheduled its second quarter 2025 financial and operating results announcement for Friday, August 1, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time on the same day.

Investors can access the conference call through a webcast on Regeneron's investor relations website. Telephone participants must pre-register to receive dial-in details. A replay and transcript will be available on the company's website for at least 30 days after the event.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced a groundbreaking donation matching program with Good Days, an independent charitable organization. The company will match donations up to $200 million at a one-to-one rate through 2025 for Good Days' Retinal Vascular and Neovascular Disease Fund.

The initiative aims to help patients with retinal diseases afford their medications through copay assistance for FDA-approved treatments. This program builds on Regeneron's track record of charitable giving, having donated over $2.5 billion to independent charitable organizations supporting patient financial assistance over the past decade.

The matching program is part of Regeneron's broader strategy to improve healthcare access through various initiatives including product support, Managed Access Programs, and patient assistance programs.

The FDA has approved Dupixent (dupilumab) as the first targeted treatment for adults with bullous pemphigoid (BP), a rare skin disease affecting approximately 27,000 U.S. adults. The approval is based on the ADEPT Phase 2/3 trial results, where Dupixent showed significant improvements compared to placebo: 18.3% of patients achieved sustained disease remission vs 6.1%, 38.3% experienced meaningful itch reduction vs 10.5%, and patients required lower oral corticosteroid doses (2.8g vs 4.1g). BP primarily affects elderly patients, causing intense itching, painful blisters, and skin lesions. Dupixent is now approved for eight distinct diseases with type 2 inflammation, spanning skin, gut, and respiratory conditions. The FDA granted Priority Review and Orphan Drug Designation for this indication.

Regeneron and Sanofi presented groundbreaking results from the EVEREST Phase 4 trial comparing Dupixent to Xolair in treating chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. The study, involving 360 adults, demonstrated Dupixent's superiority across all primary and secondary endpoints. Key achievements include a 1.60-point greater reduction in nasal polyp size and an 8.0-point superior improvement in smell identification compared to Xolair. Dupixent also showed significant advantages in nasal congestion reduction, symptom severity, and quality of life measures. In asthma-related outcomes, Dupixent demonstrated a 150 mL improvement in lung function and better asthma control. The safety profiles were comparable, with adverse events reported in 64% of Dupixent patients versus 67% for Xolair, and serious adverse events at 2% and 4% respectively.