Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

Regeneron and Sanofi presented promising Phase 4 DISCOVER trial results for Dupixent in treating atopic dermatitis patients with skin of color at the 2025 RAD Conference. The trial, involving 120 patients (82% Black), showed significant improvements in disease severity and symptoms. Key findings at 24 weeks included: 76% of patients achieved ≥75% improvement in disease severity (EASI-75), 53% experienced meaningful itch reduction, and a 53% reduction in post-inflammatory hyperpigmentation. The percentage of patients very/extremely bothered by dry skin decreased from 78% to 18%. Safety results aligned with Dupixent's known profile, with a 42% adverse event rate. These results mark the first large-scale clinical trial of Dupixent in patients with darker skin tones, addressing an underserved population disproportionately affected by atopic dermatitis.

Regeneron Pharmaceuticals has entered a strategic in-licensing agreement with Hansoh Pharmaceuticals for HS-20094, a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. The deal grants Regeneron exclusive development and commercial rights outside China Mainland, Hong Kong, and Macau. The weekly injectable has shown promising results in over 1,000 patients, with data suggesting similarity to the only FDA-approved GLP-1/GIP receptor agonist. Regeneron will pay $80 million upfront, with potential additional payments up to $1.93 billion based on milestones, plus low double-digit royalties on global net sales. The acquisition aims to enhance Regeneron's obesity treatment portfolio, focusing on quality weight loss and muscle mass maintenance. The drug is currently undergoing Phase 3 trials for obesity in China and Phase 2b studies for diabetes.

Regeneron Pharmaceuticals (REGN) reported interim Phase 2 COURAGE trial results evaluating combinations of semaglutide with muscle-preserving antibodies for obesity treatment. The study revealed that 35% of semaglutide-induced weight loss came from lean mass loss. When combined with trevogrumab (with/without garetosmab), the treatment preserved 50-80% of lean mass while enhancing fat loss compared to semaglutide alone. The triplet combination (semaglutide + trevogrumab + garetosmab) showed the highest fat loss (-25.4 lbs) and total weight loss (-30.0 lbs) but had significant safety concerns with a 28.3% discontinuation rate. The dual combination of semaglutide with trevogrumab demonstrated better tolerability while still providing meaningful lean mass preservation and enhanced fat loss. The trial's complete data will be available later in 2025.

Regeneron Pharmaceuticals announced significant Phase 3 trial results for Libtayo (cemiplimab) in treating high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery. The C-POST trial demonstrated remarkable efficacy, with Libtayo reducing disease recurrence or death risk by 68% compared to placebo. The drug showed 80% reduction in locoregional recurrence risk and 65% reduction in distant recurrence risk. After 24 months of follow-up, disease-free survival was 87% with Libtayo versus 64% with placebo. The safety profile was manageable, with 24% of Libtayo patients experiencing Grade ≥3 adverse events compared to 14% in the placebo group. Regulatory applications have been submitted in both the US and EU, positioning Libtayo as potentially the first immunotherapy to demonstrate significant benefit in high-risk CSCC in the adjuvant setting.