Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 3 trial results for its first-in-class allergen-blocking antibodies targeting cat and birch allergies. The trials demonstrated significant symptom reduction compared to placebo.

In the cat allergy trial, a single dose of REGN1908/REGN1909 reduced itch by 52%, conjunctival redness by 39%, and skin prick reactivity by 44%. For birch allergy, REGN5713/REGN5715 showed similar efficacy with 51% itch reduction, 46% conjunctival redness reduction, and 44% decrease in skin prick reactivity.

Both treatments showed rapid onset within 8 days and durability lasting over 3 months. The company plans additional Phase 3 development, with cat allergy trials starting in H1 2026 and birch allergy trials by year-end.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced an updated presentation time for the Morgan Stanley 23rd Annual Global Healthcare Conference. The company will now present at 7:00 a.m. ET on Monday, September 8, 2025.

The presentation will be accessible through a live webcast on Regeneron's investor relations website, with replays and transcripts remaining available for at least 30 days after the event.

Regeneron (NASDAQ: REGN) announced positive Phase 3 NIMBLE trial results for cemdisiran monotherapy in treating generalized myasthenia gravis (gMG). The trial met its primary and key secondary endpoints, with cemdisiran showing a 2.3-point placebo-adjusted improvement in MG-ADL total score.

Cemdisiran, administered subcutaneously every three months, demonstrated 74% inhibition of complement activity. The trial also tested a cemdisiran-pozelimab combination, achieving 99% inhibition, though cemdisiran monotherapy showed numerically better results. Key efficacy metrics include 76.6% of patients achieving ≥3-point MG-ADL reduction and 48.4% achieving ≥5-point QMG reduction.

The safety profile was favorable, with no meningococcal infections and no treatment discontinuations due to adverse events in the cemdisiran arm. Regeneron plans U.S. regulatory submission in Q1 2026.

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.