TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD^® (aflibercept) Injection 8 mg across all approved indications.

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo

If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies

Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils

TARRYTOWN, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2025 financial and operating results on Tuesday, April 29, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

$250,000 top award goes to Matteo Paz in America’s longest running and most distinguished science and math competition

Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch

TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. The European Commission is expected to announce a final decision in the coming months.

FDA decision expected by July 30, 2025

As presented at ARO, 10 of 11 children with at least one post-treatment assessment showed notable improvements in hearing

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025

Acceptance follows resolution of third-party fill/finish manufacturing issues

EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks

At three years of EYLEA HD treatment, the vast majority of patients maintained visual and anatomic improvements while achieving extended dosing regimens, including those of just twice a year: 77%, 58%, 40% and 24% achieved last assigned dosing intervals of ≥3, ≥4, ≥5 and 6 months, respectively

TARRYTOWN, N.Y., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2024 and provided a business update.

The Regeneron Science Talent Search Celebrates and Rewards Today’s Most Talented Young Minds Driving Innovation and Progress through Scientific Exploration

Primary endpoint of DFS met at first prespecified interim analysis, showing a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to placebo

The Truveta collaboration will extend Regeneron Genetics Center’s^® (RGC^TM) world-leading DNA sequence-linked healthcare database (now including almost three million de-identified patient volunteers) through genetic sequencing of up to ten million additional patient volunteers, all with linked electronic health records, creating the Truveta Genome Project

TARRYTOWN, N.Y., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2024 financial and operating results on Tuesday, February 4, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast its presentation at the 43^rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025. The presentation is scheduled for 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron's website at http://investor.regeneron.com/events-and-presentations.com/events-and-presentations. A replay and transcript of the webcast will be archived on the Company's website for at least 30 days.