Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: GlobeNewswire
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program (Study A
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- ROSEN, A LEADING INVESTOR RIGHTS LAW FIRM, Encourages Regeneron Pharmaceuticals, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – REGNGlobeNewswire
- Regeneron Pharmaceuticals, Inc. Sued for Securities Law Violations - Contact Levi & Korsinsky Before March 10, 2025 to Discuss Your Rights - REGNPR Newswire
REGN
Earnings
- 2/4/25 - Beat
REGN
Sec Filings
- 2/12/25 - Form SCHEDULE
- 2/7/25 - Form 13F-HR
- 2/5/25 - Form 10-K
- REGN's page on the SEC website