Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: GlobeNewswire
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. “People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,” said Kenneth Mendez, President and Ch
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REGN
Earnings
- 10/28/25 - Beat
REGN
Sec Filings
- 12/11/25 - Form 4
- 12/11/25 - Form 4
- 12/11/25 - Form 4
- REGN's page on the SEC website