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Regeneron, SNY Win FDA Approval for a Broader Dupixent Label [Yahoo! Finance]
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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US:NASDAQ Investor Relations: investor.regeneron.com
Regeneron Pharmaceuticals, Inc . REGN announced that the FDA has approved blockbuster drug Dupixent (dupilumab) for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) for a broader population. The regulatory body approved the drug as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP. The latest approval expands the initial FDA approval (granted in June 2019) in CRSwNP for patients aged 18 years and older. Regeneron's shares have rallied 31.3% year to date compared to the industry's growth of 0.5%. Image Source: Zacks Investment Research The company has a collaboration agreement with Sanofi SNY for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs. Broader Label for SNY/REGN's Dupixent The FDA evaluated Dupixent for this expanded indication under Priority Review. The approval
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- Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis[GlobeNewswire]
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SEC Filings
- 11/5/24 - Form 4
- 11/1/24 - Form 144
- 10/31/24 - Form S-3ASR
- REGN's page on the SEC website
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