FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD [Yahoo! Finance]
Alnylam Pharmaceuticals, Inc. (ALNY)
Last alnylam pharmaceuticals, inc. earnings: 2/6 08:00 am
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Source: Yahoo! Finance
A decision from the regulatory body is expected on May 7, 2025. GSK's Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation. Please note that Nucala is already approved in the United States for four IL-5-mediated conditions — severe eosinophilic asthma (aged 6+), chronic rhinosinusitis with nasal polyps in adults, eosinophilic granulomatosis with polyangiitis in adults and hypereosinophilic syndrome in patients aged 12+. Currently, the drug is not approved for COPD worldwide. In the past three months, shares of GSK have plunged 21.6% compared with the industry's 6.2% decline. Image Source: Zacks Investment Research GSK's regulatory filing seeking the approval of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype was supported by positive data from its phase III MATINEE study. The late-stage study evaluated the efficacy and safety of the drug in 8
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ALNY
Earnings
- 10/31/24 - Beat
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Sec Filings
- 12/13/24 - Form 4
- 12/12/24 - Form 144
- 11/27/24 - Form 4
- ALNY's page on the SEC website