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Stock impact report

Disc Medicine Announces Successful End of Phase 2 Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP), Including Potential for Accelerated Approval [Yahoo! Finance]

Disc Medicine, Inc. (IRON) 
Company Research Source: Yahoo! Finance
Agreement on proposed primary endpoint of average monthly time in sunlight during the last month following a 6-month treatment period Potential for accelerated approval based on existing data and utilizing reduction of PPIX as a surrogate endpoint Plan to initiate APOLLO trial, a 6-month study of a 60 mg dose of bitopertin in EPP and XLP patients ages 12+ by mid-2025 Management will host a conference call on Monday, November 4 at 8:00 am EST WATERTOWN, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), supporting the regulatory path forward for bitopertin in EPP. “We are thrilled with the outcome of our end-of-Phase 2 meeting with the FDA, which provides us Show less Read more
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