Disc Medicine Announces Successful End of Phase 2 Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP), Including Potential for Accelerated Approval
Disc Medicine, Inc. (IRON)
Company Research
Source: GlobeNewswire
Alignment with the FDA across all proposed study parameters, providing a clear development path to registrationAgreement on proposed primary endpoint of average monthly time in sunlight during the last month following a 6-month treatment periodPotential for accelerated approval based on existing data and utilizing reduction of PPIX as a surrogate endpointPlan to initiate APOLLO trial, a 6-month study of a 60 mg dose of bitopertin in EPP and XLP patients ages 12+ by mid-2025Management 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
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News
- Disc Medicine, Inc. (NASDAQ: IRON) had its price target raised by analysts at Stifel Nicolaus from $79.00 to $90.00. They now have a "buy" rating on the stock.MarketBeat
- Disc Medicine, Inc. (NASDAQ: IRON) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $83.00 price target on the stock.MarketBeat
- Disc Medicine Presents Positive Clinical and Translational Data Across Portfolio at the 66th American Society of Hematology (ASH) Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Disc Medicine Presents Positive Clinical and Translational Data Across Portfolio at the 66th American Society of Hematology (ASH) Annual MeetingGlobeNewswire
- Disc Medicine, Inc. (NASDAQ: IRON) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $118.00 price target on the stock.MarketBeat
IRON
Earnings
- 11/12/24 - Beat
IRON
Sec Filings
- 12/18/24 - Form 4
- 12/16/24 - Form 144
- 12/9/24 - Form 8-K
- IRON's page on the SEC website