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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IRON
News
- Disc Medicine, Inc. (NASDAQ: IRON) had its price target raised by analysts at HC Wainwright from $70.00 to $118.00. They now have a "buy" rating on the stock.MarketBeat
- Disc Medicine to Participate in Upcoming Investor ConferencesGlobeNewswire
- 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, up previously from $75.00.MarketBeat
- Disc Medicine Reports Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- Disc Medicine Secures $200 Million in Non-Dilutive Debt Financing from Hercules Capital, Inc. [Yahoo! Finance]Yahoo! Finance
IRON
Earnings
- 11/12/24 - Beat
IRON
Sec Filings
- 11/20/24 - Form EFFECT
- 11/19/24 - Form 4
- 11/15/24 - Form 424B5
- IRON's page on the SEC website