Disc Medicine Announces Successful Type C Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP) and Shares Plans for NDA Submission
Disc Medicine, Inc. (IRON)
Company Research
Source: GlobeNewswire
Pursuing accelerated approval for bitopertin in EPP with protoporphyrin IX (PPIX) reduction as the surrogate endpointPlanning to submit NDA under accelerated approval pathway in H2 2025 based on existing clinical data, including results from BEACON and AURORA Phase 2 trialsAchieved regulatory alignment on APOLLO post-marketing confirmatory trial design and on track to initiate trial by mid-year 2025Aligned on average monthly time in light without pain during the last month of the 6-month treatment period and percent change from baseline in whole-blood metal-free PPIX after 6 months of treatment as coprimary endpoints for confirmatory trialManagement will host a conference call on Tuesday, January 21 at 8:00 am EST. WATERTOWN, Mass., Jan. 21, 2025 (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 diseas
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News
- Disc Medicine (NASDAQ:IRON) had its price target raised by analysts at Wells Fargo & Company from $91.00 to $109.00. They now have an "overweight" rating on the stock.MarketBeat
- Has Disc Medicine's 2025 Surge Already Gone Too Far After Pipeline Progress Fuels Rally? [Yahoo! Finance]Yahoo! Finance
- Disc Medicine (NASDAQ:IRON) had its "strong-buy" rating reaffirmed by analysts at Raymond James Financial, Inc..MarketBeat
- Disc Medicine Presents Positive Initial Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 67th American Society of Hematology (ASH) Annual MeetingGlobeNewswire
- Disc Medicine (NASDAQ:IRON) had its price target raised by analysts at Truist Financial Corporation from $86.00 to $114.00. They now have a "buy" rating on the stock.MarketBeat
IRON
Earnings
- 11/6/25 - Miss
IRON
Sec Filings
- 12/16/25 - Form 4
- 12/16/25 - Form 4
- 12/16/25 - Form 144
- IRON's page on the SEC website