Disc Medicine Announces Receipt of FDA Commissioner's National Priority Voucher (CNPV) for Bitopertin in Erythropoietic Protoporphyria (EPP) [Yahoo! Finance]
Disc Medicine, Inc. (IRON)
Company Research
Source: Yahoo! Finance
The CNPV program is designed to reduce the drug application review process to 1-2 months WATERTOWN, Mass., Oct. 16, 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 diseases, today announced that it received a Commissioner's National Priority Voucher (CNPV) from the U.S. Food and Drug Administration (FDA) for bitopertin in erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP). Disc submitted a New Drug Application (NDA) to the FDA for bitopertin for patients aged 12 years and older with EPP following the FDA's accelerated approval pathway in September 2025. Bitopertin has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA. “We are honored to have received this voucher which underscores the potential impact of bitopertin and reinforces the immen
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News
- 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
- What Disc Medicine (IRON)'s Bitopertin Fast-Track Review and Rising R&D Spend Mean for Shareholders [Yahoo! Finance]Yahoo! Finance
- Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire
- Disc Medicine Announces Presentation of 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 "buy" rating reaffirmed by analysts at Stifel Nicolaus. They now have a $125.00 price target on the stock.MarketBeat
IRON
Earnings
- 11/6/25 - Miss
IRON
Sec Filings
- 11/13/25 - Form 4
- 11/12/25 - Form 144
- 11/6/25 - Form 10-Q
- IRON's page on the SEC website