Welcome to our dedicated page for Disc Medicine news (Ticker: IRON), a resource for investors and traders seeking the latest updates and insights on Disc Medicine stock.
Disc Medicine Inc (NASDAQ: IRON) is a clinical-stage biopharmaceutical company pioneering novel therapies for hematologic disorders through innovative research in iron metabolism and red blood cell biology. This page serves as the definitive source for verified corporate developments, research milestones, and regulatory updates.
Investors and researchers will find timely updates on clinical trials for lead candidates including bitopertin (targeting erythropoietic protoporphyria) and DISC-0974 (for anemia management). Our curated news collection covers essential updates, partnership announcements, and scientific presentations without speculative commentary.
Key content categories include phase trial results, FDA communications, intellectual property developments, and peer-reviewed research findings. All materials are vetted for accuracy and relevance to therapeutic advancements in hematology.
Bookmark this page for streamlined access to IRON's latest progress in developing first-in-class therapies that address unmet needs in iron-related disorders. Check regularly for objective updates on pipeline candidates and corporate strategy.
Disc Medicine (NASDAQ: IRON) priced an upsized public offering totaling 2,919,191 aggregate shares/units, including 2,619,049 new shares and 59,523 pre-funded warrants, plus 297,619 shares sold by a selling stockholder.
The public offering price is $84.00 per share (pre-funded warrant at $83.9999). Aggregate gross proceeds to Disc are expected to be approximately $225 million (before fees), and proceeds to the selling stockholder about $25 million. The underwriters have a 30-day option for up to 446,428 additional shares. The offering is expected to close on October 22, 2025. Disc intends to use net proceeds to support potential commercialization of bitopertin for EPP/XLP, fund R&D and for working capital.
Disc Medicine (NASDAQ: IRON) announced on October 20, 2025 the commencement of an underwritten offering of $220.0 million of common stock and pre-funded warrants, consisting of $200.0 million of shares offered by Disc and $20.0 million offered by AI DMI LLC (Selling Stockholder).
The underwriters have a 30-day option to purchase up to an additional $33.0 million. The offering is subject to market conditions. Disc intends to use net proceeds to support potential commercialization of bitopertin for EPP and XLP, fund research and clinical development, and for working capital and general corporate purposes.
Disc Medicine (NASDAQ:IRON) reported submission of an NDA for bitopertin in erythropoietic protoporphyria (EPP) on Sept 29, 2025, and receipt of an FDA Commissioner’s National Priority Voucher (CNPV) intended to shorten review to 1–2 months, targeting potential US approval and launch in late 2025 or early 2026. The company plans to accelerate commercial readiness and continue enrollment in the APOLLO confirmatory trial to support broader approvals.
Disc also plans near-term development for DISC-0974 (anemia of myelofibrosis) and DISC-3405 (polycythemia vera), with Phase 2 data timelines and additional trials in 2025–2026. Cash position at end of Q3 was approximately $616 million.
Disc Medicine (NASDAQ:IRON) will present Phase 1b clinical data for DISC-0974 at the 2025 American Society of Nephrology Kidney Week in Houston, Nov 6-9, 2025.
The poster (Abstract 4351248, Poster SA-PO1183) is scheduled for Nov 8, 2025 at 10:00 am CST (11:00 am EST) with Pablo Pergola, M.D., Ph.D. as presenting author. The randomized, double-blind, placebo-controlled Phase 1b study evaluates single ascending and multiple doses in nondialysis-dependent CKD patients with anemia, reporting safety, tolerability, PK, and pharmacodynamic markers including hepcidin, iron, and hematologic parameters. The abstract is available on the ASN Kidney Week website.
Disc Medicine (NASDAQ:IRON) received a Commissioner’s National Priority Voucher (CNPV) from the FDA for bitopertin in erythropoietic protoporphyria (EPP) on Oct 16, 2025.
Disc submitted a New Drug Application (NDA) in September 2025 seeking accelerated approval for patients aged 12 and older. Bitopertin holds Orphan Drug and Rare Pediatric Disease designations. The CNPV program can shorten FDA review to 1–2 months and provides enhanced communications and rolling review benefits.
Disc Medicine (NASDAQ:IRON) has submitted a New Drug Application (NDA) to the FDA for bitopertin, targeting patients aged 12 and older with erythropoietic protoporphyria (EPP). The company is pursuing accelerated approval and priority review for the drug, which has received Orphan Drug and Rare Pediatric Disease Designations.
The NDA submission is backed by positive results from the Phase 2 BEACON and AURORA studies, showing significant PPIX reductions and improvements in light tolerance, phototoxic reactions, and quality of life. The safety database includes over 4,000 clinical trial participants. If granted Priority Review, the FDA's review timeline would be reduced to 6 months instead of the standard 10 months following the 60-day filing period.
Disc Medicine (NASDAQ:IRON), a clinical-stage biopharmaceutical company specializing in hematologic disease treatments, has announced its participation in four major investor conferences in September 2025.
The company will engage in fireside chats at the Cantor Fitzgerald Global Healthcare Conference (Sept 3, 10:55 AM ET), Wells Fargo Healthcare Conference (Sept 4, 4:30 PM ET), H.C. Wainwright Global Investment Conference (Sept 9, 12:00 PM ET), and Morgan Stanley Global Healthcare Conference (Sept 10, 1:05 PM ET). All sessions will be accessible via webcast through Disc Medicine's investor relations website.
Disc Medicine (NASDAQ:IRON) reported Q2 2025 financial results and significant pipeline progress. The company plans to submit an NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval in October 2025, following a successful pre-NDA meeting.
Key pipeline developments include expected initial data from DISC-0974's Phase 2 study in myelofibrosis anemia and Phase 1b study in NDD-CKD anemia in Q4 2025. The company also initiated a Phase 2 study of DISC-3405 in polycythemia vera.
Financially, Disc ended Q2 with $650.0 million in cash, providing runway into 2028. Q2 net loss was $55.2 million, with R&D expenses at $46.3 million and SG&A expenses at $15.1 million.
Disc Medicine (NASDAQ:IRON) has received positive feedback from its pre-NDA meeting with the FDA regarding bitopertin, its treatment for Erythropoietic Protoporphyria (EPP). The company has confirmed plans to submit its New Drug Application (NDA) in October 2025 under the FDA's accelerated approval pathway.
CEO John Quisel expressed confidence in the alignment with the FDA regarding the submission's timing and content. The company is preparing for its first potential product launch, marking a significant milestone in bringing bitopertin to the EPP community.
Disc Medicine (NASDAQ:IRON) has appointed Nadim Ahmed to its Board of Directors. Ahmed, currently President and CEO of Cullinan Therapeutics, brings over 25 years of leadership experience in drug development and commercialization.
The appointment comes at a strategic time as Disc Medicine prepares for potential NDA filing and launch of bitopertin for EPP (erythropoietic protoporphyria). Ahmed's previous roles include President of Hematology at Bristol Myers Squibb and President of Global Hematology & Oncology at Celgene Corporation, where he oversaw multiple successful product launches.
FAQ
What is the current stock price of Disc Medicine (IRON)?
What is the market cap of Disc Medicine (IRON)?
