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WATERTOWN, Mass. - Disc Medicine, Inc. (NASDAQ:IRON), whose stock has surged 25% in the past week and 113% over six months, submitted a New Drug Application for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, the company announced Monday.
The clinical-stage biopharmaceutical company, currently valued at $3.13 billion, also received the FDA Commissioner’s National Priority Voucher (CNPV), which is designed to shorten the NDA review period to 1-2 months. This could potentially lead to approval and commercialization in late 2025 or early 2026. InvestingPro data shows the company maintains a strong financial health score of 2.62, rated as "GOOD" by analysts.
Disc Medicine is accelerating commercial readiness activities to ensure patient access upon potential approval. The company continues enrollment in its APOLLO confirmatory trial of bitopertin in EPP, which is intended to support potential approval in territories outside the U.S.
The company is also advancing its iron homeostasis portfolio. DISC-0974, an anti-hemojuvelin antibody, is being developed for anemia of myelofibrosis (MF) with initial Phase 2 data expected by year-end. DISC-3405, an anti-TMPRSS6 antibody, is being developed for polycythemia vera (PV) with topline Phase 2 data anticipated in 2026.
"We’re positioning DISC-0974 for development in anemia of MF and look forward to providing an initial set of data from the Phase 2 RALLY-MF trial by the end of this year," said John Quisel, Chief Executive Officer and President of Disc Medicine.
The company plans to initiate a Phase 2 trial of DISC-0974 in anemia of inflammatory bowel disease in Q1 2026 and a Phase 1b trial of DISC-3405 in sickle cell disease by year-end.
Disc Medicine reported a strong financial position with approximately $616 million in cash, cash equivalents, and marketable securities at the end of Q3 2025.
The information in this article is based on a press release statement from the company. Bitopertin, DISC-0974, and DISC-3405 are investigational agents not yet approved for use in any jurisdiction worldwide.
In other recent news, Disc Medicine has received a significant boost with the announcement of an FDA Commissioner’s National Priority Review Voucher (CNPV) for its drug candidate bitopertin. This voucher is expected to accelerate the approval timeline for bitopertin, which is aimed at treating erythropoietic protoporphyria (EPP) and X-linked protoporphyria. The FDA’s initiative is designed to expedite the development and review of drugs addressing major health priorities. Additionally, Cantor Fitzgerald has raised its price target for Disc Medicine from $132 to $153, maintaining an Overweight rating, following the company’s receipt of the FDA voucher. Wells Fargo also reiterated its Overweight rating with a price target of $91, reflecting continued positive sentiment from analysts. In further developments, Disc Medicine is preparing to present updated clinical data on its Phase 1b study of DISC-0974 at the American Society of Nephrology Kidney Week. This presentation will cover safety, tolerability, and other key markers related to the treatment of non-dialysis-dependent chronic kidney disease and anemia. These recent developments highlight the company’s strategic progress in advancing its drug candidates.
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