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Disc Medicine Highlights Recent Achievements and Key Business Objectives and Milestones for 2026

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WATERTOWN, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-st...

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AI Summary

Disc Medicine's bitopertin NDA submitted for accelerated FDA review under CNPV. Positive data from DISC-0974 study shows potential in myelofibrosis anemia. 2026 key milestones include multiple Phase 2 updates and potential bitopertin launch. Company's cash reserves stand at $791 million, ensuring runway till 2029. DISC-3405 progresses to Phase 2 studies for polycythemia vera and sickle cell disease.

Sentiment Rationale

The FDA's rapid review of bitopertin indicates strong market potential. Similar FDA projects have historically boosted stock.

Trading Thesis

Immediate impact expected from FDA approval timeline, affecting stock price within months.

Market-Moving

  • Disc Medicine's bitopertin NDA submitted for accelerated FDA review under CNPV.
  • Positive data from DISC-0974 study shows potential in myelofibrosis anemia.
  • 2026 key milestones include multiple Phase 2 updates and potential bitopertin launch.

Key Facts

  • Disc Medicine's bitopertin NDA submitted for accelerated FDA review under CNPV.
  • Positive data from DISC-0974 study shows potential in myelofibrosis anemia.
  • 2026 key milestones include multiple Phase 2 updates and potential bitopertin launch.
  • Company's cash reserves stand at $791 million, ensuring runway till 2029.
  • DISC-3405 progresses to Phase 2 studies for polycythemia vera and sickle cell disease.

Companies Mentioned

  • PTGX (PTGX)
  • AXSM (AXSM)
  • SABR (SABR)

Corporate Developments

Key advancements in pipeline with imminent FDA decisions can greatly influence IRON's price.

Disc Medicine Outlines Ambitious 2026 Goals and Recent Achievements

WATERTOWN, Mass., January 12, 2026 (GLOBE NEWSWIRE) – Disc Medicine, Inc. (NASDAQ: IRON), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for serious hematologic disorders, has publicly detailed its key accomplishments from 2025 and its strategic goals for 2026. Notably, the company has made substantial progress within its pipeline, laying a robust foundation for upcoming initiatives.

Major Breakthroughs in 2025

2025 proved to be a pivotal year for Disc Medicine, marked by significant advancements across its operational portfolio. Among the highlights:

  • Bitopertin NDA submitted and accepted under the FDA's accelerated approval pathway with priority review.
  • Commissioner’s National Priority Voucher (CNPV) for bitopertin awarded, facilitating an expedited review process.
  • Established a commercial-ready organization through the expansion of marketing, market access, medical science liaison, and sales teams.
  • Positive initial data from the Phase 2 RALLY-MF study of DISC-0974, demonstrating significant hematologic efficacy for anemia of myelofibrosis.
  • Patent exclusivity secured for DISC-0974 until 2041, with potential extensions.
  • Commencement of Phase 2 studies for DISC-3405 in polycythemia vera (PV) and Phase 1b studies in sickle cell disease (SCD).
  • $791 million in cash, cash equivalents, and marketable securities reported at year-end, ensuring operational flexibility through 2029.

Vision and Objectives for 2026

Looking forward to 2026, Disc Medicine aims to achieve several critical objectives to ensure continued progression within its clinical pipeline:

  • Bitopertin: Anticipation of an FDA decision on the NDA under the CNPV program and plans for a successful U.S. launch if approved. The next phase includes ongoing enrollment in the global APOLLO confirmatory study, with topline data expected by early 2027.
  • DISC-0974: Progress the ongoing Phase 2 trial for MF anemia with updated data due in H2 2026 and conduct an End of Phase 2 meeting with the FDA.
  • DISC-3405: Maintain momentum in the Phase 2 trial for PV and the Phase 1b trial for SCD, with data updates expected in H2 2026.

Executive Insights

John Quisel, J.D., Ph.D., President and CEO of Disc Medicine, commented on the company's trajectory: “2025 was a transformative year for Disc, marked by strong execution across our portfolio. The recognition of bitopertin through CNPV and the submission of our NDA has positioned us for rapid FDA review. As we look ahead, we are entering an exciting and pivotal period for Disc, with strategic plans for commercializing our products and continuing our pipeline updates.”

About Disc Medicine

Founded with a vision to revolutionize treatments for hematologic diseases, Disc Medicine (NASDAQ: IRON) focuses on developing novel solutions targeting essential biological pathways of red blood cell biology. The company aims to create first-in-class therapeutic candidates tackling a spectrum of hematologic conditions through innovative approaches to heme biosynthesis and iron homeostasis. For more information, visit www.discmedicine.com.

Forward-Looking Statements

This article contains forward-looking statements regarding Disc Medicine’s future performance and expectations, including timelines for clinical trials and anticipated regulatory interactions. These forward-looking statements involve risks and uncertainties that may affect actual outcomes and performance. Potential investors are advised to consider these factors when evaluating the company's prospects.

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