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Disc Medicine prepares for potential 2026 bitopertin FDA decision

Story Highlights
  • Disc Medicine reported transformative 2025 progress, including bitopertin’s priority NDA review and strong funding.
  • For 2026, Disc aims for bitopertin approval and launch while advancing DISC-0974 and DISC-3405 trials.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Disc Medicine prepares for potential 2026 bitopertin FDA decision

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The latest update is out from Disc Medicine ( (IRON) ).

On January 12, 2026, Disc Medicine highlighted 2025 as a transformative year in which it submitted and secured priority review for a U.S. new drug application for bitopertin, received a Commissioner’s National Priority Review Voucher, reported positive initial Phase 2 data for DISC-0974 in myelofibrosis-related anemia, advanced DISC-3405 into proof-of-concept studies, and strengthened its balance sheet to $791 million in cash and securities as of December 31, 2025, providing runway into 2029. For 2026, the company outlined plans centered on an anticipated FDA decision and potential U.S. launch of bitopertin for erythropoietic protoporphyria, continued enrollment of the APOLLO confirmatory trial, Phase 2 progression and regulatory interactions for DISC-0974 including expansion into inflammatory bowel disease–associated anemia, and continued Phase 2 and Phase 1b development of DISC-3405 in polycythemia vera and sickle cell disease, positioning Disc to transition into a fully integrated clinical and commercial hematology player.

The most recent analyst rating on (IRON) stock is a Buy with a $120.00 price target. To see the full list of analyst forecasts on Disc Medicine stock, see the IRON Stock Forecast page.

Spark’s Take on IRON Stock

According to Spark, TipRanks’ AI Analyst, IRON is a Neutral.

The score is held back primarily by pre-revenue financials with increasing losses and cash burn, alongside weak near-term technical momentum. Offsetting factors include a strong, low-leverage balance sheet and favorable corporate/regulatory catalysts around bitopertin and broader pipeline progress.

To see Spark’s full report on IRON stock, click here.

More about Disc Medicine

Disc Medicine, Inc. (NASDAQ: IRON) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel treatments for serious hematologic diseases. Its portfolio targets fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis, with a pipeline that includes bitopertin, DISC-0974 and DISC-3405 aimed at conditions such as erythropoietic protoporphyria, myelofibrosis-related anemia, polycythemia vera and sickle cell disease.

Average Trading Volume: 600,803

Technical Sentiment Signal: Buy

Current Market Cap: $2.99B

For an in-depth examination of IRON stock, go to TipRanks’ Overview page.

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