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Disc Medicine ( (IRON) ) has issued an announcement.
On January 21, 2025, Disc Medicine announced positive feedback from the FDA regarding their APOLLO post-marketing confirmatory trial for bitopertin, a treatment for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). The meeting resulted in alignment on the trial design, which includes key features such as co-primary endpoints and a double-blind, placebo-controlled study. The company plans to initiate the trial by mid-2025 and anticipates submitting a New Drug Application in the second half of 2025 under the Accelerated Approval Program. This development marks a significant step forward in potentially providing a life-changing therapy for EPP patients, enhancing Disc Medicine’s position in the biopharmaceutical industry.
More about Disc Medicine
Disc Medicine is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel treatments for serious hematologic diseases. The company is building a portfolio of innovative therapeutic candidates that target fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.
YTD Price Performance: -6.73%
Average Trading Volume: 320,890
Technical Sentiment Consensus Rating: Strong Sell
Current Market Cap: $1.73B
Learn more about IRON stock on TipRanks’ Stock Analysis page.
