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Disc Medicine's Bitopertin Could See US FDA Approval by Early February 2026, Wedbush Says
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Disc Medicine's Bitopertin Could See US FDA Approval by Early February 2026, Wedbush Says
Oct 17, 2025 12:10 PM

02:42 PM EDT, 10/17/2025 (MT Newswires) -- Disc Medicine's ( IRON ) drug candidate bitopertin is expected to get a priority review decision from the US Food and Drug Administration in late November or early December, which could imply regulatory approval by early February 2026, Wedbush said in a Friday note.

Based on this scenario, Wedbush said it increased its sales estimates for 2026, 2027, 2028 and 2029 to $35 million, $190 million, $375 million, and $615 million, respectively.

On Thursday, Disc Medicine ( IRON ) announced that it has received Commissioner's National Priority Voucher, meant to expedite the drug review process, from the FDA for bitopertin to treat erythropoietic protoporphyria, a rare and potentially life-threatening disease that causes severe reactions when patients are exposed to sunlight.

Wedbush reiterated its outperform rating and increased its price target to $110 from $90.

Shares of Disc Medicine ( IRON ) jumped past 21% in recent Friday trading.

Price: 90.05, Change: +15.69, Percent Change: +21.10

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