Disc Medicine's Bitopertin Could See US FDA Approval by Early February 2026, Wedbush Says

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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 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 jumped past 21% in recent Friday trading.

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

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