Disc Medicine Inc.IRON
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FDA Complete Response Letter rejecting bitopertin NDA due to uncertainties

The Rosen Law Firm is investigating potential securities claims on behalf of Disc Medicine shareholders, alleging the company may have issued materially misleading business information. The investigation follows a February 13, 2026 Complete Response Letter from the FDA regarding Disc Medicine’s bitopertin program, which stated the new drug application could not be approved due to uncertainties requiring additional evidence. On that news, Disc Medicine’s stock price fell 22%. The law firm is preparing a class action seeking recovery of investor losses on a contingency fee basis.
Disc Medicine Inc.FDA Complete Response Letter rejecting bitopertin NDA due to uncertainties