Disc Medicine Inc.FDA Complete Response Letter rejecting bitopertin NDA due to uncertainties, causing 22% stock drop and securities investigation.

The Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Disc Medicine, Inc. following allegations that the company may have issued materially misleading business information. The investigation stems from a February 13, 2026 Complete Response Letter from the U.S. Food and Drug Administration 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 Rosen 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, causing 22% stock drop and securities investigation.