Disc Medicine, Inc. Class Action Lawsuit - IRON

The filed complaint alleges that Disc Medicine, Inc. made materially false and/or misleading statements and/or failed to disclose that: On February 13, 2026, Disc disclosed that the FDA had issued a Complete Response Letter (CRL) for bitopertin, the company’s lead therapeutic candidate targeting EPP, a rare genetic disorder characterized by extreme photosensitivity. A CRL indicates that the FDA has completed its review of a drug application and determined that it cannot approve the application in its current form. The CRL requires additional data submissions before the agency will reconsider the application. Erythropoietic protoporphyria is an orphan disease with limited treatment options, and bitopertin had been positioned as a potentially transformative therapy for the approximately 4,000 EPP patients in the United States and beyond. The FDA’s CRL effectively delays any potential approval until at least 2027, eliminating the near-term commercial revenue that analysts had incorporated into their valuation models. Following the CRL announcement, Disc shares declined 21.9%. The severity of the decline reflects the degree to which the market had priced in a favorable FDA outcome based on the company’s prior public communications regarding the bitopertin program’s regulatory trajectory. The investigation focuses on whether Disc and its senior executives made statements to investors about the bitopertin program’s regulatory prospects that did not fully reflect the risks and challenges the company was encountering in its interactions with the FDA prior to the CRL.

In order to be eligible to join the IRON class action lawsuit, you must have incurred a loss on shares of Disc Medicine, Inc. purchased during the class period listed above.