Rosen Law Firm investigates Disc Medicine after FDA Complete Response Letter and 22% stock drop

The investor-rights firm said it is preparing a prospective securities class action after the FDA declined to approve Disc Medicine’s bitopertin application without additional evidence.

Summary

Rosen Law Firm said it is investigating potential securities claims on behalf of Disc Medicine, Inc. shareholders over allegations that the company may have provided materially misleading business information to investors. The firm said it is preparing a prospective securities class action and that investors who purchased Disc Medicine securities may be able to seek compensation through a contingency fee arrangement. The investigation follows a February 13, 2026 Complete Response Letter from the U.S. Food and Drug Administration regarding Disc Medicine’s bitopertin program. The FDA said it could not approve the company’s new drug application because of uncertainties in the filing that would require additional evidence. Disc Medicine’s stock fell 22% on February 13, 2026. Rosen asked investors interested in joining the prospective class action to submit information through its website or contact Phillip Kim, Esq. by phone or email for details.

Terms & Concepts
  • Complete Response Letter: An FDA notice stating that a drug application cannot be approved in its current form.
  • new drug application: A formal submission seeking U.S. regulatory approval to market a drug.
  • contingency fee arrangement: Lawyers are paid only if money is recovered.