New York, New York--(Newsfile Corp. - March 4, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into Disc Medicine, Inc. ("Disc Medicine, Inc.") (NASDAQ: IRON) concerning potential violations of the federal securities laws.

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.

If you suffered a loss on your Disc Medicine, Inc. securities and would like to explore a potential recovery under the federal securities laws, Learn More About the Investigation or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212)363-7500 to speak to our team of experienced shareholder advocates.

WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.

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Source: Levi & Korsinsky, LLP