Disc Medicine stock price plummets, FDA issues full response letter

LootboxPhobia · 2026-02-13T21:24:05+00:00

Disc Medicine Inc's stock price plummeted 21.1% due to the FDA issuing a complete response letter(CRL) for its EPP treatment drug bitopertin. The FDA requires review of the APOLLO Phase III study results before approval, delaying the market launch. Although the drug showed a significant reduction in related biomarkers, the FDA believes the trial did not sufficiently demonstrate the correlation between PPIX reduction and clinical endpoints. Disc Medicine plans to complete the APOLLO trial, expecting to obtain data in 2026, and is seeking support for FDA approval.

LootboxPhobia

2026-02-13 21:24:05

Abstract generation in progress

Investing.com – Disc Medicine Inc (NASDAQ: IRON) stock plummeted 21.1% on Friday after the company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its erythropoietic protoporphyria (EPP) treatment drug bitopertin.

The FDA stated that, before making an approval decision, it needs to see the results of the ongoing Phase III APOLLO study, which effectively delays the potential market launch of the drug. While the agency acknowledged that bitopertin significantly reduced PPIX (protoporphyrin IX) levels and recognized the biological rationale for using this biomarker in protoporphyria, it believed that previous trials failed to demonstrate a sufficient correlation between PPIX reduction and endpoints related to sunlight exposure.

Disc Medicine has been seeking accelerated approval for bitopertin as part of the FDA’s Breakthrough Therapy designation pilot program. The company now expects to complete the APOLLO trial, with primary data anticipated in Q4 2026, followed by a response to the CRL, with an updated FDA decision expected by mid-2027.

“We are committed to providing bitopertin to patients because we know how important this potential disease-modifying therapy is to the EPP community,” said John Quisel, President and CEO of Disc Medicine. “Although our efforts to leverage the accelerated pathway to bring bitopertin to patients quickly have not yet been realized, we will continue to explore all avenues to support FDA approval.”

The company noted that recruitment for the APOLLO trial is ahead of schedule, with completion expected in March 2026. Disc Medicine reported that as of December 31, 2025, the company had approximately $791 million in cash, cash equivalents, and marketable securities, which it believes will support operations through 2029.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

View Original

This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.