Disc Medicine said its bitopertin trial met every main and secondary goal, supporting its plans to seek FDA approval. The FDA has not yet approved the drug, and the company cited uncertainty about having enough money for future work, but the trial findings are the stronger news.
This gives Disc Medicine strong evidence that bitopertin can help people with EPP and XLP. The company plans to send its application to the FDA by the end of 2026, but the drug is not approved yet. The FDA decision and the company's ability to fund its work remain important risks.
Follow Disc Medicine, Inc. (IRON) free. When we publish a story about it, you get the plain-English explanation as an alert.
Get alerts for IRON