Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced it has completed a Type A meeting with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria (EPP). In this meeting, Disc aligned with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a response to the CRL and could potentially support a traditional approval.

"The discussion with the FDA provided valuable clarity on the path forward for the bitopertin NDA," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "We look forward to reporting results from the APOLLO study later this year and remain committed to advancing bitopertin as a potential treatment option for patients with EPP."

APOLLO is a double-blind, placebo-controlled Phase 3 study of bitopertin in patients ages 12 and above with EPP and X-linked protoporphyria (XLP), that includes sites in the US, Canada, Europe, and Australia. The co-primary endpoints are average monthly total time in sunlight without pain between 10:00 and 18:00 during the last month of the 6-month treatment period and percent change from baseline in whole blood metal-free PPIX after 6 months of treatment. Data from APOLLO is expected in Q4 2026, after which a CRL response will be submitted with an FDA decision expected by mid-2027.