(RTTNews) - Disc Medicine, Inc. (IRON) announced it has completed a Type A meeting with the U.S. FDA regarding the CRL for its NDA of bitopertin in erythropoietic protoporphyria (EPP). The company confirmed alignment with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a CRL response and potentially support a traditional approval.
The APOLLO trial is a double-blind, placebo-controlled Phase 3 study enrolling patients aged 12 and above with EPP and X-linked protoporphyria (XLP) across sites in the U.S., Canada, Europe, and Australia. Its co-primary endpoints measure average monthly time in sunlight without pain during the last month of the six-month treatment period, and percent change from baseline in whole blood metal-free protoporphyrin IX (PPIX) after six months. Data are expected in Q4 2026, with a CRL response submission planned by year-end and an FDA decision anticipated by mid-2027.
Bitopertin is an investigational oral inhibitor of glycine transporter 1 (GlyT1), designed to modulate heme biosynthesis. It has been studied in multiple trials including the Phase 2 BEACON and AURORA studies, the HELIOS extension, and the ongoing APOLLO trial. Disc obtained global rights to bitopertin from Roche in 2021.
CEO John Quisel said the FDA discussion provides valuable clarity on the regulatory path forward, adding that Disc remains committed to advancing bitopertin as a potential first disease-modifying therapy for patients with EPP.
IRON has traded between $40.00 and $99.50 over the past year. The stock is currently trading at $67.49, up 2.56%.
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