Bitopertin - (APOLLO)

June 9, 2026: Disc Medicine, Inc. (NASDAQ: IRON) reported it completed a Type A meeting with the FDA regarding the Complete Response Letter (CRL) issued to the NDA for bitopertin in erythropoietic protoporphyria (EPP). The company said it aligned with FDA that the ongoing Phase 3 APOLLO trial, if successful, can serve as the basis for the CRL response and could potentially support a traditional approval.

APOLLO is a double-blind, placebo-controlled Phase 3 study of bitopertin in patients ≥12 years with EPP and X-linked protoporphyria (XLP) across the US, Canada, Europe, and Australia. Co-primary endpoints are (1) average monthly total time in sunlight without pain (10:00–18:00) during the last month of the 6-month treatment period and (2) percent change from baseline in whole blood metal-free PPIX after 6 months.

Disc expects APOLLO data in Q4 2026, plans to submit the CRL response by end of 2026, and anticipates an FDA decision by mid-2027.