Disc Medicine Outlines FDA CRL for Bitopertin, Plans APOLLO Completion and Response by Late 2026
Disc Medicine received an FDA Complete Response Letter for bitopertin over PPIX. It plans to complete APOLLO enrollment by March 2026, with topline data in Q4 2026 and a decision targeted by mid-2027.
Disc Medicine received a Complete Response Letter (CRL) from the FDA for bitopertin, delaying approval, and aims to respond after completing the Phase 3 APOLLO trial. The CRL, dated Feb. 13, 2026, cited insufficient evidence that PP9 reduction predicts clinical benefit, with the main objection being the sufficiency of PPIX as a surrogate biomarker.
The FDA requested the outcome of the ongoing Phase 3 APOLLO trial. Disc Medicine plans to complete APOLLO enrollment by March 2026 and expects topline data in Q4 2026 to support its CRL response. The company will include APOLLO safety data and integrate it with a prior >4,000-subject database.
Disc Medicine intends to request a Type A meeting with the FDA and targets an updated decision by mid-2027 after approximately a six-month review. The company says it is well-capitalized through the APOLLO readout and maintains commitment to patient access and advancing the program.