IRON Disc Medicine

Disc Medicine Reports Positive Phase 3 APOLLO Topline Results for Bitopertin in EPP

The APOLLO Phase 3 trial met all co-primary and secondary endpoints with statistically significant reductions in PPIX, increases in time in light, and reductions in phototoxic reactions. Disc plans to resubmit the NDA by end of 2026 with anticipated FDA decision by mid-2027.

bitopertin · NCT06910358 registry update

status: ACTIVE_NOT_RECRUITING → COMPLETED; primary_completion: 2026-09 → 2026-09-08; completion: 2026-10 → 2026-09-08

Disc Medicine receives CRL for bitopertin NDA in EPP

FDA issued a CRL for bitopertin NDA, citing lack of correlation between PPIX reduction and clinical endpoints in AURORA and BEACON trials. The agency requires Phase 3 APOLLO results to support traditional approval. Topline data from APOLLO are expected in Q4 2026, with a potential resubmission and FDA decision by mid-2027.

Disc Medicine, Inc. · complete response letter (NDA 220707)

FDA issued a complete response letter for NDA 220707 dated 2026-02-13.

Disc Medicine: Bitopertin NDA accepted Nov 28 under CNPV pilot

FDA accepted the bitopertin NDA on November 28. The application was selected for the Commissioner’s National Priority Voucher pilot, which shortens the expected review period to 1-2 months and keeps the anticipated action date by the end of January 2026.

Disc Medicine submits NDA for bitopertin in EPP; receives CNPV

Disc submitted an NDA for bitopertin seeking accelerated approval in EPP on September 29, 2025. The FDA awarded the Commissioner’s National Priority Voucher, shortening the expected review to 1-2 months from acceptance. The company is accelerating launch preparations for a potential US approval in late 2025 or early 2026.

Disc Medicine submits NDA for bitopertin in EPP

Disc Medicine submitted an NDA for accelerated approval of bitopertin in EPP on September 29, 2025. The FDA granted the Commissioner’s National Priority Voucher, shortening the expected NDA review period to 1-2 months. The company now expects potential US approval and launch in late 2025 or early 2026.

Disc Medicine receives FDA CNPV for bitopertin in EPP

The FDA granted Disc Medicine a Commissioner’s National Priority Voucher for bitopertin in EPP, providing enhanced communications, rolling review, and the potential to shorten NDA review time to 1-2 months. The NDA was submitted in September 2025 under the accelerated approval pathway for patients aged 12 years and older.