Disc spins past FDA setback with ‘overwhelmingly positive’ data
Disc spins past FDA setback with ‘overwhelmingly positive’ data
Disc Medicine
Disc Medicine is a clinical-stage biopharmaceutical company developing novel hematology therapeutics for patients with serious and rare blood diseases. The company's pipeline includes bitopertin (a glycine transport-1 inhibitor) for erythropoietic protoporphyria (EPP) and other hematologic disorders.
Company Info
Sector:Biotechnology / Rare Hematology
Headquarters:Watertown, Massachusetts, USA
Founded:2017
Website:www.discmedicine.com/
Upcoming Milestones & Key Dates
Q4 2026 / Q1 2027
Clinical Trial
APOLLO Phase 3 top-line data for bitopertin in EPP
Q2 2026
Earnings
Q1 2026 Earnings — Pipeline update and FDA interaction summary
Clinical Development Pipeline
Bitopertin
Target: Glycine transporter 1 (GlyT1) inhibitorDISC-0974
Target: Anti-hemojuvelin monoclonal antibody (hemojuvelin modulator)DISC-0974
Target: Anti-hemojuvelin monoclonal antibodyWorkforce & Restructuring Tracker
View Industry Layoff Tracker →31 roles (20%)Confirmed
Disc Medicine laid off approximately 20% of its staff (31 commercial and support roles) after receiving an FDA Complete Response Letter (CRL) declining accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) based on a PPIX surrogate biomarker, shifting resources toward completing its confirmatory Phase 3 APOLLO trial.
Recent News
Disc Medicine's FDA Meeting Sets 'Clear Path' for Embattled Rare Blood Disease Drug
Following productive meetings with the FDA, Disc Medicine outlined a regulatory path forward for its rare blood disease program, with Phase 3 data and a potential approval submission targeted for late 2026 / early 2027.