Disc Medicine Inc., a clinical-stage biopharmaceutical company, has announced a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). The meeting discussed the planned NDA submission for their drug bitopertin, intended for the treatment of Erythropoietic Protoporphyria $(EPP.UK)$. The company has confirmed alignment with the FDA on the expected timing and content of the NDA submission, which is slated for October 2025. This progress indicates Disc Medicine's preparation for its potential first product launch, aiming to utilize the FDA's accelerated approval pathway based on existing data.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Disc Medicine Inc. i published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9497398-en) on July 21, 2025, and is solely responsible for the information contained therein.