Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025, and subsequently was awarded the FDA Commissioner’s National ...

In Q1 2025, the Company will discuss the plans for NDA submission under a potential accelerated approval path for bitopertin in erythropoietic protoporphyria (EPP), following a Type C meeting with FDA ...