Camurus submits New Drug Application to the US FDA for Oclaiz™ for treatment of acromegaly
Lund, Sweden — 21 December 2023 — Camurus (NASDAQ STO: CAMX) today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Oclaiz[TM] (CAM2029), the company’s investigational, once-monthly octreotide subcutaneous (SC) depot for the treatment of patients with acromegaly. “The NDA submission follows recent announcements of positive results from the two Phase 3 ACROINNOVA studies and completed pre-NDA meetings with the US FDA”, says Fredrik Tiberg, President & CEO, Camurus. “The ACROINNOVA results suggest that Oclaiz[TM], if approved, could