FDA refuses to file Savara BLA for Molbreevi

Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94.

Unlike a post-review rejection in the form of a complete response letter, an RTF letter means the FDA has declined to evaluate Savara’s application as submitted.

Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the agency, Savara noted. Typically, Type A meetings are granted by the FDA within 30 days of the request.