Why Is Rare Lung Disease-Focused Savara Stock Trading Lower On Tuesday?

Savara Inc. SVRA on Tuesday announced that it received a U.S. Food And Drug Administration (FDA) refusal To File (RTF)) letter regarding the Biologic license application (BLA) for Molbreevi, a therapy for treating patients with autoimmune Pulmonary Alveolar Proteinosis (PAP).

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the lungs’ alveoli.

Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing.

As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange and clinical symptoms of shortness of breath, often with cough and frequent fatigue.

Also Read: AbbVie To Present Cancer Trial Data At Upcoming ASCO Event

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 did not result from safety concerns, and the FDA did not request or recommend additional efficacy studies.

Within 30 days, the company intends to request a Type A meeting with the Agency.

“The requested CMC data outlined in the RTF letter are currently being generated, and we look forward to meeting with the FDA to align on next steps,” said Matt Pauls, Chair and CEO, Savara. “Based on our understanding of the letter, we are confident we can thoroughly address the Agency’s request and expect to resubmit our BLA in the fourth quarter of 2025. We remain highly confident in our program for autoimmune PAP and believe that our clinical data demonstrate that MOLBREEVI improves pulmonary gas transfer and respiratory health-related quality of life in this rare disease.”

Pauls continued, “As outlined in our Annual Report, we are working to establish a redundant supply chain. Pursuant to that strategy, we remain on track to complete the technology transfer with our second-source drug substance contract manufacturer in the fall. We have completed three upstream process performance qualification (PPQ) batches, are in the process of completing our downstream PPQ campaign, and have begun our analytical comparability analysis.”

Price Action: SVRA stock is down 28.9% at $2.02 at the last check Tuesday.

Read Next:

• Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For ‘Healthy’ Pregnant Women, Children

Photo via Shutterstock