Savara Upgraded to Buy by H.C. Wainwright on Potential FDA Refiling for Molbreevi

H.C. Wainwright upgraded Savara to Buy from Neutral and raised its price target to $5 from $2 per share, citing a potential resubmission of the company's marketing application for its lead asset, Molbreevi, with the FDA.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported its financial results for the second quarter ending June 30, 2025, and provided a business update. The company reported a net loss of $30.4 million, or $(0.14) per share, compared to a net loss of $22.2 million, or $(0.12) per share, in the same period last year.

Research and development expenses increased by $3.1 million, or 17.8%, to $20.8 million for the three months ended June 30, 2025, primarily driven by initiatives related to the MOLBREEVI program. General and administrative expenses increased by $5.1 million, or 92.3%, to $10.7 million, mainly due to strategic personnel additions and commercial activities.

Savara also announced significant progress in its MOLBREEVI program, a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The company has reached alignment with the U.S. Food and Drug Administration (FDA) on the information needed for the resubmission of the Biologics License Application (BLA) for MOLBREEVI. The BLA is expected to be resubmitted in December with FUJIFILM Biotechnologies (Fujifilm) as the drug substance manufacturer, with a request for priority review. The company anticipates submitting the MOLBREEVI Marketing Authorization Applications to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in the first quarter of 2026.

As of June 30, 2025, Savara had cash, cash equivalents, and short-term investments of approximately $146.4 million and debt of approximately $29.7 million. The company believes it is sufficiently capitalized to support its operations into the first quarter of 2027.

H.C. Wainwright & Co. recently upgraded Savara to "Buy" from "Neutral" and raised its price target to $5 from $2 per share, citing the potential resubmission of the company's marketing application for MOLBREEVI with the FDA [1].

References:
[1] https://investors.savarapharma.com/news/news-details/2025/Savara-Reports-Second-Quarter-2025-Financial-Results-and-Provides-a-Business-Update/default.aspx