Savara Upgraded to Buy by H.C. Wainwright Amid Resubmission Prospects

H.C. Wainwright analyst Andrew Fein upgraded Savara to Buy from Neutral with a price target of $5, up from $2, citing alignment with the FDA on the chemistry, manufacturing, and controls data for Molbreevi and reduced risk of the filling not being accepted. The analyst believes the data generated from campaigns at Fuji and alignment with the FDA lessens the risk of the filling not being accepted.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, has reported its financial results for the second quarter ending June 30, 2025. The company also provided a significant business update, highlighting its 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 as a treatment for autoimmune pulmonary alveolar proteinosis (Autoimmune PAP).

During a recent Type A meeting with the FDA, Savara reached alignment on the path forward for the information required to resubmit the BLA. The company plans to resubmit the BLA in December, with FUJIFILM Biotechnologies (Fujifilm) as the drug substance manufacturer. Savara expects to request priority review for MOLBREEVI. Additionally, 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.

Savara's net loss for the second quarter of 2025 was $30.4 million, or $(0.14) per share, compared to a net loss of $22.2 million, or $(0.12) per share, for the same period in 2024. 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 due to activities related to the MOLBREEVI program. General and administrative expenses also increased by $5.1 million, or 92.3%, to $10.7 million, primarily due to the strategic addition of personnel and related costs.

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

H.C. Wainwright analyst Andrew Fein upgraded Savara to "Buy" from "Neutral" with a price target of $5, up from $2, citing the alignment with the FDA on the chemistry, manufacturing, and controls data for MOLBREEVI and reduced risk of the filling not being accepted. Fein believes the data generated from campaigns at Fuji and the alignment with the FDA lessen the risk of the filling not being accepted.

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