Savara upgraded to Buy by H.C. Wainwright on potential Molbreevi marketing application resubmission.

H.C. Wainwright has 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. The upgrade is based on the potential for a refiling of the marketing application, which could lead to Molbreevi receiving FDA approval.

H.C. Wainwright & Co. has upgraded Savara Inc. (Nasdaq: SVRA) to a "Buy" rating from "Neutral," raising its price target to $5 from $2 per share. The upgrade is driven by the potential resubmission of Savara's marketing application for its lead asset, Molbreevi, with the U.S. Food and Drug Administration (FDA) [1, 2].

Savara reported its financial results for the second quarter ending June 30, 2025, showing 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 [1, 2]. Research and development expenses increased by $3.1 million, or 17.8%, to $20.8 million, primarily due to initiatives related to the MOLBREEVI program [1, 2]. General and administrative expenses also increased by $5.1 million, or 92.3%, to $10.7 million, mainly due to strategic personnel additions and commercial activities [1, 2].

Significant progress has been made in Savara's MOLBREEVI program, a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) [1, 2]. The company has reached alignment with the FDA on the information needed for the resubmission of the Biologics License Application (BLA) for MOLBREEVI, which is expected to be resubmitted in December with FUJIFILM Biotechnologies (Fujifilm) as the drug substance manufacturer, requesting priority review [1, 2].

Savara 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 [1, 2]. As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $146.4 million and debt of approximately $29.7 million, believing it is sufficiently capitalized to support its operations into the first quarter of 2027 [1, 2].

H.C. Wainwright analyst Andrew Fein cited alignment with the FDA on the chemistry, manufacturing, and controls (CMC) data for Molbreevi and reduced risk of the filing not being accepted as the primary reasons for the upgrade [2]. The analyst believes the data generated from campaigns at Fuji and alignment with the FDA lessen the risk of the filling not being accepted [2].

References:
[1] https://www.ainvest.com/news/savara-upgraded-buy-wainwright-potential-fda-refiling-molbreevi-2508/
[2] https://www.ainvest.com/news/savara-upgraded-buy-wainwright-resubmission-prospects-2508/