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.

H.C. Wainwright has upgraded Savara (NASDAQ:SVRA) to a Buy rating from Neutral, raising its price target to $5 per share from $2. The upgrade is based on the potential resubmission of the company's marketing application for its lead asset, Molbreevi, with the FDA. Savara's biologics license application (BLA) for Molbreevi was initially refused by the FDA in May due to insufficient Chemistry, Manufacturing, and Controls (CMC) data. However, H.C. Wainwright analyst Andrew Fein is optimistic about the prospects of a revised BLA, which is expected to be refiled in December. The analyst notes that the company has reached alignment with the FDA regarding the CMC data needed for the BLA's resubmission, and that the risk of another refusal is lessened by data generated from Process Performance Qualification (PPQ) campaigns at Fujifilm Diosynth Biotechnologies, which is now serving as the drug substance manufacturer. Savara aims for a priority review with a target action date potentially in August 2026 [1].

References:
[1] https://seekingalpha.com/news/4486226-savara-stock-upgraded-hc-wainwright