Savara upgraded at H.C. Wainwright on potential refiling of marketing application

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Pharrel Wiliams

H.C. Wainwright upgraded Savara (NASDAQ:SVRA [https://seekingalpha.com/symbol/SVRA]) to Buy from Neutral and raised its price target to $5 from $2 per share on Friday, citing a potential resubmission of the company’s marketing application for its lead asset, Molbreevi, with the FDA.

The agency issued a refusal to file in response to the Langhorne, Pennsylvania-based biotech’s biologics license application for Molbreevi in May, citing insufficient data related to its Chemistry, Manufacturing, and Controls. [https://seekingalpha.com/news/4452509-savara-to-meet-fda-as-marketing-application-is-found-to-be-incomplete]

However, H.C. Wainwright analyst Andrew Fein cites higher prospects for its revised BLA, expected to be refiled in December, with Fujifilm Diosynth Biotechnologies (OTCPK:FUJIY [https://seekingalpha.com/symbol/FUJIY]) (OTCPK:FUJIF [https://seekingalpha.com/symbol/FUJIF]) as its drug substance manufacturer rather than privately held GEMA biotech.

He also noted a Type A meeting in which Savara (NASDAQ:SVRA [https://seekingalpha.com/symbol/SVRA]) has reached alignment with the FDA regarding the CMC data needed for the BLA’s resubmission, which the company targets for a priority review with a target action date potentially in August 2026.

Fein added that “considerable data generated from the Process Performance Qualification (PPQ) campaigns at Fuji and alignment with the FDA regarding both the analytical comparability analysis and the CMC data that will be submitted” with the BLA lessens the risk of another refusal.

MORE ON SAVARA

* Savara: Repairing The Molbreevi aPAP Opportunity After RTF [https://seekingalpha.com/article/4803224-savara-repairing-the-molbreevi-apap-opportunity-after-rtf]
* Savara to meet FDA as marketing application is found to be incomplete [https://seekingalpha.com/news/4452509-savara-to-meet-fda-as-marketing-application-is-found-to-be-incomplete]
* Seeking Alpha’s Quant Rating on Savara [https://seekingalpha.com/symbol/SVRA/ratings/quant-ratings]
* Historical earnings data for Savara [https://seekingalpha.com/symbol/SVRA/earnings]
* Financial information for Savara [https://seekingalpha.com/symbol/SVRA/income-statement]