Oppenheimer assumed coverage of Savara (SVRA) with an Outperform rating with a price target of $5, down from $15, following quarterly results. Management announced it received a Refusal to File for its BLA for Molbreevi, with the FDA requesting additional CMC data. The firm says that while unexpected, it’s encouraging that the RTF was not related to safety or efficacy, and no additional efficacy trials were requested/recommended. Based on the strength of the Phase 3 IMPALA trial, and considering the lack of approved drug therapies and the challenges of whole lung lavage, Oppenheimer still believes Molbreevi is well-positioned for commercial success. New ATS data further supports its clinical potential. Savara also remains on track to submit Molbreevi MAA in Europe and U.K. by year-end 2025, the firm adds.
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