Savara Gets Outperform Rating at Oppenheimer Despite FDA Request for Additional Data

Oppenheimer assumed coverage of Savara (SVRA) with an Outperform rating and a reduced price target of $5, after the company received a Refusal to File for its BLA for Molbreevi. Although the FDA requested additional CMC data, Oppenheimer believes the drug is well-positioned for commercial success due to its strong Phase 3 trial results and lack of approved therapies. Savara remains on track to submit Molbreevi for MAA in Europe and the U.K. by year-end 2025.

Oppenheimer analysts have assumed coverage of Savara Inc. (SVRA) with an Outperform rating and a price target of $5, following the company's receipt of a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Molbreevi. The FDA requested additional Chemistry, Manufacturing, and Controls (CMC) data, but there were no concerns about safety or efficacy [1].

Despite the regulatory setback, Oppenheimer remains optimistic about Molbreevi's commercial potential. The analysts highlighted the drug's strong Phase 3 trial results and the absence of approved therapies for autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease. Savara is also on track to submit its Marketing Authorization Application (MAA) for Molbreevi in Europe and the UK by the end of 2025 [2].

Savara plans to meet with the FDA and resubmit the BLA in the fourth quarter of 2025, aiming to address the agency's concerns. The company's strong liquidity position, with a current ratio of 14.9x, provides a solid financial foundation for these efforts [3].

References:
[1] https://www.gurufocus.com/news/2888782/savara-receives-refusal-to-file-rtf-letter-from-the-us-food-and-drug-administration-fda-for-the-biologics-license-application-bla-for-molbreevi-to-treat-patients-with-autoimmune-pulmonary-alv
[2] https://www.investing.com/news/analyst-ratings/oppenheimer-assumes-savara-stock-at-outperform-sets-5-price-target-93CH-4075975
[3] https://www.investing.com/news/swot-analysis/savaras-swot-analysis-molbreevis-potential-drives-stock-outlook-93CH-4065856