Oppenheimer Maintains Outperform Rating for Savara Despite FDA Setback

Oppenheimer initiated coverage on Savara (SVRA) with an Outperform rating and revised price target of $5, despite the FDA's Refusal to File for Molbreevi due to additional CMC data required. The firm remains optimistic about Molbreevi's market prospects, citing its strong performance in the Phase 3 IMPALA trial and the absence of approved therapies for its targeted condition. Savara plans to submit its Marketing Authorization Application in Europe and the U.K. by the end of 2025.

Savara Inc. (SVRA) recently received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for MOLBREEVI, a therapy intended to treat autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The FDA has requested additional Chemistry, Manufacturing, and Controls (CMC) data, with no concerns about safety or efficacy identified [1].

Despite the setback, Oppenheimer initiated coverage on Savara with an Outperform rating and revised price target of $5. The firm remains optimistic about Molbreevi's market prospects, citing its strong performance in the Phase 3 IMPALA trial and the absence of approved therapies for the targeted condition. Savara plans to submit its Marketing Authorization Application in Europe and the U.K. by the end of 2025 [2].

The RTF letter is a procedural hurdle rather than a clinical one, as the FDA's concerns are operational and not related to safety or efficacy. Savara has outlined a clear path forward, including a Type A meeting with the FDA within 30 days to discuss the required data and aims to resubmit the BLA by the fourth quarter of 2025. The company is also preparing to secure a second-source manufacturer to ensure production stability [3].

MOLBREEVI retains several important designations, including Fast Track, Breakthrough Therapy, and Orphan Drug Designations from the FDA, as well as the UK's Innovation Passport and Promising Innovative Medicine designations. These designations are not revoked by the RTF and can accelerate review timelines once the BLA is resubmitted. Analysts are bullish on Molbreevi's chances of approval, with some estimating a 90% probability of success [2].

Autoimmune PAP affects approximately 2,000–4,000 people in the U.S., with no FDA-approved treatments. MOLBREEVI offers a first-in-class therapeutic option, targeting the disease mechanism directly. The drug's market exclusivity post-approval could be substantial, given its Orphan Drug status and the lack of competitors in late-stage development [2].

Savara's liquidity is a critical buffer, with a current ratio of 14.91 and ample cash to fund regulatory and supply chain initiatives. The stock's post-RTF dip has created a valuation disconnect, with a $150 million market cap for a company with a potentially $1 billion+ asset in MOLBREEVI [2].

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.ainvest.com/news/savara-fda-setback-strategic-opportunity-rare-disease-innovation-2505/
[3] https://www.investing.com/news/swot-analysis/savaras-swot-analysis-molbreevis-potential-drives-stock-outlook-93CH-4065856