Japan PM Ishiba to announce resignation by August end – Mainichi
On Monday, Oppenheimer analysts assumed coverage of Savara stock (NASDAQ: NASDAQ:SVRA) with an Outperform rating and a price target of $5, representing over 100% upside from the current price of $2.40. According to InvestingPro data, the stock has declined nearly 20% in the past week, though analyst consensus remains bullish with targets ranging from $2 to $16.
Savara management disclosed that the company received a Refusal to File (RTF) 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. Importantly, the RTF was not related to safety or efficacy concerns, and no further efficacy trials were suggested. While the company maintains a strong liquidity position with a current ratio of 14.9x, InvestingPro analysis indicates the company is quickly burning through cash.
The analysts noted the strength of Savara’s Phase 3 IMPALA trial and highlighted the absence of approved drug therapies and the challenges associated with whole lung lavage (WLL). They expressed confidence in Molbreevi’s potential for commercial success, supported by new data from the American Thoracic Society (ATS).
Savara is also on track to submit its Marketing Authorization Application (MAA) for Molbreevi in Europe and the UK by the end of 2025. The analysts’ positive outlook on Savara’s prospects reflects these strategic developments.
In other recent news, Savara Inc. has faced several significant developments concerning its drug Molbreevi, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). The U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter for Savara’s Biologics License Application (BLA), citing incomplete Chemistry, Manufacturing, and Controls (CMC) data. Despite this setback, Savara remains optimistic and plans to address the FDA’s concerns by resubmitting the BLA in late 2025. Analysts have responded to these developments with mixed reactions. H.C. Wainwright downgraded Savara’s stock from Buy to Neutral, citing uncertainty around the regulatory path and market opportunity for Molbreevi. Meanwhile, Guggenheim maintained a Buy rating but lowered the price target from $9.00 to $8.00, reflecting a slight decrease in Molbreevi’s probability of success. Evercore ISI also adjusted its price target to $2.00, while JMP Securities maintained a more optimistic stance with a $10.00 target, expressing confidence in Molbreevi’s approval prospects. These recent developments highlight the varied analyst perspectives on Savara’s regulatory journey and potential market impact.
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