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Investing.com - JMP Securities has reiterated its Market Outperform rating and $8.00 price target on Savara (NASDAQ:SVRA), currently trading at $3.09, following the publication of Phase 3 data for Molbreevi in the New England Journal of Medicine. According to InvestingPro data, analyst targets range from $5 to $16, with strong consensus recommendations.
The publication highlights the robust findings from the IMPALA-2 trial for autoimmune pulmonary alveolar proteinosis (aPAP), with JMP noting the data underscores the high unmet need in this condition. The trial showed Molbreevi resulted in a 9.8% improvement in DLCO after 24 weeks and an 11.6% improvement after 48 weeks, compared to 3.8% and 4.7% with placebo. With a market capitalization of $648 million, Savara maintains strong liquidity with a current ratio of 11.08 and holds more cash than debt on its balance sheet.
An accompanying editorial suggested that inhaled GM-CSF (Molbreevi) could replace whole lung lavage as the standard of care for aPAP. JMP also highlighted that 100% of eligible patients rolled over to the extension study, demonstrating enthusiasm for the treatment.
Savara plans to resubmit its Biologics License Application (BLA) for Molbreevi in December after receiving a Refusal to File letter based on Chemistry, Manufacturing, and Controls issues. JMP maintains that approval is likely, noting the FDA did not list safety concerns or request additional efficacy studies.
JMP projects a U.S. launch in 2027 and estimates worldwide Molbreevi sales could reach approximately $1.2 billion at peak.
In other recent news, Savara Inc. announced positive results from its Phase 3 IMPALA-2 clinical trial for molgramostim inhalation solution, a treatment for autoimmune pulmonary alveolar proteinosis (PAP). The trial showed significant improvements in pulmonary gas transfer compared to a placebo after 24 weeks of treatment. Additionally, Savara’s partner, TrilliumBiO, will present research on a new diagnostic tool for PAP at the upcoming European Respiratory Society Congress in Amsterdam. H.C. Wainwright upgraded Savara’s stock rating from Neutral to Buy, raising the price target to $5.00, following the company’s alignment with the FDA on resubmitting its Biologics License Application (BLA) for Molbreevi. Oppenheimer also raised its price target on Savara stock to $6.00 while maintaining an Outperform rating. This decision follows Savara’s recent second-quarter financial report and the business update on their BLA resubmission plans. At Savara’s annual meeting, stockholders elected six directors to the company’s board and approved key proposals, including the appointment of RSM US LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025.
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