Savara stock holds Buy rating, $6 target from H.C. Wainwright

On Friday, Savara Inc. (NASDAQ:SVRA), currently valued at $582 million, maintained a positive outlook from H.C. Wainwright, with analyst Andrew S. Fein upholding a Buy rating and a $6.00 price target for the company’s shares. According to InvestingPro data, analyst targets for the stock range from $5 to $16, suggesting significant upside potential from current levels around $2.78. Fein’s optimism is rooted in the recent completion of a Biologics License Application (BLA) submission to the FDA for Molbreevi, Savara’s recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) therapy.

Fein highlighted the possibility of a Priority Review for Molbreevi, which could result in a Prescription Drug User Fee Act (PDUFA) date by the end of 2025. Additionally, he noted that commercial launch preparations are already in progress, aiming for a potential early 2026 market introduction, aligning with the firm’s current projections. The company’s strong financial position, with a current ratio of 17.7x and more cash than debt on its balance sheet, provides a solid foundation for these commercial preparations.

Molbreevi is poised to become a significant advancement in the treatment landscape for patients with autoimmune pulmonary alveolar proteinosis (aPAP), as it stands to be the first and only approved therapy for this condition. The anticipation is whether commercial efforts will be able to reach 1,000 aPAP patients by the time of Molbreevi’s launch.

Fein also addressed the challenges in diagnosing aPAP, as it often presents with symptoms similar to pneumonia, bronchitis, or asthma, which can lead to misdiagnosis. The availability of the aPAP ClearPath blood test, which aids in the accurate detection of autoantibodies, is seen as a crucial tool in improving diagnosis. The adoption of this test among physicians is considered essential for the successful introduction of Molbreevi.

As the aPAP program continues to make progress, H.C. Wainwright reaffirms its confidence in Savara’s potential and its $6 price target, awaiting the initial commercial trajectory of Molbreevi following its anticipated approval. While the company currently shows negative earnings per share of -$0.43, InvestingPro analysis reveals several additional insights about the company’s financial health and future prospects. For deeper analysis and access to comprehensive financial metrics, including exclusive ProTips and Fair Value calculations, investors can explore the detailed Pro Research Report available on InvestingPro.

In other recent news, Savara Inc. announced the completion of its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). The company is seeking a Priority Review from the FDA, which could expedite the approval process to six months. Savara’s recent data indicates that MOLBREEVI has shown significant improvements in lung function and quality of life for aPAP patients, with no discontinuations due to adverse events reported in trials. JMP Securities has maintained a Market Outperform rating for Savara, with a price target of $9.00, citing confidence in the drug’s approval and its potential market impact.

The company has launched its aPAP ClearPath Dried Blood Spot test in the U.S., aiming to improve diagnosis and access to testing. Savara estimates initial annual sales of MOLBREEVI could range from $300 million to $500 million, with peak U.S. sales potentially reaching $750 million. The company has identified a larger patient population than previously estimated, with approximately 3,600 diagnosed patients and an additional 3,700 likely to have aPAP. Additionally, Savara has set executive bonus targets for 2025, aligning them with corporate and individual performance goals. The recent developments underscore Savara’s strategic focus on advancing its product candidates for rare respiratory diseases.

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