H.C. Wainwright analyst Andrew Fein maintained a Buy rating on Savara today and set a price target of $8.00.
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Andrew Fein has given his Buy rating due to a combination of factors that highlight Savara’s strong positioning for the potential launch of Molbreevi. One significant aspect is the company’s plan to resubmit the Biologics License Application (BLA) for Molbreevi in December, with Fujifilm Diosynth Biotechnologies as the drug substance manufacturer. This decision, along with the alignment with the FDA on the analytical comparability package and CMC data, reduces the risks associated with the filing process. Additionally, Savara’s progress in identifying a significant portion of the aPAP patient population further strengthens its market readiness.
Recent developments have also positively impacted the market and regulatory outlook for Molbreevi. The increase in confirmed aPAP patients to approximately 5,500, coupled with higher U.S. prevalence rates, alleviates concerns about the initial addressable market. This growth is likely due to increased awareness and diagnosis rates rather than an epidemiologic shift, which supports the expansion of the patient pool. On the regulatory front, the switch to Fujifilm as the manufacturer after an initial Refusal to File (RTF) with GEMA Biotech has de-risked the CMC package, positioning Savara favorably for BLA acceptance and a potential mid-2026 launch.
In another report released today, LifeSci Capital also reiterated a Buy rating on the stock with a $11.00 price target.