Savara price target lowered to $8 from $9 at Guggenheim

Guggenheim analyst Vamil Divan lowered the firm’s price target on Savara (SVRA) to $8 from $9 and keeps a Buy rating on the shares. After speaking with the Savara management after the “surprise announcement” that the company had received a Refusal to File letter from the FDA for the Molbreevi application to treat autoimmune pulmonary alveolar proteinosis, the firm tells investors that management “maintains a high level of confidence in Molbreevi ultimately getting approved,” but indicated they will be requesting a Type A Meeting to better understand the additional CMC data that the FDA would like to see. Given the setback, the firm is lowering its view of Molbreevi probability of success to 90% from 95% and pushing out the launch timing by about a year to early 2027, but tells investors that it is “reassuring” that the FDA does not appear to be requesting any additional efficacy or safety data at this time.