Evercore ISI downgraded Savara (SVRA, Financials) to "in line" from "outperform," citing worries over Molbreevi's FDA approval.
The downgrading highlights possible obstacles in Savara's strategy to bring the medication to market resulting from doubts about the company's manufacturing capacity.
Evercore also lowered Savara's price target to $5 from $7; SVRA stock is down 9.5% to open Wednesday's trading at $3.45. Analyst Liisa Bayko clarified that although Savara wants to finish its rolling Biologics License Application for Molbreevi by the end of the first quarter in 2025, its current manufacturing approach may hinder FDA clearance path. Should accepted with a priority evaluation, Molbreevi might enter the market by the end of 2025, possibly bringing in more than $500 million yearly, Bayko said.
Bayko expressed worries about Savara's main manufacturing partner, GEMA, an Argentinean company without past FDA-approved product production experience. Particularly in areas of chemistry, manufacturing, and controls, this lack of experience could make it difficult to satisfy FDA criteria—known to be strict. Savara has picked Fujifilm-Dyxth as a backup manufacturer in order to lower these hazards. Bayko, however, voiced dismay that Fujifilm-Diosynth was not chosen as a manufacturing partner sooner, therefore reducing the danger of regulatory delays or problems resulting from GEMA's poor FDA record.
A non-glycosylated version of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), molbreevi, is sometimes known as a molgramostim nebulizer solution. It is in development as a treatment for autoimmune pulmonary alveolar proteinosis, a disorder in which lipids and proteins build up in the lungs, therefore restricting oxygen flow. Should approved, Molbreevi could be a major breakthrough for many of the people with this rare illness, many of whom now have few therapeutic choices.
