Roth Capital Partners reinitiated coverage of Savara (NASDAQ:SVRA) with a “buy” rating and $40 price target. The stock closed at $9.24 on Sept. 26.
Savara is developing inhalable formulations of therapeutics with proven efficacy for lung conditions. It has three candidates in clinical development: Molgradex is in Phase 3 for autoimmune pulmonary alveolar proteinosis (aPAP); AeroVanc has started Phase 3 for MRSA infections in cystic fibrosis (MRSA-CF); and Aironite is in Phase 2 for heart failure with preserved ejection fraction (HFpEF).
“We believe multiple factors favor Molgradex, an inhalable GM-CSF growth factor, as aPAP pathobiology and GM-CSF’s central role are well understood, and a pulmonary disease maximizes the advantages of inhaled delivery,” analyst Michael Higgins writes.
In addition, GM-CSF has consistent positive clinical trials and clear benefits over the alternative whole lung lavage, an invasive procedure requiring general anesthesia, he added.
Molgradex also was granted orphan drug designation in Europe and U.S. and the ongoing Phase 2/3 IMPALA study would be sufficient to support approval in Europe, U.S. and Japan. The trial should complete enrollment in the first quarter of 2018, with results announced in the final quarter.
Savara is developing inhalable vancomycin (AeroVanc) for an increasingly frequent complication of CF, MRSA lung infections.
“We believe an inhaled version would be well received and could change the current standard of care from merely treating acute exacerbations to daily preventative regimens, as when inhaled antibiotics first became available for CF-associated P. aeruginosa lung infections,” Mr. Higgins said.
AeroVanc received orphan drug and qualified infectious disease product designations from the FDA. Pivotal testing began in the third quarter of 2017.