Yeji

$SVRA

Savara Inc

Runway:18 mo
NasdaqMarket cap: —CIK 0001160308

Upcoming catalysts

3 surfaced
NDA/BLA filedDate TBD~ low confidence
$SVRASavara Inc
“Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC).”
FDA approvalDate TBD~ low confidence
$SVRASavara Inc
“Subject to FDA approval of the Company\'s MOLBREEVI product candidate for the treatment of aPAP (the \”
FDA approvalDate TBD~ low confidence
$SVRASavara Inc
“subject in each case to FDA approval of the Company's MOLBREEVI product candidate for the treatment of aPAP (the "Approval Milestone")”

Drug pipeline

molgramostim inhalation
autoimmune pulmonary alveolar proteinosis
Molgramostim
Autoimmune Pulmonary Alveolar Proteinosis
Inhaled molgramostim
Mycobacterium Infections, Nontuberculous
Vancomycin hydrochloride inhalation powder
Cystic Fibrosis
AeroVanc
Healthy
Vancomycin inhalation powder
MRSA
Molgramostim nebulizer solution
Mycobacterium Infections, Nontuberculous

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT06431776MolgramostimPhase 3Recruiting2027-06-01
NCT04544293MolgramostimPhase 3Active Not Recruiting2023-11-30
NCT03482752MolgramostimPhase 3Terminated2021-01-14
NCT03597347Molgramostim nebulizer solutionPhase 2Terminated2020-10-02
NCT03181932Vancomycin inhalation powderPhase 3Completed2020-07-28
NCT03421743Inhaled molgramostimPhase 2Completed2019-10-15
NCT02702180MolgramostimPhase 2Completed2019-04-19
NCT02468908MolgramostimPhase 1Completed2015-10-01
NCT01746095Vancomycin hydrochloride inhalation powderPhase 2Completed2014-11-01
NCT01537666AeroVancPhase 1Completed2012-03-01
NCT06546098Molgramostim nebulizer solution—Available—

Recent catalysts

CRLMay 27, 2025· 375d ago
$SVRASavara Inc
molgramostim inhalation · autoimmune pulmonary alveolar proteinosis
“On May 27, 2025, Savara Inc. issued a press release announcing that it has received a refusal to file letter from the U.S. Food and Drug Administration for the Biologics License Application for molgramostim inhalation solution to treat patients with autoimmune pulmonary alveolar proteinosis.”