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SVRA PDUFA Date: MOLBREEVI (Molgradex)

FDA decision (PDUFA) target 2026-11-22 · Savara Inc. · Autoimmune pulmonary alveolar proteinosis (aPAP)
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The story

MOLBREEVI (Molgradex) is under FDA review to treat autoimmune pulmonary alveolar proteinosis (aPAP) - a rare lung disease where protein clogs the air sacs. Balance sheet: about 23 months of cash, runway ~23 mo (estimated).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthARQT . 2026-06-29Same area: Immunology / Dermatology . ZORYVE (roflumilast) Cream 0.3%PFE-brepocitinib . 2026-09-30Same area: Immunology / Dermatology . BrepocitinibBTAI . 2026-11-14Same month decision . IGALMI® (dexmedetomidine)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

SVRA run-up into the PDUFA (last ~120 days)

$6.07$4.72
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-11-22
Drug / candidateMOLBREEVI (Molgradex)
IndicationAutoimmune pulmonary alveolar proteinosis (aPAP)
CompanySavara Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT04544293 · Breakthrough Therapy Designation (BTD), Fast Track Designation (FTD), Orphan Drug Designation (ODD)

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FAQ

When is the SVRA PDUFA date?
The FDA PDUFA target date for SVRA (Savara Inc.) is 2026-11-22 for MOLBREEVI (Molgradex). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is SVRA's drug MOLBREEVI (Molgradex)?
MOLBREEVI (Molgradex) is Savara Inc.'s candidate under FDA review for Autoimmune pulmonary alveolar proteinosis (aPAP).
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.