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Home › PDUFA Calendar › SVRA

SVRA PDUFA Date: MOLBREEVI (Molgradex)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-11-22 · Savara Inc. · Autoimmune pulmonary alveolar proteinosis (aPAP)
More Immunology & Inflammation FDA decisions →All November 2026 PDUFA dates →

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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.