pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › PDUFA Calendar › BFRI

BFRI PDUFA Date: Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series

FDA decision (PDUFA) target 2026-09-28 · Biofrontera Inc. · Basal cell carcinoma

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

$1.15$0.78
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-28
Drug / candidateAmeluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series
IndicationBasal cell carcinoma
CompanyBiofrontera Inc.
Market-cap tierMicro
Cohort decision-day move (history)±7% median
ClinicalTrials.govNCT02144077 · completed

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

FAQ

When is the BFRI PDUFA date?
The FDA PDUFA target date for BFRI (Biofrontera Inc.) is 2026-09-28 for Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is BFRI's drug Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series?
Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series is Biofrontera Inc.'s candidate under FDA review for Basal cell carcinoma.
What typically happens to a micro-cap stock into a PDUFA date?
Historically, micro-cap names had a median decision-day move around ±7% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.