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

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-09-28 · Biofrontera Inc. · Basal cell carcinoma
More Cancer & Oncology FDA decisions →All September 2026 PDUFA dates →

The story

Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series is under FDA review to treat basal cell carcinoma - the most common form of skin cancer (a light-activated gel, Ameluz). Balance sheet: about 8 months of cash, runway ~8 mo (estimated). ELEVATED: thin runway around catalyst
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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See the full 2026 PDUFA calendar →

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 ±5% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · micro-cap cohortn=302 · median -0.9% · 43% up
under -30%: 26 of 302 (9%)<-30-30 to -15%: 15 of 302 (5%)-15 to -7%: 24 of 302 (8%)-7 to -3%: 36 of 302 (12%)-3 to +3%: 118 of 302 (39%)±3+3 to +7%: 38 of 302 (13%)+7 to +15%: 19 of 302 (6%)+15 to +30%: 11 of 302 (4%)over +30%: 13 of 302 (4%)>+30
Distribution of next-day % moves after the FDA decision for micro-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.