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Home › PDUFA Calendar › BFRI

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

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on September 9, 2026, 19 days before its September 28, 2026 goal date. Decision page with the source and measured reaction.
FDA decision Approved September 9, 2026 · 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 was approved by the FDA on September 9, 2026 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 decisionApproved September 9, 2026
FDA goal 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

What did the FDA decide on BFRI's Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series?
The FDA decided BFRI's (Biofrontera Inc.) application for Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series on September 9, 2026: Approved. The FDA goal date for this application was 2026-09-28. Verify against the linked primary source.
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 drug, approved by the FDA on September 9, 2026 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.