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

March 19, 2026: Biofrontera Inc. (NASDAQ: BFRI) reported 4Q and full-year 2025 results and provided catalyst-focused business updates for its Ameluz® photodynamic therapy (PDT) franchise using the RhodoLED® red-light lamp platform.

Ameluz – superficial basal cell carcinoma (sBCC): The company said the FDA completed its filing review and accepted Biofrontera’s supplemental NDA (sNDA) for Ameluz PDT in sBCC. A PDUFA date is set for September 2026.

Ameluz – actinic keratoses (AKs) on extremities/neck/trunk: Biofrontera announced positive, statistically significant top-line Phase 3 results evaluating Ameluz PDT with RhodoLED for mild-to-moderate AKs on extremities, neck, and trunk. It also announced database lock of a required Phase 1 pharmacokinetics study supporting an FDA filing for treatment fields up to 240 cm².

Ameluz – acne vulgaris: The company reported positive Phase 2b results for Ameluz topical gel, 10% plus RhodoLED in moderate-to-severe acne vulgaris.

Business/portfolio actions: Biofrontera closed the purchase of all Ameluz/RhodoLED U.S. assets from Biofrontera AG, reducing the earnout to 12%–15% of U.S. net sales; divested Xepi antibiotic cream to Pelthos Pharmaceuticals for $3M upfront plus milestones.