Biofrontera Inc. BFRI
Biofrontera Inc. (Nasdaq: BFRI) is a dermatology drug developer. Its lead program, Ameluz (aminolevulinic acid gel) with RhodoLED lamps, photodynamic therapy, is in Phase 3 for Actinic keratosis (face and scalp); label-expansion programs in superficial basal cell carcinoma, AK trunk/extremities, acne. Its next catalyst on record is Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% with BF-RhodoLED lamp: Biofrontera plans to officially launch the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% with BF-RhodoLED lamp — Biofrontera plans to officially launch the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027. (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ameluz PDT | Actinic keratosis, face and scalp (marketed) | small molecule | Approved |
| Ameluz PDT | Superficial basal cell carcinoma (sNDA) | small molecule | Phase 3 |
| Ameluz PDT | Actinic keratosis, trunk and extremities (Phase 3 complete, sNDA planned) | small molecule | Phase 3 |
| Ameluz PDT | Moderate to severe acne (Phase 2) | small molecule | Phase 2 |
| Ameluz PDT | AK pain reduction | small molecule | Pre-clinical |
Recent results and decisions
- Sep 14, 2026approval FDA approved the sNDA for Ameluz PDT in sBCC, supported by a Phase 3 with 66% composite complete response vs 5% placebo-PDT (95/145 vs 2/42).
the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED® lamp series, for the treatment of superficial Basal Cell C
Filing - Sep 14, 2026met Multicenter Phase 3 trial of Ameluz PDT in superficial BCC achieved primary endpoint with 66% clinical and histological complete response versus 5% for placebo-PDT.
The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared with 5% of subjects treated with placebo-PDT
Filing - Mar 19, 2026accepted FDA accepted the sBCC sNDA for filing (previously announced); CEO cites a PDUFA date in September 2026.
Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz® Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.