We are a United States based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”). The Company’s products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamp series (together, the “RhodoLED Lamps”), are used for the treatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous lesions (or “AKs”).
Partnerships Former Ameluz Licensor (Biofrontera Pharma GmbH) Second A&R Ameluz LSA terminated; earnout replaces the prior transfer pricing model (25% of net revenue replaced by direct cost plus 12-15% earnout)
Indications
Actinic keratosis (AK)(Approved)
Superficial basal cell carcinoma (sBCC)(Stage not disclosed)
Moderate to severe acne(Phase 2)
Catalysts
— Q3 2026
— 2027
Status note Principal commercial product; prescription drug approved in the U.S. in October 2016 for PDT use with RhodoLED Lamps. sBCC sNDA submitted to FDA in Q4 2025. Moderate-to-severe acne Phase 2 completed (last patient out of treatment Q3 2025; data obtained Q1 2026) and the trial is being wound down, but the filing states no discontinuation of the acne program. FDA approved sNDAs increasing the maximally approved dosage from one to three tubes and a new propylene-glycol-free formulation.
Per-asset detail extracted from the 10-Q filed 2026-08-13. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Sponsor-matched active trials from ClinicalTrials.gov (1 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.