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WOBURN, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025.
Acne vulgaris is a common skin condition characterized by inflammatory and non-inflammatory lesions that frequently lead to permanent scarring. Beyond the physical burden, AV often has a significant psychological impact, including reduced self-esteem and depression.
Current U.S. guidelines recommend a range of treatment options for AV, including topical agents, systemic antibiotics, hormonal therapies, isotretinoin and physical treatments. However, many of these options carry limitations such as serious side effects, teratogenic risks, the need for continuous daily dosing, or—particularly with antibiotics—growing concerns about resistance. As a result, there remains a critical unmet need for alternative treatment options.
Biofrontera's Phase 2b trial is a multicenter, randomized, double-blind study comparing Ameluz® with vehicle gel for the treatment of moderate to severe acne vulgaris using red-light Photodynamic Therapy (PDT). Following application of one tube of Ameluz® or vehicle gel to the entire face, participants were incubated for either 1 or 3 hours before illumination with the BF-RhodoLED® lamp. Up to 3 PDT sessions were performed at monthly intervals and participants were followed up for an additional 2 months after receiving the last PDT.
Posted In: BFRI
