Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz® for Actinic Keratoses on Trunk and Extremities
Biofrontera Inc. (BFRI)
Company Research
Source: GlobeNewswire
Phase 1 maximal-use pharmacokinetics (PK) study completed in support of planned U.S. label expansionData to complement previously announced positive Phase 3 efficacy results on extremities, neck and trunkSupplemental NDA submission for extremities, neck and trunk indication expected in Q3 2026 WOBURN, Mass., Feb. 17, 2026 (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 database of its Phase 1 PK study evaluating Ameluz® (aminolevulinic acid hydrochloride) topical gel for the treatment of mild to moderate actinic keratoses (AKs) on neck, trunk and extremities was locked on February 11, 2026. The Phase 1, non-randomized, open-label study assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz® in combination with the re
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News
- U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma's Patent 11,697,028 To Be Unpatentable [Yahoo! Finance]Yahoo! Finance
- U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be UnpatentableGlobeNewswire
- Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz® for Actinic Keratoses on Trunk and Extremities [Yahoo! Finance]Yahoo! Finance
- Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell CarcinomaGlobeNewswire
- Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary EndpointGlobeNewswire
BFRI
Earnings
- 11/12/25 - Miss
BFRI
Sec Filings
- 2/26/26 - Form 8-K
- 2/11/26 - Form SCHEDULE
- 2/9/26 - Form 8-K
- BFRI's page on the SEC website