Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities
Biofrontera Inc. (BFRI)
Company Research
Source: GlobeNewswire
Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 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 the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). The last patient visit took place on 24 November 2025. Data from this study, together with results from Biofrontera’s recently completed Phase 3 clinical trial, will form the ba
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News
- Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT [Yahoo! Finance]Yahoo! Finance
- Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDTGlobeNewswire
- Biofrontera (NASDAQ:BFRI) had its "buy" rating reaffirmed by analysts at Benchmark Co..MarketBeat
- Biofrontera Inc. (BFRI) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- Biofrontera Inc. Reports Third Quarter 2025 Financial Results and Provides a Business UpdateGlobeNewswire
BFRI
Earnings
- 11/12/25 - Miss
BFRI
Sec Filings
- 11/13/25 - Form 8-K
- 11/12/25 - Form 10-Q
- 11/12/25 - Form SCHEDULE
- BFRI's page on the SEC website