Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma
Biofrontera Inc. (BFRI)
Company Research
Source: GlobeNewswire
Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT photosensitizer indicated for the treatment of superficial Basal Cell Carcinoma (sBCC) in the USBCC is the most common skin cancer in the US with 3.6 million cases diagnosed annually1 WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of photodynamic therapy (PDT), today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company’s supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026. If approved, this
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BFRI
News
- Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary EndpointGlobeNewswire
- Biofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year GrowthGlobeNewswire
- Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory MilestonesGlobeNewswire
- Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property PortfolioGlobeNewswire
- Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and ExtremitiesGlobeNewswire
BFRI
Earnings
- 11/12/25 - Miss
BFRI
Sec Filings
- 2/11/26 - Form SCHEDULE
- 2/9/26 - Form 8-K
- 1/28/26 - Form SCHEDULE
- BFRI's page on the SEC website