Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT
Biofrontera Inc. (BFRI)
Company Research
Source: GlobeNewswire
sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025First Phase 3 PDT study in patients with sBCC in the United States submitted to FDAPrimary and key secondary endpoints met with high statistical significance (p Favorable recurrence outcomes at one-year follow-upBCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1 WOBURN, Mass., Dec. 02, 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 submission of an sNDA to the FDA, seeking approval of Ameluz®-PDT for the treatment of sBCC. The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera’s U.S. and European Basal Cell Carcino
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News
- Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and ExtremitiesGlobeNewswire
- 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 (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
- 12/5/25 - Form S-1
- 11/13/25 - Form 8-K
- 11/12/25 - Form 10-Q
- BFRI's page on the SEC website