News
Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma
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...
Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint
Study findings met its primary endpoint and showed highly statistically significant superiority for Ameluz® vs. vehicle gel (p<0.0003)Actinic keratosis (AK) is the most common skin condition diagnosed by US dermatologists1If left untreated, AK may progress to...
Biofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year Growth
Fourth quarter results represent highest quarterly revenue in Company's historyQ4 year-over-year growth of 35% to 39% driven by sales execution of Ameluz®Full year 2025 revenues also expected to show double-digit growth of 11% to 13% WOBURN, Mass., Jan. 13, 2026...
Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones
Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026Data generated will support key regulatory milestones for Ameluz PDT in both indicationsAK and acne are the two most commonly diagnosed skin disorders in the US1 WOBURN,...
Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio
Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc. Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various...
Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities
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...
Biofrontera Inc. to Report First Quarter FY 2025 Financial Results on May 15, 2025
WOBURN, MA / ACCESS Newswire / May 6, 2025 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces it will report financial results for the three months...
Biofrontera Inc. to Present at The Benchmark Company’s Upcoming Discovery One-on-One Investor Conference
WOBURN, MA / ACCESSWIRE / December 3, 2024 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced it will be presenting at The...
Biofrontera Inc. to Report Third Quarter Financial Results on November 13, 2024
WOBURN, MA / ACCESSWIRE / November 1, 2024 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of PDT, announces it will report financial results for the three and nine...
Biofrontera to Present at the 3rd Annual ROTH Healthcare Opportunities Conference
WOBURN, MA / ACCESSWIRE / September 25, 2024 / Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that management will present at the 3rd Annual ROTH Healthcare Opportunities...