BFRI

10-K - Biofrontera Inc. (0001858685) (Filer)

8-K - Biofrontera Inc. (0001858685) (Filer)

Conference call will be held today, Thursday, March 19 at 10:00 am ET Woburn, MA, March 19, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and twelve months ended December 31, 2025 and provided a business update. Fourth Quarter Financial Highlights Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024.Gross margins were 82.4%, a roughly 2,400 basis point year over year increase compared to 58.0% in 4Q24, reflecting the transitio

WOBURN, Mass., March 09, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announces it will report financial results for the three months and full year ended December 31, 2025 after the close of the U.S. financial markets on Thursday, March 19, 2026. The Company will host a conference call on Thursday, March 19, 2026 at 10:00 a.m. Eastern Time to discuss those results, provide a business update and answer questions. Conference Call and Webcast Information Event:Biofrontera Inc. Fourth Quarter and Full Year 2025 Financial Results and Busi

8-K - Biofrontera Inc. (0001858685) (Filer)

• Phase 2b study demonstrated greater reductions in inflammatory acne lesions with Ameluz® PDT versus vehicle • 3-hour incubation regimen identified as the most promising protocol for further clinical development • Acne vulgaris represents a promising potential future indication for Ameluz®, significantly broadening the Company's dermatology pipeline WOBURN, Mass., March 09, 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 results of its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid HCL) topical gel, 1

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

4 - Biofrontera Inc. (0001858685) (Issuer)

8-K - Biofrontera Inc. (0001858685) (Filer)

WOBURN, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization and development of photodynamic therapy ("PDT"), today announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board (the "Board") issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 (the "'028 Patent") to be unpatentable. As previously disclosed in Biofrontera's filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District

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 kera

SCHEDULE 13G/A - Biofrontera Inc. (0001858685) (Subject)

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 Ne

8-K - Biofrontera Inc. (0001858685) (Filer)

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 squamous cell carcinoma2,3 WOBURN, Mass., Feb. 09, 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 positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® PDT with the red-light LED (RhodoLED®) platform for the tre

SCHEDULE 13G/A - Biofrontera Inc. (0001858685) (Subject)

8-K - Biofrontera Inc. (0001858685) (Filer)

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 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a leader in photodynamic therapy (PDT) development and commercialization, today announced preliminary unaudited revenue results for the fourth quarter ended December 31, 2025. Fourth quarter revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company's history. For the full year 2

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, Mass., Jan. 08, 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 the successful database lock of two clinical studies evaluating Ameluz® PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026. The databases for th

8-K - Biofrontera Inc. (0001858685) (Filer)