$BFRIW News
Last published 5d ago
- 5d agoBFRIBFRIWBiofrontera Inc. to Report Third Quarter 2026 Financial Results on November 13, 2026GlobeNewswireWOBURN, Mass., Nov. 06, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) (
- 5d agoBFRIBFRIWBiofrontera Inc. to Report Third Quarter 2026 Financial Results on November 13, 2026GlobeNewswireWOBURN, Mass., Nov. 06, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a U.S.-based biopharmaceutical company engaging in the development, manufacturing, and
- 1mo agoBFRIBFRIWBiofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full BodyGlobeNewswireSubmission seeks to extend the Ameluz® label beyond the face and scalp to treatment fields of up to approximately 240 cm² on the rest of the body, with an adjusted illumination protocol WOBURN, Mass., Oct. 08, 2026
- 1mo agoBFRIBFRIWBiofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell CarcinomaGlobeNewswireAmeluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s
- 3mo agoBFRIBFRIWBiofrontera Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue GrowthGlobeNewswireWOBURN, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of
- 3mo agoBFRIBFRIWBiofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026GlobeNewswireWOBURN, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a U.S. specialty dermatology company commercializing Ameluz® (aminolevulinic acid
- 5mo agoBFRIBFRIWBiofrontera Inc. to Participate in the Lytham Partners Spring 2026 Investor Conference on May 28, 2026GlobeNewswireWOBURN, Mass., May 21, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy
- 6mo agoBFRIBFRIWBiofrontera Inc. Reports First Quarter 2026 Financial Results and Provides a Business UpdateGlobeNewswireWoburn, MA, May 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in
- 6mo agoBFRIBFRIWBiofrontera Launches Second Annual "Hats On" Campaign to Raise Awareness of Actinic KeratosisGlobeNewswireThe second annual #HatsonforAK Campaign runs May 18–24, 2026, culminating on Global Actinic Keratosis (AK) Awareness DayThis social media–driven initiative invites people to wear a hat, share a photo, and help raise
- 6mo agoBFRIBFRIWBiofrontera Inc. to Report First Quarter 2026 Financial Results and Host a Conference Call on May 14, 2026GlobeNewswireWOBURN, Mass., May 08, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy
- 8mo agoBFRIBFRIWBiofrontera Inc. to Report Fourth Quarter and Full Year 2025 Financial Results and Host a Conference Call on March 19, 2026GlobeNewswireWOBURN, 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
- 8mo agoBFRIBFRIWBiofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne VulgarisGlobeNewswire• 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
- 8mo agoBFRIBFRIWU.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma's Patent 11,697,028 To Be UnpatentableGlobeNewswireWOBURN, 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
- 8mo agoBFRIBFRIWBiofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz® for Actinic Keratoses on Trunk and ExtremitiesGlobeNewswirePhase 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
- 9mo agoBFRIBFRIWBiofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell CarcinomaGlobeNewswirePrescription 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
- 9mo agoBFRIBFRIWBiofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary EndpointGlobeNewswireStudy 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
- 10mo agoBFRIBFRIWBiofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year GrowthGlobeNewswireFourth 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
- 10mo agoBFRIBFRIWBiofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory MilestonesGlobeNewswireDatabase 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
- 10mo agoBFRIBFRIWBiofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property PortfolioGlobeNewswire• 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,
- 11mo agoBFRIBFRIWLast Patient Completes Biofrontera's Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and ExtremitiesGlobeNewswirePhase 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
- 11mo agoBFRIBFRIWBiofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDTGlobeNewswiresNDA 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
- 12mo agoBFRIBFRIWBiofrontera Inc. Reports Third Quarter 2025 Financial Results and Provides a Business UpdateGlobeNewswireConference call will be held today, Thursday, November 13 at 10:00 am ET Woburn, MA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing
- 1y agoBFRIBFRIWBiofrontera Inc. announces sale of license to Xepi® Antibiotic Cream to Pelthos Therapeutics Inc. for up to $10MGlobeNewswireProceeds of up to $10 million, consisting of $3 million at closing, $1 million upon availability of commercial product, and up to $6 million in sales-related milestone payments. Transaction further bolsters our cash
- 1y agoBFRIBFRIWBiofrontera Inc. to Report Third Quarter 2025 Financial Results on November 12, 2025 and Host a Conference Call on November 13, 2025GlobeNewswireWOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological
- 1y agoBFRIBFRIWBiofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AGGlobeNewswireBiofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG.New earnout structure reduces payment rate to
- 1y agoBFRIBFRIWBiofrontera Inc. to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025GlobeNewswireWoburn, MA, Sept.
- 1y agoBFRIBFRIWBiofrontera Inc. Engages Lytham Partners to Lead Strategic Investor Relations and Shareholder Communication ProgramGlobeNewswireWOBURN, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and TrunkGlobeNewswireAll 172 patients have now entered the 12-month follow-up phaseTrial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatmentStudy results expected to
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisGlobeNewswireFinal patient visit marks key milestone for Biofrontera, with top-line results expected Q1 2026Company plans FDA discussion in Q3 2026 to advance Phase 3 program and potential label expansionMore than 50 million people
- 1y agoBFRIBFRIWBiofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business UpdateGlobeNewswireWoburn, MA, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy in
- 1y agoBFRIBFRIWBiofrontera Inc. Appoints George Jones as Chief Commercial OfficerGlobeNewswireWoburn, MA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced
- 1y agoBFRIBFRIWBiofrontera Inc. to Report Second Quarter FY 2025 Financial Results on August 13, 2025GlobeNewswireWoburn, MA, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc., (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Major Restructuring of Relationship With Biofrontera AG Backed By $11 Million InvestmentGlobeNewswireBiofrontera Inc. has signed an agreement to acquire all US assets related to Ameluz® and RhodoLED® including New Drug Application (NDA) and associated patents from Germany-based Biofrontera AG.Under their new
- 1y agoBFRIBFRIWBIOFRONTERA INC. IS NEGOTIATING FUNDAMENTAL CHANGES TO ITS COOPERATION WITH BIOFRONTERA AGGlobeNewswireWOBURN, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), confirms a disclosure by the
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange BookGlobeNewswireBiofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043.The Orange Book is published by the U.S. Food and Drug Administration
- 1y agoBFRIBFRIWBiofrontera Inc. Reports First Quarter 2025 Financial Results and Provides a Business UpdateGlobeNewswireConference call begins at 10:00 a.m. Eastern time on Friday, May 16, 2025 WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company
- 1y agoBFRIBFRIWBiofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisGlobeNewswireBiofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043Ameluz PDT offers the potential for effective treatment of moderate to severe
- 1y agoBFRIBFRIWBiofrontera and Almirall Launch the Hats On Challenge to Raise Awareness and Support for Actinic KeratosisGlobeNewswireThe initiative is a social media challenge ahead of Global AK Awareness Day, on May 24, which supports the work of The Skin Cancer Foundation and EuromelanomaThe Hats On Challenge provides an opportunity to take part in
- 1y agoBFRIBFRIWBiofrontera Inc. Reports Record Fiscal Year 2024 Financial Results and Provides a Business UpdateGlobeNewswireConference scheduled for Friday, March 21, 2025 at 10:00 a.m. Eastern time Woburn, Mass., March 21, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and TrunkGlobeNewswireFirst US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremitiesProtocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over a surface area of up to 240
- 1y agoBFRIBFRIWBiofrontera Inc. to Report Fourth Quarter and Full Year 2024 Financial Results on March 21, 2025GlobeNewswireWOBURN, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the development and commercialization of dermatological products, today announced that it
- 1y agoBFRIBFRIWBiofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)GlobeNewswireLast patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024.Data from follow-up will be included in FDA submission, expected in Q3 2025.Biofrontera announced highly statistically significant results
- 1y agoBFRIBFRIWBiofrontera Inc. Announces 100 RhodoLED® XL Machines Now Placed in US MarketGlobeNewswireBiofrontera started commercial distribution of the RhodoLED XL in June 2024 and has seen rapid uptake in the US market since launch.The RhodoLED XL is approved by the FDA in combination with Ameluz® (aminolevulinic
- 1y agoBFRIBFRIWBiofrontera Inc. Closes a $4.2 Million Senior Secured Convertible NoteGlobeNewswireWOBURN, Mass., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic
- 1y agoBFRIBFRIWBiofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results and Provides Business UpdateGlobeNewswire●Total revenues for the third quarter 2024 were $9.0 million, an increase of 1.5% from Q3 2023. Revenue increase would have been 19% if shipments were not delayed due to Hurricane Milton. ●Total revenues for the
- 2y agoBFRIBFRIWBiofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)GlobeNewswireFirst Phase 3 PDT study in patients with sBCC in the United States.Primary and secondary endpoints all highly statistically significant p<0.0001Correlates to data seen in Europe where sBCC is already incorporated in
- 2y agoBFRIBFRIWBiofrontera Inc. Announces Database Lock Of Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)GlobeNewswireFirst Phase 3 PDT study in patients with sBCC in the United States.Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions.Data now being analyzed, interim results expected
- 2y agoBFRIBFRIWFDA Approves Use of Up To Three Tubes of Biofrontera Inc.'s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One TreatmentGlobeNewswireApproval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lampSupplemental New Drug Application (sNDA) supported by two Phase 1
- 2y agoBFRIBFRIWBiofrontera Inc. Reports Second Quarter 2024 Financial Results and Provides a Business UpdateGlobeNewswireWoburn, MA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial
- 2y agoBFRIBFRIWBiofrontera Announces the Launch of a New, FDA-Approved Red Light Source, the RhodoLED® XL LampGlobeNewswireThe RhodoLED XL is approved by the FDA in combination with Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10% for photodynamic therapy (PDT) of actinic keratoses of mild-to-moderate severity on the face