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11.02.26 - 15:18
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Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma (GlobeNewswire EN)
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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....
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09.02.26 - 15:18
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Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint (GlobeNewswire EN)
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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 treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk....
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18.12.25 - 14:48
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Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio (GlobeNewswire EN)
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• 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 trademarks associated with Ameluz® and the RhodoLED® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)• In addition, 19 international patent applications and/or registered designs for RhodoLED® lamps outside of the US were acquired and registration of the transfer has been initiated...
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07.11.25 - 14:03
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Pelthos Therapeutics Acquires Xepi® (ozenoxacin) Cream, 1% and Announces $18 Million Private Convertible Notes Financing (GlobeNewswire EN)
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DURHAM, N.C., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced it has acquired the U.S. commercialization rights to Xepi® (ozenoxacin) Cream, 1%, from Biofrontera Inc. and Ferrer Internacional S.A. (the “Acquisition”). Xepi is a non-fluorinated quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older....
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07.11.25 - 14:03
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Biofrontera Inc. announces sale of license to Xepi® Antibiotic Cream to Pelthos Therapeutics Inc. for up to $10M (GlobeNewswire EN)
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WOBURN, Mass., Nov. 07, 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 that it has divested its US license for Xepi® (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc. Biofrontera received $3 million at closing, and is to receive an additional $1 million upon availability of commercial product, and up to $6 million in milestone payments, with $3 million each tied to achieving $10 million and $15 million in annual net revenues for Xepi®, respectively, within the U.S., Puerto Rico and the U.S. Virgin Islands. ...
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06.11.25 - 22:06
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Biofrontera Inc. to Report Third Quarter 2025 Financial Results on November 12, 2025 and Host a Conference Call on November 13, 2025 (GlobeNewswire EN)
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WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- 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 and nine months ended September 30, 2025 after the close of the U.S. financial markets on Wednesday, November 12, 2025. The company will host a conference call on Thursday, November 13 at 10:00am Eastern Time to discuss those results, provide a business update and answer questions....
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23.10.25 - 14:48
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Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG (GlobeNewswire EN)
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WOBURN, Mass., Oct. 23, 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 closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz® and RhodoLED®, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights and contracts, all intellectual property, and related personnel....
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