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Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update Biofrontera (NASDAQ:BFRI) reported record Q4 2025 revenue of $17.1M (+36% YoY) and a Q4 gross margin of 82.4% versus 58.0% a year earlier. The company posted Q4 net income of $5.6M, cash of $6.4M, and full‑year 2025 revenue of $41.7M.Key operational moves include purchase of U.S. Ameluz and RhodoLED assets with a reduced earnout (12%–15%), FDA filing acceptance for an sNDA with a PDUFA in September 2026, positive acne and AK trial results, and the Xepi divestiture.

#BFRI #BFRIW Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

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Biofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne Vulgaris  • 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 ® ,

#BFRI #BFRIW Biofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne Vulgaris 

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U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be Unpatentable Biofrontera (Nasdaq: BFRI) announced the U.S. Patent Trial and Appeal Board issued a Final Written Decision on Feb 23, 2026 finding all challenged claims of Sun Pharma’s U.S. Patent No. 11,697,028 unpatentable. Biofrontera had filed Inter Partes Review petitions after Sun Pharma sued for alleged infringement in June 2024.The decision does not affect Biofrontera’s separate petition on the ’512 patent, which the Patent Office denied review for administrative reasons. Sun Pharma may seek rehearing or appeal to the Federal Circuit.

#BFRI #BFRIW U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be Unpatentable

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Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones Biofrontera (Nasdaq: BFRI) announced that the databases for its Phase 3 actinic keratosis (AK) study and Phase 2 acne vulgaris study of Ameluz PDT were locked on January 5, 2026, enabling unblinding and statistical analysis. The company expects topline data for both studies in February 2026. Pending positive AK results, Biofrontera plans an sNDA submission in Summer 2026 to expand Ameluz PDT use beyond face and scalp. Phase 2 acne results are planned for FDA discussion in early Q3 2026 to inform a future Phase 3 program.

#BFRI #BFRIW Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones

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Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio Biofrontera (Nasdaq: BFRI) completed transfer of the Ameluz NDA and IND and FDA approvals, effective December 17, 2025, giving the company full US regulatory control for Ameluz and the RhodoLED lamp series.The company also filed assignments for US trademarks and completed transfer filings for intellectual property including 11 granted US patents, 10 US patent applications and 19 international patent filings/registered designs. These transfers were secured in part by an $11.0 million investment.

#BFRI #BFRIW Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio

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Biofrontera (Nasdaq: BFRI) wraps Ameluz Phase 1 PK trial on trunk, plans 2026 FDA sNDA Final patient visit in Biofrontera’s maximal-use Phase 1 PK study of Ameluz for AKs on neck, trunk and extremities supports a planned summer 2026 FDA sNDA for broader body use.

#BFRI #BFRIW Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities

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Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT sNDA for treatment of sBCC with Ameluz ® -PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p

#BFRI #BFRIW Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT

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Biofrontera Inc. Reports Third Quarter 2025 Financial Results and Provides a Business Update Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology,

#BFRI #BFRIW Biofrontera Inc. Reports Third Quarter 2025 Financial Results and Provides a Business Update

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Biofrontera Inc. announces sale of license to Xepi® Antibiotic Cream to Pelthos Therapeutics Inc. for up to $10M Proceeds 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 position, which is expected to fund Biofrontera to profitability. Proceeds will

#BFRI #BFRIW Biofrontera Inc. announces sale of license to Xepi® Antibiotic Cream to Pelthos Therapeutics Inc. for up to $10M

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Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG Biofrontera Inc. (Nasdaq: BFRI) closed its restructuring and asset purchase with former parent Biofrontera AG on October 23, 2025, acquiring all U.S. assets and rights to Ameluz and RhodoLED, including the NDA, IND, manufacturing contracts, intellectual property, and related personnel.The deal replaces a perpetual transfer-pricing model with a capped monthly earnout of 12% on U.S. net sales up to $65 million and 15% above that threshold, with payments ending at patent expiry. The transaction was funded by an $11 million investment (with $8.5M earlier funded and $2.5M released at closing) led by Rosalind Advisors and AIGH Capital, and Biofrontera AG received a 10% post-money equity stake. The company expects full asset/personnel transfer by late Q4 2025 or early Q1 2026 and anticipates gross margin expansion starting Q4 2025.

#BFRI #BFRIW Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

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$11M Funded Dermatology Leader Biofrontera Taps Top IR Firm Following Major Business Transformation Biofrontera Inc. engages Lytham Partners for investor relations after securing $11M funding, restructuring parent relationship, and acquiring US IP. Company targets profitability in specialty dermatology.

#BFRI #BFRIW Biofrontera Inc. Engages Lytham Partners to Lead Strategic Investor Relations and Shareholder Communication Program

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Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update Biofrontera Inc. (NASDAQ:BFRI) reported strong Q2 2025 financial results with total revenues of $9.0 million, marking a 15% increase year-over-year. The company achieved significant milestones, including a major restructuring of its relationship with Biofrontera AG, acquiring U.S. IP rights and NDAs for Ameluz® and RhodoLED®.Key financial highlights include H1 2025 revenue of $17.7 million (up 12% YoY) and cash position of $7.2 million. The company secured an additional $11 million in funding and negotiated a new royalty structure of 12-15% with Biofrontera AG, replacing the previous 25-35% transfer pricing model.Clinical progress includes completion of patient follow-up in sBCC Phase 3 study and enrollment completion in Phase 3 study for AK treatment and Phase 2b acne vulgaris study. A new U.S. patent extends Ameluz® protection through 2043.

#BFRI #BFRIW Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update

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Biofrontera Inc. Announces Major Restructuring of Relationship With Biofrontera AG Backed By $11 Million Investment Biofrontera Inc. (NASDAQ: BFRI) has announced a major restructuring agreement with Biofrontera AG, backed by an $11 million investment from Rosalind Advisors and AIGH Capital Management LLC. The company will acquire all US assets related to Ameluz® and RhodoLED®, including the New Drug Application (NDA) and associated patents.Under the new agreement, Biofrontera Inc. will pay a significantly reduced royalty rate of 12% of net sales (increasing to 15% for revenue above $65 million), down from the previous 25-35% transfer pricing model. Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc.The $11 million investment will be funded in two tranches: $8.5 million with the signing of the royalty agreement and $2.5 million upon finalizing the asset transfer agreement by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share.

#BFRI #BFRIW Biofrontera Inc. Announces Major Restructuring of Relationship With Biofrontera AG Backed By $11 Million Investment

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BIOFRONTERA INC. IS NEGOTIATING FUNDAMENTAL CHANGES TO ITS COOPERATION WITH BIOFRONTERA AG Biofrontera Inc. (BFRI) has confirmed ongoing negotiations with Biofrontera AG regarding potential significant changes to their business relationship. The discussions center around two possible outcomes: a merger between the companies or modifications to their existing license and supply agreement. The potential agreement modifications could involve transferring certain rights and obligations from Biofrontera AG to Biofrontera Inc., along with a reduction in transfer pricing for Biofrontera Inc.'s US-licensed products. However, no definitive terms have been established yet, and any final agreement remains subject to various conditions and the execution of definitive agreements between both parties.

#BFRI #BFRIW BIOFRONTERA INC. IS NEGOTIATING FUNDAMENTAL CHANGES TO ITS COOPERATION WITH BIOFRONTERA AG

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Biofrontera Secures 18-Year Patent Protection for Allergen-Free Ameluz Formula in FDA Orange Book New allergen-free Ameluz formula receives FDA Orange Book recognition. Patent blocks generic competition until 2043. Learn how this impacts market exclusivity.

#BFRI #BFRIW Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book

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Biofrontera Inc. Reports First Quarter 2025 Financial Results and Provides a Business Update Biofrontera Inc. (NASDAQ:BFRI) reported its Q1 2025 financial results with total revenues of $8.6 million, marking a 9% increase from Q1 2024. The company's cash position was $1.8 million as of March 31, 2025, down from $5.9 million at year-end 2024. Notable achievements include completing enrollment in Phase 3 trials for Ameluz® for actinic keratoses treatment, receiving patent protection through 2043, and finalizing a Phase 2b study for acne vulgaris treatment. The company reported a net loss of $4.2 million ($0.47 per share), improved from a $10.4 million loss in Q1 2024. Operating expenses decreased to $13.1 million from $13.4 million year-over-year, while Adjusted EBITDA improved to ($4.4) million from ($4.6) million.

#BFRI #BFRIW Biofrontera Inc. Reports First Quarter 2025 Financial Results and Provides a Business Update

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Biofrontera Inc. Reports Record Fiscal Year 2024 Financial Results and Provides a Business Update Biofrontera Inc. (NASDAQ:BFRI) reported record financial results for fiscal year 2024, achieving total revenues of $37.3 million, a 9.5% increase from 2023. Q4 2024 revenue grew 18.5% to $12.6 million.Key highlights include: reduced operating expenses to $54.5 million (down 3.9%), improved cash position to $5.9 million, and restructured agreements resulting in Ameluz® transfer price reduction from 50% to 25%. The company successfully placed 100 RhodoLED® XL lamps since June 2024 launch.Notable achievements include FDA approval for using up to three Ameluz® tubes per treatment, significant Phase 3 study results for Superficial Basal Cell Carcinoma treatment, and accelerated patient recruitment in clinical trials. However, the company reported a net loss of $(17.8) million for 2024, though improved from $(20.1) million in 2023.

#BFRI #BFRIW Biofrontera Inc. Reports Record Fiscal Year 2024 Financial Results and Provides a Business Update

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Biofrontera Hits Major Milestone: 100th RhodoLED® XL Lamp Installed as PDT Treatment Demand Surges Biofrontera achieves rapid market adoption with revolutionary PDT device, reaching 10% penetration in Ameluz-using clinics. Enhanced capabilities drive dermatology treatment efficiency.

#BFRI #BFRIW Biofrontera Inc. Announces 100 RhodoLED® XL Machines Now Placed in US Market

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#BFRI #BFRIW Biofrontera Inc. Closes a $4.2 Million Senior Secured Convertible Note

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#BFRI #BFRIW Biofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results and Provides Business Update

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