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 ...

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 ther ...

Core Viewpoint - Biofrontera Inc. has received FDA acceptance for its supplemental New Drug Application for Ameluz, which could expand its use to treat superficial basal cell carcinoma (sBCC) if approved, addressing a significant unmet medical need in dermatology [1][4][6]. Group 1: FDA Approval and Market Potential - The FDA has completed its review and accepted the filing of Biofrontera's sNDA for Ameluz, with a PDUFA target action date set for September 28, 2026 [1][6]. - If approved, this indication would significantly expand the Ameluz PDT platform beyond its current use for actinic keratosis, validating Biofrontera's photodynamic therapy approach [2][4]. - The potential approval would make Ameluz the first PDT photosensitizer indicated for the treatment of sBCC in the U.S., which is the most common skin cancer with approximately 3.6 million cases diagnosed annually [6][8]. Group 2: Clinical Significance and Treatment Options - Basal cell carcinoma (BCC) is prevalent in the U.S., with estimates suggesting that 10-25% of cases are of the superficial subtype, highlighting the need for effective treatment options [3][6]. - Current treatment methods often involve surgical or destructive approaches, which may not be suitable for all patients, indicating a demand for non-invasive alternatives like Ameluz PDT [3][4]. Group 3: Company Strategy and Leadership - The CEO of Biofrontera emphasized the importance of this milestone in expanding the clinical utility of Ameluz and reinforcing photodynamic therapy as a versatile platform in dermatology [4]. - The company believes that the new indication for Ameluz has the potential to significantly expand its addressable market and strengthen its position in medical dermatology [4].

Core Insights - Biofrontera Inc. announced positive Phase 3 clinical trial results for Ameluz PDT, demonstrating significant efficacy in treating actinic keratoses (AKs) on various body areas [1][5][9] Study Design and Results - The Phase 3 study was a multicenter, randomized, double-blind, vehicle-controlled trial involving 172 patients, with a 4:1 randomization to receive Ameluz gel or vehicle gel [2] - The primary endpoint was the "subject complete clearance rate," defined as the percentage of patients achieving complete clearance of all treated AK lesions 12 weeks post-treatment [4] - Ameluz PDT showed a complete clearance rate of 45.6% in the Full Analysis Set (FAS) compared to 16.7% for vehicle PDT (p < 0.0003) [5] - In the Per Protocol Set (PPS), complete clearance rates were 53.2% for Ameluz PDT versus 22.2% for vehicle PDT (p < 0.001) [5] Secondary Outcomes - Key secondary outcomes indicated a 73.1% clearance rate of AK lesions in the FAS and 80.3% in the PPS 12 weeks after treatment [6] - Clearance rates by anatomical location showed 38.5% (FAS) and 46.5% (PPS) on extremities, and 74.1% (FAS) and 78.3% (PPS) on neck and trunk [6] Patient Satisfaction and Cosmetic Outcomes - Ameluz PDT demonstrated favorable cosmetic outcomes, with 75.2% of investigators rating treated skin as "good" or "very good" [7] - 70.9% of patients reported similar assessments, and 86.3% indicated they would choose PDT again for future treatment [7] Future Plans - Based on the positive results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in Q3 2026 [8]

Core Insights - Biofrontera Inc. announced preliminary unaudited revenue results for Q4 2025, expecting revenues between $17.0 million and $17.5 million, marking the highest quarterly revenue in the company's history [1][8] - For the full year 2025, revenues are projected to be between $41.5 million and $42.0 million, indicating a year-over-year growth of approximately 11% to 13% [2][8] - The strong performance in Q4 was attributed to effective sales execution of Ameluz® PDT and a pricing adjustment made in December [3][8] Financial Performance - Q4 2025 revenues are expected to show a year-over-year growth of 35% to 39% driven by the sales of Ameluz® [8] - The company anticipates reporting complete financial results for Q4 and the full year 2025 in March 2026 [2][4] Strategic Developments - The recent transaction with Biofrontera AG is expected to significantly improve the company's gross margin profile and strengthen its financial foundation [4] - The CEO expressed confidence in the company's innovative products and operational excellence, which are expected to drive sustainable growth in 2026 [3][4] Upcoming Events - Biofrontera management is scheduled to present at the Lytham Partners Healthcare Investor Summit on January 15, 2026 [5]

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 succ ...

Core Insights - Biofrontera Inc. has successfully transferred the New Drug Application (NDA) and Investigational New Drug Application (IND) for Ameluz and the RhodoLED Lamp Series, allowing the company to independently manage clinical development and marketing in the US [1][2] - The transfer includes 11 granted US patents, 10 pending US patent applications, and 19 international patent applications related to the products, enhancing Biofrontera's intellectual property portfolio [1][2] - The completion of these transfers is seen as a significant milestone in Biofrontera's strategy to optimize operations and pursue new clinical indications for its products [3] Company Overview - Biofrontera Inc. is a biopharmaceutical company focused on photodynamic therapy (PDT) for dermatological conditions, particularly Actinic Keratosis and other skin lesions [4] - The company aims to expand the use of its products to treat non-melanoma skin cancers and moderate to severe acne through ongoing clinical trials [4]

Core Insights - Soligenix, Inc. announced positive results from the third cohort of its Phase 2a trial for SGX302, a treatment for mild-to-moderate psoriasis, utilizing an optimized gel formulation of synthetic hypericin [1][2][3] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including treatments for psoriasis and cutaneous T-cell lymphoma (CTCL) [1][12] Clinical Trial Results - The third cohort of the Phase 2a trial involved four patients treated with an improved gel formulation for 18 weeks, showing no drug-related adverse events and significant improvements in various psoriasis assessment indices [2][5] - One patient achieved an "Almost Clear" status in the Investigator Global Assessment (IGA), with a PASI score improvement exceeding 50%, indicating treatment success [2][3] - The gel formulation was designed for easier application compared to the previous ointment, leading to similar or improved outcomes [2][5] Market Potential - Psoriasis affects approximately 60-125 million people globally, with a treatment market valued at around $15 billion in 2020, projected to reach $40 billion by 2027 [3][10] - The success of HyBryte™ in CTCL trials suggests potential for SGX302 in treating psoriasis, which is also linked to dysregulated T-cells [3][12] Treatment Mechanism - Synthetic hypericin is a first-in-class photodynamic therapy that activates T-cell apoptosis using visible light, avoiding long-term risks associated with traditional UV light therapies [4][7] - This approach aims to treat deeper skin lesions effectively while minimizing risks of secondary malignancies and serious infections associated with systemic treatments [7][9] Psoriasis Overview - Psoriasis is a chronic inflammatory skin condition affecting quality of life and is associated with various comorbidities, including cardiovascular and psychological conditions [8][10] - The most common type, plaque psoriasis, affects about 80% of patients, with varying severity levels impacting treatment approaches [8][9]

Registration No. 333- As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (I.R.S. Employer Identification No.) 660 Main Street Woburn, M ...

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 use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of p ...