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].

Biofrontera Inc. (BFRI), Monday announced positive and statistically significant top-line results from its Phase 3 clinical trial, evaluating Ameluz PDT with the red-light LEDplatform for the treatment of mild to moderate actinic keratoses on the extremities, neck, and trunk.Despite these positive findings, Biofrontera's stock is moving down 8.66 percent, to $0.75 on the Nasdaq. The stock opened at $0.7 and has traded as far as $0.96 in today's session.The multicenter, randomized, double-blind, vehicle-con ...

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]

Group 1: Price Trend and Technical Analysis - Biofrontera Inc. (BFRI) has experienced a bearish price trend, losing 9.9% over the past week, but a hammer chart pattern suggests a potential trend reversal as bulls may have gained control [1] - The hammer pattern indicates a nearing bottom with likely subsiding selling pressure, supporting a bullish case for the stock [2] - The hammer chart pattern is characterized by a small candle body and a long lower wick, signaling a potential reversal when formed at the bottom of a downtrend [4][5] Group 2: Fundamental Indicators - An upward trend in earnings estimate revisions for BFRI is a bullish indicator, as these revisions are strongly correlated with near-term stock price movements [7] - Over the last 30 days, the consensus EPS estimate for the current year has increased by 300%, indicating strong agreement among analysts that the company will report better earnings than previously predicted [8] - BFRI holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10]

Company Performance - Biofrontera Inc. (BFRI) has returned 55.7% year-to-date, significantly outperforming the average return of 4.3% for Medical companies [4] - The Zacks Consensus Estimate for BFRI's full-year earnings has increased by 700% over the past 90 days, indicating a strong improvement in analyst sentiment and earnings outlook [3] - Biofrontera Inc. is part of the Medical - Biomedical and Genetics industry, which has an average year-to-date return of 21%, further highlighting BFRI's superior performance [5] Industry Context - The Medical sector consists of 928 individual stocks and is currently ranked 10 in the Zacks Sector Rank [2] - The Medical - Biomedical and Genetics industry includes 449 companies and is ranked 90 in the Zacks Industry Rank [5] - Brookdale Senior Living (BKD), another Medical stock, has returned 38.1% year-to-date and is part of the Medical - Nursing Homes industry, which has a year-to-date return of +7.2% [4][6]

Biofrontera (NasdaqCM:BFRI) FY Conference January 15, 2026 08:30 AM ET Company ParticipantsBen Shamsian - VPRobert Blum - Managing PartnerFred Leffler - CFOHermann Lübbert - Founder and Executive ChairmanFrançois Roberge - CEORobert BlumHello, everyone. Welcome to the Lytham Partners 2026 Investor Healthcare Summit. I'm Robert Blum, Managing Partner here at Lytham and your host for today's event. We're excited to introduce this group of companies driving innovation across the healthcare landscape today. Thr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 13, 2026 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware 001-40943 47-3765675 (State or other jurisdiction of incorporation) (Commission File Number) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ...

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 ...