Biofrontera(BFRI)
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Biofrontera Inc. (BFRI) Could Find a Support Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2026-02-05 15:55
The price trend for Biofrontera Inc. (BFRI) has been bearish lately and the stock has lost 9.9% over the past week. However, the formation of a hammer chart pattern in its last trading session indicates that the stock could witness a trend reversal soon, as bulls might have gained significant control over the price to help it find support.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that ...
Is Biofrontera Inc. (BFRI) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2026-02-05 15:41
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Biofrontera Inc. (BFRI) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Biofrontera Inc. is one of 928 individual stocks in the Medical sector. Collectively, these companies sit at #10 in the Zacks Sector Rank ...
Biofrontera (NasdaqCM:BFRI) FY Conference Transcript
2026-01-15 14:32
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 ...
Biofrontera(BFRI) - 2025 Q4 - Annual Results
2026-01-13 13:35
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)) ...
Biofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year Growth
Globenewswire· 2026-01-13 13:30
Fourth 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 growth of 11% to 13% WOBURN, Mass., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a leader in photodynamic therapy (PDT) development and commercialization, today announced preliminary unaudited revenue results for the fourth quarter ended Decemb ...
Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones
Globenewswire· 2026-01-08 13:45
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 ...
Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio
Globenewswire· 2025-12-18 13:45
• 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 Rhodo ...
Biofrontera(BFRI) - Prospectus
2025-12-05 22:15
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 ...
Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities
Globenewswire· 2025-12-04 14:00
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 ...
Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT
Globenewswire· 2025-12-02 13:45
Core Viewpoint - Biofrontera Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for Ameluz-PDT, seeking approval for the treatment of superficial basal cell carcinoma (sBCC) [1][9]. Submission Details - The submission includes comprehensive efficacy data from a Phase 3 study and a one-year follow-up, along with an integrated safety assessment from U.S. and European clinical studies [2]. - The filing aims to expand the Ameluz label to include sBCC treatment using BF-RhodoLED or RhodoLED XL red light lamps [2]. Study Overview - A double-blind, randomized, placebo-controlled Phase 3 study evaluated Ameluz-PDT in 187 patients with confirmed sBCC [3]. - Participants received one or two cycles of PDT treatments, with a second cycle possible at three months if needed [3]. Efficacy Results - The primary endpoint showed a 65.5% clearance rate in the Ameluz-PDT group compared to 4.8% in the placebo group, with a highly significant statistical difference (p<0.0001) [4]. - Key secondary endpoints indicated even higher efficacy: - Complete histological clearance in 75.9% of Ameluz patients vs. 19.0% in placebo [5]. - Complete clinical clearance in 83.4% of Ameluz patients vs. 21.4% in placebo [5]. - Total clearance of all sBCC lesions in 64.1% of Ameluz patients vs. 4.8% in placebo [5]. Patient Outcomes - Patient-reported outcomes showed 85.5% rated their treatment satisfaction and aesthetic outcome with Ameluz-PDT as very good or good [6]. - One-year follow-up data indicated low recurrence rates and excellent long-term cosmetic outcomes [6]. Industry Context - BCC is the most common skin cancer in the U.S., with over 3 million cases diagnosed annually [9]. - Actinic keratosis (AK), a precursor to skin cancer, affects approximately 58 million people in the U.S., with 13 million AK treatments performed in 2020 [8]. Company Perspective - The CEO of Biofrontera expressed optimism about the submission aligning with European study results and the potential market leadership in PDT for cutaneous oncology [7]. - A board-certified dermatologist highlighted the study's findings as reinforcing the value of Ameluz-PDT for treating sBCC [7].