Welcome to our dedicated page for Biofrontera news (Ticker: BFRIW), a resource for investors and traders seeking the latest updates and insights on Biofrontera stock.
Biofrontera Inc. (BFRIW) is a biopharmaceutical innovator specializing in dermatology treatments combining prescription therapies with photodynamic light devices. This page provides comprehensive access to official company announcements, financial disclosures, and therapeutic development updates.
Investors and medical professionals will find verified information on FDA submissions, clinical trial results, and commercial partnerships. Our curated feed includes earnings reports, product launch timelines, and research collaborations relevant to skin condition therapies.
Key updates cover advancements in treating actinic keratosis, impetigo management solutions, and regulatory milestones for the RhodoLED device platform. All content is sourced directly from Biofrontera's communications to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined tracking of Biofrontera's progress in dermatological innovation. For real-time alerts, consult your brokerage platform or SEC filing system for official BFRIW disclosures.
Biofrontera (Nasdaq: BFRI) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA on November 28, 2025 seeking approval of Ameluz®-PDT for treatment of superficial basal cell carcinoma (sBCC).
The submission includes full Phase 3 treatment and one-year follow-up data from a randomized, double-blind, placebo-controlled U.S. study of 187 patients. Primary endpoint: 65.5% clearance with Ameluz®-PDT vs 4.8% with placebo (p<0.0001). Key secondary endpoints showed histological clearance 75.9%, clinical clearance 83.4%, and total lesion clearance 64.1% with low one-year recurrence and high patient satisfaction.
Biofrontera (NASDAQ:BFRI) reported third-quarter 2025 results and a business update on November 13, 2025. 3Q25 revenues were $7.0 million versus $9.0 million in 3Q24; first nine months 2025 revenues were $24.6 million versus $24.8 million a year earlier. The company closed the purchase of all U.S. Ameluz and RhodoLED assets and replaced the prior transfer-pricing structure with a royalty of 12% below $65M and 15% above. Biofrontera received the final $2.5M of an $11M financing and announced the sale of Xepi for $3M at closing plus up to $7M in future payments. Cash was $3.4M at Sept 30, 2025.
Biofrontera (Nasdaq: BFRI) sold its U.S. license for Xepi® (ozenoxacin) Cream, 1% to Pelthos Therapeutics for up to $10 million on Nov 7, 2025. Biofrontera received $3 million at closing, will receive $1 million upon availability of commercial product, and up to $6 million in sales milestones tied to achieving $10 million and $15 million in annual net revenues for Xepi within the U.S., Puerto Rico and the U.S. Virgin Islands.
The company said proceeds will bolster cash, help fund Biofrontera to profitability, and support growth of its PDT platform and expansion of Ameluz® into additional indications.
Biofrontera (Nasdaq: BFRI) will report results for the three and nine months ended September 30, 2025 after U.S. market close on Wednesday, November 12, 2025. The company will host a conference call and webcast to discuss the results, provide a business update and answer questions on Thursday, November 13, 2025 at 10:00am ET.
Conference call numbers and an investor webcast will be available for live participation. Biofrontera commercializes the drug-device combination Ameluz with the RhodoLED lamp series for photodynamic therapy (PDT) and is conducting clinical trials to expand indications to non-melanoma skin cancers and moderate to severe acne.
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.
Biofrontera (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has announced its participation in the upcoming Lytham Partners Fall 2025 Investor Conference on September 30, 2025.
The company will deliver a webcast presentation at 1:15 p.m. ET and conduct one-on-one meetings with investors throughout the virtual event. Investors can access the webcast through the conference website or directly via the provided link, with replay available after the event.
Biofrontera Inc. (NASDAQ: BFRI), a biopharmaceutical company focused on photodynamic therapy (PDT), has engaged Lytham Partners to lead its strategic investor relations and shareholder communication program. The company has recently completed several transformative actions, including restructuring its relationship with its former parent company, acquiring U.S. intellectual property and new drug applications, taking control of manufacturing, and securing $11 million in new funding.
Biofrontera commercializes Ameluz® with RhodoLED® lamp series for PDT treatment of actinic keratosis (AK), pre-cancerous skin lesions. The company is conducting clinical trials to expand product use for non-melanoma skin cancers and moderate to severe acne. Management expects to achieve meaningful profitability in the coming quarters.
Biofrontera (NASDAQ:BFRI) has announced the completion of the active treatment phase in its Phase 3 clinical trial for Ameluz® PDT, evaluating its effectiveness in treating actinic keratoses (AKs) on extremities, neck and trunk. The study, involving 172 patients, follows the October 2024 approval for using up to 3 tubes of Ameluz® per treatment.
The multicenter, randomized, double-blind trial tested Ameluz® PDT versus vehicle gel, with treatment areas ranging from 80 to 240 cm². Patients received one or two PDT treatments and have now entered a 12-month follow-up phase, expected to conclude in Q2 2026. Upon completion, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the FDA.
[ "Trial builds upon recent FDA approval for expanded Ameluz® usage (up to 3 tubes per treatment)", "Large market potential with 58 million US adults having at least one AK lesion", "Study addresses critical unmet need in dermatology for AK treatment beyond face and scalp", "Successful completion of active treatment phase with all 172 patients enrolled" ]Biofrontera Inc. (NASDAQ: BFRI) announced completion of patient participation in its Phase 2b clinical trial evaluating Ameluz® for treating moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz® with vehicle gel using red-light Photodynamic Therapy (PDT), with top-line results expected in Q1 2026.
The trial involved up to 3 PDT sessions at monthly intervals, with participants receiving either 1 or 3-hour incubation before BF-RhodoLED® lamp illumination. Following anticipated positive results, Biofrontera plans FDA discussions in Q3 2026 to advance Phase 3 program for potential label expansion.
The study addresses a significant market opportunity, with acne affecting 50 million Americans annually and a market valued at $5.7 billion in 2024. Current treatments face limitations including side effects and antibiotic resistance concerns, highlighting the need for alternative solutions.
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.
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