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. (Nasdaq: BFRI, warrants Nasdaq: BFRIW) generates a steady flow of news centered on its dermatology-focused photodynamic therapy (PDT) business. Company press releases highlight commercial performance for Ameluz® PDT, progress in clinical development, and key corporate and regulatory milestones, offering context for both the underlying common stock and the associated BFRIW warrants.
Recent announcements describe record preliminary quarterly revenues, with management attributing growth to sales execution of Ameluz PDT and pricing changes. Biofrontera also reports on clinical trial milestones, such as database locks for a Phase 3 study in actinic keratosis on the extremities, neck and trunk and a Phase 2 study in moderate to severe acne vulgaris, as well as completion of a Phase 1 pharmacokinetics study in peripheral body areas. These updates are framed as supporting future regulatory submissions and potential label expansions.
News items further cover regulatory and intellectual property developments, including submission of a supplemental New Drug Application for superficial basal cell carcinoma and the completion of transfers of FDA approvals, patents, and trademarks for Ameluz and the RhodoLED lamp series to Biofrontera Inc. Corporate and financing news, such as the restructuring of the relationship with Biofrontera AG, preferred stock financings, and the divestiture of the Xepi antibiotic cream license, also appear in the company’s disclosures.
Visitors to this BFRIW news page can review earnings releases, business updates, clinical and regulatory announcements, and transaction-related press releases that collectively illustrate how Biofrontera is advancing its PDT platform in dermatology. For investors following the BFRIW warrants, these news items provide insight into the operating and strategic developments of the underlying issuer, Biofrontera Inc.
Biofrontera (Nasdaq: BFRI) reported preliminary, unaudited fourth quarter 2025 revenue between $17.0 million and $17.5 million, the highest quarterly revenue in company history and reflecting approximately 35% to 39% year-over-year growth. Full year 2025 revenues are expected to be $41.5 million to $42.0 million, or roughly 11% to 13% growth versus 2024. Management attributed Q4 performance to strong Ameluz® sales and a December pricing adjustment, and noted a transactional change with Biofrontera AG that management says improves gross margin profile. Results remain preliminary and unaudited; final fourth quarter and full year 2025 financials will be reported in March 2026.
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.
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.
Biofrontera (Nasdaq: BFRI) completed the final patient visit in a Phase 1 pharmacokinetic study of Ameluz gel 10% for treatment of mild-to-moderate actinic keratoses on the neck, trunk and extremities; the last visit occurred on 24 November 2025.
Under maximal-use conditions three tubes were applied to ~240 cm2; 17 patients received one PDT treatment and blood samples were collected over 10 hours to assess systemic ALA and PpIX exposure. Data plus a completed Phase 3 will form the basis for a planned sNDA submission in Summer 2026 to expand Ameluz labeling to peripheral body areas.
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.
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