Welcome to our dedicated page for Biofrontera news (Ticker: BFRI), a resource for investors and traders seeking the latest updates and insights on Biofrontera stock.
Biofrontera Inc. (NASDAQ: BFRI) is a U.S.-based biopharmaceutical company specializing in dermatology and photodynamic therapy (PDT). Its news flow centers on the commercialization and clinical development of Ameluz® and the RhodoLED® lamp series for the treatment of actinic keratoses and other skin conditions.
On this page, readers can follow company announcements related to financial results, such as quarterly and annual revenue updates, as well as business updates describing trends in Ameluz® sales and operating expenses. Biofrontera frequently reports on revenue performance, gross margin developments, and the impact of its strategic agreements on its financial profile.
News items also highlight clinical and regulatory milestones. These include database locks and completion of clinical studies in actinic keratosis on peripheral body areas, Phase 1 pharmacokinetics data, Phase 3 results in superficial basal cell carcinoma, and Phase 2 progress in acne vulgaris. The company uses press releases to describe how these data support supplemental New Drug Applications and future Phase 3 programs.
In addition, Biofrontera issues updates on strategic transactions and capital markets activity, such as the acquisition of all U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, changes to royalty and earnout structures, private placements of convertible preferred stock, and the divestiture of its Xepi® antibiotic cream license. Regulatory notices regarding Nasdaq listing compliance and participation in investor conferences are also part of the company’s regular news flow.
Investors and observers who want to track developments in dermatologic photodynamic therapy, label expansion efforts for Ameluz®-PDT, and Biofrontera’s financial and strategic progress can use this news feed as a centralized source of company-issued updates.
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.
FAQ
What is the current stock price of Biofrontera (BFRI)?
What is the market cap of Biofrontera (BFRI)?
