Biofrontera Inc. (NASDAQ:BFRI) said on Monday that its Phase 3 clinical study of Ameluz photodynamic therapy (PDT) successfully achieved its primary endpoint in the treatment of actinic keratoses affecting the extremities, neck and trunk. Despite the encouraging trial outcome, shares of the micro-cap company—currently trading around $0.82 and valued at roughly $9.56 million—have fallen 8.37% over the past week.
The multicenter, randomized, double-blind trial enrolled 172 patients and showed complete clearance in 45.6% of those treated with Ameluz PDT, compared with 16.7% in the vehicle PDT group, a difference that was statistically significant (p<0.0003).
The study examined treatment effectiveness across different field sizes using Biofrontera’s proprietary RhodoLED light system. Depending on individual response, patients received one or two PDT sessions and were monitored for approximately 12 months.
Secondary endpoints supported the primary result, with 73.1% of actinic keratosis lesions cleared 12 weeks after the final treatment. Outcomes varied by anatomical site, with clearance rates of 38.5% on the extremities and 74.1% on the neck and trunk.
Investigators also reported strong cosmetic outcomes, rating the appearance of treated skin as good or very good in 75.2% of participants. Patient satisfaction was high, with 86.3% saying they would opt for PDT again.
“These data support Ameluz’s potential to treat broader, high-burden AK fields beyond the face and scalp,” said Hermann Luebbert, CEO and Chairman of Biofrontera Inc., in the company’s press release.
Actinic keratosis is the most frequently diagnosed skin condition by U.S. dermatologists and can progress to squamous cell carcinoma if not treated.
On the back of the trial results, Biofrontera said it plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration in the third quarter of 2026, seeking approval to expand Ameluz’s indications beyond the face and scalp.
Separately, the company recently disclosed preliminary, unaudited fourth-quarter 2025 revenue of between $17.0 million and $17.5 million, its highest quarterly total to date. This represents year-on-year growth of 35% to 39%, while full-year 2025 revenue is expected to come in between $41.5 million and $42.0 million, up 11% to 13% from 2024.
Biofrontera also reported progress across its pipeline, including database lock for two clinical studies evaluating Ameluz PDT in actinic keratosis and acne vulgaris, with results anticipated in February. In addition, the company completed the transfer of FDA approvals and related intellectual property for Ameluz and the RhodoLED Lamp Series, finalized a Phase 1 pharmacokinetic study of Ameluz gel for multiple body areas, and submitted a supplemental NDA for Ameluz-PDT in superficial basal cell carcinoma, supported by Phase 3 data showing a 65.5% clearance rate.
Together, these developments underline Biofrontera’s ongoing strategy to broaden its product portfolio and extend the clinical use of its photodynamic therapy platform.