Biofrontera Inc. reports news on the commercialization and development of photodynamic therapy in dermatology. The company’s core product platform includes Ameluz, an aminolevulinic acid hydrochloride topical gel used with the RhodoLED red-light lamp series, with an established focus on actinic keratoses and clinical programs addressing additional dermatologic conditions.
Recurring updates include financial results, U.S. commercial performance, clinical data for Ameluz PDT, FDA-related label-expansion activity, patent proceedings, and business updates tied to the company’s U.S. product rights, regulatory approvals, intellectual property, and manufacturing rights.
Biofrontera (Nasdaq: BFRI) reported positive Phase 2b results for Ameluz® PDT in moderate to severe acne vulgaris, with the 3-hour incubation regimen identified as most promising.
In the 3-hour per-protocol cohort, Ameluz achieved a 57.97% reduction in inflammatory lesions vs 36.51% for vehicle; total lesion reductions were 42.7 vs 31.9. Safety was consistent with prior PDT experience. Data will be presented to the FDA in Q3 2026 to discuss next steps.
Biofrontera (Nasdaq: BFRI) announced the U.S. Patent Trial and Appeal Board issued a Final Written Decision on Feb 23, 2026 finding all challenged claims of Sun Pharma’s U.S. Patent No. 11,697,028 unpatentable. Biofrontera had filed Inter Partes Review petitions after Sun Pharma sued for alleged infringement in June 2024.
The decision does not affect Biofrontera’s separate petition on the ’512 patent, which the Patent Office denied review for administrative reasons. Sun Pharma may seek rehearing or appeal to the Federal Circuit.
Biofrontera (Nasdaq: BFRI) announced that the database for a Phase 1 maximal-use pharmacokinetics (PK) study of Ameluz for actinic keratoses on neck, trunk and extremities was locked on Feb 11, 2026.
The study measured plasma ALA and PpIX after one PDT treatment in 17 patients and is intended to support a supplemental NDA to expand the U.S. label to treatment fields up to 240 cm2, with submission expected in Q3 2026.
Biofrontera (Nasdaq: BFRI) announced the FDA has accepted its supplemental New Drug Application for Ameluz® PDT to treat superficial basal cell carcinoma (sBCC) and assigned a PDUFA target action date of September 28, 2026. The FDA identified no filing deficiencies. If approved, Ameluz® would expand beyond its current FDA approval for actinic keratosis and could become the first PDT photosensitizer indicated for sBCC, a subtype representing roughly 10–25% of the ~3.6 million annual U.S. basal cell carcinoma cases. The company says this could broaden Ameluz®’s clinical use and address unmet non‑surgical needs in dermatology.
Biofrontera (Nasdaq: BFRI) reported positive Phase 3 results showing Ameluz® PDT met the primary endpoint for treating mild-to-moderate actinic keratoses (AK) on extremities, neck, and trunk.
In the Full Analysis Set, subject complete clearance was 45.6% vs. 16.7% for vehicle (p<0.0003); Per Protocol rates were 53.2% vs. 22.2% (p<0.001). Lesion clearance was 73.1% (FAS) and 80.3% (PPS). Investigators reported favorable cosmetic outcomes and high patient satisfaction. Biofrontera plans an sNDA submission in Q3 2026.
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.