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. 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 Q1 2026 revenue of $10.1 million, up ~17% from $8.6 million, driven by ~16% Ameluz unit growth and a price increase. Gross margin rose to about 80%, and operating loss was $4.3 million.
Net loss was $4.8 million ($0.41/share); Adjusted EBITDA improved to $(3.6) million. Cash stood at $6.3 million with minimal operating cash use. The company highlighted positive Phase 3 AK and Phase 2b acne data, FDA sNDA acceptance for sBCC with a September 28, 2026 PDUFA date, and regained Nasdaq bid-price compliance.
Biofrontera (Nasdaq:BFRI) launched its second annual #HatsOnForAK campaign, running May 18–24, 2026, ending on Global Actinic Keratosis Awareness Day. This social media initiative encourages people to wear hats, post photos with dedicated hashtags, and promote awareness of actinic keratosis (AK) and comprehensive sun protection.
Biofrontera (Nasdaq: BFRI) will report first quarter 2026 financial results for the period ended March 31, 2026 on Thursday, May 14, 2026, after U.S. market close. A conference call and webcast are scheduled for May 14, 2026 at 11:00 a.m. ET to discuss results and provide a business update.
The company develops and commercializes photodynamic therapy (PDT) products, including the Ameluz drug-device combination and RhodoLED lamp series, and is conducting clinical trials for non-melanoma skin cancers and moderate-to-severe acne. Webcast access and dial-in details are provided for investors and analysts.
Biofrontera (NASDAQ:BFRI) reported record Q4 2025 revenue of $17.1M (+36% YoY) and a Q4 gross margin of 82.4% versus 58.0% a year earlier. The company posted Q4 net income of $5.6M, cash of $6.4M, and full‑year 2025 revenue of $41.7M.
Key operational moves include purchase of U.S. Ameluz and RhodoLED assets with a reduced earnout (12%–15%), FDA filing acceptance for an sNDA with a PDUFA in September 2026, positive acne and AK trial results, and the Xepi divestiture.
Biofrontera (Nasdaq: BFRI) will report fourth quarter and full year 2025 financial results after U.S. market close on Thursday, March 19, 2026. The company will host a conference call and webcast on March 19, 2026 at 10:00 a.m. ET to discuss results and provide a business update.
Dial-in numbers and a webcast link are provided for investor access.
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.