Biofrontera Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $13.6M
- Price
- $0.9188
- % Change (Daily % change from the live per-ticker quote feed.)
- -1.77%
- Volume
- 231.7K
About
Biofrontera Inc., a biopharmaceutical company, engages in the commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. It offers Ameluz, BF-RhodoLED, RhodoLED XL lamp series, and RhodoLED Lamps, which are used for the treatment of actinic keratosis, which are pre-cancerous skin lesions. The company was incorporated in 2015 and is headquartered in Woburn, Massachusetts.
Quick stats
Shares outstanding14.9M
Computed float12.5M
Float / shares84.4%
Cash runway (months)5.1
Key info
SectorHealthcare
IndustryMedical - Pharmaceuticals
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001858685
AI Summary
AI-generated1/12
standardbullishregulatory
Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body
Biofrontera submitted an sNDA to the FDA to expand the Ameluz red-light PDT label beyond face and scalp to mild-to-moderate actinic keratoses on the extremities, neck and trunk, with treatment fields up to about 240 cm2.
The submission is supported by a Phase 3 trial of 172 patients in which 45.6% achieved complete clearance with Ameluz PDT versus 16.7% with vehicle (p<0.0003), plus a Phase 1 maximal-use PK study and an adjusted illumination protocol intended to improve tolerability.
Management cited 12% revenue growth for full-year 2025 and about 25% for H1 2026, and said the pending label expansion -- following September 2026 approval for superficial basal cell carcinoma -- is expected to accelerate revenue growth further.
If approved, Ameluz with red light would be the only U.S. PDT approved for full-body AKs; FDA will first complete a filing review within 60 days before substantive review begins.
Red flags
- sNDA is only a submission -- FDA could reject the filing during the 60-day review or decline approval
- small-cap biotech dependent on a single product franchise; forward-looking statements flag potential need for additional financing and Nasdaq listing compliance