8-K - Biofrontera Inc. | StockGist

AI Analysis

AI-generated analysis. Always verify with the original filing.

Biofrontera Inc. announced positive Phase 2b results for Ameluz® PDT in treating moderate to severe acne vulgaris, showing greater reductions in inflammatory lesions (57.97% vs. 36.51% vehicle) with the 3-hour incubation regimen versus vehicle. The company plans to present data to the FDA in Q3 2026 to discuss next steps.

Key Takeaways

1Phase 2b study: 57.97% reduction in inflammatory lesions with Ameluz® (n=20) vs. 36.51% vehicle (n=14) in 3-hour per-protocol population

225% of Ameluz® patients met mIGA co-primary endpoint (clear/almost clear) vs. 21.4% vehicle

3Absolute reductions: inflammatory 19.7 (Ameluz®) vs. 15.4 (vehicle), non-inflammatory 23.1 vs. 16.5, total 42.7 vs. 31.9

485.7% of 3-hour Ameluz® patients would choose PDT again; 71.4% rated esthetic outcome good/very good

5Plans to present data to FDA in Q3 2026

6Most common AEs: burning sensation and pruritus, mild to moderate

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (

Regulation Fd

9.01

Financial Statements and Exhibits. 99.1 Press Release dated March 9, 2026 104 Cover Page Interactive Data File (the cover page XBRL tags are embedded within the

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1