Ameluz — FDA meeting
Q3 2026
The Company plans to present these Phase 2b data to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss potential next steps to develop Ameluz® PDT for the treatment of acne vulgaris.Source filing
BFRI biotech catalysts & pipeline
BIOFRONTERA INC · Data as of 2026-09-08
Upcoming catalysts
Ameluz — NDA/BLA submission
Q3 2026
Based on these positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026.Source filing
Ameluz — PDUFA
Sep 28
Announced FDA's completion of its filing review and filing acceptance of the Company's supplemental New Drug Application (sNDA) for Ameluz ® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026.Source filing