Biofrontera completes Phase 1 study for Ameluz, sets FDA submission for 2026.
ByAinvest
Thursday, Dec 4, 2025 9:06 am ET1min read
BFRI--
Biofrontera has completed the final patient visit in its Phase 1 pharmacokinetic study for Ameluz, a treatment for actinic keratoses on peripheral body areas. This marks a key milestone for FDA submission in summer 2026. The study, along with results from a recent Phase 3 clinical trial, will form the basis for FDA approval.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
Comments
No comments yet