StocksMedium•19 October 2026•
1 min read
Biotech Firms Clene and UroGen Reach FDA Regulatory Milestones for New Drug Applications
Key Facts
1The FDA accepted UroGen Pharma's NDA for UGN-103 to treat bladder cancer, setting a PDUFA target date of June 14, 2027.
2Clene Inc submitted an NDA seeking accelerated approval for CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration (FDA) accepted UroGen Pharma's New Drug Application (NDA) for UGN-103, a treatment for bladder cancer, setting a PDUFA target action date of June 14, 2027. GlobeNewswire reported that Clene Inc also submitted an NDA seeking accelerated approval for its drug candidate CNM-Au8, intended for the treatment of amyotrophic lateral sclerosis (ALS).
URGN closed at $34.56 on October 16, 2026, while CLNN closed at $3.10 on the same date. The formal acceptance of UroGen's filing represents a critical regulatory milestone for the firm, although the final decision date remains distant.