Primary-source record
MaterialPDUFA date set
Clene: NDA acceptance & PDUFA date possible H2 2026 for CNM-Au8 in ALS
The letter states Clene plans to submit an NDA for CNM-Au8 via the accelerated approval pathway in Q2 2026. FDA acceptance of the NDA and issuance of a PDUFA date could occur in the second half of 2026, with potential approval in 2027.
Key facts
Source excerpt
EX-99.1 2 ex_924033.htm EXHIBIT 99.1 ex_924033.htm Exhibit 99.1 CLENE ISSUES STOCKHOLDER LETTER HIGHLIGHTING UPCOMING CNM-AU8 ® 2026 CATALYSTS ● Operating capital runway sufficient into the fourth quarter of 2026 ● In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8 data submitted in late 2025 ● Anticipated submission of a New Drug Application (NDA) to FDA for CNM-Au8 via an accelerated regulatory pathway in the second quarter of 2026 ● Potential for FDA acceptance of this NDA and issuance of a Prescription Drug User Fee Act (PDUFA) date in the second half of 2026 SALT LAKE CITY, Feb. 24, 2026 -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today issued a letter to stockholders outlining key anticipated regulatory and clinical milestones for CNM-Au8 ® in 2026. CEO Letter to Stockholders As we look to the year ahead, I want to extend my sincere gratitude for your ongoing support of Clene. As the founding CEO with over 12 years at the helm, I am driven by Clene’s mission to develop impactful and safe treatments for neurodegenerative diseases, particularly through our focus on ALS. Following the