Clene to include ALS biomarker data in NDA for accelerated approval

FREE Breaking News Alerts from StreetInsider.com!

E-mail Address

StreetInsider.com Top Tickers, 10/22/2026

1. META
2. TSLA
3. IBM
4. TXN
5. SAP
6. CSX
7. LRCX
8. LVS
9. KNX
10. QGEN

Go back to Clene to include ALS biomarker data in NDA for accelerated approval

Clene Announces Biomarker Analyses To Be Included in NDA Submission Supporting ALS Accelerated Approval

August 10, 2026 8:00 AM EDT

Survival benefit is concentrated in participants with NfL biomarker response: CNM-Au8®-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controlsFunctional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated patients whose NfL declined or stabilized had significantly better outcomes on combined measures of survival and function, including daily function (ALSFRS-R) and breathing capacity (Slow Vital Capacity), than concurrently randomized controls

SALT LAKE CITY, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq:... More