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After successful completion of FDA Type C meeting, Clene expects to submit an NDA for CNM-Au8 ® under the accelerated approval pathway in the third quarter of 2026 In January 2026, Clene completed...
SALT LAKE CITY, May 05, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary, Clene Nanomedicine, Inc., a...
SALT LAKE CITY, May 05, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical...
FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for CNM-Au8 based on neurofilament light (NfL) biomarker...
In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter 2026...
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...
SALT LAKE CITY, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical...
SALT LAKE CITY, Jan. 16, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical...
The FDA has granted an in-person Type C meeting during the first quarter of 2026 New independent analyses across large observational ALS cohorts demonstrate that modest (~10%) NfL reductions are significantly...