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 an o versubscribed registered direct offering totaling over $28 million, including an initial tranche
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 late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative
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 company focused on revolutionizing the treatment of neurodegenerative diseases,
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 data FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint Clene
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 O versubscribed registered direct offering of over $28 million priced above market Initial
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
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 company focused on improving mitochondrial health and protecting neuronal function to treat
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 company focused on improving mitochondrial health and protecting neuronal function to treat
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 associated with lower mortality risk, supporting NfL reduction as a candidate surrogate
Oversubscribed registered direct offering priced above market to new, existing and insider investors, including Boxer Capital Management, Coastlands Capital, and Vivo Capital Initial financing tranche of over $6 million, which we expect will provide cash runway into the third quarter of 2026