Clene Inc. - Press Releases

Year

Clene Reports Second Quarter 2026 Financial Results and Recent Operating Highlights

Clene expects to submit a New Drug Application for CNM-Au8® in ALS under the accelerated approval pathway in early fourth quarter of 2026 Clene announces survival and functional benefit in CNM-Au8-treated patients whose NfL declined or stabilized SALT LAKE CITY, Aug.

August 14, 2026

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

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 controls Functional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated

August 10, 2026

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Clene to Present at The Canaccord 46th Annual Growth Conference

SALT LAKE CITY, July 29, 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,

July 29, 2026

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Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights

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

May 14, 2026

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Clene Announces $7 Million Underwritten Offering of Common Stock

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

May 5, 2026

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Clene to Present at Upcoming May Conferences

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,

May 5, 2026

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After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS

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

May 4, 2026

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Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights

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

March 12, 2026

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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

February 24, 2026

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Clene to Present at the Emerging Growth Conference

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

February 19, 2026

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