Clene

CLNN

Market cap $71.7M

Clene Inc. (CLNN) came out with a quarterly loss of $0.31 per share versus the Zacks Consensus Estimate of a loss of $0.5. This compares to a loss of $0.5 per share a year ago.

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 of more than $6 million and two additional tranches totaling over $22 million tied to regulatory milestones In May 2026, Clene amended its existing $10 million convertible debt facility, extending maturity by six months to August 2027 and eliminating required monthly principal and interest payments before maturity In May 2026, Clene completed a $7 million underwritten registered direct offering with a single investor SALT LAKE CITY, May 14, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late-stage clinical biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2026 financial results and provided recent updates on its CNM-Au8 programs. “We were encouraged by the constructive dialogue during our recent Type C meeting with the FDA and appreciate the Agency's engagement as we advance toward a planned NDA submission for CNM-Au8 under the accelerated approval pathway for patients with ALS,” said Rob Etherington, President and CEO of Clene.

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 diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced the pricing of an underwritten registered direct offering of 1,000,000 shares of common stock at a purchase price of $7.00 per share to a single investor.

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, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it will participate in the following investor conferences in May. Emerging Growth Conference Date: May 6, 2026 Time of Presentation: 3:25 p.m.

Clene Inc. (NASDAQ:CLNN) shares are up 6.68% on Monday as the company is filing for accelerated approval of its ALS treatment following a constructive meeting with the FDA.

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 expects to submit an NDA for CNM-Au8 to the FDA in the third quarter of 2026 CNM-Au8 represents a potential first-in-class therapeutic approach for ALS, a disease area with significant unmet medical need SALT LAKE CITY, May 04, 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, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced receipt of final meeting minutes following its recent Type C meeting with the U.S. Food and Drug Administration (FDA). During the meeting and confirmed in the final meeting minutes, the FDA stated that Clene's “proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of ALS.

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 financing tranche of over $6 million, which will provide cash runway to the end of the third quarter enabling funding through potential NDA acceptance decision by the FDA Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into 2027 SALT LAKE CITY, March 12, 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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 financial results and provided recent updates on its CNM-Au8 programs. “Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration (FDA) on Clene's biomarker and survival data, which if positive, will facilitate filing of an new drug application (NDA) under an accelerated approval pathway for ALS by the end of the second quarter of 2026,” said Rob Etherington, President and CEO of Clene.

SALT LAKE CITY, Feb. 24, 2026 (GLOBE NEWSWIRE) -- 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.

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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference.

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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference.