StreetInsider.com News Articles

Form 4 Clene Inc. For: Oct 20 Filed by: Etherington Robert Dee

Wed, 21 Oct 2026 15:42:00 -0400

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Form 4 Clene Inc. For: Oct 20 Filed by: Mortenson Mark

Wed, 21 Oct 2026 15:32:00 -0400

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Form 4 Clene Inc. For: Oct 20 Filed by: BROWN MORGAN R

Wed, 21 Oct 2026 15:31:00 -0400

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Form 8-K Clene Inc. For: Oct 15

Tue, 20 Oct 2026 06:02:00 -0400

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Form 8-K Clene Inc. For: Oct 19

Mon, 19 Oct 2026 08:05:00 -0400

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Clene submits NDA to FDA for ALS drug CNM-Au8

Mon, 19 Oct 2026 08:00:28 -0400

Clene Inc. (Nasdaq: CLNN) announced it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration earlier in October 2026, seeking accelerated approval of CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS).

The NDA is based on neurofilament light chain biomarker data and clinical outcomes. Accelerated approval is a regulatory pathway that allows the FDA to approve drugs for serious conditions based on a surrogate endpoint reasonably likely to predict clinical benefit.

According to the company, Clene also plans to conduct a confirmatory Phase 3 study called RESTORE-ALS as part of the regulatory process.

"The submission of our NDA

Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

Mon, 19 Oct 2026 08:00:00 -0400

NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes

SALT LAKE CITY, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on revolutionizing the treatment of neurodegenerative diseases, announced that it has submitted a New Drug Application (NDA) earlier in October to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of CNM-Au8® for the treatment of amyotrophic lateral sclerosis (ALS).

“The submission of our NDA for CNM-Au8 represents an important achievement for Clene, CNM-Au8, and especially for people living with

Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

Mon, 19 Oct 2026 08:00:00 -0400

NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes

“The submission of our NDA for CNM-Au8 represents an important achievement for Clene, CNM-Au8, and especially for people living with

Form SCHEDULE 13G/A Clene Inc. Filed by: Empery Asset Management, LP

Tue, 13 Oct 2026 12:49:00 -0400

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Clene to Present at Upcoming Investor Conferences

Tue, 22 Sep 2026 08:00:00 -0400

SALT LAKE CITY, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) today announced that management will participate at the 5th Annual ROTH Healthcare Opportunities Conference and at the Lytham Partners Investor Conference Fall Event and host 1x1 investor meetings at both conferences.

5th Annual ROTH Healthcare Opportunities Conference
Date: September 29, 2026
Location: New York, NY
Format: 1x1 meetings
1x1 Meetings: Please contact your ROTH representative

Lytham Partners Investor Conference Fall Event
Date: September 29-30, 2026
Time of Presentation: 9:45 am ET
Location: Virtual
Format: Presentation and 1x1 meetings
1x1 Meetings: Please contact your Lytham representative
Webcast: link to webcast

Clene to Present at Upcoming Investor Conferences

Tue, 22 Sep 2026 08:00:00 -0400

5th Annual ROTH Healthcare Opportunities Conference
Date: September 29, 2026
Location: New York, NY
Format: 1x1 meetings
1x1 Meetings: Please contact your ROTH representative

Clene closes $4M direct offering to fund operations into 2027

Mon, 21 Sep 2026 08:30:41 -0400

Clene Inc. (NASDAQ: CLNN) has closed a $4 million registered direct offering of common stock to existing shareholders, including company insiders, according to a press release from the Salt Lake City-based biotechnology company.

The offering was led by board Chairman David Matlin, alongside founding investor Kensington Capital Holdings, the company's chief executive officer, and other existing shareholders. No placement agent, underwriter, broker, or dealer was used in the transaction, which was priced at market under Nasdaq rules.

Clene said the proceeds are expected to fund operations through mid-first quarter 2027, a period that extends beyond the potential FDA decision on whether to

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

Mon, 21 Sep 2026 08:30:00 -0400

Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders
$4 million registered direct offering was priced at market under Nasdaq rules
Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027, which is beyond the potential FDA decision to accept the CNM-Au8® NDA for review under the accelerated approval pathway

SALT LAKE CITY, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on ALS, today announced the closing of a registered direct offering

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

Mon, 21 Sep 2026 08:30:00 -0400

Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders
$4 million registered direct offering was priced at market under Nasdaq rules
Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027, which is beyond the potential FDA decision to accept the CNM-Au8® NDA for review under the accelerated approval pathway

SALT LAKE CITY, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on ALS, today announced the closing of a registered direct offering

Form 4 Clene Inc. For: Sep 16 Filed by: MATLIN DAVID J

Fri, 18 Sep 2026 13:43:00 -0400

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Form 4 Clene Inc. For: Sep 16 Filed by: Etherington Robert Dee

Fri, 18 Sep 2026 13:42:00 -0400

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Form 4 Clene Inc. For: Sep 16 Filed by: Mosca Alison

Fri, 18 Sep 2026 13:40:00 -0400

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Form 8-K Clene Inc. For: Sep 15

Wed, 16 Sep 2026 17:13:00 -0400

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Form 424B5 Clene Inc.

Wed, 16 Sep 2026 13:05:00 -0400

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Clene raises $4M in direct offering to fund operations into 2027

Tue, 15 Sep 2026 09:00:22 -0400

Clene Inc. (NASDAQ: CLNN), a clinical-stage biotechnology company, priced a registered direct offering of 1,219,513 shares at $3.28 per share, raising $4 million in gross proceeds, according to a company press release dated Sept. 15, 2026.

The offering was made to existing shareholders, including insiders. Participants include Chairman of the Board David Matlin, founding investor Kensington Capital Holdings, and the company's chief executive officer. The transaction was conducted without a placement agent, underwriter, broker, or dealer.

The offering was expected to close on Sept. 17, 2026. Clene said the proceeds, combined with existing cash, are expected to fund operations through mid-first quarter

Clene Announces $4 Million Registered Direct Offering

Tue, 15 Sep 2026 09:00:00 -0400

Investment led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders
$4 million registered direct offering priced at market under Nasdaq rules
Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027

SALT LAKE CITY, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on ALS, today announced the pricing of a registered direct offering of 1,219,513 shares at a purchase price of $3.28 per share to existing shareholders, including insiders, with total gross proceeds

Clene Announces $4 Million Registered Direct Offering

Tue, 15 Sep 2026 09:00:00 -0400

Investment led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders
$4 million registered direct offering priced at market under Nasdaq rules
Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027

A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach

Tue, 08 Sep 2026 08:30:00 -0400

AUSTIN, Texas, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) drugs on the market today can slow the disease down, but none of them stop it, and none of them give patients back what they have already lost. Nearly one million people in the United States, and close to 2.9 million worldwide, live with that reality, watching a disease that can gradually erode mobility, vision, and basic bodily control. That gap has just gotten a serious new challenger. Quantum BioPharma Ltd. (NASDAQ: QNTM) (profile) has

A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach

Tue, 08 Sep 2026 08:30:00 -0400

A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach

Tue, 08 Sep 2026 08:30:00 -0400