Clene Inc (CLNN)

$6.10 -0.03 (-0.49%)
Market Cap 77.95M
Revenue (ttm) 200,000.00
Net Income (ttm) -26.17M
EPS (ttm) N/A
PE Ratio 0.00
Forward PE N/A
Profit Margin -13,085.00%
Debt to Equity Ratio -0.25
Volume 30,000
Avg Vol 598,988
Day's Range N/A - N/A
Shares Out 12.78M
Stochastic %K 58%
Beta 0.92
Analysts Strong Sell
Price Target $32.00

Company Profile

Clene Inc., a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN) therapeutics. The company's lead drug candidate is CNM-Au8, which is being studied in various clinical trials, including a completed Phase 2 platform trial to evaluate the safety and efficacy of CNM-Au8 in patients with amyotrophic lateral sclerosis (ALS); completed Phase 2 proof of concept clinical trial in patients with early symptomatic...

Industry: Packaged Foods
Sector: Consumer Defensive
Phone: 801 676 9695
Website: clene.com
Address:
6550 South Millrock Drive, Suite G50, Salt Lake City, United States
fibonacci1170
fibonacci1170 Jul. 3 at 8:35 PM
$CLNN I just realized that I had misinterpreted the FDA minutes. I thought the FDA asked CLENE to show that the 10% lowering of Nfl levels led to clinical benefit in the cnmau8 patients, which can be very difficult to prove if cnmau8 only helps patients to live longer in a vegetative state without improving their motor functions. Now I realize that this is not what the FDA wants to see. Instead, the FDA wants to see: 1. A clear demonstration of NfL level reduction using cnmau8. (CLENE has a ton of solid data on this already). 2. Does lowering the NfL levels (by 5%, 10%, whatever..) have any clinical benefit for patients? (This need not be cnmau8 based data. This correlation can be demonstrated from previous ALS datasets. The recent poster by CLENE in Spain just proved this correlation). Overall, it seems that CLENE has all the data that the FDA wants to see in the NDA filing, and that this will be a slam dunk approval. Let me know if my understanding is still wrong.
1 · Reply
fibonacci1170
fibonacci1170 Jul. 2 at 6:07 PM
$CLNN CNM-Au8 is the most advanced nanozyme in biomedicine. I guess being alone at the top explains the skepticism and lack of buzz around CNM-Au8's efficacy. But I think CLENE has got a winner. Outrageous upside over the next 3-9 months.
0 · Reply
prusio1
prusio1 Jul. 2 at 2:54 PM
$CLNN CLNN is sitting on an absurdly thin float. It only takes one legit catalyst to wake this thing up, and once volume hits, it doesn’t move, it launches. When supply of the shares is microscopic, the upside isn’t capped. It’s undefined. Extreme patience is imperative. I am accumulating through August.
1 · Reply
Mulhollandr
Mulhollandr Jul. 2 at 2:46 PM
$CLNN https://spj.science.org/doi/10.34133/research.1318?__cf_chl_f_tk=So9IiDf.4s3nax_PAOvglp1fZ0siJCgUTDtZCjMAHFs-1783003566-1.0.1.1-.JukNwnX7NBkAvEVhQCIZdS7CHtnM28eR9E_rSBjDf0
0 · Reply
neuroinvestor3
neuroinvestor3 Jul. 1 at 1:56 PM
$CLNN Asked the ChatGPT this question "what are the odds CLNN stock price increases once they announce the filing of the FDA AA data package?" Answer: There isn't a reliable way to assign a precise probability that CLNN will rise when it announces that it has filed its FDA Accelerated Approval (AA) data package. The market reaction depends less on the filing itself than on what investors believe it implies about the likelihood of approval and commercialization. Here's how I'd think about it: A filing announcement is generally a positive catalyst. It signals the company has reached an important regulatory milestone and believes its package is complete enough to submit. However, filings are often anticipated. If investors already expect the submission, part (or most) of the positive effect may already be reflected in the stock price. The content of the announcement matters. If management provides additional details—such as the strength of the data, FDA interactions, (cont)
2 · Reply
vijaykamat14
vijaykamat14 Jul. 1 at 11:05 AM
$CLNN break through $9 soon. Q3 is here
1 · Reply
fibonacci1170
fibonacci1170 Jun. 30 at 8:28 PM
$CLNN upside in this ticker is obscene, if we can get AA for ALS.
0 · Reply
Ravery
Ravery Jun. 30 at 6:20 PM
$CLNN Something that really has not been discussed here is pricing. IF approved, what kind of annual run rate could cnm-au8 generate? With about 500,000 cases worldwide and 35,000 here in the US, that is a significant addressable market. It is relevant to ponder, even though the the fda has not even accepted the NDA yet. What kind of upside are we talking here?
1 · Reply
Mulhollandr
Mulhollandr Jun. 30 at 3:27 PM
$CLNN
0 · Reply
Takeover24
Takeover24 Jun. 30 at 12:47 PM
$CLNN It is interesting to me that people seemed to be focused on the ~10% average NfL reduction rather than what the underlying data is increasingly suggesting. Much of the discussion focuses on the overall mean effect, but that average may be masking a heterogeneous response distribution, which is exactly what you would expect in a complex neurodegenerative disease like ALS. CLNN has reported exploratory analyses suggesting that some patients experience meaningfully larger reductions in NfL, and those deeper reductions tend to track with more favorable survival trends. This is consistent with broader ALS biology, where lower NfL is strongly and reproducibly associated with improved prognosis across multiple independent datasets. So the key issue is not whether the average is “modest,” but whether a meaningful subset of patients is shifting into a higher-response category with biologically significant NfL reductions. (con't)
2 · Reply
Latest News on CLNN
Roth says FDA approving Clene’s ALS treatment NDA a ‘long shot’

2026-05-14T19:55:37.000Z - 7 weeks ago

Roth says FDA approving Clene’s ALS treatment NDA a ‘long shot’

Clene reports Q1 EPS (69c), consensus (70c)

2026-05-14T16:30:10.000Z - 7 weeks ago

Clene reports Q1 EPS (69c), consensus (70c)

Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights

May 14, 2026, 8:00 AM EDT - 7 weeks ago

Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights

Clene Quarterly report: Q1 2026

May 14, 2026, 7:00 AM EDT - 7 weeks ago

Clene Quarterly report: Q1 2026

Clene Earnings release: Q1 2026

May 14, 2026, 7:00 AM EDT - 7 weeks ago

Clene Earnings release: Q1 2026

Clene price target raised to $50 from $48 at Canaccord

2026-05-08T11:23:32.000Z - 2 months ago

Clene price target raised to $50 from $48 at Canaccord

Clene Transcript: Emerging Growth Conference 92

May 6, 2026, 3:25 PM EDT - 2 months ago

Clene Transcript: Emerging Growth Conference 92

Clene Announces $7 Million Underwritten Offering of Common Stock

May 5, 2026, 8:45 AM EDT - 2 months ago

Clene Announces $7 Million Underwritten Offering of Common Stock

Clene to Present at Upcoming May Conferences

May 5, 2026, 8:00 AM EDT - 2 months ago

Clene to Present at Upcoming May Conferences

Clene provides update on NDA for ALS following Type C meeting with FDA

2026-05-04T13:21:26.000Z - 2 months ago

Clene provides update on NDA for ALS following Type C meeting with FDA

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

May 4, 2026, 8:00 AM EDT - 2 months ago

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

Clene Proxy statement: Proxy filing

Apr 10, 2026, 8:00 AM EDT - 3 months ago

Clene Proxy statement: Proxy filing

Clene Proxy statement: Proxy filing

Apr 10, 2026, 8:00 AM EDT - 3 months ago

Clene Proxy statement: Proxy filing

Clene reports FY25 EPS ($2.65), consensus ($2.35)

2026-03-12T12:12:18.000Z - 4 months ago

Clene reports FY25 EPS ($2.65), consensus ($2.35)

Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights

Mar 12, 2026, 8:00 AM EDT - 4 months ago

Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights

Clene Annual report: Q4 2025

Mar 12, 2026, 8:00 AM EDT - 4 months ago

Clene Annual report: Q4 2025

Clene Annual report: Q4 2025

Mar 12, 2026, 8:00 AM EDT - 4 months ago

Clene Annual report: Q4 2025

Clene Earnings release: Q4 2025

Mar 12, 2026, 8:00 AM EDT - 4 months ago

Clene Earnings release: Q4 2025

Clene Transcript: Emerging Growth Virtual Conference

Feb 25, 2026, 1:45 PM EST - 4 months ago

Clene Transcript: Emerging Growth Virtual Conference

Clene issues letter to shareholders on CNM-Au8 2026 catalysts

2026-02-24T13:13:07.000Z - 4 months ago

Clene issues letter to shareholders on CNM-Au8 2026 catalysts

Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts

Feb 24, 2026, 8:00 AM EST - 4 months ago

Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts

Clene to Present at the Emerging Growth Conference

Feb 19, 2026, 8:30 AM EST - 4 months ago

Clene to Present at the Emerging Growth Conference

Clene Transcript: Emerging Growth Conference 89

Jan 21, 2026, 3:10 PM EST - 5 months ago

Clene Transcript: Emerging Growth Conference 89

Clene announces additional CNM-Au8 biomarker data for potential NDA filing

2026-01-12T14:08:41.000Z - 6 months ago

Clene announces additional CNM-Au8 biomarker data for potential NDA filing

Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting

Jan 12, 2026, 8:30 AM EST - 6 months ago

Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting

Clene announces over $28M registered direct offering

2026-01-09T13:41:01.000Z - 6 months ago

Clene announces over $28M registered direct offering

Clene Announces Registered Direct Offering of Over $28 Million

Jan 9, 2026, 8:30 AM EST - 6 months ago

Clene Announces Registered Direct Offering of Over $28 Million

Clene Transcript: Emerging Growth Conference 88

Dec 10, 2025, 4:25 PM EST - 7 months ago

Clene Transcript: Emerging Growth Conference 88

Clene price target raised to $30 from $20 at Maxim

2025-12-03T18:15:36.000Z - 7 months ago

Clene price target raised to $30 from $20 at Maxim

Clene Transcript: Study Update

Dec 3, 2025, 8:30 AM EST - 7 months ago

Clene Transcript: Study Update

Clene Press release: Study Update

Dec 3, 2025, 8:30 AM EST - 7 months ago

Clene Press release: Study Update

Clene Slides: Study Update

Dec 3, 2025, 8:30 AM EST - 7 months ago

Clene Slides: Study Update

Clene announces significant reductions in NfL, GFAP when treated with CNM-Au8

2025-12-03T13:15:33.000Z - 7 months ago

Clene announces significant reductions in NfL, GFAP when treated with CNM-Au8

Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®

Dec 3, 2025, 8:00 AM EST - 7 months ago

Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®

Clene to Provide CNM-Au8® ALS Program Update

Dec 2, 2025, 5:39 PM EST - 7 months ago

Clene to Provide CNM-Au8® ALS Program Update

Clene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference

Nov 20, 2025, 8:00 AM EST - 8 months ago

Clene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference

Clene reports Q3 EPS (85c), consensus (56c)

2025-11-13T13:10:28.000Z - 8 months ago

Clene reports Q3 EPS (85c), consensus (56c)

Clene sees cash runway into 2Q26

2025-11-13T13:10:16.000Z - 8 months ago

Clene sees cash runway into 2Q26

Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights

Nov 13, 2025, 8:00 AM EST - 8 months ago

Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights

Clene Earnings release: Q3 2025

Nov 13, 2025, 8:00 AM EST - 8 months ago

Clene Earnings release: Q3 2025

Clene Quarterly report: Q3 2025

Nov 13, 2025, 8:00 AM EST - 8 months ago

Clene Quarterly report: Q3 2025

Clene Transcript: Emerging Growth Conference

Oct 23, 2025, 3:10 PM EDT - 9 months ago

Clene Transcript: Emerging Growth Conference

Clene to Participate in a Panel Discussion at the Maxim Growth Summit

Oct 15, 2025, 8:30 AM EDT - 9 months ago

Clene to Participate in a Panel Discussion at the Maxim Growth Summit

Clene announces presentation of combined REPAIR-MS results

2025-09-25T12:10:32.000Z - 10 months ago

Clene announces presentation of combined REPAIR-MS results

Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients

Sep 25, 2025, 8:00 AM EDT - 10 months ago

Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients

Clene price target lowered to $31 from $33 at Benchmark

2025-09-10T12:00:43.000Z - 10 months ago

Clene price target lowered to $31 from $33 at Benchmark

Clene files to sell 491,496 shares of common stock for holders

2025-09-05T20:20:08.000Z - 10 months ago

Clene files to sell 491,496 shares of common stock for holders

Clene Registration statement: Registration Filing

Sep 5, 2025, 8:00 AM EDT - 10 months ago

Clene Registration statement: Registration Filing

Clene Transcript: H.C. Wainwright 27th Annual Global Investment Conference

Sep 5, 2025, 7:00 AM EDT - 10 months ago

Clene Transcript: H.C. Wainwright 27th Annual Global Investment Conference

Clene presents preclinical data supporting CNM-Au8 for Parkinson’s disease

2025-09-04T12:46:04.000Z - 10 months ago

Clene presents preclinical data supporting CNM-Au8 for Parkinson’s disease

Clene presents preclinical data supporting CNM-Au8 for Parkinson’s disease

2025-09-04T12:45:58.000Z - 10 months ago

Clene presents preclinical data supporting CNM-Au8 for Parkinson’s disease

Clene Presents Preclinical Data Supporting CNM-Au8® for the Treatment of Parkinson's Disease

Sep 4, 2025, 8:30 AM EDT - 10 months ago

Clene Presents Preclinical Data Supporting CNM-Au8® for the Treatment of Parkinson's Disease

Clene to Present at the H.C. Wainwright 27th Annual Global Investment Conference

Sep 2, 2025, 8:00 AM EDT - 10 months ago

Clene to Present at the H.C. Wainwright 27th Annual Global Investment Conference

Clene Transcript: Emerging Growth Conference 85

Aug 20, 2025, 2:20 PM EDT - 11 months ago

Clene Transcript: Emerging Growth Conference 85

Clene price target lowered to $48 from $83 at Canaccord

2025-08-18T10:40:11.000Z - 11 months ago

Clene price target lowered to $48 from $83 at Canaccord

Clene reports Q2 EPS (78c) vs ($1.06) last year

2025-08-14T12:45:43.000Z - 11 months ago

Clene reports Q2 EPS (78c) vs ($1.06) last year

Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights

Aug 14, 2025, 8:38 AM EDT - 11 months ago

Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights

Clene Earnings release: Q2 2025

Aug 14, 2025, 8:30 AM EDT - 11 months ago

Clene Earnings release: Q2 2025

Clene Quarterly report: Q2 2025

Aug 14, 2025, 8:30 AM EDT - 11 months ago

Clene Quarterly report: Q2 2025

Clene Transcript: Canaccord Genuity’s 45th Annual Growth Conference

Aug 12, 2025, 3:30 PM EDT - 11 months ago

Clene Transcript: Canaccord Genuity’s 45th Annual Growth Conference

Clene to Present at the Canaccord 45th Annual Growth Conference

Aug 5, 2025, 8:30 AM EDT - 11 months ago

Clene to Present at the Canaccord 45th Annual Growth Conference

Clene Transcript: Emerging Growth Conference 84

Jul 17, 2025, 3:10 PM EDT - 1 year ago

Clene Transcript: Emerging Growth Conference 84

Clene provides regulatory update following FDA Type C meeting

2025-06-30T14:38:15.000Z - 1 year ago

Clene provides regulatory update following FDA Type C meeting

Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings

Jun 30, 2025, 8:00 AM EDT - 1 year ago

Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings

Clene Transcript: Q2 Virtual Investor Summit Event

Jun 10, 2025, 1:00 PM EDT - 1 year ago

Clene Transcript: Q2 Virtual Investor Summit Event

Clene Inc. Chief Executive Officer Rob Etherington to Present at the Investor Summit Virtual on June 10, 2025

Jun 9, 2025, 9:00 AM EDT - 1 year ago

Clene Inc. Chief Executive Officer Rob Etherington to Present at the Investor Summit Virtual on June 10, 2025

Clene Transcript: Emerging Growth Conference 82

May 21, 2025, 3:10 PM EDT - 1 year ago

Clene Transcript: Emerging Growth Conference 82

Clene Slides: Investor Presentation

May 14, 2025, 7:00 AM EDT - 1 year ago

Clene Slides: Investor Presentation

Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights

May 7, 2025, 8:00 AM EDT - 1 year ago

Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights

Clene Earnings release: Q1 2025

May 7, 2025, 8:00 AM EDT - 1 year ago

Clene Earnings release: Q1 2025

Clene Quarterly report: Q1 2025

May 7, 2025, 8:00 AM EDT - 1 year ago

Clene Quarterly report: Q1 2025

Clene Proxy statement: Proxy Filing

Apr 8, 2025, 8:00 AM EDT - 1 year ago

Clene Proxy statement: Proxy Filing

Clene Proxy statement: Proxy Filing

Apr 8, 2025, 8:00 AM EDT - 1 year ago

Clene Proxy statement: Proxy Filing

Clene to Present at the Jones Healthcare and Technology Innovation Conference

Apr 1, 2025, 8:30 AM EDT - 1 year ago

Clene to Present at the Jones Healthcare and Technology Innovation Conference

Clene Proxy statement: Proxy Filing

Mar 28, 2025, 8:00 AM EDT - 1 year ago

Clene Proxy statement: Proxy Filing

Clene Annual report: Q4 2024

Mar 24, 2025, 9:00 AM EDT - 1 year ago

Clene Annual report: Q4 2024

Clene Earnings release: Q4 2024

Mar 24, 2025, 9:00 AM EDT - 1 year ago

Clene Earnings release: Q4 2024

Clene Reports Full Year 2024 Financial Results and Recent Operating Highlights

Mar 24, 2025, 8:00 AM EDT - 1 year ago

Clene Reports Full Year 2024 Financial Results and Recent Operating Highlights

Clene Registration statement: Registration Filing

Mar 24, 2025, 8:00 AM EDT - 1 year ago

Clene Registration statement: Registration Filing

Clene Transcript: 37th Annual ROTH Conference

Mar 18, 2025, 12:30 PM EDT - 1 year ago

Clene Transcript: 37th Annual ROTH Conference

Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment

Mar 12, 2025, 8:00 AM EDT - 1 year ago

Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment

Clene to Present at the 37TH Annual Roth Conference

Mar 6, 2025, 8:30 AM EST - 1 year ago

Clene to Present at the 37TH Annual Roth Conference

Clene Inc. Rob Etherington, CEO, and Morgan Brown, CFO, to Present at the Investor Summit Virtual on March 11

Feb 27, 2025, 9:15 AM EST - 1 year ago

Clene Inc. Rob Etherington, CEO, and Morgan Brown, CFO, to Present at the Investor Summit Virtual on March 11

Clene and APST Enter Into an Agreement to Support FDA's Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®'s Impact on NfL Reduction

Feb 25, 2025, 8:00 AM EST - 1 year ago

Clene and APST Enter Into an Agreement to Support FDA's Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®'s Impact on NfL Reduction

Clene Registration statement: Registration Filing

Jan 24, 2025, 7:00 AM EST - 1 year ago

Clene Registration statement: Registration Filing

FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS

Dec 10, 2024, 8:30 AM EST - 1 year ago

FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS

Clene Slides: Investor Presentation

Dec 10, 2024, 7:00 AM EST - 1 year ago

Clene Slides: Investor Presentation

Clene Quarterly report: Q3 2024

Nov 13, 2024, 7:00 AM EST - 1 year ago

Clene Quarterly report: Q3 2024

Clene Earnings release: Q3 2024

Nov 13, 2024, 7:00 AM EST - 1 year ago

Clene Earnings release: Q3 2024

Clene Registration statement: Registration Filing

Nov 13, 2024, 7:00 AM EST - 1 year ago

Clene Registration statement: Registration Filing

Clene Announces $7.3 Million Registered Direct Offering and Concurrent Private Placements Priced at Market Under Nasdaq Rules

Sep 30, 2024, 8:30 AM EDT - 1 year ago

Clene Announces $7.3 Million Registered Direct Offering and Concurrent Private Placements Priced at Market Under Nasdaq Rules

Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data

Sep 16, 2024, 8:30 AM EDT - 1 year ago

Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data

Clene to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Sep 3, 2024, 8:00 AM EDT - 1 year ago

Clene to Present at the H.C. Wainwright 26th Annual Global Investment Conference

IBN Announces Latest Episode of The BioMedWire Podcast featuring Rob Etherington, CEO of Clene Inc.

Aug 8, 2024, 8:00 AM EDT - 2 years ago

IBN Announces Latest Episode of The BioMedWire Podcast featuring Rob Etherington, CEO of Clene Inc.

Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights

Aug 7, 2024, 8:23 AM EDT - 2 years ago

Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights

Clene Quarterly report: Q2 2024

Aug 7, 2024, 7:00 AM EDT - 2 years ago

Clene Quarterly report: Q2 2024

Clene Earnings release: Q2 2024

Aug 7, 2024, 7:00 AM EDT - 2 years ago

Clene Earnings release: Q2 2024

Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8® in ALS

Jul 11, 2024, 9:00 AM EDT - 2 years ago

Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8® in ALS

Clene Announces 1-for-20 Reverse Stock Split

Jul 9, 2024, 8:00 AM EDT - 2 years ago

Clene Announces 1-for-20 Reverse Stock Split

Clene to Present at H.C. Wainwright's 5th Annual Neuro Perspectives Virtual Conference

Jun 24, 2024, 8:00 AM EDT - 2 years ago

Clene to Present at H.C. Wainwright's 5th Annual Neuro Perspectives Virtual Conference

Clene Presents Preliminary Data for CNM-Au8® as a Potential Treatment for Rett Syndrome

Jun 21, 2024, 7:09 AM EDT - 2 years ago

Clene Presents Preliminary Data for CNM-Au8® as a Potential Treatment for Rett Syndrome

Clene Presents Extended Survival Data Through 3.5 Years and New NfL Responder Results with CNM-Au8® 30 mg Treatment from the HEALEY ALS Platform Trial Open Label Extension at the 2024 ENCALS Meeting

Jun 18, 2024, 7:00 AM EDT - 2 years ago

Clene Presents Extended Survival Data Through 3.5 Years and New NfL Responder Results with CNM-Au8® 30 mg Treatment from the HEALEY ALS Platform Trial Open Label Extension at the 2024 ENCALS Meeting

Clene Provides Update on Its NIH-Funded Expanded Access Program for CNM-Au8® in ALS (ACT-EAP)

May 28, 2024, 7:30 AM EDT - 2 years ago

Clene Provides Update on Its NIH-Funded Expanded Access Program for CNM-Au8® in ALS (ACT-EAP)

Clene Reports First Quarter 2024 Financial Results and Recent Operating Highlights

May 8, 2024, 8:00 AM EDT - 2 years ago

Clene Reports First Quarter 2024 Financial Results and Recent Operating Highlights

Clene Quarterly report: Q1 2024

May 8, 2024, 7:00 AM EDT - 2 years ago

Clene Quarterly report: Q1 2024

Clene Earnings release: Q1 2024

May 8, 2024, 7:00 AM EDT - 2 years ago

Clene Earnings release: Q1 2024

Evidence for Clene's CNM-Au8® as a Treatment for Repair and Remyelination in Multiple Sclerosis Presented in the Emerging Science Session at the 2024 American Academy of Neurology Annual Meeting

Apr 16, 2024, 4:01 PM EDT - 2 years ago

Evidence for Clene's CNM-Au8® as a Treatment for Repair and Remyelination in Multiple Sclerosis Presented in the Emerging Science Session at the 2024 American Academy of Neurology Annual Meeting

Clene Proxy statement: Proxy Filing

Apr 16, 2024, 8:00 AM EDT - 2 years ago

Clene Proxy statement: Proxy Filing

Clene Proxy statement: Proxy Filing

Apr 16, 2024, 8:00 AM EDT - 2 years ago

Clene Proxy statement: Proxy Filing

Clene Proxy statement: Proxy Filing

Apr 5, 2024, 8:00 AM EDT - 2 years ago

Clene Proxy statement: Proxy Filing

Clene Announces Peer-Reviewed Publication Characterizing the Protein Corona of the Investigational Neurodegenerative Disease Drug, CNM-Au8®

Mar 15, 2024, 8:00 AM EDT - 2 years ago

Clene Announces Peer-Reviewed Publication Characterizing the Protein Corona of the Investigational Neurodegenerative Disease Drug, CNM-Au8®

Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights

Mar 13, 2024, 8:00 AM EDT - 2 years ago

Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights

Clene Annual report: Q4 2023

Mar 13, 2024, 8:00 AM EDT - 2 years ago

Clene Annual report: Q4 2023

Clene Earnings release: Q4 2023

Mar 13, 2024, 8:00 AM EDT - 2 years ago

Clene Earnings release: Q4 2023

Clene Presents Clinical Results of CNM-Au8® 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024

Feb 29, 2024, 8:00 AM EST - 2 years ago

Clene Presents Clinical Results of CNM-Au8® 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024

Clene says FDA finds ALS drug data not enough for accelerated nod

Dec 21, 2023, 11:25 AM EST - 2 years ago

Clene says FDA finds ALS drug data not enough for accelerated nod

Clene Reports Reduction in Biomarker Plasma Neurofilament Light (NfL) Levels and Improved Survival With CNM-Au8® Treatment From HEALEY ALS Platform Trial Long-Term Open Label Extension

Dec 21, 2023, 7:00 AM EST - 2 years ago

Clene Reports Reduction in Biomarker Plasma Neurofilament Light (NfL) Levels and Improved Survival With CNM-Au8® Treatment From HEALEY ALS Platform Trial Long-Term Open Label Extension

Clene Provides Update on ALS Clinical Development Meeting With FDA

Dec 21, 2023, 7:00 AM EST - 2 years ago

Clene Provides Update on ALS Clinical Development Meeting With FDA

Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Brain Target Engagement In Neurodegenerative Diseases

Dec 14, 2023, 8:36 AM EST - 2 years ago

Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Brain Target Engagement In Neurodegenerative Diseases

Clene Reports Third Quarter 2023 Financial Results and Operating Highlights

Nov 7, 2023, 8:00 AM EST - 2 years ago

Clene Reports Third Quarter 2023 Financial Results and Operating Highlights

fibonacci1170
fibonacci1170 Jul. 3 at 8:35 PM
$CLNN I just realized that I had misinterpreted the FDA minutes. I thought the FDA asked CLENE to show that the 10% lowering of Nfl levels led to clinical benefit in the cnmau8 patients, which can be very difficult to prove if cnmau8 only helps patients to live longer in a vegetative state without improving their motor functions. Now I realize that this is not what the FDA wants to see. Instead, the FDA wants to see: 1. A clear demonstration of NfL level reduction using cnmau8. (CLENE has a ton of solid data on this already). 2. Does lowering the NfL levels (by 5%, 10%, whatever..) have any clinical benefit for patients? (This need not be cnmau8 based data. This correlation can be demonstrated from previous ALS datasets. The recent poster by CLENE in Spain just proved this correlation). Overall, it seems that CLENE has all the data that the FDA wants to see in the NDA filing, and that this will be a slam dunk approval. Let me know if my understanding is still wrong.
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fibonacci1170
fibonacci1170 Jul. 2 at 6:07 PM
$CLNN CNM-Au8 is the most advanced nanozyme in biomedicine. I guess being alone at the top explains the skepticism and lack of buzz around CNM-Au8's efficacy. But I think CLENE has got a winner. Outrageous upside over the next 3-9 months.
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prusio1
prusio1 Jul. 2 at 2:54 PM
$CLNN CLNN is sitting on an absurdly thin float. It only takes one legit catalyst to wake this thing up, and once volume hits, it doesn’t move, it launches. When supply of the shares is microscopic, the upside isn’t capped. It’s undefined. Extreme patience is imperative. I am accumulating through August.
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Mulhollandr
Mulhollandr Jul. 2 at 2:46 PM
$CLNN https://spj.science.org/doi/10.34133/research.1318?__cf_chl_f_tk=So9IiDf.4s3nax_PAOvglp1fZ0siJCgUTDtZCjMAHFs-1783003566-1.0.1.1-.JukNwnX7NBkAvEVhQCIZdS7CHtnM28eR9E_rSBjDf0
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neuroinvestor3
neuroinvestor3 Jul. 1 at 1:56 PM
$CLNN Asked the ChatGPT this question "what are the odds CLNN stock price increases once they announce the filing of the FDA AA data package?" Answer: There isn't a reliable way to assign a precise probability that CLNN will rise when it announces that it has filed its FDA Accelerated Approval (AA) data package. The market reaction depends less on the filing itself than on what investors believe it implies about the likelihood of approval and commercialization. Here's how I'd think about it: A filing announcement is generally a positive catalyst. It signals the company has reached an important regulatory milestone and believes its package is complete enough to submit. However, filings are often anticipated. If investors already expect the submission, part (or most) of the positive effect may already be reflected in the stock price. The content of the announcement matters. If management provides additional details—such as the strength of the data, FDA interactions, (cont)
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vijaykamat14
vijaykamat14 Jul. 1 at 11:05 AM
$CLNN break through $9 soon. Q3 is here
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fibonacci1170
fibonacci1170 Jun. 30 at 8:28 PM
$CLNN upside in this ticker is obscene, if we can get AA for ALS.
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Ravery
Ravery Jun. 30 at 6:20 PM
$CLNN Something that really has not been discussed here is pricing. IF approved, what kind of annual run rate could cnm-au8 generate? With about 500,000 cases worldwide and 35,000 here in the US, that is a significant addressable market. It is relevant to ponder, even though the the fda has not even accepted the NDA yet. What kind of upside are we talking here?
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Mulhollandr
Mulhollandr Jun. 30 at 3:27 PM
$CLNN
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Takeover24
Takeover24 Jun. 30 at 12:47 PM
$CLNN It is interesting to me that people seemed to be focused on the ~10% average NfL reduction rather than what the underlying data is increasingly suggesting. Much of the discussion focuses on the overall mean effect, but that average may be masking a heterogeneous response distribution, which is exactly what you would expect in a complex neurodegenerative disease like ALS. CLNN has reported exploratory analyses suggesting that some patients experience meaningfully larger reductions in NfL, and those deeper reductions tend to track with more favorable survival trends. This is consistent with broader ALS biology, where lower NfL is strongly and reproducibly associated with improved prognosis across multiple independent datasets. So the key issue is not whether the average is “modest,” but whether a meaningful subset of patients is shifting into a higher-response category with biologically significant NfL reductions. (con't)
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paule815
paule815 Jun. 30 at 12:35 PM
$CLNN does anyone have 20k shares or more? If you do, can I be your friend? I do not have 20k shares. I’ll submit a friendship application to HR.
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Chris150
Chris150 Jun. 30 at 11:55 AM
$CLNN Clene Inc.(NasdaqCM:CLNN) added to Russell Microcap Index https://www.marketscreener.com/news/clene-inc-nasdaqcm-clnn-added-to-russell-microcap-index-ce7f5fdedd89f221 Russell Microcap Index Reconstitution/Rebalancing List - June 2026, Clene Inc. bottom of 1st page https://www.lseg.com/content/dam/ftse-russell/en_us/documents/other/rmicro-additions-20260626.pdf
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fibonacci1170
fibonacci1170 Jun. 30 at 1:49 AM
$CLNN CLENE says 10% reduction in Nfl levels led to 7% survival benefit How did they deduce that? Was this data statistically significant? For example, if a patient lives 15 instead of 14 months, that's 7% survival benefit. But how did clene estimate that the baseline is 14%? I hope it is not the case but it all sounds a massive amount of handwaving and cherry picking data points. Any kind of survival benefit is welcome news for the patients, but from the FDA's standpoint, how did clene perform the statistical analysis to come up with such numbers? Seems marginal, and contrived analysis. Hope to be wrong but clene will have a nearby impossible task to convince the FDA biostatisticians. $10 would 2x my investment, and I might half my position to play with only the house money. From these numbers I am not convinced CLENE has the data to warrant accelerated approval.
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Takeover24
Takeover24 Jun. 29 at 5:07 PM
$CLNN Another new high profile ALS diagnosis revealed with former NFL star Chris Johnson announcing during an interview with Michael Strahan on GMA that he has ALS. So much attention now on this horrible disease and will be a lot of pressure on FDA to approve a new treatment or have a robust justification for another rejection. Given CNM Au8 is safe for all and perhaps the easiest drug to administer / take, even if it only helps some how can FDA possibly tells these patients sorry you have to wait another few years for a phase 3? I know it is not as simple as this but I do feel that the political climate has completely shifted in the past year and CLNN's chances are stronger than ever for AA.
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Chris150
Chris150 Jun. 29 at 2:21 PM
$CLNN Just fyi FDA posted a video about clinical outcome vs surrogate endpoints for rare diseases, which is applicable for ALS as well. Understanding Endpoints in Rare Disease Drug Development https://www.youtube.com/watch?v=lHQ66qjXPoU
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Chris150
Chris150 Jun. 29 at 11:18 AM
$CLNN 2/2 The abstracts from the two publications about Clene's posters below. https://www.aan.com/msa/Public/Events/AbstractDetails/65039 https://www.mdaconference.org/abstract-library/lb-igfbp7-as-a-nexus-biomarker-identifying-a-coordinated-treatment-response-phenotype-in-als-post-hoc-exploratory-analysis-from-regimen-c-of-the-healey/
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Chris150
Chris150 Jun. 29 at 11:13 AM
$CLNN 1/2 Clene presented two posters at the ENCALS Meeting in Madrid last week. (I think this is the Linkedin post @Takeover24 wanted to share). https://www.linkedin.com/posts/clene-nanomedicine_encals-als-activity-7476276845445943296-QVG0 We were proud to have our Vice President of Medical Affairs, Marjan Sepassi, present two posters at the ENCALS Meeting in Madrid. The meeting brought together members of the global ALS community to share research, exchange insights, and advance conversations around improving care and outcomes for people living with ALS. We thank Marjan, our collaborators, and everyone who contributed to this work.
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Takeover24
Takeover24 Jun. 27 at 2:32 PM
$CLNN https://www.linkedin.com/feed Continuing to establish the link between NFL decrease and survival!
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Mulhollandr
Mulhollandr Jun. 26 at 8:01 PM
$CLNN not upset with that close.
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goldenegg1
goldenegg1 Jun. 26 at 3:06 PM
$CLNN Looks like a cap, but it’s just low‑float biotech mechanics. Market makers and algos pin the price when liquidity is thin and positioning isn’t finished. These walls vanish the moment volume spikes or a real buyer steps in. Nothing fundamental changed — just tape games in a small name. Accumulating when I can.
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Mulhollandr
Mulhollandr Jun. 25 at 10:00 PM
$CLNN I fed info and asked Claude to challenge me over a lengthy exchange where I provided points and counter points to Claude’s pushback. Here is where we landed. (1) $CLNN bull case, comprehensively. Sub-$100M cap with NDA submission targeted Q3 2026 for CNM-Au8 in ALS under accelerated approval pathway (Subpart H). FDA’s final May 2026 meeting minutes confirmed the proposed data may support submission, with NfL serving as a reasonably likely surrogate endpoint. This wasn’t a one-meeting outcome — it’s the product of years of iterated FDA dialogue. Multiple Type C meetings, written guidance from DN1, FDA-recommended analyses pursued and delivered. The agency walked Clene through the gate. That dialogue pattern materially lowers the probability of an efficacy-driven CRL relative to base rate.
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Mulhollandr
Mulhollandr Jun. 25 at 8:36 PM
$CLNN short interest dropped just a touch to just over a million shares.
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