Clene Inc. CLNN Archives

TuesdaySep 09, 2025 2:49 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Advances Toward NDA Submission for ALS Therapy

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, recently released second quarter 2025 financial results and provided an update on clinical programs. “The company emphasized progress toward an NDA submission for its lead asset CNM-Au8® in ALS, expected in the fourth quarter of 2025,” reads an article discussing this. “We look forward to engaging with the FDA in our upcoming meeting this quarter focused on the extensive survival data that CNM-Au8® has generated in ALS patients,” said CEO Rob Etherington.…

TuesdaySep 02, 2025 9:20 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) to Present at H.C. Wainwright Global Investment Conference

Clene (NASDAQ: CLNN) announced that management will present at the H.C. Wainwright 27th Annual Global Investment Conference and host one-on-one investor meetings. To view the full press release, visit https://ibn.fm/9cLjp About Clene Inc. Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8(R)is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and…

ThursdayAug 21, 2025 12:45 pm

Clene Inc. (NASDAQ: CLNN) Reports Q2 2025 Results as Company Prepares for NDA Submission and Extends Runway into 2026

Clene Inc. plans to submit a New Drug Application (“NDA”) for lead candidate CNM-Au8® in ALS by year-end 2025. FDA meetings scheduled in Q3 2025 will address ALS survival benefit data and MS development plans. Neurofilament light biomarker data analysis from the NIH-sponsored EAP program is expected in early Q4 2025. The company reported $7.3 million in cash and cash equivalents as of June 30, 2025, together with recent financing extending the company’s cash runway into Q1 2026. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and…

ThursdayAug 14, 2025 10:15 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Reports Q2 2025 Results, Targets Year-End NDA Submission for ALS Therapy

Clene (NASDAQ: CLNN), a late clinical-stage biopharma company developing treatments for neurodegenerative diseases, reported Q2 2025 results and said it has sufficient cash runway into Q1 2026. The company plans to meet with the FDA this quarter to review survival data for lead candidate CNM-Au8 in amyotrophic lateral sclerosis (ALS) and is preparing analyses of NIH-sponsored Expanded Access Program neurofilament light biomarker data, expected in Q4. These steps are intended to support a potential New Drug Application submission under the FDA’s accelerated approval pathway for ALS by year-end 2025. Management said its focus remains on delivering an impactful therapy to the…

MondayJul 28, 2025 9:00 am

Clene Inc. (NASDAQ: CLNN) Offers Investors a Compelling Entry into the Growing ALS Market with Key FDA Milestones for Lead Drug Candidate

Clene is progressing toward a potential FDA accelerated approval for its ALS (Amyotrophic Lateral Sclerosis) drug CNM-Au8® in 2026, a market that is expected to reach $1.3 billion by 2034 with significant unmet need. Clene’s technology targets mitochondrial dysfunction, a novel approach to neurodegenerative diseases, and key FDA meetings in the coming months of 2025 could be major valuation catalysts for investors. Biomarker and survival data from over 150 patients will be critical to the company’s regulatory case and expects important NfL data in the fourth quarter of 2025. Clene is preparing to initiate a confirmatory Phase 3 ALS trial…

MondayJul 07, 2025 11:50 am

Clene Inc. (NASDAQ: CLNN) to Conduct Neurofilament Biomarker Analysis for CNM-Au8(R) in ALS in Early Q4 2025

The FDA offered supportive feedback on Clene’s proposed statistical analysis plan during a recent Type C meeting. The neurofilament biomarker analysis results could support an accelerated approval submission for CNM-Au8 later in 2025. Clene has two additional FDA meetings scheduled in Q3 2025 to discuss ALS survival data and its MS program. Nearly 200 ALS patients are participating in the NIH-sponsored Expanded Access Program for CNM-Au8. The analysis aims to validate the neuroprotective effects shown in previous HEALEY Platform Trial results. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving…

MondayJun 30, 2025 9:30 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs

Clene (NASDAQ: CLNN) announced key regulatory developments following a Type C meeting with the FDA, where it received feedback on its statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for ALS. The company has resubmitted a revised SAP and anticipates FDA acceptance this summer, with NfL analyses scheduled for early Q4 2025 to support a potential NDA submission under the accelerated approval pathway. Clene also confirmed two additional FDA meetings in Q3 2025: one to assess long-term ALS survival data for accelerated approval consideration and another End-of-Phase 2 Type B meeting to review…

WednesdayApr 02, 2025 9:45 am

Clene Inc. (NASDAQ: CLNN) to Share CNM-Au8(R) Progress at Jones Las Vegas Conference

The company will present at the Jones Las Vegas Technology and Innovation Conference on April 8-9, to update investors on its lead drug candidate. The conference will provide one-on-one meetings and networking opportunities for institutional investors and executives. Clene recently received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS treatment. New analyses suggest CNM-Au8 improves survival for ALS patients, with a 4.1-month increase in restricted mean survival time. Clene plans to begin enrollment for a Phase 3 confirmatory trial (RESTORE-ALS) in mid-2025. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage…

TuesdayApr 01, 2025 9:50 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) to Present at Jones Healthcare and Technology Innovation Conference on April 9

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company advancing treatments for neurodegenerative diseases like ALS and MS, will present at the Jones Healthcare and Technology Innovation Conference on April 9, 2025, at 11:30 a.m. PT. The event will be held at the Venetian Resort in Las Vegas and include 1x1 investor meetings. A webcast of the presentation will be available via the events section of Clene’s website. To view the full press release, visit https://ibn.fm/16NsQ About Clene Inc. Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving…

ThursdayMar 27, 2025 9:45 am

Clene Inc.’s (NASDAQ: CLNN) Q1 Virtual Investor Summit Presentation Available for On-Demand Viewing

Clene’s presentation by CEO Rob Etherington and CFO Morgan Brown is now available on demand on the event’s website, covering the company’s recent achievements and immediate plans for lead drug candidate CNM-Au8®. Clene is planning to submit a New Drug Application (“NDA”) to the FDA for potential accelerated approval for CNM-Au8 for ALS in the second half of 2025. The company recently released the latest data from a cross-regimen analysis of HEALEY ALS Platform Trial, showing that CNM-Au8 significantly extends survival in patients with ALS. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical…

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