Clene Inc. CLNN Archives

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…

TuesdayMar 25, 2025 9:30 am

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) to Present at Jones Las Vegas Technology and Innovation Conference

Clene (NASDAQ: CLNN), a clinical-stage biopharmaceutical company advancing treatments for neurodegenerative diseases such as ALS and MS, will participate in the Jones Las Vegas Technology and Innovation Conference on April 8–9, 2025. Held at The Venetian Resort, the event will feature one-on-one meetings, panels, and networking with institutional investors. Clene CEO Rob Etherington will represent the company as it continues to highlight progress across its therapeutic pipeline. The conference is hosted by JonesTrading with marketing support from B2i Digital, Inc. To view the full press release, visit https://ibn.fm/WoJcw About Clene Inc. Clene (along with its subsidiaries, “Clene”) and its wholly owned…

FridayMar 21, 2025 12:28 pm

QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Unveils Progress on CNM-Au8(R), Eyes Potential Fast-Track FDA Approval

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, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is actively advancing its lead drug candidate, CNM-Au8®. The company presented its progress at two key investor events this month, including the Q1 Virtual Investor Summit and the 37th Annual Roth Conference. At both events, Clene’s management discussed the latest achievements with CNM-Au8, a gold nanocrystal-based oral suspension that targets mitochondrial dysfunction and promotes neuronal health. The drug has shown promising results in…

WednesdayMar 19, 2025 9:00 am

Clene Inc.’s (NASDAQ: CLNN) CNM-Au8(R) Delivers Significant Survival Benefits in New Analyses of Healey ALS Platform Trial Data

Clene's CNM-Au8® treatment was demonstrated to improve survival in ALS patients by up to 14.8 months. The findings come from a post hoc analysis of the HEALEY ALS Platform Trial, comparing CNM-Au8 to a concurrently enrolled control. Strong survival benefit was observed in patients meeting the planned criteria for Clene’s upcoming Phase 3 RESTORE-ALS trial. The company is preparing to submit a New Drug Application (“NDA”) to the FDA later this year for potential accelerated approval, and further regulatory discussions and a confirmatory Phase 3 trial are planned for mid-2025. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine…

WednesdayMar 12, 2025 9:00 am

Clene Inc. (NASDAQ: CLNN) to Present CNM-Au8(R) Updates at 37th Annual Roth Conference

The 37th Annual Roth Conference, to be held March 16-18 in Dana Point, California, will showcase the broadest group of companies in the event’s history, with senior executives from approximately 500 companies across various industries, including business services, consumer, healthcare, insurance, sustainability and technology, media and entertainment. Clene’s management will participate in a virtual fireside chat at 9:20 a.m. PST on March 18, as well as one-on-one investor meetings during the event. During the fireside chat and in investor meetings, the company will detail recent achievements and next steps for lead drug candidate CNM-Au8 for ALS and MS. Clene Inc.…

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