Clene Inc.
Clene develops clean-surfaced nanotechnology therapeutics for diseases, with a focus on central nervous system disorders including amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease. Its platform produces catalytically active nanocrystals and ionic solutions of transition elements. The lead drug candidate, CNM-Au8, is an oral gold-nanocrystal suspension being developed for those three disorders. Other early-stage assets include CNM-ZnAg, an aqueous zinc-and-silver ion solution, and CNM-AgZn17, a zinc-and-silver gel for topical use. Clene also develops low-concentration dietary supplements through its wholly owned subsidiary dOrbital and an exclusive license with 4Life Research. Products include dOrbital’s rMetx zinc-silver supplement and 4Life’s KHC46 gold supplement, which 4Life markets and distributes worldwide under the exclusive license. Clene is headquartered in Salt Lake City, Utah.
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See all $CLNN insider activity →Clene Inc. received a $7.2 million subaward from NYU under an NIH grant to support its Expanded Access Program for CNM-Au8, a treatment for ALS. The agreement, signed on Oct 15, 2026, covers the period from Sep 1, 2026, to Aug 31, 2027, according to the company's SEC filing.
Clene Inc. (CLNN) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Item 1.01 Entry into a Material Definitive Agreement. Previously, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the “Company”) announced (i) on October 5, 2023, a four-year, $45.1 million grant (“the NIH
HC Wainwright & Co. maintained a Buy rating on Clene's stock with a $31 price target, implying a 900% upside from the Oct 16 close. The firm cited promising clinical data for CNM-Au8, showing reductions in biomarkers linked to ALS progression, and a strategic regulatory milestone with the NDA submission and planned Phase 3 trial.
Recent CLNN coverage spans regulation, corporate actions and financial news.
The grant provides additional non‑dilutive funding for the CNM‑Au8 ALS program, which may improve trial progress and reduce cash‑burn concerns.
The additional grant funding may support continued clinical development and could be viewed positively by investors.
HC Wainwright & Co. maintained a Buy rating on Clene's stock with a $31 price target, implying a 900% upside from the Oct 16 close. The firm cited promising clinical data for CNM-Au8, showing reductions in biomarkers linked to ALS progression, and a strategic regulatory milestone with the NDA submission and planned Phase 3 trial.
The NDA filing is a primary regulatory event that could lift the stock on approval expectations.
The NDA filing introduces a potential catalyst that could lift the stock if the FDA grants accelerated approval.
AlphAI scores every news story that mentions CLNN with an AI model for sentiment and relevance, and aggregates insider trades from Clene Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Clene Inc. received a $7.2 million subaward from NYU under an NIH grant to support its Expanded Access Program for CNM-Au8, a treatment for ALS. The agreement, signed on Oct 15, 2026, covers the period from Sep 1, 2026, to Aug 31, 2027, according to the company's SEC filing.
1 min readClene Inc. (CLNN) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Item 1.01 Entry into a Material Definitive Agreement. Previously, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the “Company”) announced (i) on October 5, 2023, a four-year, $45.1 million grant (“the NIH
1 min readHC Wainwright & Co. maintained a Buy rating on Clene's stock with a $31 price target, implying a 900% upside from the Oct 16 close. The firm cited promising clinical data for CNM-Au8, showing reductions in biomarkers linked to ALS progression, and a strategic regulatory milestone with the NDA submission and planned Phase 3 trial.
1 min readClene Inc. (CLNN) filed an SEC Form 8-K — Other Events. Exhibit 99.1 CLENE ANNOUNCES NEW DRUG APPLICATION SUBMISSION TO FDA FOR CNM-Au8 FOR THE TREATMENT OF ALS ● NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes SALT LAKE CITY, October 19, 2026 — Clene Inc. (N
2 min readClene Inc. (CLNN) submitted an FDA New Drug Application for accelerated approval of CNM-Au8 to treat ALS and plans a Phase 3 study. The FDA has not yet accepted the application or set a review timeline, according to the company.
1 min readClene Inc (CLNN) plans to submit an FDA application for its ALS drug CNM-Au8 in Q4, aiming for a mid-2027 decision. CEO Etherington cited survival benefits and neurofilament light changes as supporting data. The company has held five FDA meetings and completed financing to support the filing. If approved, CNM-Au8 could address thousands of patients annually, with Clene working on insurer and payer agreements.
2 min readClene Inc. (CLNN) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Exhibit 99.1 CLENE ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING ● 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 dire
1 min readPDS Biotech (PDSB) announced a $22.55M PIPE financing for late-stage cancer drug development, shares up 50.64%. Avaí Bio (AVAI) completed cell bank testing, shares up 14.29%. Clene (CLNN) priced a $4M offering, shares up 25.25%. NurExone (NRX.V) partnered with NanoPass, shares up 8.06%. Cardiff Oncology (CRDF) settled a licensing dispute, shares up 4.58%. Indaptus (INDP) shares surged 16.88% without specific news.
3 min readClene Inc. (CLNN) announced a $4M direct offering of 1.22M shares at $3.28 each, expected to close on September 17, 2026. The company plans to use the funds for corporate purposes, including regulatory activities and CNM-Au8 development. CLNN stock closed at $3.28 on Monday, down 8.12%, and is up 11.71% in pre-market trading.
2 min readClene (CLNN) plans to submit an NDA for its ALS drug in Q4, following FDA-requested biomarker analyses. The company reported consistent neurofilament reductions across trials and believes its data links biomarker changes to clinical benefits. Clene aims for an FDA decision by year-end and a potential commercialization decision by early 2027.
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