CLENE ANNOUNCES NEW DRUG APPLICATION SUBMISSION TO FDA FOR CNM-Au8 FOR THE TREATMENT OF ALS

Clene Inc. (CLNN) submitted an NDA to the FDA for accelerated approval of CNM-Au8, an investigational therapy for ALS, based on biomarker data and clinical outcomes. The company plans to collaborate with the FDA and prepare for a Phase 3 study, aiming to improve neuronal function and survival in ALS patients. CLNN stock is up 4.52% at $3.24.

Clene Inc. submitted a New Drug Application to the FDA for accelerated approval of CNM-Au8 to treat ALS, using biomarker data and clinical outcomes. The company will prepare for a Phase 3 study during the review. According to Clene, CNM-Au8 may restore neuronal health and improve survival rates in ALS patients.

Clene Inc. (CLNN) submitted a New Drug Application to the FDA for accelerated approval of CNM-Au8, a treatment for amyotrophic lateral sclerosis. The submission is based on biomarker data and clinical outcomes. The company plans a confirmatory Phase 3 study. The FDA has not yet set a review timeline.

Clene 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.

Clene 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.

Clene (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.