Clene (CLNN – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Joseph Pantginis from H.C. Wainwright maintained a Buy rating on the stock and has a $31.00 price target.
Joseph Pantginis has given his Buy rating due to a combination of factors related to Clene’s strategic advancements in their ALS treatment, CNM-Au8. The company has entered into a partnership with APST Research to analyze extensive biomarker data, which is expected to provide robust evidence of CNM-Au8’s impact on neurofilament light chain (NfL) reductions. This collaboration is anticipated to support Clene’s submission for accelerated regulatory approval by aligning the biomarker data with clinical assessments and outcomes.
Furthermore, Clene is actively working with the FDA to satisfy requirements for accelerated approval, including the collection of new NfL biomarker data from multiple Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial. The ongoing analyses and planned submission of a New Drug Application (NDA) in 2025, along with the initiation of a Phase 3 confirmatory trial, demonstrate a clear path forward for CNM-Au8. Pantginis views the FDA’s openness to reviewing the EAP data as a positive development, enhancing the potential for approval and supporting his optimistic outlook on Clene’s stock.