H.C. Wainwright Reiterates Buy Rating on Clene, Inc. (CLNN)

H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating and $31.00 price target on Clene, Inc. (NASDAQ: CLNN).

The analyst commented: "Following receipt of the final formal Type C meeting minutes, which confirmed that the proposed data may be capable of supporting the submission and review of an NDA under the accelerated approval pathway for ALS, Clene’s efforts have focused on demonstrating the effects of CNM-Au8 on NfL levels and showing that the magnitude of NfL change is reasonably likely to predict clinical benefit in ALS patients. In summary, CNM-Au8-treated patients whose NfL levels declined or stabilized lived significantly longer than concurrently randomized controls, and performed significantly better on composite measures of survival and function, including ALSFRS-R and SVC, indicating favorable effects between magnitude of change and clinical benefits. In parallel, the company intends to launch the confirmatory RESTORE-ALS Phase 3 trial in ALS in 2Q27 (more below). With essentially the complete dataset in hand, including results from HEALEY ALS, RESCUE-ALS, EAP, long-term survival benefits, biomarker reductions, and favorable correlations between biomarker declines and improved survival/function, the company plans to submit the NDA in 4Q26. We believe that regulatory alignment with the FDA supporting the potential NDA review and approval pathway for CNM-Au8 as a first-in-class therapy for ALS marks an important step forward for CNM-Au8 and for Clene, and look forward to the next regulatory updates. Clene announced 2Q26 results, posting EPS of ($1.08), compared to our estimate of ($0.35), and consensus of ($0.26). The company ended the quarter with $9.7 million in cash, which management believes provides runway to fund ongoing operations through 4Q26. Reiterate Buy rating and $31 PT."

For an analyst ratings summary and ratings history on Clene, Inc. click here. For more ratings news on Clene, Inc. click here.

Shares of Clene, Inc. closed at $4.14 yesterday.

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