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: "Clene provided updates on June 30 from a recent Type C meeting with the FDA to discuss the proposed statistical analysis plan (SAP) of neurofilament light (NfL) biomarker data from the ongoing NIH-sponsored Expanded Access Protocol (EAP) vs. matched ALS controls (see details from the previous Type C meeting below). Recall, this dataset could substantiate the effect of CNM-Au8 on NfL decline, and meet the regulatory standard for evidence of effectiveness supporting accelerated approval. Based on FDA feedback, the primary analysis is planned to include NfL changes following nine months of treatment, and the supportive analysis will include NfL changes after six months of treatment. We expect these results to validate previous biomarker data supporting CNM-Au8-mediated NfL declines (see more in our prior note: Connecting Biomarker, Survival, Functional, and MoA Dots Ahead of Type C Meeting in 3Q24; Split-Adjusted Target to $31). The acceptance of the SAP is anticipated this summer (the revised SAP incorporating FDA’s requests has been resubmitted), followed by biomarker analyses planned for 4Q25. If the findings demonstrate a clinically meaningful NfL decline, they may support an NDA for CNM-Au8 in ALS under the accelerated approval pathway by the end of 2025. Clene is scheduled to have two additional meetings with the FDA in 3Q25 to: 1) review CNM-Au8’s long-term survival benefits compared to concurrently randomized controls from another HEALEY ALS Platform Trial regimen; and 2) discuss results from the Phase 2 VISIONARY-MS clinical trial, and a potential Phase 3 study in MS. We believe these regulatory steps and discussions involve positive support from regulators, and expect the new NfL biomarker analyses to address FDA’s concerns. Here is a summary of upcoming milestones for CNM-Au8 programs: 3Q25: ALS survival data Type C meeting; 3Q25: MS end-of-Phase 2 Type B meeting; 4Q25: Conduct ALS biomarker analyses; and YE25: Accelerated Approval NDA submission in ALS. 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 $3.91 yesterday.

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