Salt Lake City-based Clene Inc. (CLNN:NASDAQ) reported both encouraging clinical data and a regulatory setback for its ALS drug candidate CNM-Au8, reported Roth MKM analyst Dr. Jonathan Aschoff in a December 21 research note.
In an update on the Phase 2 HEALEY trial, Clene noted that the neurofilament light (NfL) biomarker in patients consistently on 30mg of CNM-Au8 declined by 16% after 76 weeks of treatment. In contrast, patients initially on a placebo who switched to treatment saw NfL levels rise.
"Long-term NfL biomarker levels appear to correlate with clinical outcomes in ALS," Aschoff commented.
Clene also presented survival analyses estimating a 60% reduced mortality risk for patients randomized to CNM-Au8 versus placebo.
However, based on a recent meeting, the FDA declined Clene's request for accelerated approval of CNM-Au8 for ALS and asked for additional evidence. The company aims to provide supplemental data in the first half of 2024.
Despite the regulatory hurdle, Aschoff maintains a Buy rating and US$7 price target on Clene, seeing over 200% upside for the US$0.33 stock.
"Though the FDA wants more data, Clene's ALS program shows encouraging efficacy signals in both biomarkers and survival that warrant continuation," he concluded.
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Disclosures for Roth MKM, Clene Inc., December 21, 2023
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from Clene, Inc.. ROTH makes a market in shares of Clene, Inc. and as such, buys and sells from customers on a principal basis. Shares of Clene, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
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