Shares of Clene Inc. (NASDAQ: CLNN) experienced a sharp rally Monday after the company disclosed that meeting minutes from the U.S. Food and Drug Administration indicated its current data package could support a New Drug Application (NDA) under the accelerated approval pathway for its lead candidate, CNM-Au8, in amyotrophic lateral sclerosis (ALS).
The stock climbed as high as $9.74 during the session before settling at $6.94, a gain of $0.80. Trading volume was heavy at approximately 15.1 million shares, pushing the company's market capitalization to around $71.7 million.
Regulatory Path Clears
The development marks a significant regulatory milestone for the small Salt Lake City-based biotechnology firm, which has been navigating a challenging landscape in ALS drug development. Clene now expects to submit its NDA in the third quarter of 2026, a shift from its earlier target of the end of June. The company also plans to initiate a Phase 3 confirmatory trial in the first quarter of 2027.
At the heart of the FDA's feedback is the biomarker neurofilament light (NfL), a blood-based indicator of nerve cell damage. The agency indicated that NfL may qualify as a "reasonably likely surrogate endpoint," which would allow Clene to use reductions in NfL as a stand-in for clinical benefit in its accelerated approval application.
Data Package and Precedent
The NDA will incorporate biomarker and clinical data from several studies, including the Phase 2 HEALEY ALS Platform Trial, its open-label extension, the Phase 2 RESCUE-ALS study, and an expanded-access protocol supported by the National Institutes of Health. Clene has highlighted that NfL reductions observed in open-label follow-up were associated with longer survival.
There is limited precedent for accelerated approval in ALS. Last year, the FDA granted accelerated approval to Biogen and Ionis's Qalsody for SOD1-ALS based on plasma NfL reduction. Meanwhile, Mitsubishi Tanabe's Radicava remains the broader ALS treatment option, and Amylyx's Relyvrio was withdrawn from both the U.S. and Canadian markets after a failed Phase 3 trial.
Financial Considerations
Despite the positive regulatory news, Clene faces significant financial hurdles. As of December 31, 2025, the company reported only $5.2 million in cash and cash equivalents. In its annual report, Clene warned that it would not have sufficient capital to sustain operations for the next 12 months without additional financing.
However, a registered direct offering completed in January 2026 brought in an initial $6 million, which is expected to fund operations through the third quarter of 2026. Further milestone-based payments could extend the cash runway into 2027.
CNM-Au8 is a gold nanocrystal oral suspension designed to enhance cellular energy metabolism and protect nerve cells. Clene is also evaluating the drug platform in trials for Parkinson's disease and multiple sclerosis.
While the FDA's openness to an accelerated filing is encouraging, the agency has requested stronger evidence linking NfL reductions to clinical benefit. Accelerated approval remains contingent on confirmatory data, and the FDA retains the authority to withdraw approval if post-market studies fail to demonstrate clinical efficacy.
