Seizures May Signal Occult Cancer Risk, Clene Moves Toward NDA Filing for CNM-Au8, the Future of Friedreich Ataxia Care

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Welcome to the Neurology News Network, my name is Louie Pasculli and here’s a look at the top stories in Neurology.

Data from a large nationwide cohort study published in JAMA Neurology suggest that adults presenting with a first-time seizure face a markedly elevated short-term risk of cancer, particularly neurological malignancies, with more modest but persistent risk observed over long-term follow-up.¹

In the population-based analysis, investigators—led by researchers from Aarhus University including senior author Henrik Toft Sørensen—evaluated nearly 50,000 adults identified from Danish national registries between 1996 and 2022, all without prior cancer diagnoses. Median follow-up for participants was 5.7 years.

Participants experienced incident seizures and the study found that cancer diagnoses were substantially more frequent within the first year after seizure onset compared with the general population, raising the possibility that seizures may serve as an early clinical signal of occult malignancy.¹

According to a new announcement, Clene Nanoscience is preparing to submit a new drug application (NDA) under the FDA’s accelerated approval pathway for its investigational agent CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS) following a recent Type C meeting with the agency.1 The submission, expected in the third quarter of 2026, would be supported primarily by neurofilament light (NfL) biomarker data and prior phase 2 clinical studies.²

The regulatory discussion is notable because the FDA indicated that the available dataset “may be capable” of supporting NDA review under accelerated approval and acknowledged that NfL could potentially serve as a reasonably likely surrogate endpoint to show benefit in ALS, a progressive neurodegenerative disease with limited disease-modifying treatment options.²

“We are encouraged by the FDA’s careful evaluation of the benefits and risks associated with Clene’s ALS drug candidate, CNM-Au8, including the biomarker data the company provided,” said Rob Etherington, President and CEO of Clene, in a statement. “The filing of an NDA submission represents an important milestone for CNM-Au8 and for the ALS community. We are committed to working with the Agency on this filing and are conducting the Phase 3 confirmatory study for CNM-Au8, which we intend to commence in the first quarter of 2027.”²

Bill Nye, widely known for his work as a science educator and host of Bill Nye the Science Guy, has spent decades translating complex scientific concepts into accessible, engaging content for broad audiences. With a background in mechanical engineering and a career spanning television, advocacy, and public science communication, Nye has become a recognizable voice in bridging the gap between scientific discovery and public understanding.

In recent years, Nye has also become more involved in raising awareness for neurologic conditions, including Friedreich ataxia (FA), a rare genetic disease that affects the nervous system and heart. His connection to ataxia is personal, with family members affected by a related form of the disorder, shaping his interest in promoting education, earlier diagnosis, and continued research efforts in this space.

At the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18-22 in Chicago, Illinois, Nye participated in a session focused on the science and clinical realities of FA, alongside neurologists and researchers. The discussion incorporated real patient case studies, emphasized the importance of early symptom recognition and genetic testing, and highlighted how interdisciplinary collaboration can advance both understanding and care for rare neurologic diseases.

In a follow-up conversation with NeurologyLive®, Nye reflected on his experience engaging with a clinical audience and discusses the broader importance of awareness in rare diseases like FA. He shared insights on communicating complex neurologic topics across different audiences, the challenges of misdiagnosis, and why improving recognition remains a critical step toward better outcomes for patients and families.

To read the full piece and to get more direct access to expert insight, head to NeurologyLive.com. Be sure to tune in next week to remain informed on the latest in neurology. I’m Louie Pasculli, thanks for watching Neurology News Network.

REFERENCES
1. Pedersen L, Körmendiné Farkas D, Fuglsang K, et al. Risk of cancer in patients with first-time seizure. JAMA Neurol. Published online April 27, 2026. doi:10.1001/jamaneurol.2026.0894
2. After successful FDA meeting, Clene plans accelerated approval NDA submission for CNM-Au8 in ALS. Clene Nanoscience. News release. May 4, 2026. Accessed May 4, 2026. https://www.globenewswire.com/news-release/2026/05/04/