Columbia University

Clene received FDA guidance on an accelerated approval pathway for CNM-Au8 in ALS, recommending leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial. Clene plans to submit an NDA in mid-2025, incorporating EAP NfL biomarker analyses, and commence the RESTORE-ALS Phase 3 trial before NDA submission.

Clene Inc. received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS, following a November 1 meeting where additional data was presented. The FDA recommended leveraging data from ongoing compassionate use EAPs to substantiate CNM-Au8's effect on NfL decline. Clene plans to submit additional NfL biomarker data by Q2 2025 and commence the Phase 3 RESTORE-ALS trial before NDA submission.

Clene plans to submit an NDA for ALS in mid-2025, incorporating NfL biomarker analyses from EAPs. The FDA recommends leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial to support earlier findings and suggests a follow-up meeting to discuss analyses for accelerated approval.

Nuvalent appoints Grant Bogle to its Board of Directors, enhancing its transition from development to commercialization of novel kinase inhibitors, with pivotal data expected in 2025.

A study from Mexico reveals 75% of heat-related deaths occur among people younger than 35, with nearly a third in young adults ages 18 to 35. Researchers attribute this to outdoor work and lack of AC in indoor jobs, noting that young adults and children are most vulnerable to rising temperatures.

Pixelgen Technologies to present at ASH Annual Meeting in San Diego, showcasing Molecular Pixelation technology for hematology research.

Pregnancy challenges for women with epilepsy include medication risks like valproate's link to autism and lower IQ, and the need for dose adjustments due to faster metabolism. A study followed 298 children of women with epilepsy to age 6, finding no difference in verbal abilities compared to healthy women's children, though medication levels in the third trimester had nuanced effects. Folate supplementation was beneficial, while acetaminophen showed risks. Further research is needed to understand the long-term effects of various epilepsy drugs and genetic factors influencing outcomes.