Neuraltus Pharmaceuticals, Inc.

Neuvivo Seeks FDA Approval for NP001, a Novel Immunotherapy for ALS

8 months ago

• Neuvivo has submitted a New Drug Application (NDA) to the FDA for NP001, an investigational treatment for amyotrophic lateral sclerosis (ALS). • NP001 is designed to restore balance to the innate immune system, potentially modifying the course of ALS by addressing uncontrolled inflammation. • Clinical data suggest NP001 may preserve lung function and extend overall survival, particularly in patients with specific biomarkers indicating inflammation. • The FDA has granted NP001 Orphan Drug and Fast Track designations, potentially expediting the review and approval process.