Tags : Amyotrophic Lateral Sclerosis

Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation

Shots: The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from […]Read More

Zambon Signs a License Agreement with Aquestive to Develop and

Shots: Aquestive to receive up front, development & commercial milestones and royalties on sales of Riluzole oral film (ROF) in EU. Zambon to get a license for the development and commercialization of ROF to treat ALS in EU Zambon will be responsible for the regulatory approval and marketing of ROF in the EU while Aquestive […]Read More

Voyager to Present Preclinical Data of VY-HTT01 & VY-SOD102 at

Shots: Voyager’s program for Huntington’s Disease and Amyotrophic Lateral Sclerosis assessing VY-HTT01 at five wks. post-dosing in adult non-human primates & VY-SOD102 one-time intraparenchymal infusion after laminectomy The program demonstrated reduction in HTT mRNA by 68% in the caudate, 67% in the putamen, 73% in the thalamus, and 32% in cortical neurons & reduction in […]Read More