Neurizon Therapeutics' potential drug NUZ-001 for ALS gets nod for traditional FDA approval pathway
Neurizon Therapeutics shares rose as much as 14.3% to A$0.096 after the U.S. Food and Drug Administration (FDA) affirmed the potential of a traditional approval pathway for its drug NUZ-001, given substantial evidence of effectiveness in its ongoing trial. NUZ-001 is Neurizon's treatment for amyotrophic lateral sclerosis (ALS), a rare and fatal neurodegenerative disease. The FDA advised Neurizon to resubmit Fast Track Designation (FTD) with current data.
S. Food and Drug Administration affirmed the potential for a traditional approval pathway for NUZ-001, citing substantial evidence of effectiveness in the drug's ongoing trial. The company said the FDA advised it to resubmit Fast Track Designation with current data. NUZ-001 is Neurizon's treatment for amyotrophic lateral sclerosis, or ALS, a rare and fatal neurodegenerative disease that destroys the nerve cells controlling voluntary muscle movement.
096, the highest level since March 13. 1 mln shares changed hands, or 2 times the 30-day average. 7% year to date, including the day's move.