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# FDA Delays Clinical Hold Review on Neurizon ALS Drug
- URL: https://www.fdaweb.com/fda-delays-clinical-hold-review-on-neurizon-als-drug/
- Published: 2025-08-15T12:00:00.000Z
- Updated: 2026-09-14T15:19:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159693

FDA has extended until 10/3 its review of a clinical hold response from Neurizon Therapeutics’ NUZ-001, its lead experimental treatment for amyotrophic lateral sclerosis (ALS). The agency’s standard review period for such responses is 30 days, but Neurizon said the delay stems from FDA-wide staffing cuts and restructuring under recent administrative reforms. Those changes have created review backlogs across multiple divisions, affecting other ALS programs as well, the company says , adding that earlier this year Coya Therapeutics also faced an FDA IND delay on its ALS drug COYA-302 due to internal workload pressures.

“This delay is extremely disappointing — particularly given the straightforward nature of the information provided in our response,” said Neurizon CEO **Michael Thurn**. “We remain confident in the potential of NUZ-001 as a transformative therapy for ALS and are working with U.S. experts and patient groups to advocate for an expedited review.”