FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone
Neurizon Therapeutics announced that the FDA has extended the review timeline for its response to a clinical hold on NUZ-001, its lead investigational drug for ALS, now expecting a decision by October 3, 202523.
Neurizon attributes the delay to broader capacity issues at the FDA, citing agency restructuring and staffing reductions, not the quality of their submission25.
Neurizon's CEO expressed disappointment over the delay, highlighting ongoing engagement with stakeholders to urge an expedited review for ALS treatments2.
Omeros Corporation, seeking approval for its transplant drug narsoplimab, also experienced a three-month delay in the FDA review, with the new decision date set for December 26, 202514.
Omeros took a more forgiving stance, noting that review delays are affecting the broader industry, possibly due to agency-wide layoffs and restructuring15.
Both companies represent a growing trend of biotechs publicly attributing regulatory delays to staffing and resource challenges at the FDA, with Omeros’ comments reflecting a more sympathetic tone toward the agency, while Neurizon has been more direct in its criticism35.
Sources:
1. https://www.fiercebiotech.com/biotech/fda-delays-omeros-2nd-attempt-transplant-drugs-approval-3-months
2. https://www.sharecafe.com.au/2025/08/15/fda-extends-review-timeline-for-neurizons-nuz-001-clinical-hold-response/
3. https://firstwordpharma.com/story/5989738
4. https://cafepharma.com/index.php/content/fda-delays-omeros-2nd-attempt-at-transplant-drugs-approval-by-3-months