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FDA decision on Neurizon’s ALS therapy delayed until October

Ella Day | August 18, 2025 | News story | Medical Communications Coya Therapeutics, Neurizon, Neurology, US Food and Drug Administration, amyotrophic lateral sclerosis 

Neurizon Therapeutics has announced that the US Food and Drug Administration (FDA) will delay its decision on the company’s Clinical Hold Complete Response (CHCR) for NUZ-001, a therapeutic candidate for amyotrophic lateral sclerosis (ALS). The ruling, originally expected within the FDA’s standard 30-day review period, is now anticipated by 3 October 2025.

According to Neurizon, the delay reflects wider pressures on the FDA, including restructuring and staff reductions, which have led to slower review cycles across multiple therapy areas. Recent ALS programmes, such as Coya Therapeutics’ COYA-302, have faced similar delays.

Michael Thurn, managing director and CEO of Neurizon, said: “While this delay is extremely disappointing, we remain confident in the potential of NUZ-001 as a transformative therapy for ALS.”

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The company is continuing engagement with US key opinion leaders and patient advocacy groups in an effort to push for expedited review. ALS, the most common form of motor neurone disease, remains an area of significant unmet clinical need, with limited treatment options available.

Neurizon stated it will provide updates as further feedback is received and reiterated its commitment to advancing NUZ-001 towards regulatory approval and patient access.

Ella Day

18/8/25

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