Yet another biotech is facing a delay from the FDA as the agency reels from intense staffing cuts. Neurizon, an Australian biotech focusing on neurodegenerative diseases, will now have to wait until Oct. 3 before receiving a response on whether its amyotrophic lateral sclerosis (ALS) asset will be lifted from a clinical hold.
“While this delay is extremely disappointing, particularly given the straightforward nature of the information provided in our response, we remain confident in the potential of NUZ-001 as a transformative therapy for ALS,” Neurizon CEO Michael Thurn, Ph.D., said in an Aug. 15 release. “We are actively engaging with leading U.S. key opinion leaders and patient advocacy groups to advocate for an expedited review, recognizing the critical and urgent unmet need in ALS.”
After submitting an investigational new drug application for NUZ-001, the FDA placed the candidate on a clinical hold on Jan. 17, requesting more information about the planned dosing regime and potential risks to trial patients.
Neurizon sent its response on July 25, providing the agency with new data from studies on rats and dogs. The FDA's "standard statutory review period" for hold responses is 30 calendar days, Neurizon said in its Friday press release.
NUZ-001 is a repurposed version of the veterinary drug monepantel, which is used to treat roundworm infections in sheep and goats.
Neurizon’s postponement may spark some déjà vu, as Coya Therapeutics was hit with a similar delay at the end of July for its own ALS asset. In Neurizon’s release, CEO Thurn referenced Coya’s situation to make sense of his company’s own.
“The delay follows a broader pattern in the sector, with other sponsors experiencing extended review timelines,” Thurn said. “The FDA has acknowledged persistent resourcing challenges, which have been exacerbated by organizational changes implemented under the current administration, resulting in increased review backlogs.”
During President Trump’s second term, the FDA and other federal agencies have undergone significant shakeups. The FDA has lost at least 3,500 full-time employees and a large portion of the agency’s former leadership. In April, more than 200 biotech leaders signed a letter expressing worry over the FDA’s capacity after these layoffs, especially for small biotechs that depend on investor support to meet agency standards.