
Neuren bolts higher on FDA green light to proceed trials

Shares in Neuren Pharmaceuticals (ASX: NEU) were up 17% at the open after the biotech stock flagged productive discussions with the United States Food and Drug Administration (FDA) on a clinical trial linked to its drug candidate. What appears to have excited investors this morning were revelations that the upcoming Phase 3 trial for NNZ-2591 - a potential treatment for Phelan-McDermid syndrome (PMS) - has been given the all clear from the FDA to proceed as planned. Best estimates suggest that between 1 in 8,000 and 1 in 15,000 people have PMS, which has severe quality of life impacts on those living with it, including moderate to severe developmental and intellectual impairment and developmental delay. Communication is one of the most impactful health concerns in PMS reported by caregivers. Receptive communication, as measured by VABS-3 Receptive-Raw Score, is the ability to receive and understand non-verbal and verbal interactions which is a foundational skill for the development of learning, social interaction, and speech. What makes Neuren's progress all the more significant and potentially commercially valuable is the absence of any current approved PMS treatments. Building on strong Phase 2 results, the com