Neuren Pharmaceuticals Soars 18% After FDA Clears Phase 3 Trial for Rare Disorder Treatment

Mon 14 Apr 25, 02:43 AM | Team Kalkine

Neuren shares soar 18% after US FDA clears Phase 3 trial for Phelan-McDermid syndrome (PMS).

The Phase 3 trial builds on Phase 2 results where 89% of patients showed clinical improvement.

With no need for additional capital, the company is poised to begin the pivotal trial mid-2025.

Shares of Neuren Pharmaceuticals Ltd (ASX:NEU) surged 18% to AU$10.83 in morning trade, marking one of the biotech sector's performances to kick off the week. The sharp rally follows a significant regulatory milestone that could bring the company closer to launching a world-first treatment for a rare neurological disorder.

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