FDA grants breakthrough therapy designation to Neuraptive's NTX-001
FDA grants breakthrough therapy designation to Neuraptive Therapeutics’ NTX-001 for peripheral nerve injury treatment, based on Phase II NEUROFUSE study results. Neuraptive plans to initiate a Phase III programme in early 2025, including a randomized, double-blind, placebo-controlled trial. The final study protocol is under discussion with the FDA, with full 48-week data expected soon.
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Neuraptive Therapeutics' NTX-001 receives FDA Breakthrough Therapy Designation for peripheral nerve injuries, expediting its development. A pivotal Phase 3 trial is planned for early 2025, following promising results in Phase 2.
Interim 24-week data from NEUROFUSE study shows NTX-001's safety and efficacy for peripheral nerve injuries, to be presented at 2024 ASSH Annual Meeting.
FDA grants breakthrough therapy designation to Neuraptive Therapeutics’ NTX-001 for peripheral nerve injury treatment, based on Phase II NEUROFUSE study results. Neuraptive plans to initiate a Phase III programme in early 2025, including a randomized, double-blind, placebo-controlled trial. The final study protocol is under discussion with the FDA, with full 48-week data expected soon.
FDA grants Breakthrough Therapy designation to NTX-001 by Neuraptive Therapeutics for peripheral nerve injury repair. Phase 3 program set to begin in early 2025, following positive Phase 2 NEUROFUSE study results.