NTX-001
- Generic Name
- NTX-001
Neuraptive's NTX-001 Receives FDA Breakthrough Therapy Designation for Peripheral Nerve Injury
• NTX-001, a drug-device combination by Neuraptive Therapeutics, has received Breakthrough Therapy Designation from the FDA for treating peripheral nerve injuries requiring repair.
• The designation was granted based on promising Phase 2 NEUROFUSE study results, potentially accelerating NTX-001's development and review process.
• Neuraptive is preparing to launch a Phase 3 pivotal program in early 2025, featuring a randomized, double-blind, placebo-controlled study.
• Interim Phase 2 data showed significant improvement in MHQ total scores and reduced post-operative pain with NTX-001 compared to standard of care.
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