 for its fusogen featured in the NTX-001 treatment kit.){kind=link}
Neuraptive Therapeutics Receives Orphan Drug Designation from the FDA for NTX-001 in Peripheral Nerve Injury Treatment
Wayne, PA – Neuraptive Therapeutics Inc., a pioneering biotechnology company specializing in innovative medical solutions, proudly announces that it has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for its fusogen featured in the NTX-001 treatment kit. This prestigious designation represents a significant achievement in the development of NTX-001, a groundbreaking therapeutic approach for repairing peripheral nerve injuries.
Dr. Seth Schulman, Chief Medical Officer of Neuraptive Therapeutics Inc., expressed his enthusiasm, stating, “Receiving the Orphan Drug Designation for NTX-001 is a testament to our commitment to advancing healthcare solutions for patients impacted by peripheral nerve injuries, who currently face limited options.” The Orphan Drug Designation is specifically designated for drugs aiming to treat rare diseases or conditions in the United States.
Key Highlights of the Orphan Designation include:
- 7-year marketing exclusivity for sponsors of approved orphan products
- Federal tax credit for expenses incurred in conducting clinical research within the United States
- Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs
- Qualification to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs
- Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.
“The granting of orphan drug designation by the FDA comes at an important time, as we prepare to meet with regulators in the coming months to seek their input on the future development work and the ultimate path to approval,” remarked Evan L. Tzanis, Chief Operating Officer and EVP of R&D. “Following this designation, Neuraptive Therapeutics plans to accelerate the development of NTX-001, aiming to bring this promising treatment to patients as soon as possible.”
For more information about Neuraptive Therapeutics, Inc., and their efforts in peripheral nerve injury treatments, please visit Neuraptive.com.
About NTX-001:
NTX-001 stands out as the only surgical technology capable of rapidly improving functional outcomes in patients with peripheral nerve injuries. It achieves this by preventing Wallerian degeneration after PEG-fusing severed axons, utilizing an optimized and specific treatment sequence within a controlled nerve isolation chamber.
About Neuraptive Therapeutics, Inc.:
Neuraptive Therapeutics, Inc. is a biotechnology company committed to developing novel therapeutics and medical products to address the unmet needs of physicians and patients affected by peripheral nerve injuries. The company is headquartered in Wayne, PA. For more information, please visit www.neuraptive.com.
Note: This press release contains forward-looking statements that are subject to risks and uncertainties. Due to various factors, actual results may differ materially from those indicated in the forward-looking statements. The company disclaims any obligation to update or revise forward-looking statements.