Neuraptive Therapeutics Inc. Receives Orphan Drug Designation for its Lead Development Asset

January 15, 2024 |

2 min read

Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit.

WAYNE, Pa.--(BUSINESS WIRE)-- Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit. This designation marks a significant milestone in developing NTX-001, a novel treatment for peripheral nerve injury requiring repair.

Dr. Seth Schulman, Chief Medical Officer of Neuraptive Therapeutics Inc., stated, “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 today have limited options.” The Orphan Drug Designation is granted to drugs intended to treat rare diseases or conditions in the US.

Highlights of Orphan Designation are:

7-year marketing exclusivity to 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
Ability to qualify 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, “ said 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.” Said Mr. Tzanis.

For more information about Neuraptive Therapeutics, Inc., and our work in peripheral nerve injury treatments, please visit Neuraptive.com.

About NTX-001

NTX-001 is the only surgical technology that may rapidly improve functional outcomes in patients with peripheral nerve injuries by preventing Wallerian degeneration after PEG-fusing severed axons using an optimized and specific treatment sequence in a controlled nerve isolation chamber.

About Neuraptive Therapeutics, Inc.:

Neuraptive Therapeutics, Inc. is a biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs of physicians and patients impacted by peripheral nerve injuries. The company is headquartered in Wayne, PA. For more information, see www.neuraptive.com.

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.