Business Wire

PA-NEURAPTIVE

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

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240115132196/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system28.11.2025 12:00:00 CET | Press release

FOR USE IN CE-MARK EUROPEAN COUNTRIES ONLY GE HealthCare announces CE Mark for its Omni 128cm total body PET/CT,i a next-generation imaging system designed to advance precision care as well as cancer diagnosis, staging and treatment planning The new system is designed to accommodate head-to-thigh imaging in a single bed to improve workflow and efficiency, and enable a significant reduction in dose/scan time – all important factors, especially for populations like pediatric patients Built for both clinical and research excellence, the system may support the development and evaluation of new clinical pathways, novel PET tracers and emerging theranostic agents GE HealthCare today announced CE Mark for its next-generation Omni 128cm total body positron emission tomography / computed tomography (PET/CT) system,i a major milestone in its mission to advance precision care. Designed to advance cancer diagnosis, staging, therapeutic planning and treatment response monitoring, this innovative sy

King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah28.11.2025 10:53:00 CET | Press release

King Abdulaziz Foundation (Darah) held the first edition of the Forum on the “History of Hajj and the Two Holy Mosques”, convened as part of the program of the “Hajj Conference and Exhibition 2025” at the Super Dome Hall in Jeddah, in cooperation with the Ministry of Hajj and Umrah and the Guests of God Service Program, during the period from 9–12 November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251128600368/en/ King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah (Photo: AETOSWire) The forum’s activities were inaugurated following the announcement by His Royal Highness Prince Faisal bin Salman bin Abdulaziz Al Saud, Special Advisor to the Custodian of the Two Holy Mosques and Chairman of the Board of Directors of the King Abdulaziz Foundation, who declared the launch of the forum during the opening ceremony of the “Hajj Conference and Exh

VSO Unveils VCP v1.0, a First-of-Its-Kind Cryptographic Audit Protocol to Restore Trust in AI-Driven Markets28.11.2025 06:30:00 CET | Press release

New open standard replaces opaque server logs with mathematically verifiable evidence, helping market participants meet EU AI Act and MiFID II transparency requirements The VeritasChain Standards Organization (VSO), an independent international standards body, today announced the global release of VeritasChain Protocol (VCP) v1.0, an open cryptographic audit protocol designed to provide mathematically provable transparency for AI‑driven and algorithmic trading systems. VCP replaces mutable server logs with a tamper‑evident chain of cryptographic evidence, enabling regulators, brokers, exchanges and trading firms to move from trust‑based oversight to verification‑based supervision. Why This Matters Now The launch of VCP v1.0 comes at a pivotal moment for global market infrastructure: More than 80 proprietary trading firms collapsed between 2024 and 2025 amid regulatory scrutiny, opaque execution models and frozen payout disputes, leaving a trust gap between traders and platforms. Regula

Andersen Consulting styrker sine kompetencer med BMA27.11.2025 22:48:00 CET | Pressemeddelelse

Andersen Consulting udvider sine kompetencer inden for bæredygtighed og virksomhedsforandring gennem en samarbejdsaftale med BMA, der er et sydafrikansk firma, som arbejder for at styrke konkurrenceevnen i fremstillingsindustrien og fremme inkluderende industriel vækst. BMA, der blev etableret for mere end to årtier siden, arbejder på tværs af produktionsværdikæder – fra producenter til deres kunder – sammen med myndigheder og udviklingsagenturer for at fremme bæredygtig industriel konkurrenceevne. Gennem sine sektorfokuserede industrielle klynger leverer firmaet integrerede tjenester inden for industriel politik og strategisk udvikling, værdikædestrategi, produktionskonkurrenceevne og lean-rådgivning, reduktion af CO2-udledning samt udvikling af små og mellemstore virksomheder og samler interessenter omkring fælles prioriteter og skalerbare, langsigtede løsninger. "Bæredygtig produktion handler om mere end effektivitet. Det drejer sig om at skabe økosystemer, der er regenerative, resi

Stronghold’s SHx Token Lists on Uphold27.11.2025 16:00:00 CET | Press release

Multi-Chain Expansion Accelerates With New Listing on a Trusted Platform Supporting Both Stellar and Ethereum Stronghold announced that its SHx token is now available for retail users to trade on Uphold, the global multi-asset digital money platform known for its transparency, regulatory alignment, and seamless support for assets across both the Stellar and Ethereum networks. The listing marks a major milestone for SHx, expanding access for users and businesses who rely on Stronghold’s token for payments, settlements, and governance participation. "Uphold is one of the only platforms that provides seamless support for both Stellar and Ethereum-based tokens, making it a perfect fit for SHx as we grow our multi-chain ecosystem. This listing was championed by our community, and we’re thrilled to deliver on a request that so many SHx holders have been asking for." — Tammy Camp, CEO & Co-Founder, Stronghold SHx is Stronghold’s native utility token, powering interoperable payments, DeFi-base

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye