PA-NEURAPTIVE
15.1.2024 14:29:31 CET | Business Wire | Press release
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
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
MTU Maintenance Lease Services Invests in TRecs to Digitalise Engine Transition Management13.5.2026 10:05:00 CEST | Press release
MTU’s engine leasing arm becomes a shareholder in TRecs, reinforcing its commitment to digitalising engine lifecycle management MTU Maintenance Lease Services B.V. (“MLS”), the engine leasing and asset management arm of MTU Maintenance, today announced a strategic minority investment in TRecs (trecs.aero). TRecs is a platform digitalising Open Item List (OIL) management across the engine lifecycle, from initial technical review through transitions, shop visits, and beyond. Terms of the transaction are kept confidential. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513682497/en/ Through its deployment of TRecs, MLS moves further into its leading role in moving the engine leasing industry toward a cloud-based, collaborative standard designed specifically for leasing and asset management customers. MLS will use the platform across the engine lifecycle, from the initial technical review of acquired or leased-in engines thro
NIPPON KINZOKU Strengthens Promotion of "L-Core" as an Eco-Product: Functional Stainless Steel Achieving High Conductivity via Surface Modification13.5.2026 10:01:00 CEST | Press release
- Eliminates Plating, Lowers Costs, and Resists Corrosion even in high-temperature, high-humidity environments - NIPPON KINZOKU CO., LTD. (TOKYO: 5491) (Headquarters: Minato-ku, Tokyo) is proud to announce the strengthened promotion of "L-Core," a functional stainless steel that utilizes proprietary surface modification technology to achieve extremely low contact resistance while maintaining the inherent corrosion resistance of stainless steel. We have repositioned L-Core as a strategic "Eco-Product" to support sustainable manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513728897/en/ While conventional stainless steel excels in corrosion resistance due to its "passive film," this same film typically acts as an electrical insulator. Consequently, components requiring conductivity have traditionally relied on high-cost nickel (Ni) plating or conductive tapes. L-Core solves this challenge by making the passive
Hermes Reply Presents Brick Cognitive, the Agentic Operating System for Manufacturing13.5.2026 10:00:00 CEST | Press release
Hermes Reply, the Reply Group company specialized in digital transformation for manufacturing, presents Brick Cognitive, the new agentic operating system designed to bring AI to the centre of industrial operations. A natural extension of Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but isable to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513981153/en/ Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but is able to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. In production environments, data and processe
MC Advances Supply Chain Transformation with Blue Yonder Cognitive Solutions13.5.2026 10:00:00 CEST | Press release
Leadingretailer strengthens agility with AI and machine learning to improve allocation and replenishment decisions across its network and brands MC, the retail division of Sonae and a leading player in Portugal’s grocery market and health, wellness, and beauty retail across the Iberian Peninsula, has selected Blue Yonder Cognitive Solutions for Allocation and Replenishment to advance its supply chain transformation. With more than 400 stores across multiple formats, MC operates major supermarkets and hypermarkets such as Continente, along with convenience stores, health and wellness shops, and online grocery services. Blue Yonder’s advanced artificial intelligence (AI) and machine learning (ML) enabled solutions will help the company improve visibility into demand forecasting. The new solutions will be implemented by Blue Yonder Services. “The grocery retail sector is adapting to a period of significant change, underlining the need for more agile operations across the supply chain. We
Oral‑B Announces The Big Rethink 2026, Launching One of Europe’s Largest Disability‑Focused Oral Health Studies13.5.2026 09:06:00 CEST | Press release
Oral‑B and iADH build on four years of action to advance inclusive oral care and whole‑body health41% of Europeans identify as living with a disability, representing a four‑point increase wave‑on‑wave Oral‑B today announces The Big Rethink 2026, the next evolution of its flagship oral health inclusion programme, developed in partnership with the International Association for Disability and Oral Health (iADH). The new phase introduces Project Steady, one of Europe’s largest real‑world studies exploring oral care experiences among people with disabilities, their carers and dental professionals. The programme aims to reduce everyday barriers to oral care through inclusive design, evidence-based research and professional education. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511175864/en/ Oral B Announces The Big Rethink 2026, Launching One of Europe’s Largest Disability Focused Oral Health Studies Oral health for Whole-Bo
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