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
NIQ and INTAGE HD Partner to Expand Retail Measurement Across Japan and Global Markets24.4.2026 04:00:00 CEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, and INTAGE HOLDINGS Inc. (hereafter "INTAGE HD"), a leading market research company in Japan, today announced a mutual sales partnership to expand access to retail measurement insights between Japan and global markets. Through the collaboration, NIQ and INTAGE HD bring together complementary strengths— INTAGE HD’s deep local retail store panel data and insights into the Japanese domestic market, and NIQ’s global and regional retail store panel data and insights into various international markets—to enable better comparison and understanding of market performance and trends across countries and regions. This collaboration enhances both companies’ ability to support clients with more consistent and comparable insights, helping clients unlock growth opportunities across markets. The collaboration enables global clients to access INTAGE HD’s nationwide retail store panel data in Japan (SRI+ and SRI+EC) to support market entry
Andersen Global styrker sin vestafrikanske platform med tilføjelsen af et medlemsfirma i Ghana24.4.2026 03:46:00 CEST | Pressemeddelelse
Andersen Global fortsætter sin ekspansion i Afrika, hvor Lima Partners tilslutter sig som medlemsfirma og introducerer Andersen-navnet i Ghana. Det nuværende Andersen in Ghana blev stiftet i 2014, har hovedkontor i Accra og ledes af administrerende partner Daniel Addo Okoe. Firmaet tilbyder et komplet udvalg af professionelle services, herunder skatterådgivning, regulatorisk compliance, regnskab og rådgivning, transfer pricing, lønadministration, immigration og selskabsretlige sekretærydelser til både lokale og internationale klienter, der opererer i Ghana og den bredere vestafrikanske region. "At indtræde som medlemsfirma i Andersen Global markerer en betydelig milepæl for vores organisation," udtalte Kwame Amporful, seniorpartner hos Andersen in Ghana. "Vores kunder vil få glæde af forbedrede kompetencer på tværs af landegrænser, samtidig med at de beholder adgangen til praktisk kvalitetsrådgivning, der er skræddersyet til markedet i Ghana.” "Ghana spiller en afgørende rolle i at fre
Pacífico Mexinol Celebrates the Symbolic Groundbreaking in Topolobampo, Positioning Mexico in the New Low-Carbon Chemical Industry24.4.2026 02:29:00 CEST | Press release
The initiative brings together governments, diplomats, and global investors around a Net Zero industrial model. The project establishes Topolobampo, Sinaloa as a key hub for industrial development in North America. The Pacifico Mexinol project (“Mexinol”) celebrated the beginning of its pre-construction phase by symbolically laying a first stone, marking the start of one of the most significant global industrial investments in blue and ultra-low carbon methanol. The event brought together diplomats, authorities, and national and international business leaders, reflecting the project’s strategic importance for Mexico and its integration into the emerging low-carbon economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423775301/en/ Adolfo Murietta, Project Shareholder; Rommel Gallo, CEO Transition Industries; Ron Johnson, United States Ambassador to Mexico; Drew Hoster, Counsel General of the United States in Hermosillo,
The New World ID: Proof of Human for the AI Era Scales Across the Digital Platforms People and Businesses Use Every Day24.4.2026 02:20:00 CEST | Press release
Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers Last week, World announced the next generation of World ID, its proof of human protocol, designed to increase trust on the internet. The announcement was made during “Lift Off,” a live event in San Francisco. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260417530721/en/ Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers As AI makes it easier than ever to generate convincing content, identities, and interactions, trust online has decreased. World ID addresses this challenge by enabling individuals to privately prove they are a real, unique human, without revealing their identity across apps, platforms, and services. “If anything online can be faked, you no longer know who or what to trust,” said Tiago Sada, Chief Product Officer at Tools for Humanity, a co
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
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