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
NTT DATA Launches GCC Innovation Acceleration Program to Support Innovation Creation by Global Companies16.3.2026 04:30:00 CET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announced the launch of its GCC Innovation Acceleration Program. This is designed to support global companies rapidly establishing and scaling their strategic offshore hubs in India, including Global Capability Centers (GCC) and other innovation and delivery hubs. Launched in October 2025, the program aims to support more than 50 companies over the next three years. The demand for highly skilled IT personnel has expanded globally, and as a result, companies are increasingly using overseas bases to meet innovation needs. NTT DATA identified India as a stand-out market to launch the GCC Innovation Acceleration Program because of its abundance of talent and strong technical capabilities. India’s Global Capability Center ecosystem, delivering IT services and back-office functions to multinationals, is poised for strong growth of nearly 70%, targeting $110 billion in 2030 from the current $65 billion, according
OXMIQ Labs and AM Intelligence Labs Partner to Architect One of the World’s Largest Renewable-Powered AI Compute Platforms16.3.2026 01:50:00 CET | Press release
Optimizing from photons to outcomes. Powered by 100% renewable energy. OXMIQ Labs (“OXMIQ”), the GPU architecture and AI technology company founded by Raja Koduri, today announced a strategic technology partnership with AM Intelligence Labs, a business division of AM Group, to provide data center and system infrastructure advisory for AM Intelligence Labs' 2 GW AI Compute Capability by 2030 with initial 1 GW AI Compute Hub in Uttar Pradesh, India. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260315355703/en/ OXMIQ and AM Intelligence Labs are building one of the world's largest renewable-powered AI compute platforms - 2 Gigawatts by 2030, Phase 1 online in Noida, India by 2027. AM Intelligence Labs is a strategic business division of AM Group, parent of Greenko, India's largest green energy producer with 50 GW of renewable capacity across solar, wind, and hydro, backed by 100 GWh of intelligent energy storage and supplying
4th Digital Engineering Awards Celebrate Global Innovators, AI Trailblazers: Herald the Rise of Engineering Intelligence14.3.2026 17:46:00 CET | Press release
Developed in association with ISG and CNBC-TV18, the fourth edition draws more than 250 nominations from 90+ global companies The Digital Engineering Awards concluded its fourth edition at Boston, Massachusetts on Thursday, honoring technology pioneers and organizations for their contributions to technology solutions and AI advancements. The gala night presented by L&T Technology Services (BSE: 540115, NSE: LTTS) along with ISG as the knowledge and research partner and CNBC-TV18 as the media partner, hosted both industry leaders and individual changemakers from 17 countries across North America, Europe, and the rest of the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260314443410/en/ The 4th edition of the Digital Engineering Awards, in association with ISG, CNBC-TV18 and L&T Technology Services, drew more than 250 nominations from 90+ global companies A total of 258 nominations from leading organizations and engine
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 15:23:00 CET | Press release
$8.6 billion project financing for CP2 Phase 2 brings project’s total financing to $20.7 billionProject expected to make Venture Global the largest exporter of US LNGUnprecedented milestone of five FIDs in less than 7 years, with over $95 billion in capital markets transactions Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third g
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 12:00:00 CET | Press release
AI-guided analysis helps brands and retailers turn data into decision-ready insights NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do nex
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
