PA-NEURAPTIVE
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
CMA Approves Amendments to Investment Accounts Instructions to Strengthen Foreign Investor Access and Enhance Market Efficiency27.10.2025 18:29:00 CET | Press release
The Capital Market Authority (CMA) of Saudi Arabia has approved a set of amendments to the regulatory framework governing the procedures for opening and operating investment accounts. These changes aim to facilitate access for a broader base of foreign investors and align with the Kingdom's regulatory and technological developments. The amendments are part of CMA’s ongoing efforts to enhance the investment environment and expand the investor base in the Saudi capital market. The requirements for opening an investment account for individual foreign investors residing in one of the GCC countries have been developed. In addition, the scope of securities that they can directly invest in now includes the shares of listed companies on the Saudi Main Market (TASI). Before these facilitations, their access was limited to the debt instruments market, the Parallel Market (Nomu), investment funds, and the derivatives market. Furthermore, trading in the main market was previously restricted to bei
Carbon Measures and International Chamber of Commerce Launch Technical Expert Panel on Carbon Accounting27.10.2025 17:11:00 CET | Press release
Carbon Measures and the International Chamber of Commerce (ICC) today announced the formation of an independent expert panel that will work to develop the guidelines and implementation steps to establish a global carbon emissions accounting system based on financial accounting principles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027348594/en/ The Technical Expert Panel on Carbon Accounting will be comprised of experts from academia, financial accounting, industry and civil society, representing multiple perspectives and geographies. Together, they will define the principles, scope, and applications of a carbon emissions accounting system modeled on financial accounting principles. Such a system would provide accurate, transparent, verifiable, and timely company- and product-level data, ensuring every tonne of carbon emissions is counted only once and attributed correctly at each step of the value chain. The panel wi
IAMPHENOM Europe Expands All-Star Speaker Lineup27.10.2025 14:30:00 CET | Press release
Newly Confirmed Speakers to Deliver What HR Leaders Need: AI Strategy, Proven Solutions and Bold Talent Thinking Phenom, an applied AI company that helps organisations hire faster, develop better and retain longer, announced a second wave of confirmed speakers joining its inaugural IAMPHENOM Europe conference — the only applied AI event for human resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027606156/en/ Phenom announced a second wave of confirmed speakers joining its inaugural IAMPHENOM Europe conference — the only applied AI event for human resources. Featuring visionary keynotes, customer-led breakout sessions, live demonstrations of use-case specific AI agents, and networking opportunities across HR and IT, the in-person event will take place 6 November in Munich. Session topics will include how to: assess AI and automation maturity levels; deploy 25+ AI agents; uphold compliance while navigating European
Klarna Launches Memberships: Premium Perks Without Expensive Credit27.10.2025 14:00:00 CET | Press release
Klarna’s new Premium and Max memberships pack cashback, travel perks, and top subscriptions into one plan, delivering 10x the value with no spending targets. Klarna, the global digital bank and payments provider, today unveiled its new global membership program, introducing Premium and Max. The program delivers premium benefits like cashback, travel perks, and lifestyle rewards in a transparent, monthly plan, without the need to take on expensive credit. The launch marks a major step in Klarna’s evolution into a full-scale digital bank helping consumers manage their money with greater value and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027643962/en/ “We believe consumers shouldn’t have to take on expensive credit to access premium benefits,” said David Sandström, Chief Marketing Officer at Klarna. “For decades, exclusive perks such as airport lounge access, concierge-style subscriptions, and premium travel i
ThetaRay and Kaufman Rossin Announce AI AML Model Validation at Money20/20 USA27.10.2025 14:00:00 CET | Press release
Independent review affirms ThetaRay’s transaction monitoring and sanctions screening modules meet rising U.S. and EU regulatory expectations. ThetaRay, a global leader in Cognitive AI financial crime compliance, today announced that Kaufman Rossinhas completed an independent validation of its AML Transaction Monitoring and OFAC Screening Modules. Finalized in August 2025, the review confirms that ThetaRay’s AI models demonstrate the governance, transparency, and robustness regulators increasingly expect from AI-driven compliance systems. The announcement will be featured at Money20/20 USA, where the future of finance and compliance technology takes center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027724792/en/ A timely milestone in a shifting regulatory landscape In the United States, regulators are sharpening their focus on model risk management. FinCEN’s proposed modernization of the Bank Secrecy Act emphasi
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