PA-NEURAPTIVE
28.4.2020 22:17:07 CEST | Business Wire | Press release
Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs in the treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has cleared Neuraptive's Investigational New Drug (IND) application for NTX-001 in patients with acute single transected PNI.
"We are pleased to have received clearance for the company’s first IND, and are excited to initiate the trial later this year," said Evan Tzanis, Executive Vice President and Head of Research and Development. "We look forward to working with investigators as we advance Neuraptive’s NTX-001 into the clinic for the treatment of peripheral nerve injuries."
Peripheral nerve injuries resulting in surgeries are common, occurring in more than 600,000 patients annually in the United States, with approximately 80% of nerve injuries occur in the upper extremities. Neuraptive’s Phase 2 study will evaluate the safety and efficacy of NTX-001 versus the current standard of care in upper extremity injuries. NTX-001 is being developed in the U.S. via the FDA 505 (b) (2) development pathway, in which the components contained in the product are present in existing, approved drug products, allowing for the potential of a more streamlined development program.
"Current interventions do not prevent the irreversible degeneration that occurs within 48 to 72 hours following injury. We believe that NTX-001 has the potential to diminish or prevent this degenerative process so that nerves recover more quickly, and patients can avoid disabilities that commonly result from these types of nerve injuries," said Ivan Gergel, MD, Executive Chairman of the Board of Neuraptive. "We are hopeful that NTX-001 can be a revolutionary treatment for physicians to offer their patients undergoing PNI repairs."
About Neuraptive Therapeutics
Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com .
About New Rhein Healthcare Investors
New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer’s disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein’s partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.com .
Cautionary Note on Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200428005968/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
Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 115.10.2026 02:30:00 CEST | Press release
− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) − Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role − ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwide Takeda (TSE:4502/NYSE:TAK)announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1. “We’re ex
Celltrion to Spotlight Subcutaneous (SC) Infliximab (Remsima™ SC) and Broader IBD Portfolio at UEG Week 202615.10.2026 02:10:00 CEST | Press release
Celltrion to showcase its broad IBD portfolio, including Remsima™ IV, Remsima™ SC, the newly launched Remsima™ IV Liquid formulation, Steqeyma™ and Yuflyma™Symposium and Meet the Experts sessions to highlight long-term clinical evidence and real-world experience with subcutaneous (SC) infliximab (Remsima™ SC) across different IBD patient scenarios Celltrion, Inc. (KRX:068270) announced its participation in United European Gastroenterology (UEG) Week 2026, in Barcelona, Spain (Oct. 17-20), highlighting its inflammatory bowel disease (IBD) treatment portfolio, led by Remsima™ SC (subcutaneous infliximab). Celltrion will showcase its comprehensive infliximab portfolio, comprising Remsima™ intravenous (IV) and subcutaneous (SC) formulations, as well as the Remsima™ IV liquid formulation launched in Europe earlier this year.1 Additionally, the company will highlight its broader IBD portfolio, including SteQeyma™ (ustekinumab) and Yuflyma™ (adalimumab), reflecting its continued efforts to ex
ProcureTEX Returns for Its Second Year, Bringing AI and Best-of-Breed Procurement Technology to Amsterdam14.10.2026 18:26:00 CEST | Press release
Founding partners Beroe, Keelvar and Zip bring back the community-driven event with a practitioner-shaped agenda spanning real-world AI use and the future of procurement ProcureTEX, the community-driven event for best-of-breed procurement technology, returns for its second year on November 3, 2026, at Circa in Amsterdam. Following its London debut in 2025, the event sharpens its focus on how AI is reshaping procurement. It will bring together over 250 procurement leaders and digital transformation teams from large enterprises, with vetted best-of-breed technology providers, to see AI agents and interoperable tools working together on real enterprise challenges. Co-founded by Beroe, Keelvar and Zip, the event is built on the belief that the future of procurement isn’t a monolithic all-in-one suite, but an ecosystem of best-of-breed tools working together. It is designed for procurement and enterprise leaders seeking scalable, modern solutions, whether they’re driving transformation, fru
eM Client 11 Launches: A European Outlook Alternative Bringing AI Freedom, Digital Sovereignty, and Next-Generation Productivity14.10.2026 18:16:00 CEST | Press release
eM Client, the European developer of the popular email and productivity application used by millions worldwide, today announced the release of eM Client 11, its most significant update yet. The new version introduces advanced AI capabilities, and major productivity improvements, strengthening its position as an independent alternative to Microsoft Outlook. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014945464/en/ eM Client 11 main window AI Without Vendor Lock-In eM Client 11 introduces a powerful AI Assistant that enables users to search, summarize, organize, and manage emails using natural language. Additional features include personalized AI writing, context-aware quick replies, automatic task and event detection, and AI-powered email rules. Unlike traditional AI integrations, eM Client 11 supports Bring Your Own Key (BYOK), allowing organizations to connect compatible AI providers and models of their choice. The re
iQmetrix and Stratus HR Partner to Give Wireless Retailers a Complete, Outsourced HR Department14.10.2026 17:15:00 CEST | Press release
New integration connects the employee lifecycle to the store – new hires, terminations, rehires, position moves, and security-role updates flow straight into the POS, with payroll, benefits, and compliance handled by Stratus HR’s certified experts. Stratus HR, a full-service human resources outsourcing provider, today announced a partnership with iQmetrix, the Intelligent Commerce Operating System for telecom. As a Professional Employer Organization (PEO), Stratus HR becomes the complete, outsourced HR partner for wireless retailers on iQmetrix – payroll, benefits, compliance, and on-call HR experts – so retail teams stay focused on selling and serving customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014178512/en/ Fully integrated with iQmetrix, Stratus HR’s custom-built technology connects the employee lifecycle to the store: new hires, terminations, rehires, position moves, and security-role updates flow straig
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
