Business Wire

PA-NEURAPTIVE

28.4.2020 22:17:07 CEST | Business Wire | Press release

Share
Neuraptive Therapeutics Announces FDA Clearance of IND Application for NTX-001, a Novel Approach for the Treatment of Patients with Peripheral Nerve Injuries

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.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Klarna Group Plc Clarifies Mechanics of March 9 Lock-Up Expiration6.3.2026 20:23:00 CET | Press release

Klarna Group plc (NYSE: KLAR) today issues the following clarification to ensure investors and market participants have accurate information regarding the mechanics of its lock-up expiration on March 9, 2026, the processes required before pre-IPO shares can be traded on the NYSE, and the prior liquidity opportunities already available to shareholders. This release contains only factual descriptions of the Company's share structure and applicable processes. It does not constitute guidance or a projection of any kind regarding future trading volumes, share price, or the intentions of any shareholder and speaks only as of the date of this press release. 1. 335 million locked-up shares — but two different categories Of the 378 million total ordinary shares outstanding, approximately 335 million are subject to lock-up restrictions expiring March 9, 2026. However, these shares fall into two distinct categories governed by separate sets of regulations. A. 159 million shares (48% of locked-up

Lone Star Funds Announces Agreement to Acquire the Capsules & Health Ingredients Division of Lonza Group AG6.3.2026 18:30:00 CET | Press release

Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has entered into a definitive agreement to acquire the Capsules & Health Ingredients (“CHI”) division of Lonza Group AG. As part of the transaction, Lonza will retain a 40% equity position in the business. Headquartered in Basel, Switzerland, CHI operates globally across the Americas, Europe and Asia Pacific. The business comprises three segments: Hard Empty Capsules: leading global manufacturer of gelatin and plant-based capsules offering a broad range of innovative solutions for pharmaceutical and nutraceutical customers. Dosage Form Solutions: end-to-end development and manufacturing platform serving nutraceutical and pharmaceutical customers. Health Ingredients: provider of branded, science-backed nutrition ingredients serving joint health, energy and active lifestyle markets. Lone Star believes CHI is a high-quality, globally recognized platform with strong technical capabilities, different

Sutherland Launches FinAI Hub to Industrialize Agentic AI for Banking and Financial Services6.3.2026 14:00:00 CET | Press release

A domain-trained AI agent workforce enables production-scale AI across regulated financial institution operations Today, Sutherland announced the launch of Sutherland FinAI Hub, an enterprise Agentic AI platform built exclusively for Banking and Financial Services. As financial institutions accelerate AI adoption, many initiatives remain confined to pilots, unable to scale across legacy systems and core operations. Sutherland FinAI Hub is designed to help close that gap. FinAI Hub is an innovation ecosystem where Sutherland works with clients to design, prototype, and scale Agentic AI workflows across core operations. At launch, the platform brings together a large and expanding workforce of domain-trained AI agents purpose-built for financial institutions, supporting functions across retail banking, payments, cards, consumer and commercial lending, servicing, back office, risk and compliance functions. These modular agents can operate independently or be orchestrated across end-to-end

Hytera Announces 450Connect Whitelisting of PNC660 450MHz at MWC 20266.3.2026 13:02:00 CET | Press release

Hytera, a leading global provider of critical communications technologies and solutions, announced that its mission-critical smart device, the PNC660 450MHz, has been granted whitelist certification by 450Connect during the Mobile World Congress 2026 (MWC26), held from March 2 to 5 in Barcelona, Spain. This certification authorizes the device for full commercial deployment across European 450MHz private broadband networks, marking a significant milestone for Hytera in delivering reliable, secure, and robust communication solutions to energy providers and other critical infrastructure sectors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305205209/en/ Hytera launches the MCX Smart Device PNC660 450MHz 450Connect is the exclusive licensee and operator of the nationwide 450MHz radio network in Germany and across Europe. Its whitelist program enforces stringent evaluation criteria covering device compatibility, network inte

Andersen Consulting udvider sine kompetencer gennem samarbejde med Opinno6.3.2026 12:41:00 CET | Pressemeddelelse

Andersen Consulting styrker sin platform gennem en samarbejdsaftale med Opinno, et globalt konsulentfirma med hovedsæde i Spanien, der integrerer digital transformation med virksomhedsinnovation. Opinno blev stiftet i 2008 og hjælper organisationer med at gentænke, hvordan de innoverer, transformerer og vokser i den digitale økonomi. Firmaet anvender designtænkning, agile metoder og åbne samarbejdsmodeller til at levere resultater inden for tre kerneområder: Digital transformation, innovation samt indhold og økosystemer. Deres praksis inden for digital transformation lægger vægt på ai fra både et strategisk og et designmæssigt perspektiv, mens deres innovationspraksis accelererer udviklingen og markedsføringen af produkter og tjenester. I kraft af sine programmer for indhold og økosystemer fremmer Opinno engagement og hjælper med at opbygge sammenhængende, fremtidsparate organisationer. "Hos Opinno er innovation og digital transformation mere end blot processer; de er kanaler for mærkb

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye