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

Reply: a New Study Shows that Agentic AI will Become a Strategic Alternative to Traditional Sourcing Models for 93% of Tech Leaders10.3.2026 11:26:00 CET | Press release

Reply [EXM, STAR: REY] today announced the release of “From Code to Control: AI’s Takeover of Software Development Lifecycle”, a commissioned study conducted by Forrester Consulting. The research, which surveyed 536 IT Executives across Europe and the US, highlights the progressive transition from simple AI coding assistants to autonomous agents capable of orchestrating the entire software development lifecycle (SDLC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310922600/en/ Silicon Shoring is Reply’s delivery model designed to leverage this shift toward Agentic AI. By using the Silicon Reply multi-agent system, this methodology offers a robust alternative to traditional offshoring. The study underscores a critical turning point for software development: as traditional offshoring models struggle with hidden costs and regulatory hurdles, 93% of organisations plan to adopt Agentic AI within the next two to three years a

WHOOP Broadens WHOOP Advanced Labs Offering, Announcing a Women’s Health Specialized Blood Biomarker Panel10.3.2026 11:00:00 CET | Press release

WHOOP deepens investment in women’s physiology with clinically meaningful lab testing, predictive symptom modeling, and new Menstrual Cycle White Paper WHOOP, the human performance company, today unveiled multiple initiatives and new clinically-backed features, including the coming launch of the company’s Women's Health Specialized Blood Biomarker Panel. Building on the WHOOP Advanced Labs Baseline Panel launched last year, the Women’s Health Specialized Blood Biomarker Panel adds 11 clinically backed, female-specific blood biomarkers that expand insight into areas that are frequently under-measured or misinterpreted in traditional women’s health testing. WHOOP has also announced a new Hormonal Symptom Insights and Predictions update, along with a comprehensive Menstrual Cycle White Paper detailing the science behind its cycle modeling. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310966566/en/ WHOOP Broadens WHOOP Adva

Spring into Smarter Home Protection: EZVIZ Launches Standout Deals for the Amazon Spring Sale10.3.2026 10:30:00 CET | Press release

As the new season brings longer days and fresh beginnings, EZVIZ is turning up the excitement with a lineup of irresistible offers during the Amazon Spring Sale. Known for delivering easy-to-use smart security products, EZVIZ is giving households the perfect opportunity to refresh their home protection with technology designed for modern living. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310567932/en/ Spring into smarter home protection: EZVIZ launches standout deals for the Amazon Spring Sale As homes open up to the energy of spring, whether welcoming guests, receiving more deliveries, or simply spending more time outdoors, this seasonal sales on Amazon offers a timely chance to upgrade everyday security. During the Spring Sale, shoppers can enjoy limited-time savings on a curated selection of EZVIZ’s smart cameras and entryway products, making it easier to safeguard front doors, gardens, and outdoor spaces while emb

For the First Time, Ferring Reports Revenue of Over €2.5 Billion in 202510.3.2026 10:00:00 CET | Press release

Ferring's total revenues for 2025 exceeded €2.5 billion, an increase of 10% from 2024, mainly driven by our flagship product Menopur®Continued ramp-up in the US for Adstiladrin®, our novel gene-based therapy for bladder cancer, confirming its position as Ferring’s second major growth driverCommitment to sustainability demonstrated by SBTi approval of our targets to reduce greenhouse gas emissions, and by our programme to reduce maternal deaths in low- and lower middle-income countries Ferring today published its 2025 Annual Report and Sustainability Report. The company achieved total revenues of over €2.5 billion in 2025, an increase of 7% over the previous year at actual exchange rates (AER) and 10% at constant exchange rates (CER). These were mainly driven by our flagship product Menopur® (menotropins for injection) in reproductive medicine, and the ramp-up in the US of our breakthrough gene-based therapy for non-muscle invasive bladder cancer, Adstiladrin® (nadofaragene firadenovec-

Quectel Unveils Versatile Pi Series SBCs to Power Developer Innovation10.3.2026 09:00:00 CET | Press release

Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announces the launch of its range of Quectel Pi series of single-board computers (SBCs), designed for a broad range of industrial use cases. The portfolio currently includes three compact development platforms - the Quectel Pi M1, L1, and H1 boards - engineered for low power consumption, cost efficiency, and full-stack software support. Designed to accelerate prototyping and product development, they are well suited for embedded applications, IoT solutions, robotics projects, and edge computing deployments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310949640/en/ Quectel unveils versatile Pi series SBCs to power developer innovation “We’re delighted to launch the affordable, versatile, open source Quectel Pi series of SBCs to help developers of real IoT projects in areas such as home automation, robotics, sensors and edge computing to achiev

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