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

Smartstream Research Reveals Five Realities Redefining Buy-Side Reconciliations22.4.2026 10:05:00 CEST | Press release

Key Facts Over 70% of firms still rely primarily on end-of-day reconciliation, while 53% cite timing differences and data mismatches as the leading causes of breaks. 59% of participants identified external data dependencies as the primary risk, while 47% highlighted internal inconsistencies. And 41% struggle with incomplete or insufficiently enriched data. 69% describe their T+1 model as partially adapted and still evolving. Whilst 41% say T+1 has made data quality a critical priority. Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces new findings from its latest industry research report, Smart Reconciliations: The Buy-Side Perspective, highlighting the structural shifts transforming reconciliation, control, and operational confidence across buy-side firms. Based on insights gathered from a roundtable of senior operations leaders across asset management and investment firms, the report identifies five critical re

‘Concrete in Life 2025/26’ Winners Announced – Spectacular Photographs From Around the World22.4.2026 10:00:00 CEST | Press release

Concrete in Life Photo of the Year from the Philippines wins $10,000 top prize Over 20,000 international entries from professional photographers and smartphone amateurs Concrete is the world’s most used substance after water Powerful and striking images from around the world have been chosen as the winners of the Concrete in Life 2025/26 global photography competition, showcasing the essential role concrete plays in daily life, infrastructure, cities, and design. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422352135/en/ OVERALL WINNER: Pillars Across the Sea by Celbert Palaganas, Cebu City, Philippines Run by the Global Cement and Concrete Association (GCCA), the annual competition received more than 20,000 entries from professional and amateur photographers, as well as smartphone users, spanning every continent. The competition highlights how concrete supports modern life while also offering moments of beauty, creativ

Netceed Publishes Its First Environmental, Social and Governance Report22.4.2026 09:30:00 CEST | Press release

Netceed, a global infrastructure supply chain solutions provider, has published our first Annual Environmental, Social and Governance (ESG) Report, marking a major milestone in the Group’s sustainability journey and reinforcing our commitment to transparency, accountability, and responsible business practices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422579806/en/ Netceed Sustainability Report 2025 The report presents Netceed’s progress across environmental, social, and governance topics, including the verification of its carbon footprint data by an independent third party and the completion of its first climate risk analysis. Key highlights include: A reduction in Scope 1 and 2 CO2e emissions compared to 2024 Improved gender diversity in senior management positions – we now have 23% of senior management positions filled by women 70% of our suppliers (by spend) are working with us on our climate action priorities A

IONCHI byder AITO velkommen til at gå sammen med BMW og Mercedes-Benz om at udvikle premium høj-effekt opladningsnetværk i Kina22.4.2026 09:21:00 CEST | Pressemeddelelse

IONCHI, et joint venture mellem BMW og Mercedes-Benz inden for høj-effekt opladningstjenester, annoncerede i dag, at SERES vil tiltræde selskabet som en ligeværdig aktionær. Gennem denne kapitalinvestering vil AITO, premium-brandet fra SERES Group, støtte udviklingen af IONCHIs premium opladningsinfrastruktur. Med denne udvidelse fortsætter IONCHI med at levere premium opladningstjenester gennem avanceret teknologi og digitale services til alle kvalificerede køretøjer, samtidig med at der tilbydes eksklusive opladningsoplevelser til kunder hos BMW, AITO og Mercedes-Benz. Det udvidede trepartssamarbejde markerer begyndelsen på et nyt kapitel for premium opladningsnetværket og muliggør yderligere vækst samt en bredere kundedækning. Hver af de tre aktionærer vil eje en andel på 33,3 % i joint venturet. Etableret i 2024 har IONCHI til formål at løfte Kinas premium-oplevelse inden for elektrisk mobilitet gennem et avanceret offentligt høj-effekt opladningsnetværk. Netværket prioriterer attr

Europcar Mobility Group Announces Exclusive Partnership With MIC Co., Ltd. to Expand Presence in Japan22.4.2026 09:02:00 CEST | Press release

Europcar Mobility Group has entered into an exclusive partnership agreement with MIC Co., Ltd., the operator of Japan’s extensive "Niconico Rent-A-Car" network. This landmark agreement marks Europcar Mobility Group’s first exclusive partnership in the Japanese market, aimed at providing seamless mobility solutions for the growing number of international travelers visiting the region. Enhancing possibilities for Inbound Travelers Since April 10, 2026, customers can book car rentals at Niconico Rent-A-Car’s directly-operated airport locations through Europcar’s global booking platform, allowing foreign travelers to arrange their transportation in Japan from overseas using a familiar interface, eliminating common booking hurdles and improving the overall travel experience.To date, the service is available across key gateway locations: Major Airports: Haneda, Narita, New Chitose, Fukuoka, Kagoshima, Nagasaki, and Kumamoto. Key Transit Hubs: Shin-Yokohama Station and Kansai Airport Rinku To

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