PA-NEURAPTIVE
15.1.2024 14:29:31 CET | Business Wire | Press release
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
Marquee Brands Enters Strategic Partnership With DAMAC Group for a Majority Interest in Roberto Cavalli20.5.2026 20:30:00 CEST | Press release
The Partnership Positions Roberto Cavalli for a New Phase of Global Expansion and Omnichannel Growth Marquee Brands, the premier global brand management company and leading brand accelerator, today announced a definitive agreement for a majority interest in Roberto Cavalli, through a strategic partnership with DAMAC Group, the leading Dubai-based global conglomerate and luxury real estate developer. The transaction is expected to close in the second quarter of 2026, after which DAMAC Group will remain a significant shareholder. Founded in Florence in 1970, Roberto Cavalli the iconic luxury house celebrated for its avant-garde design and distinct Italian craftsmanship joins Marquee Brands’ portfolio of timeless global brands, including Martha Stewart, Laura Ashley, Sur La Table, BCBGMAXAZRIA and Stance. The addition of Roberto Cavalli further strengthens Marquee Brands’ position as a leader in the luxury and lifestyle sectors, bringing total portfolio-wide retail sales to approximately
Variational Secures ~$50M to Bring Liquidity from Traditional Markets To Crypto20.5.2026 19:07:00 CEST | Press release
Already powering $200B+ in crypto volume, Variational is using its zero-fee liquidity aggregation model to bring traditional markets on-chain. Variational, a protocol for on-chain derivatives trading, has announced a ~$50M Series A raise led by Dragonfly with support from Bain Capital Crypto, Coinbase Ventures, and other strategic investors. The funding coincides with the launch of the protocol’s first Real-World Asset (RWA) markets. This initial rollout allows traders to access perpetuals on select commodities alongside their crypto portfolio, laying the groundwork for Variational to route liquidity directly from traditional markets in the coming months. While the broader crypto industry is attempting to bootstrap RWA liquidity from scratch on isolated Central Limit Order Books (CLOBs), Variational introduces a fundamentally different architecture. Instead of starting new order books from scratch for each new market, Variational aggregates and routes liquidity from both existing tradi
EIG’s MidOcean Energy Announces $120m Investment from The Arab Energy Fund as Part of Equity Raise20.5.2026 17:29:00 CEST | Press release
MidOcean Energy (“MidOcean” or the “Company”), a liquefied natural gas (LNG) company formed and managed by EIG, today announced a $120 million equity investment from The Arab Energy Fund (‘’TAEF’’), a leading multilateral impact financial institution, as part of its current equity capital raise. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520063539/en/ TAEF’s investment further strengthens MidOcean’s high-quality investor base and underscores continued strong interest in the Company’s strategy to build a diversified, resilient and long-life global LNG business. There is significant further momentum from additional investors currently in documentation, and MidOcean will continue to raise capital, with a cumulative target of up to $2 billion from new investors. R. Blair Thomas, MidOcean Chairman and EIG CEO, said: “We are delighted to welcome The Arab Energy Fund as a shareholder in MidOcean. Their significant expertise
TestMu AI Expands Real Device Testing With Multi-Language Playwright Support and Advanced Audio Testing for iOS20.5.2026 17:26:00 CEST | Press release
The latest updates enable Playwright automation across Java, Python, and C#, and introduce real-time audio injection capabilities on real iOS devices TestMu AI (formerly LambdaTest), the world’s first full-stack Agentic AI Quality Engineering platform, today announced two major enhancements to its Real Device Cloud: expanded support for Playwright automation across multiple programming languages and the introduction of Audio Injection and Live Audio Input capabilities for real iOS devices. These updates address a growing need for testing modern applications that are not only cross-platform but also increasingly multimodal, involving voice, audio, and real-time user interactions. With the latest release, TestMu AI now supports running Playwright tests on real devices using Java, Python, and C# in addition to existing capabilities. This allows enterprise teams to adopt Playwright within their preferred language ecosystems without being restricted to JavaScript-based workflows. As Playwri
Nexo Championship Returns to Aberdeenshire as Nexo Expands DP World Tour Footprint20.5.2026 16:00:00 CEST | Press release
Nexo renews its Nexo Championship title partnership for the second year in 2026. The Nexo Championship, with a newly increased prize fund of $3 million, will return to Aberdeenshire on August 20-23, 2026. The tournament concludes the 2026 Closing Swing on the Race to Dubai schedule. Nexo, the premier digital assets wealth platform, and the DP World Tour have confirmed a renewed agreement that will see the Nexo Championship return to Trump International Golf Links in Aberdeenshire from August 20-23, 2026. The tournament will serve as the concluding event of the DP World Tour’s Closing Swing – the final event of the first phase of the 2026 Race to Dubai. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520684059/en/ Nexo Championship 2026 In 2025, Nexo joined the DP World Tour as its Official Digital Wealth Platform through 2027 before soon adding the title rights at the Nexo Championship. For its part, the Nexo Championship
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