PA-NEURAPTIVE
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
1GLOBAL Empowers Revolut to Offer Mobile Plans in Poland16.12.2025 13:04:00 CET | Press release
1GLOBAL, a technology-driven global mobile communications provider, strengthens its partnership with Revolut, expanding the leading neobank’s mobile data plan offering to the Polish market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216769985/en/ 1GLOBAL strengthens its partnership with Revolut, expanding the leading neobank’s mobile data plan offering to the Polish market. By integrating 1GLOBAL’s eSIM capability into its multi-service app, Revolut’s customers in Poland who signed up to the waitlist can now enjoy bundled mobile plans that include competitively priced domestic data plans starting at zł 25 per month (approx. €6.00 per month) with unlimited calls and texts in Poland and the EU, in just a few taps. For 1GLOBAL, this expansion marks another milestone in the company’s embedded telco services strategy. The services are trusted by more than 4,000 corporate partners across a variety of industries including fi
Dompé Doses First Patients in Europe and US in Phase 3 Studyof Isocyclosporin for Atopic Keratoconjunctivitis16.12.2025 13:00:00 CET | Press release
Atopic keratoconjunctivitis(AKC) is a chronic inflammatory disease of the eye that is frequently associated with atopic conditions, and limited disease awareness often leads to delayed or missed diagnosis. Isocyclosporin is a novel, dual inhibitor oftwo critical immunepathways in ocular inflammation like AKC. Dompé, a leading biopharmaceutical company with operations in Italy and the U.S., announced the first patients have been enrolled in a Phase 3 study of Isocyclosporin for the treatment of atopic keratoconjunctivitis (AKC). Isocyclosporin is a dual inhibitor of transient receptor potential (TRP) cation channel, mucolipin subfamily, member 2 (TRPML2) and calcineurin, key regulators of immune and inflammatory response in chronic inflammatory eye diseases. The Phase 3 trial is a multicenter, randomized, double-masked study comparing isocyclosporin against vehicle control in improving ocular signs and symptoms after six weeks of treatment. “This milestone underscores Dompé’s commitment
Visa Launches Stablecoin Settlement in the United States, Marking a Breakthrough for Stablecoin Integration16.12.2025 13:00:00 CET | Press release
With more than $3.5B in annualized stablecoin settlement volume1, Visa brings USDC settlement to U.S. institutions. Visa Inc. (V) today announced the launch of USDC settlement in the United States, marking a major milestone in the company’s stablecoin settlement pilot program and strategy to modernize its settlement layer underpinning global commerce. For the first time, U.S. issuer and acquirer partners can settle with Visa in Circle’s USDC, a fully reserved, dollar-denominated stablecoin. With USDC settlement, issuers can benefit from faster funds movement over blockchains, seven‑day availability and enhanced operational resilience across weekends and holidays - without any change to the consumer card experience. Initial banking participants include Cross River Bank and Lead Bank, which have started settling with Visa in USDC over the Solana blockchain. Broader availability in the U.S. is planned through 2026. Additionally, Visa is a design partner for Arc, a new Layer 1 blockchain d
Volante Technologies Customers Successfully Navigate Critical Regulatory Deadlines for EU SEPA Instant and Global SWIFT Cross-Border Payments16.12.2025 10:00:00 CET | Press release
PaaS leader ensures seamless migrations and uninterrupted payment operations Volante Technologies, the global leader in Payments as a Service (PaaS), today announced it has successfully upgraded its clients to meet the latest SEPA Instant Payments Regulation (IPR) and SWIFT SRG 2025 mandate, which came into effect October 9th and November 22nd, 2025, respectively. This announcement follows the major FedISO upgrade in July, which shifted trillions of dollars in payments to the new ISO 20022 messaging format. SEPA IPR is a significant European milestone, requiring payments to be made within 10 seconds and at any time of day, throughout the year. Adoption was mandatory and Eurozone banks were compelled to meet strict deadlines, with January 9th, 2025 the deadline for receiving incoming instant payments and October 9th the deadline for sending outgoing instant payments. The latest deadline impacted more than 700 banks across Europe, with non-compliance penalties reaching at least 10% of an
TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth16.12.2025 09:05:00 CET | Press release
TreeFrog Therapeutics, a French biotech focused on bringing regenerative medicine to millions through their proprietary cell technology, C-Stem™ is delighted to announce the appointment of skilled biotech leader, Mark Rothera, as Chief Executive Officer and Board member. He succeeds Frédéric Desdouits, who is stepping down after five years in the role. In the new leadership configuration, co-founders Kévin Alessandri and Maxime Feyeux will transition from daily operations to focus on their roles on the Board. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215145193/en/ Mark Rothera, CEO TreeFrog Therapeutics Elsy Boglioli, Chair of the Board of TreeFrog Therapeutics, commented “On behalf of the Board, we are delighted to welcome Mark to TreeFrog. His 30+ years of biopharma leadership, including most recently, three biotech CEO roles in gene therapy and biologics, will be invaluable as we advance our Parkinson’s and liver
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