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
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease1.5.2026 23:28:00 CEST | Press release
Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib)Once-daily Jakafi XR was shown to provide consistent, day-long exposure comparable to twice-daily JakafiJakafi XR will be available for pharmacy orders by May 8 Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501334677/en/ “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meetin
Barilla Hosts Surprise Formula 1® Family Reunion Dinner During Miami Race Weekend1.5.2026 18:08:00 CEST | Press release
Drivers and team members of Formula 1® were reunited with their loved ones during a night that also celebrated the new partnership between Barilla and the Visa Cash App Racing Bulls Formula 1® Team. A special invitation, a table, and a plate of pasta shared by people who are often apart. That’s all it took for Barilla to bring the spirit of togetherness to Miami during the opening day of the FORMULA 1® CRYPTO.COM MIAMI GRAND PRIX 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430832316/en/ Barilla hosts Arvid Lindblad, Mikaela Shiffrin, and Nico Rosberg with Chef Massimo Bottura at Torno Subito, where the Formula 1® community came together for a surprise dinner. Barilla, the Official Pasta Partner of Formula 1®, welcomed team members and their families to Torno Subito Miami, the restaurant by three-Michelin-starred Chef Massimo Bottura, with the kitchen led by Chef Bernardo Paladini, for an evening where engines wer
TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health1.5.2026 12:07:00 CEST | Press release
Time Magazine has named pioneering medical technology company Xenco Medical as one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health. Widely regarded as the most prestigious recognition in business and technology, being selected to the TIME100 List remains the most coveted accolade that a company can achieve globally. The TIME100 Impact Awards are given to only 5 recipients each year, making it the rarest of honors that a company can receive and a profound recognition of transformative, global impact. Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare. According to Time Magazine, the TIME100 Most Influential Companies list highlights “companies making an extraordinary impact around the world.” The honor bestowed by Time comes after Xenco Medical was named the 2025 Medical Device/ Diagnostics Company of the
Andersen Consulting styrker sine kompetencer inden for digital transformation med Weexa1.5.2026 10:07:00 CEST | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Weexa, en global leverandør af løsninger inden for digital transformation, B2B-integration og digitalisering af forsyningskæden. Med hovedsæde i Frankrig leverer Weexa end-to-end-tjenester, der hjælper organisationer med at optimere, sikre og skalere deres digitale økosystemer. Virksomheden specialiserer sig i styring af B2B-datastrømme og digitalisering, hvilket muliggør problemfri kommunikation mellem applikationer både internt og på tværs af organisationer gennem teknologier som EDI, API'er og e-fakturering. Weexa tilbyder også SAP-integration og supply chain-løsninger til styring af lager og transport, sideløbende med strategisk rådgivning, projektlevering og vedligeholdelse af tredjepartsapplikationer. Weexa betjener organisationer inden for fødevaresektoren, detailhandel, engros, logistik, transport, bilindustrien, sundheds- og mediesektoren og hjælper globale virksomheder med at optimere deres ydeevne samt at overholde de nyeste
Inspirit Capital Completes Acquisition of Kaplan Languages Group1.5.2026 01:17:00 CEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, and Kaplan, the global education company, have announced the completion of Inspirit’s acquisition of Kaplan Languages Group (KLG) from Kaplan. Financial terms are not being disclosed. KLG, a leading global language education platform, comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. The next phase of ownership will see the development and launch of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. KLG will continue to use the Kaplan name under a transitional license from Kaplan, Inc. until a new brand is announced. About Kaplan Languages Group Since 2006, KLG has provided the highest quality language education and cultural immersion experiences. Kaplan
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
