Business Wire

PA-NEURAPTIVE

15.1.2024 14:29:31 CET | Business Wire | Press release

Share
Neuraptive Therapeutics Inc. Receives Orphan Drug Designation for its Lead Development Asset

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

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Axelspace Secures Japan Ministry of Defense Satellite Constellation Project20.2.2026 12:01:00 CET | Press release

As an optical imagery provider, Axelspace has entered into a contract for the acquisition of image data Axelspace Corporation (“Axelspace”), a leading developer and operator of microsatellites dedicated to realizing its vision of “Space within Your Reach,” announced that, for the purpose of carrying out the Ministry of Defense’s satellite constellation project, it has entered into a contract with Tri-Sat Constellation Co., Ltd. and Mitsui Bussan Aerospace Co., Ltd. for acquisition of optical imagery data. Tri-Sat Constellation Co., Ltd. is a special purpose company (SPC) established by Mitsubishi Electric Corporation, SKY Perfect JSAT Corporation, and Mitsui & Co., Ltd. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260220758297/en/ An imagery of satellite constellation © the Ministry of Defense The Ministry of Defense’s satellite constellation project was awarded to a consortium comprising Mitsubishi Electric Corporation, S

Sai Life Sciences to Recruit 700+ Professionals in FY2720.2.2026 10:09:00 CET | Press release

Sai Life Sciences Limited (BSE: 544306 | NSE: SAILIFE), one of India’s leading integrated contract research, development and manufacturing organizations (CRDMOs), today announced plans to hire 700+ scientific, technical, and management professionals during 2026–27 as it scales capabilities to meet growing global demand for end-to-end drug discovery, development and manufacturing services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260220711675/en/ Integrated R&D Campus, Sai Life Sciences, Hyderabad, India The recruitment will span roles across medicinal chemistry, biology, DMPK, process and analytical development, formulation development, process engineering, technology transfer, quality, peptides, business development, program management, and manufacturing, among others. A specific area of focus through this recruitment drive will be on attracting high-calibre scientists from leading institutions in India and globally,

Balmain Beauty Introduces Destin de Balmain: A New Prestige Fragrance20.2.2026 08:30:00 CET | Press release

Balmain Beauty unveils Destin de Balmain, its debut prestige fragrance. The new feminine fragrance is a bold, floral fruity eau de parfum that captures the unstoppable energy of the Balmain woman: independent, youthful, and unapologetic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219851364/en/ Destin de Balmain (Photo Credit: Balmain Beauty) THE STORY: LIVE YOUR DESTINY Destin de Balmain is destiny you hold in your hands, a journey of optimism and infinite possibilities. The refillable fragrance unites those who express themselves without rules or expectations. Inspired by the Parisian House’s savoir-faire and modern pulse, the daring fragrance celebrates choosing your path and living your destiny. “Destin de Balmain features a joyful, optimistic spark of ripe strawberry,” said Quentin Bisch, Perfumer. “The fruit’s juicy vivacity brings bright, elevated sweetness to the composition. Notes of peony further convey the f

SOLUM and EWQ Announce Strategic Partnership Expansion at EuroShop to Advance Integrated In-Store Digital Communication20.2.2026 08:00:00 CET | Press release

SOLUM (KOSPI: 248070), a global retail solutions provider, and EWQ, a leading retail infrastructure innovator, have announced the expansion of their strategic partnership to accelerate integrated in-store digital communication. Building on their existing collaboration, the two companies will deepen technology integration and commercial cooperation to deliver a unified platform connecting Electronic Shelf Labels (ESL), large-format E-Paper displays, and digital signage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219422813/en/ ScanToPair enables seamless pairing of products and digital signage through simple barcode scanning, automatically synchronizing product and pricing information. (Image: SOLUM) A central focus of the expanded partnership is the integration of EWQ’s ScanToPair solution with SOLUM’s Newton ESL and digital signage. ScanToPair enables seamless pairing of products and digital signage through simple bar

Fra Jiangnans ekkoer til global resonans – Zhejiang Satellite TVs Yue Opera Forårsfestivalgalla genskaber østlig elegance20.2.2026 03:39:00 CET | Pressemeddelelse

På den anden dag af det kinesiske nytår, sammenfaldende med 120-årsjubilæet for Yue-operaens tilblivelse, blev “Yue Rhyme Chinese New Year — 2026 Yue Opera Spring Festival Gala” sendt som planlagt. Gallashowet samlede Kinas førende operamestre, anerkendte sangere og Yue-operaentusiaster fra hele verden for at præsentere en kunstnerisk fest, der kombinerede klassisk arv, tværgenre-fusion og teknologisk udtryk – og viste verden de grænseløse muligheder i østlige traditionelle kunstformer i en moderne kontekst. Zhejiang Satellite TVs virtuelle vært Gu Xiaoyu optrådte sammen med kanalens første robotvært, Lan Xiaotian, og skabte en “cyberscene”, der overskred virkelighedens grænser. Over et dusin traditionelle operafærdigheder blev bragt til live i digitale omgivelser og tilbød et visuelt futuristisk spektakel for et globalt publikum. Gallashowet fremhævede også en kulturel rejse, der krydser bjerge og have. Kunstnere, som i 1959 rejste til den autonome uiguriske region Xinjiang for at stø

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