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
Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector18.12.2025 03:41:00 CET | Press release
SteQeyma™45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD)1The new autoinjector option increases convenience, enhances individual patient experience and expands administration options Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution f
Megaport Expands into India, Accelerating Global Growth with Extreme IX Acquisition18.12.2025 02:15:00 CET | Press release
Through the Extreme Exchange (IX) acquisition, Megaport gains seven Internet Exchanges and access to 40+ data centres across India’s fastest-growing digital hubs. Megaport Limited (ASX: MP1) (“Megaport”), the world’s leading Network as a Service (NaaS) provider, today announced the acquisition of Extreme IX,India’s leading Internet Exchange operator, from Extreme Labs, a Bulgaria-headquartered software and network engineering company that incubated the Extreme IX platform. The acquisition expands Megaport’s global platform into one of the world’s fastest-growing digital infrastructure markets and supports the Company’s strategy to deliver scalable, high-performance connectivity services across APAC. The acquisition establishes Megaport’s presence across seven Internet Exchanges in major Indian metros: Delhi, Kolkata, Hyderabad, Chennai, Bengaluru, Mumbai, and Pune, connecting 40+ data centres and more than 400 customers. It also accelerates Megaport’s planned market entry by nearly thr
IonQ and QuantumBasel Expand Long-Term Partnership in Next-Generation Quantum Systems17.12.2025 22:10:00 CET | Press release
Extension solidifies QuantumBasel as IonQ’s Innovation Center in Europe; adds IonQ Tempo and next-generation system to advance quantum commercialization IonQ (NYSE: IONQ), the world’s leading quantum company, today announced an expanded agreement with QuantumBasel, the quantum initiative of uptownBasel, Switzerland’s innovation campus. The extended contract grants QuantumBasel ownership of its existing IonQ Forte Enterprise system and secures ownership of a next-generation Tempo system. This new agreement brings the total deal value of the QuantumBasel and IonQ partnership to over $60 million and extends IonQ’s on-site presence in Switzerland four more years, continuing through 2029. QuantumBasel is IonQ’s official Innovation Center in Europe, serving as a hub for European industry, academia, and research institutions to explore practical quantum computing applications and access IonQ’s latest enterprise-grade systems. “Our extended partnership with QuantumBasel represents a cornerston
Suzano Starts Up New Production Line, Boosting Its Fluff Pulp Capacity by 400%17.12.2025 21:50:00 CET | Press release
A R$490 million investment expands the supply of raw material used in the production of absorbent items Suzano, the world’s largest pulp producer, has commenced operations this week at its new fluff pulp production line located in its Limeira unit in Brazil’s São Paulo state. This R$490 million investment increases Suzano’s total fluff pulp production capacity by more than 400%, from 100,000 to 440,000 tonnes per year. The project involved converting the existing pulp line at the Limeira unit into a flexible machine, capable of producing both Eucafluff® and market pulp. Eucafluff® is used in the production of absorbent and personal hygiene products, such as baby and adult diapers, sanitary pads and pet pads. Then market pulp is supplied for making products including toilet paper, printing and writing papers, and paper packaging. Launched in 2015, Eucafluff® is the world’s first fluff pulp made from eucalyptus, delivering unique advantages like enhanced softness and flexibility, which t
SES Acknowledges Moody’s Rating Action and Reiterates Deleveraging Commitments17.12.2025 21:36:00 CET | Press release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Moody’s Investor Service today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. Consistent with this plan, it remains management’s intention to de-lever and return to credit metrics that are commensurate with investment grade, with a policy objective of reducing adjusted net leverage1 to at least 3.0x or below. Today’s rating action does not change the Company’s ability to operate its business, serve customers, or execute its strategic plan. SES maintains a balanced weighted average debt maturity profile of approximately five years, and the rating action from Moody’s is not expected to have a material impact on the interest payable under the Company’s existing debt facilities. SES also ben
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