Business Wire

NOVAREMED-AG

18.12.2020 10:34:14 CET | Business Wire | Press release

Share
Novaremed Receives Fast Track Designation from the FDA for NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy

Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, announced today that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the development of NRD135S.E1 for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).

By awarding Fast Track Designation to NRD135S.E1, an investigational candidate for the treatment of PDPN, the FDA has recognized its potential to meaningfully improve outcomes for patients with this debilitating disease. This is an excellent acknowledgement as we plan to initiate our Phase 2b study,” said Sara Mangialaio, MD, PhD, Head of R&D and CMO of Novaremed. “FTD is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious conditions.”

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track Designation can lead to an Accelerated Approval and Priority Review, if certain criteria are met.

Notes to the Editor:

About Novaremed

Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed Ltd is developing NRD135S.E1, an orally active non-opioid small molecule with a novel mechanism of action against PDPN. In a Phase 2a Proof of Concept study, NRD135S.E1 showed clinically relevant reduction in patient-reported pain and an excellent safety and tolerability profile. Novaremed Ltd is currently preparing to conduct a Phase 2b study in PDPN patients in USA.

About Business Wire

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

http://businesswire.com

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

Corpay Cross-Border Named the Official FX Supplier of Vålerenga Fotball AS4.6.2026 14:30:00 CEST | Press release

Providing access to currency risk management and cross-border payments solutions Corpay, Inc.*, (NYSE: CPAY) a global leader in corporate payments, is pleased to announce that Corpay’s Cross-Border business has entered into an agreement with Vålerenga Fotball AS to become their Official Foreign Exchange (FX) Supplier. Through this partnership, Corpay Cross-Border will deliver comprehensive FX risk management solutions to support Vålerenga Fotball AS’s operations. In addition, its award-winning platform will enable the club to manage global payments seamlessly through a single point of access. “Corpay Cross-Border is proud to be named the Official FX Supplier of Vålerenga Fotball AS,” said Brad Loder, Chief Marketing Officer, Corpay Cross-Border Solutions. “This partnership reinforces Corpay’s position as a leading provider of corporate payments and currency risk management solutions within professional football, while giving us a strong platform to expand our brand and business in Norw

CloudInteract and Red Kite Launch Joint Delivery Partnership for Agentic AI Voice on Amazon Connect and Pega4.6.2026 14:19:00 CEST | Press release

This expert partnership takes agentic voice deployments for customers from quarters to weeks; a demonstrator can be seen at PegaWorld 2026 CloudInteract, the Amazon Connect and agentic AI specialist, and Red Kite, the Pega delivery partner, today announced a joint delivery partnership to bring autonomous AI voice agents to enterprises using the Pega and Amazon Connect platforms. The partnership debuts a working solution on Amazon Connect, Amazon Bedrock, that can be seen at PegaWorld® in Las Vegas, 7–9 June 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604645983/en/ Initial use cases span healthcare, financial services, insurance, government, and BPO. The companies will demonstrate a healthcare appointment booking call at PegaWorld, but the same architecture applies to any regulated environment where AI interactions must be executed within governed workflows, using real-time customer context, policy, and decisionin

Mobix Labs to Acquire U.S.-Built Drone Manufacturer Vision Aerial, Expanding Into Global Drone and Aerial Intelligence Markets4.6.2026 14:00:00 CEST | Press release

Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a binding Letter of Intent to acquire Vision Aerial, Inc., a Montana-based manufacturer of American-built drones trusted in national security, government, energy, public safety, and critical infrastructure operations. The acquisition expands Mobix Labs into a fast-growing global market and marks the latest step in its previously announced strategy to grow through targeted, mission-critical acquisitions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604386607/en/ Built in America. Trusted Where Performance Matters. Founded in 2013, Vision Aerial designs, manufactures, and supports rugged drone systems built for the most demanding field operations. Each aircraft can carry swappable cameras and sensors—from high-resolution and heat-sensing thermal cameras to laser-based 3-D mapping and gas-leak detection—allowing one platform to support multiple mission prof

Visa and Brale Explore Private Stablecoin Settlement for Institutional Payments4.6.2026 14:00:00 CEST | Press release

Proof of concept will test how privacy-enabled blockchain infrastructure can support secure, scalable settlement for institutional payment flows Visa (NYSE: V) today announced a collaboration with Brale to explore stablecoin-based settlement using SBC, a U.S. dollar-backed stablecoin issued by Brale, on the Canton Network. The proof of concept will evaluate how privacy-enabled blockchain infrastructure can support faster, more programmable settlement while helping financial institutions and payment companies maintain control over the visibility of sensitive settlement transaction data. Visa began enabling stablecoin settlement in 2021 and continues to expand its capabilities, allowing VisaNet obligations to be settled using supported stablecoins. A central focus of this collaboration is the Canton Network’s privacy architecture. As stablecoin adoption grows, financial institutions are assessing how they can use blockchain-based settlement while meeting strict privacy and compliance req

The Open Group Publishes Industrial Advanced Nuclear™ Consortium’s Inaugural Application Scenarios Whitepaper4.6.2026 14:00:00 CEST | Press release

The Whitepaper provides a blueprint on how advanced nuclear energy can be deployed across heavy industry The Open Group, the vendor-neutral technology standards organization, today announced the publication of the Industrial Advanced Nuclear™ Consortium (IANC) Application Scenarios Whitepaper, setting out how advanced nuclear technologies can be deployed to deliver reliable, low‑carbon heat and power across heavy industry. The Whitepaper, driven by IANC, an industrial end-user-driven organization, represents a significant step forward in the role of nuclear energy in relation to energy transition. Outlining real-world use cases where Small Modular Reactors (SMRs) and Micro Modular Reactors (MMRs) could be integrated directly into industrial operations, it focuses on sectors that are amongst the most difficult to decarbonize, including: Offshore energy Refining and petrochemicals Mining Energy‑intensive manufacturing. Developed by leading industrial end users, the Whitepaper provides a

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