NOVAREMED-AG
18.12.2020 10:34:14 CET | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201218005198/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
Meraki Capital Launches Tessero Across Six European Markets Following Landmark Hays Acquisition1.9.2026 22:36:00 CEST | Press release
Meraki Capital has launched Tessero,a new European specialist recruitment group created from the six former Hays plc businesses it acquired earlier this summer. Launching simultaneously across Sweden, Denmark, Hungary, Romania, Luxembourg and Czechia, Tessero brings six established recruitment businesses together under one independent European brand, creating an international platform with experienced teams, existing clients and active candidate networks from day one. The launch follows one of the most significant transactions in Meraki Capital’s history and the completion of a major transition programme across all six countries within weeks of the acquisition. 130 employees will now operate under the Tessero brand, with established country leadership teams remaining in place and continuing to lead their respective markets. Gary Elden OBE, CEO of Meraki Capital and Director of Tessero, said: “Tessero launches with something that normally takes years to build: established businesses, ex
SBC Medical to Participate in Several Upcoming Investor Conferences in September 20261.9.2026 19:35:00 CEST | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced its participation in several upcoming investor conferences in September 2026. SBC Medical will conduct presentations and one-on-one meetings with institutional investors. Below is a summary of the Company’s scheduled participation in upcoming investor conferences: H.C. Wainwright 28th Annual Global Investment Conference Date: September 14 2026 Format: In-person (NY) Registration: https://my.ct.events/register.aspx?meid=cff43623-9e9f-45d4-bbc3-ee19e9c372c1&rpid=a667ca45-171e-4306-98eb-c466e8b7e6c1 ArcStone Kingswood Growth Summit 2026 Date: September 16 2026 Format: In-person (Toronto) Registration:https://www.meetmax.com/sched/event_144037/investor_reg_new.html?attendee_role_id=ARCSTONE_ATTENDEE CLSA 33rd Investors’ Forum 2026 Date: September 21, 2026 Format: In-person (Hong K
Crimson Moon Available Now, Bringing Heavy-Metal Gothic Action to Solo and Co-op Players on PC, PlayStation 5, and Xbox Series X|S1.9.2026 19:00:00 CEST | Press release
ProbablyMonsters’ action-adventure RPG offers blood-soaked combat, monstrous showdowns, and deep replay value for $19.99 USD ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today launched Crimson Moon on PC via Steam and Epic Game Store, PlayStation 5, and Xbox Series X|S for $19.99 USD. A $29.99 USD Deluxe Edition is also available and includes an exclusive armor set, weapon cosmetic, and upcoming game expansion. Watch the official Crimson Moon launch trailer on YouTube to see the game’s gothic heavy-metal power fantasy, crafted for both solo and co-op players, in action. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901064893/en/ Crimson Moon is a gothic high renaissance action-adventure RPG built around intense, replayable missions that blend brutal precision with deep character progression. Players take on the role of the Nephilim, powerful human-angel hybrids bo
Rigaku Launches CT Lab HR160 High-Resolution X-ray CT System1.9.2026 17:00:00 CEST | Press release
- Developed in collaboration with Excillum for battery, semiconductor devices, and advanced materials analysis - Rigaku Corporation, a global solutions partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (Headquarters: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), today announced the launch of the CT Lab HR160, a high-resolution X-ray computed tomography (CT) system for battery, semiconductor devices, electronic components, and advanced materials analysis. The system is developed in collaboration with Excillum AB, the global source for X-ray innovation (Headquarters: Stockholm, Sweden; CEO: David Lindblom; “Excillum”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901074099/en/ Photo: CT Lab HR160 High-Resolution X-ray CT System CT Lab HR160 combines Rigaku’s X-ray CT imaging expertise with Excillum’s NanoTube N3 X-ray source. Operating at up to 160 kV to support a wide r
GigaDevice Joins the Zephyr® Project to Foster Global Open-Source Ecosystem1.9.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has officially joined the Zephyr® Project, one of the world’s leading open-source real-time operating systems (RTOS). Hosted by the Linux Foundation®, the Zephyr® Project welcomes GigaDevice as a Silver Member, making GigaDevice a dual Silver Member of both the Zephyr® Project and the Linux Foundation. Leveraging its comprehensive GD32 MCU portfolio, GigaDevice will actively participate in the Zephyr® community, promoting deeper integration between its MCU technologies and the global open-source RTOS ecosystem. This will provide customers and developers in industrial, IoT, consumer electronics, and other fields with a more open, standardized, and efficient embedded development environment, while continuing to contribute to the growth of the global embedded open ecosystem and broader access to technology. With the continued evolution of the Internet of
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