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
vVARDIS Announces Pricing of Initial Public Offering13.11.2026 06:02:00 CET | Press release
vVARDIS Holding AG (“vVARDIS”), a Swiss healthcare company operating in the dental med-tech sector, today announced the pricing of its initial public offering of 9,722,223 Class A ordinary shares at a public offering price of $18.00 per share. In connection with the offering, vVARDIS has granted the underwriters a 30-day option to purchase up to an additional 1,458,333 Class A ordinary shares at the initial public offering price to cover over-allotments. The Class A ordinary shares are expected to begin trading on the New York Stock Exchange on November 13, 2026 under the symbol “VVVV.” The closing of the offering is expected to occur on or about November 16, 2026 subject to the satisfaction of customary closing conditions. Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint bookrunning managers for the offering, with William Blair, UBS Investment Bank and Deutsche Bank Securities acting as bookrunners. A registration statement on Form F-1 relating to the offering has been file
Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4*12.11.2026 23:07:00 CET | Press release
The multi-level takeover includes a Throne Room, interactive photo opportunities, special lighting, and more The Empire State Building (ESB) is the gateway to Mount Olympus in Percy Jackson’s world, and now fans can experience the magic like never before. On Nov. 16, the Empire State Building Observation Deck (ESBOD) will unveil “Olympus Awaits,” a multi-level “Percy Jackson and the Olympians” takeover, in partnership with Disney+. The immersive takeover – included with every Observation Deck ticket – will feature an epic Throne Room, interactive photo opportunities, surprise giveaways, ESB x “Percy Jackson” merch, and more, available through Dec. 4, 2026.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112442266/en/ Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4* “This immersive NYC experience
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 18:09:00 CET | Press release
Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks
WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network12.11.2026 18:00:00 CET | Press release
New feature lets members follow friends and family, share performance and health insights, and celebrate life's moments together WHOOP, the human performance brand, today launched WHOOP Humans, a new feature that lets members follow friends and family, share fitness, health, and performance data they choose, and support each other's progress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112176779/en/ WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network For more than a decade, WHOOP has helped members better understand their own health and performance. Now, WHOOP Humans extends that experience beyond the individual, making it easier to celebrate achievements, encourage progress, and look out for the people who matter most. "In a world that's becoming increasingly artificial, we're building something deeply human,” said Will Ahmed, Founder and CEO of WHOOP. “This is the most verifiably human network ever
Integrated Hubs for Green Chemistry Research Aim to Transform How Chemicals and Materials Are Designed12.11.2026 17:00:00 CET | Press release
International network will investigate fundamental principles for creating safer, higher-performing chemicals and materials The Gordon and Betty Moore Foundation today announced four Integrated Research Hubs to explore new frontiers in chemical design, from materials that respond to their surroundings to molecules designed for safety from the start. Bringing together global researchers across institutions and disciplines, the hubs will investigate fundamental principles that could enable new capabilities in chemicals and materials while improving performance and protecting human health and the environment. The research priorities emerged through extensive engagement with the scientific community to identify the questions that could transform what chemistry can achieve. Each hub will connect researchers across institutions around one of four green chemistry focus areas: Safer molecular design: Led by The George Washington University, this hub will combine artificial intelligence and qua
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