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
IntouchCX Recognized for Operations led AI and End to End CX Transformation by HFS Research6.11.2026 15:00:00 CET | Press release
IntouchCX a global leader in AI-powered customer experience (CX) management, trust and safety, digital engagement, and back-office operations, has been positioned in the Horizon 2 end-to-end experience transformation, in the HFS Horizons Customer Experience Services 2026 report for its operations led approach to AI adoption and its model connecting advisory with delivery, from strategy through frontline executions. HFS Research evaluates customer experience service providers based on their capabilities, innovation, and potential to deliver value. The 2026 report examines how providers are helping businesses adopt AI, improve customer experiences and strengthen operations. “AI transformation delivers the greatest value when strategy, technology, and operations work together,” said Brent Stevenson, Chief Experience Officer at IntouchCX. “Our approach and expertise goes beyond technology. We identify business challenges and build the right solutions by connecting the dots between data, wo
The Estée Lauder Companies Unveils Mastering Skin Longevity, a Breakthrough Scientific Innovation Platform Advancing the Next Era of Skin Science6.11.2026 15:00:00 CET | Press release
New Platform Focuses on Master Regulators of Skin Longevity to Drive Discovery Across Ingredients, Technologies, Formulations and Future Product Innovation At the China International Import Expo (CIIE), The Estée Lauder Companies Inc. (NYSE: EL) today unveiled Mastering Skin Longevity, a breakthrough scientific innovation platform designed to advance the next era of skin science and transformative product innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106776704/en/ The Estée Lauder Companies' Skin Longevity Clock serves as the visual representation for the Mastering Skin Longevity scientific innovation platform. Moving beyond the study of individual Hallmarks of Aging, the platform focuses further upstream on the Master Regulators of Skin Longevity. These interconnected biological pathways and proteins influence multiple hallmarks at once. By deepening understanding of these systems and how they help support s
Experian Named a Leader in 2026 IDC MarketScape for Worldwide Decision Intelligence Platforms6.11.2026 15:00:00 CET | Press release
IDC MarketScape recognizes Experian for strengths in proprietary data foundation, integrated orchestration and deployment flexibilityKey SummaryExperian named a Leader: IDC MarketScape positions Experian as a Leader in its 2026 vendor assessment of worldwide decision intelligence platform providers. Data and decisioning at scale: Experian Ascend Platform™ brings together proprietary data, analytics, decisioning, fraud detection, identity verification and model management and is used to process millions of transactions daily. Agentic AI orchestration and governance: Experian Agent Operating System™ provides a trusted agentic AI layer within Experian Ascend Platform designed to help organizations scale AI with explainability, auditability and human oversight. Experian today announced it has been named a Leader in the IDC MarketScape: Worldwide Decision Intelligence Platforms 2026 Vendor Assessment (Doc #US54118426, September 2026), which evaluates providers helping organizations design,
Midas Atlantic Partners, in Partnership With the Najafi Companies, Has Entered Into a Put Option Agreement With Sylvamo Relating to the Potential Acquisition of Its European Operations6.11.2026 12:04:00 CET | Press release
Sylvamo’s European operations include its uncoated freesheet paper mills in Saillat (France) and Nymölla (Sweden), as well as its forestry and supporting business operations across EuropeRevenues of approximately EUR 630 million for the fiscal year ended December 2025Transaction expected to close in the first quarter of 2027 once the required consultation processes are completed and regulatory approvals are obtained Midas Atlantic Partners (“Midas Atlantic”), in partnership with The Najafi Companies, has signed a put option agreement with Sylvamo Corporation (“Sylvamo”) relating to the potential acquisition of its European operations (the “Business”). The transaction comprises Sylvamo’s uncoated freesheet paper mills in Saillat and Nymölla, as well as its forestry and supporting business operations across Europe. Closing is expected in the first quarter of 2027, once the required consultation processes are completed and regulatory approvals are obtained. The Business is a leading Europ
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 00:23:00 CET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
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