Report

Orexo - Vorvida submitted to the FDA

Orexo announced on 6 March 2020 that it has submitted an application to the FDA for its vorvida digital therapy for the treatment of heavy drinking. It expects a hearing from the FDA on the approval status of the program in Q220 and to commercialize the product in H220 if it is cleared. The product uses cognitive behavioral therapy coupled with machine learning and has been vetted in a randomized, controlled study to reduce problematic drinking episodes.
Underlying
Orexo AB

Orexo is a pharmaceutical company and engaged in the development and commercialization of drugs based on patented drug delivery technologies primarily in Sweden and the United States. Co.'s product portfolio includes Zubsolv® tablets for maintenance treatment of opioid dependence; Abstral® for the treatment of breakthrough pain in cancer patients; Edluar®, an active substance zolpidem and for the treatment of short-term insomnia; Diabact UBT, which is used to diagnose the presence of Helicobacter pylori, a bacterium that causes gastric ulcers; and Heliprobe System, which is a doctor's office test to detect the presence of the gastric ulcer bacterium, Helicobacter pylori.

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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