Palm Beach, FL – March 17, 2020 — The coronavirus fear has become palpable. Businesses and schools around the world are closing down. Global indices are plunging. Sports and concert events are being canceled. And, as the number of U.S. cases jumps to 3,485 with 65 deaths, fear has only grown worse. It’s why President Trump just released a new series of guidelines to slow the spread of the virus that calls for the lockdown of America, including closing restaurants and schools for the next 15 days. At the same time, Trump said his administration may look at lockdowns for “certain areas” or “hot spots” in the nation, as reported by CNBC. That’s creating sizable opportunity for top companies like CleanSpark, Inc. (NASDAQ:CLSK), Gilead Sciences Inc. (NASDAQ:GILD), Novavax Inc. (NASDAQ:NVAX), Johnson & Johnson (NYSE:JNJ), and Regeneron Inc. (NASDAQ:REGN).
CleanSpark, Inc. (NASDAQ:CLSK) BREAKING NEWS: CleanSpark, Inc. a diversified software and intelligent energy services company, just announced that a mobile application it was engaged to design is helping keep residents nationwide aware of the Coronavirus risks in their neighborhoods. AlertNest engaged p2klabs, a wholly owned subsidiary of CleanSpark, to help design its latest mobile app to keep residents informed on what’s happening in their neighborhoods. The AlertNest app was designed as a go-to mobile app to provide individuals with all the information they need to conduct their lives in one place. AlertNest collects and shares police, crime, local current events and weather data and now also includes updates and alerts from the Center for Disease Control, and other vetted sources with respect to Coronavirus (COVID-19). These alerts allow users to see updated Coronavirus statistics on a global, domestic and state by state basis. “We are pleased to see the products we designed providing valuable information in this time of crisis. AlertNest provides important and relevant information free of charge to anyone with a mobile device.” said Amer Tadayon, Chief Revenue Officer of CleanSpark. “We created AlertNest to help empower people to live better and safer lives, by providing them with valuable information about their neighborhoods. The current situation we are in demonstrates the value of access to information and data.” said Becky Wanta CEO of AlertNest.
Other related developments from around the markets include:
Gilead Sciences Inc. (NASDAQ:GILD) announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March. The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19. The new clinical studies expand the ongoing research into remdesivir, which includes two clinical trials in China’s Hubei province led by the China-Japan Friendship Hospital as well as the recently initiated clinical trial in the United States led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from those in Chinaexpected in April. “Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time. The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the highest urgency,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Novavax Inc. (NASDAQ:NVAX) announced that the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support Novavax’ efforts to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax’ costs through Phase 1. “This first stage of funding from CEPI is critical to enable ongoing development of our COVID-19 vaccine candidates,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We commend CEPI for its role as a vital partner to bridge the funding gap for innovative biotech companies like Novavax, which have robust vaccine technology platforms. Novavax is working tirelessly to create a vaccine against this growing epidemic.”Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020. Novavax’ COVID-19 vaccine candidates were created with its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavaxalso expects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidates to enhance immune responses. “The current crisis shows that we cannot prevent all infectious diseases from emerging. But we can and must double down on developing vaccines,” said Richard Hatchett, Chief Executive Officer of CEPI.
Johnson & Johnson (NYSE:JNJ) announced that its Janssen Pharmaceutical Companies have entered a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of a preventive vaccine candidate for COVID-19. The parties have commenced preclinical testing of multiple vaccine prospects, with the aim to identify by the end of the month a COVID-19 vaccine candidate for clinical trials. Janssen is optimistic that, in collaboration with multiple global strategic partners, it can initiate a Phase 1 clinical study of a potential vaccine candidate by the end of the year. In parallel to these efforts, Janssen is preparing to upscale production and manufacturing capacities to levels required to meet global public health vaccination needs. “It is critical to work with the best scientific minds as we look to rapidly identify and develop solutions to the COVID-19 outbreak,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We are grateful for talented and experienced collaboration partners like Dan Barouch and his team at BIDMC. By mobilizing our collective resources, we believe we can leverage the top science and cutting-edge capabilities to respond to this pandemic.”
Regeneron Inc. (NASDAQ:REGN) and Sanofi announced they have started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody. This U.S.-based trial will begin at medical centers in New York, one of the epicenters of the U.S. COVID-19 outbreak, and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo. The multi-center, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enroll up to 400 patients. The first part will recruit patients with severe COVID-19 infection across approximately 16 U.S. sites, and will evaluate the impact of Kevzara on fever and patients’ need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.
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