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Meridian Bioscience, Inc. (NASDAQ: VIVO) has launched its new Air-Dryable Direct DNA qPCR Blood Mix, aimed at enhancing molecular diagnostic assays directly from whole blood, serum, or plasma. This innovative product allows for room-temperature stable diagnostics without the need for DNA purification, addressing challenges posed by PCR inhibitors and mitigating the costs and complexities associated with traditional methods. The technology facilitates faster, simpler assays, enabling manufacturers to enhance their workflow and efficiency in cancer detection.
Meridian Bioscience, a leading provider of diagnostic testing solutions, announced its participation in the H.C. Wainwright Global Life Sciences 2021 Virtual Conference. The CEO, Jack Kenny, will present a pre-recorded session accessible from March 9, 2021. The presentation link will be available on the company's Investor Relations website for 90 days. Meridian is dedicated to delivering innovative diagnostic products and raw materials for various applications, including human and environmental testing. The company's stock is traded on NASDAQ under the symbol VIVO.
Meridian Bioscience (NASDAQ: VIVO) has announced the withdrawal of its Emergency Use Authorization (EUA) application for its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. Following communication with the FDA, the company clarified that it cannot distribute the test until EUA approval is granted. This is a reversal from their earlier statement regarding resuming shipments upon re-submission of the EUA application. The company emphasizes that all forward-looking statements are subject to various risks and uncertainties that could impact future performance.
Meridian Bioscience, Inc. (NASDAQ: VIVO) announced the withdrawal of its Emergency Use Authorization (EUA) application for the SARS-CoV-2 molecular diagnostic test on the Revogene platform. This decision follows a request for additional information from the FDA. Meridian plans to conduct a new clinical validation and Limit-of-Detection study by the end of March 2021, with the intention to re-submit the EUA application afterward. The company anticipates resuming shipments of the test during the third fiscal quarter, with financial guidance updates to be discussed on May 7, 2021.
On February 16, 2021, Meridian Bioscience (NASDAQ: VIVO) announced updates regarding its application for Emergency Use Authorization (EUA) of its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. Following a communication from the FDA requesting more information, the company has opted to pause shipments of the test kits while it prepares a detailed response. Meridian is dedicated to improving diagnostic solutions and provides essential life science raw materials globally.
Meridian Bioscience reported strong Q1 2021 results, with net revenues at $92.9 million, a 96% increase year-over-year. The Life Science segment soared, generating $62.6 million in revenues, up 396%. However, the Diagnostics segment faced a 13% decline to $30.3 million despite a 2% recovery from Q4 2020. The company secured a NIH RADx grant for its Revogene® SARS-CoV-2 assay and raised its FY2021 revenue guidance to $320-$350 million, indicating strong demand in Life Sciences. Adjusted EPS is forecasted between $1.70-$1.90.
Meridian Bioscience (NASDAQ: VIVO) has announced an expansion of production for its SARS-CoV-2 diagnostic test on the Revogene® platform, following a $5.5 million award from the NIH and additional funding from JobsOhio. This initiative aims to increase production at its Quebec facility and build a new state-of-the-art facility in Newtown, Ohio. The goal is to reach a capacity of 800,000 tests per month by the end of 2021, supporting the demand for COVID-19 testing amidst the pandemic.
Meridian Bioscience, Inc. (NASDAQ: VIVO) will report its first quarter fiscal 2021 financial results on February 5, 2021. CEO Jack Kenny and CFO Bryan Baldasare will host a conference call at 10:00 a.m. ET to discuss the results. Interested participants in the U.S. can call (866) 443-5802, while international callers can dial (513) 360-6924. A replay of the call will be available for 14 days starting at 1:00 p.m. ET on the same day. Meridian is a leading provider of diagnostic testing solutions and life science raw materials, operating in over 70 countries.
Meridian Bioscience (NASDAQ: VIVO) announced its participation in the H. C. Wainright Bioconnect 2021 Virtual Conference. CEO Jack Kenny will partake in a pre-recorded fireside chat available from January 11, 2021, and a live panel discussion on FDA regulations on January 12, 2021. The panel, hosted by Scott Gottlieb, will feature industry leaders including Dwight Egan and Michael Nall. Webcast links will be accessible via Meridian’s Investor Relations site. The fireside chat will be available for 90 days.
Meridian Bioscience (NASDAQ: VIVO) announced a $1M funding award from the NIH RADx initiative to expedite the launch of its SARS-CoV-2 molecular diagnostic test on the Revogene platform. The Emergency Use Authorization (EUA) application was submitted to the FDA on December 7. This funding will help develop a new assay consumable for detecting SARS-CoV-2 directly from viral transport media, optimizing clinical results. Meridian is among 47 projects advancing to Phase 1 for initial technology validation under the RADx initiative, aimed at accelerating COVID-19 testing innovation.
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