Moderna Announces FDA Clearance for Phase 2 Study of mRNA Vaccine (mRNA-1273) for COVID-19; Company Awarded Up to $483 Million from BARDA for Accelerated Development of mRNA-1273; Lonza to Manufacture Up to One Billion Doses of mRNA-1273 Per Year

On May 7, 2020, Cambridge, MA-based Moderna, Inc. (Nasdaq: MRNA), a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today reported financial results and provided business updates for the first quarter of 2020 and highlighted pipeline progress. The company also announced FDA approval of the company progressing to a Phase 2 trial for its mRNA vaccine (mRNA-1273) for COVID-19. Moderna is conducting clinical trials of this vaccine in collaboration with the National Institute of Allergy and Infectious Diseaes (NIAID), headed by Dr. Anthony Fauci. “The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We also are continuing to progress our development pipeline and invest in our future. We are very pleased with Vertex’s decision, based on our preclinical progress, to extend our strategic collaboration working to develop the technology to allow for delivery of mRNA in the lung.”
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