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Moderna COVID Vaccine - FDA
clearance to proceed with Phase 2 study
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Moderna shares surge after FDA approves coronavirus vaccine for phase 2 trial
Published Thu, May 7 2020
https://www.cnbc.com/2020/05/07/fda-approves-moderna-vaccine-candidate-for-phase-2-study.html
The Food and Drug Administration has approved Moderna's coronavirus vaccine candidate for phase 2 trial, the company announced Thursday.
The company said it will begin the next round of trials with 600 participants shortly and is finalizing plans for a phase 3 trial as early as this summer.
press release
Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates
May 7, 2020
https://investors.modernatx.com/news-releases/news-release-details/moderna-reports-first-quarter-2020-financial-results-and
Progress on novel coronavirus vaccine (mRNA-1273) includes FDA clearance to proceed with Phase 2 study
Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020
Awarded up to $483 million funding from BARDA for accelerated development of mRNA-1273
Entered strategic collaboration with Lonza Ltd. to manufacture up to one billion doses of mRNA-1273 per year
Up to $2.4 billion to invest, including cash and investments of $1.7 billion and up to $0.7 billion in potentially available grants and awards; reconfirms 2020 guidance that net cash used in operating activities and for purchases of property and equipment is expected to be approximately $500 million
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 7, 2020-- 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 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."
New updates and recent progress include:
Infectious Diseases
•The U.S. Food and Drug Administration (FDA) completed its review of the Company's Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273) allowing it to proceed to Phase 2 study, expected to begin shortly; finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020
•Positive interim results announced from Phase 1 Zika vaccine candidate (mRNA-1893) study
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