Healthcare Roundup – Moderna’s COVID vaccine scheduled for FDA review, BioNTech -2% post-market following BofA downgrade

Published on: December 1, 2020
Author: Amy Liu

Moderna’s COVID vaccine scheduled for FDA review on Dec. 17

  • Moderna (NASDAQ:MRNA+6.9% post-market after soaring to another all-time high in today’s trade, as the company asked U.S. and European health regulators to authorize use of its COVID-19 vaccine, which was shown to be 94.1% effective – with 100% efficacy in preventing severe COVID – in a full analysis of a pivotal study.
  • A panel of outside experts advising the U.S. Food and Drug Administration will meet Dec. 17 to review the evidence for Moderna’s vaccine and vote on whether to recommend that the agency authorize its emergency use; a similar meeting has been set for Dec. 10 for the Pfizer-BioNTech vaccine.
  • It is unclear how long the FDA will take to make a decision on allowing use, but Moderna CEO Stéphane Bancel says it is possible the agency could decide within a few days of the advisory panel meeting, or between Dec. 18-20.
  • Both vaccines have shown more than 90% efficacy, and mRNA-1273’s less-rigorous distribution and shipping requirements give the Moderna drug a slight edge, though both will be used given current production constraints.
  • Moderna’s market value has now reached a record $60B, topping pharma heavyweights such as Vertex and Regeneron, even though it has yet to bring a drug to market.
  • Moderna shares rose 20.2% to close today at $152.74; the stock traded just below $20 at the start of the year.

BioNTech -2% post-market following BofA downgrade

Moderna to seek regulatory authorization for Covid-19 vaccine after final trial shows 94.1% effectiveness

  • Moderna (NASDAQ:MRNA) jumps 10% in premarket in reaction to primary efficacy analysis data from Phase 3 study of its COVID-19 vaccine candidate, mRNA-1273 demonstrating efficacy of 94.1%, while vaccine efficacy against severe COVID-19 was 100%.
  • Continuous review of safety data is ongoing and no new serious safety concerns have been identified.
  • Primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
  • Today, the company will file for US Emergency Use Authorization (EUA), as well as apply for a conditional marketing authorization with the European Medicines Agency.
  • In reaction to the news, Pfizer (NYSE:PFE) is up 2% while BioNTech (NASDAQ:BNTX) is +3%.

XS Financial reports Q3 results

  • XS Financial (OTCQB:XSHLF): Q3 Non-GAAP EPS of $0.00; GAAP EPS of -$0.02.
  • Revenue of $3.86M (+484.8% Y/Y)

MedX Health reports Q3 results

  • MedX Health (OTC:MDXHF): Q3 GAAP EPS of -$0.01.
  • Revenue of $0.17M (-26.1% Y/Y)

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