Blockonomi

Moderna (MRNA) Stock Slips Despite Beating Q4 Revenue and Earnings Estimates

Moderna (MRNA) stock fell 0.3% Friday despite beating Q4 revenue estimates at $678M and posting narrower loss of $2.11/share after FDA rejected flu vaccine review.

FDA refuses Moderna's application for new mRNA flu vaccine

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.
Healio

More data show mRNA COVID-19 vaccination during pregnancy is safe

The messenger RNA COVID-19 vaccine is not tied to neurodevelopmental disorders in youth whose mothers who were vaccinated immediately before or during pregnancy, data show.The study, presented at The Pregnancy Meeting and “conducted through a rigorous scientific process in an NIH clinical trials network,

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna
STV News

First mRNA vaccine to be manufactured in UK approved by regulators

Darius Hughes, UK general manager of Moderna, said: “With this approval from the MHRA, we are incredibly proud that our LP.8.1 vaccine will be the first commercially available mRNA vaccine manufactured within the UK.