StockWatch: FDA Reversal Boosts Moderna, But Not Other Vaccine Companies

StockWatch: FDA Reversal Boosts Moderna, But Not Other Vaccine Companies

The FDA’s reversal of its earlier refusal to review mRNA-1010, the seasonal flu vaccine being developed by Moderna (NASDAQ: MRNA), accelerated a revival of Moderna shares that has been in progress over recent months—but the rebound has not lifted the prices of other vaccine stocks. Moderna announced Wednesday a positive outcome to a “Type A” meeting with FDA officials in which the agency agreed to set aside its earlier refusal to file (RTF) lett…

Why did the FDA reverse its decision on Moderna?

How the agency's change of course unfolded and its implications Regulators initially declined to accept an application for review, citing concerns about whether the trial evidence met the agency’s standards for an “adequate and well controlled” study. After further discussions between the company…