Street View: Better regulatory odds for Moderna's flu shot after FDA reversal

Moderna MRNA.O said on Wednesday the U.S. Food and Drug Administration changed course and will review an amended application for its new influenza vaccine

This comes a week after the FDA rejected MRNA's earlier submission, which fueled drugmaker and investor concerns over policy changes at the agency under President Donald Trump

Stock of the vaccine maker closed up 6% on Wednesday after falling as much as 12% after the FDA's initial refusal was made public

FDA REVERSES COURSE

RBC Capital Markets ("sector perform," PT: $30) says the FDA's swift reversal "fits within the broader MO of the administration," describing a pattern of "we play tough" followed by "we are always willing to negotiate" seen previously in areas such as tariffs, drug pricing and most-favored-nation or MFN policies

William Blair ("market perform") lifted its probability of regulatory success for Moderna's mRNA‑1010 flu vaccine to 55% from 10% following the FDA's update; brokerage does not expect meaningful U.S. revenue contribution until the 2027-28 season given the need for ACIP recommendation and CDC adoption to enable vaccine reimbursement

TD Cowen ("hold," PT: $40) says it is a "remarkably short turnaround"; the move likely reflects concerns over reports that the director of the FDA's Center for Biologics Evaluation and Research had overruled staff, prompting the agency to find "an acceptable solution" after media scrutiny