Moderna Inc (MRNA.O): FDA‘s VRBPAC AdCom unanimous backing of mFluSiva adds regulatory confidence

研报英文原文证据摘录

Moderna Inc (MRNA.O): FDA‘s VRBPAC AdCom unanimous backing of mFluSiva adds regulatory confidence

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18 Jun 2026 15:55:32 ET │ 11 pages

Moderna Inc (MRNA.O)

FDA’s VRBPAC AdCom unanimous backing of mFlusiva adds regulatory

confidence

CITI’S TAKE Neutral / High Risk

We view today’s unanimous 9-0 VRBPAC yes votes for Moderna’s Price (17 Jun 26 16:00) US$61.80

mFlusiva (mRNA-1010) as a clear positive and meaningful de-risking event Target price US$41.00

into the 8/5 PDUFA. Indeed, MRNA shares are up following the vote,

Expected share price return -33.7% reflecting improved approval confidence. Panel support extended across

both the cleaner 50–64yo full approval case, where phase 3 study P304 Expected dividend yield 0.0%

showed ~27% lower likelihood of flu-like illness versus standard-dose Expected total return -33.7%

vaccine, and the more debated ≥65yo accelerated approval pathway Market Cap US$24,521M

anchored on immunogenicity versus high-dose Fluzone. FDA and

panelists acknowledged limitations — one-season efficacy data, limited

influenza B case accrual, and comparatively sparse immunocompromised

/ very frail elderly data — but safety looked manageable despite higher Geoff Meacham, Ph.D.AC

reactogenicity. Commercially, mFlusiva is unlikely to contribute revenue +1-404-443-4701

until 2H27 given the missed 2026 US contracting window, although it geoffrey.meacham@citi.com

does highlight potential respiratory franchise optionality (risk-adj. BBG Jarwei Fang

cons peak: $1.2B). Maintain Neutral / HR and $41 TP. +1-212-816-5127

jarwei.fang@citi.com

VRBPAC votes unanimously yes across both age groups — VRBPAC voted 9-0 yes Nishant Gandhi, Ph.D.

on whether mFlusiva’s benefits outweigh risks for prevention of influenza disease in nishant.gandhi@citi.com