Background on mFlusiva ahead of VRBPAC Meeting

研报英文原文证据摘录

Background on mFlusiva ahead of VRBPAC Meeting

Flash Note Health Care | Biotechnology / SMID Cap

June 17, 2026

Moderna, Inc. Cory Kasimov Adhi Sikand, PhD 917-733-5320 212-497-0813

MRNA | $55.40 cory.kasimov@evercoreisi.com adhi.sikand@evercoreisi.com

In Line | Target Price/Base Case: $50.00 Johnny Phan Joshua Chazaro, MD

Commentary 646-705-1846 917-750-5601

johnny.phan@evercoreisi.com joshua.chazaro@evercoreisi.com

We will closely follow tomorrow’s AdCom on MRNA’s flu vaccine and wanted to provide context on the program and

its role within the broader story. Mgmt has consistently positioned flu as a key growth driver beginning in 2027. In

our view, mFlusiva approval is less about the standalone commercial opty and more about establishing a regulatory

pathway for COVID/flu combo. Flu approval could aid a return to growth while oncology franchise matures (the LT

focus). While the panel’s outcome may drive NT stock volatility, we do not view the flu franchise alone as a

fundamental thesis changer. That said, the current FDA leadership team no longer includes some of the agency's

most vocal critics of the mRNA platform, which may create a more favorable backdrop for approval than investors

would have assumed several months ago.

Key points ahead of VRBPAC:

- Setup appears favorable. FDA briefing documents released on 6/16/26 identified no major deficiencies related

to efficacy nor any safety concerns based on ~6mos of follow-up. The mkt viewed the briefing package as

balanced, with shares trading higher following publication.

- The panel will vote on 2 separate benefit-risk questions: one for adults 50–64yrs (traditional approval) and

another for adults ≥65yrs (immunogenicity data-based AA).

- FDA highlighted evidence gaps but no apparent deal-breakers.