Moderna MRNA shares gained 3.5% on Thursday after the company cleared a key regulatory hurdle for its investigational seasonal influenza vaccine, mFlusiva (mRNA-1010). The positive move followed a unanimous endorsement from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which voted 9-0 that the vaccine's benefits outweigh its risks for the prevention of influenza disease in adults aged 50-64 and in those aged 65 and older.
This outcome was expected since the briefing documents for the committee meeting were issued by the FDA earlier this week. Several investors had construed these documents to be broadly constructive and significantly less negative than anticipated. The FDA staff did not identify any major deficiencies in Moderna's biologics license application (BLA) for mFlusiva in influenza and acknowledged the data supporting the vaccine.
The investors had earlier braced for a more difficult regulatory review after the FDA initially declined to review Moderna's mFlusiva BLA in February due to concerns related to the study design in adults aged 65 years and older. The agency later reversed course after Moderna revised its regulatory strategy for the vaccine based on age. The BLA was subsequently modified to seek traditional approval of mFlusiva in adults aged 50-64 years and accelerated approval for adults aged 65 years and older.
Year to date, MRNA stock has skyrocketed 116.9% against the industry’s 1% decline.
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The advisory committee's backing is viewed as an important step toward potential approval, significantly improving investor confidence ahead of the FDA's Aug. 5, 2026, decision date for Moderna's mFlusiva BLA for influenza. While the FDA is not obligated to follow advisory committee recommendations, a unanimous endorsement from VRBPAC is widely viewed as a positive signal that strengthens the vaccine's prospects for approval and reduces regulatory uncertainty.
The panel's review was based on data from Moderna's phase III influenza vaccine program, including results from its pivotal late-stage study that demonstrated the vaccine's potential as a non-egg-based alternative for seasonal flu prevention in older adults. The safety findings discussed during the meeting were consistent with previously reported studies, further supporting the vaccine's regulatory case.
With regulatory reviews already underway in the United States, the EU, Canada and Australia, the unanimous VRBPAC vote strengthens expectations that mFlusiva could become Moderna's next commercially important vaccine product. Regulatory submissions in additional countries are also planned during 2026.
Why Is the VRBPAC Meeting Outcome Important for Moderna?
The unanimous VRBPAC vote carries significance beyond the potential approval of mFlusiva. Moderna's long-term growth strategy increasingly depends on expanding its respiratory vaccine franchise beyond COVID-19, and a successful flu vaccine launch would provide the company with an important new commercial product in a large seasonal market. It would also further validate the versatility of Moderna's mRNA platform in infectious diseases.
The opportunity is particularly important given the substantial burden of seasonal influenza among older adults, a population that accounts for a disproportionate share of flu-related hospitalizations and deaths. If approved, mFlusiva could strengthen Moderna's position in respiratory vaccines while reducing the company's reliance on its COVID-19 franchise.
Investors are also focused on the broader pipeline implications. Regulatory progress for mFlusiva could provide greater clarity for mCombriax (mRNA-1083), Moderna's combination influenza/COVID vaccine. Moderna withdrew a filing for the vaccine last year after the FDA requested additional efficacy data related to the influenza component. Since mCombriax incorporates the same influenza component used in mFlusiva, a favorable regulatory path for the flu vaccine is viewed as an encouraging signal for the combination vaccine’s prospects. Moderna is currently awaiting further FDA guidance regarding a potential future filing for mCombriax. This combination vaccine recently secured approval in the EU.
Moderna, Inc. Price and Consensus
Moderna, Inc. price-consensus-chart | Moderna, Inc. Quote
MRNA’s Zacks Rank & Stocks to Consider
Moderna currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Liquidia Corporation LQDA, Indivior Pharmaceuticals INDV and Immunocore IMCR, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 106.1% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 17.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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This article originally published on Zacks Investment Research (zacks.com).