Moderna MRNA announced that its seasonal influenza vaccine candidate, mRNA-1010, achieved superior relative vaccine efficacy (rVE) than an approved flu shot marketed by GSK plc GSK in a phase III efficacy study (P304) in adults aged 50 and above.
Per the company, mRNA-1010 met the “most stringent superiority criterion” prespecified in the study protocol. The vaccine’s efficacy was 26.6% higher than GSK’s flu shot in the overall study population that covered over 40,000 participants across 11 countries.
mRNA-1010 also demonstrated strong efficacy against key influenza strains included in the shot, with rVE of 29.6% for A/H1N1, 22.2% for A/H3N2 and 29.1% for the B/Victoria lineage. Moderna also reported that the vaccine’s benefit was consistent across age groups, risk factors and previous influenza vaccination status. In a subgroup analysis, mRNA-1010 achieved an rVE of 27.4% in participants aged 65 and older – a population at high risk of influenza.
The P304 study results are also consistent with Moderna’s previously conducted phase III immunogenicity study (P303), which showed that the mRNA-1010 generated immune responses across all four A and B strains of influenza that were at least as effective as currently available standard and high-dose flu vaccines.
Moderna plans to discuss the above results with the FDA and other global regulators for potential regulatory submissions on mRNA-1010. It also intends to present data from the P304 study at a future medical meeting.
MRNA Stock Price Performance
Post the above news, shares of Moderna rose nearly 2% yesterday. The encouraging P304 study results not only improve the company’s prospects of securing a potential approval for a standalone flu vaccine but also support broader development efforts.
In May, Moderna withdrew a regulatory filing with the FDA for mRNA-1083, an investigational combination vaccine against COVID-19 and influenza, after the agency requested additional efficacy data for the flu component. This candidate integrates the company’s COVID-19 shot with mRNA-1010. The latest efficacy data could help support a future refiling of mRNA-1083, which the company plans to submit later this year.
Year to date, the stock has plummeted 34% compared with the industry’s 4% decline.
Image Source: Zacks Investment Research
Moderna Stock Under Pressure
There is currently a negative sentiment around MRNA’s stock, driven by a series of recent developments. In May, the U.S. government terminated contracts worth $766 million awarded to the company for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine. This funding loss comes at a time when Moderna is working to scale back operating expenses and streamline its R&D pipeline.
The recently issued FDA guidelines for COVID-19 vaccine boosters restrict booster eligibility for healthy individuals under 65 years — a move that can reduce demand.
MRNA’s Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold).
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Agenus AGEN and Amarin Corporation AMRN, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $3.46 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $3.91 to $1.99. AGEN stock has soared 67% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
In the past 60 days, loss per share estimates for Amarin’s 2025 have improved from $4.60 to $2.30. Loss per share estimates for 2026 have narrowed from $3.84 to $1.50 during the same period. AMRN stock has surged 67% year to date.
Amarin’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed in the other, delivering an average surprise of 29.11%.
Only $1 to See All Zacks' Buys and Sells
We're not kidding.
Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.
Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.
See Stocks Now >>GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
Moderna, Inc. (MRNA) : Free Stock Analysis Report
Agenus Inc. (AGEN) : Free Stock Analysis Report
Amarin Corporation PLC (AMRN) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
