Moderna Stock Gains on Encouraging Flu Vaccine Data

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 PerformancePost 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 ResearchModerna Stock Under PressureThere 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 RankModerna currently carries a Zacks Rank #3 (Hold).Moderna, Inc. Price  Moderna, Inc. price | Moderna, Inc. QuoteKey Picks Among Biotech StocksSome 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 SellsWe'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 >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report 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 ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks