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GSK to Advance mRNA Influenza Vaccine Into Phase III Development
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Key Takeaways
GSK will begin a Phase III efficacy study of its mRNA flu vaccine later in September 2026.
The vaccine produced higher immune responses than standard and high-dose flu vaccines in phase II.
GSK's vaccine candidate targets both HA and NA, unlike most existing flu vaccines that target mainly HA.
GSK plc (GSK - Free Report) announced that it plans to advance the mRNA-based seasonal influenza (flu) vaccine candidate into late-stage development.
This advancement is supported by positive results from a phase II study, which showed that the company’s investigational flu vaccine generated higher immune responses compared with standard-dose and high-dose flu vaccines in younger and older adults, respectively. The vaccine was also generally well tolerated.
Based on these results, the company plans to start a phase III efficacy study on the mRNA-based flu vaccine, which is expected to begin later in September 2026.
Unlike most existing flu vaccines that primarily target haemagglutinin (“HA”), GSK’s vaccine candidate is designed to target both HA and neuraminidase (“NA”), potentially improving protection against illness and transmission.
The planned phase III study will be the first study of an mRNA flu vaccine designed to target both HA and NA, per GSK.
The FDA granted a Fast Track designation to the vaccine candidate for the targeted age indication, reflecting the need for improved flu protection.
GSK’s Price Performance
Year to date, GSK stock has increased 6.1% compared with the industry’s 9.7% rise.
Image Source: Zacks Investment Research
GSK’s Competition in the Broader Vaccine Market
The advancement of the flu vaccine candidate into phase III marks a significant step for GSK’s mRNA vaccine program. Positive phase III data could support further development of the next-generation flu vaccine and potentially broaden GSK’s seasonal influenza vaccine portfolio.
Despite GSK deciding to advance its mRNA-based seasonal flu vaccine candidate into phase III development, shares of rival vaccine maker Moderna (MRNA - Free Report) jumped nearly 10% yesterday following the announcement of the news.
MRNA probably climbed as investors might have read GSK's phase III mRNA flu commitment as platform validation rather than a competitive threat to mFlusvia.
Last month, the FDA approved Moderna’s mRNA-based seasonal influenza vaccine, mFlusiva (mRNA-1010), for adults aged 50 years and older. The approval covers the prevention of influenza disease caused by influenza A and B viruses.
mFlusiva is expected to be available for the 2026/2027 U.S. respiratory season.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 3.8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 119.7% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950%.
View the Zacks #1 Rank List
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GSK to Advance mRNA Influenza Vaccine Into Phase III Development
Key Takeaways
GSK plc (GSK - Free Report) announced that it plans to advance the mRNA-based seasonal influenza (flu) vaccine candidate into late-stage development.
This advancement is supported by positive results from a phase II study, which showed that the company’s investigational flu vaccine generated higher immune responses compared with standard-dose and high-dose flu vaccines in younger and older adults, respectively. The vaccine was also generally well tolerated.
Based on these results, the company plans to start a phase III efficacy study on the mRNA-based flu vaccine, which is expected to begin later in September 2026.
Unlike most existing flu vaccines that primarily target haemagglutinin (“HA”), GSK’s vaccine candidate is designed to target both HA and neuraminidase (“NA”), potentially improving protection against illness and transmission.
The planned phase III study will be the first study of an mRNA flu vaccine designed to target both HA and NA, per GSK.
The FDA granted a Fast Track designation to the vaccine candidate for the targeted age indication, reflecting the need for improved flu protection.
GSK’s Price Performance
Year to date, GSK stock has increased 6.1% compared with the industry’s 9.7% rise.
Image Source: Zacks Investment Research
GSK’s Competition in the Broader Vaccine Market
The advancement of the flu vaccine candidate into phase III marks a significant step for GSK’s mRNA vaccine program. Positive phase III data could support further development of the next-generation flu vaccine and potentially broaden GSK’s seasonal influenza vaccine portfolio.
Despite GSK deciding to advance its mRNA-based seasonal flu vaccine candidate into phase III development, shares of rival vaccine maker Moderna (MRNA - Free Report) jumped nearly 10% yesterday following the announcement of the news.
MRNA probably climbed as investors might have read GSK's phase III mRNA flu commitment as platform validation rather than a competitive threat to mFlusvia.
Last month, the FDA approved Moderna’s mRNA-based seasonal influenza vaccine, mFlusiva (mRNA-1010), for adults aged 50 years and older. The approval covers the prevention of influenza disease caused by influenza A and B viruses.
mFlusiva is expected to be available for the 2026/2027 U.S. respiratory season.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , both 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 Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 3.8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 119.7% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950%.