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MRNA Stock Jumps as FDA Briefing Docs Ease Flu Shot Approval Concerns
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Key Takeaways
MRNA rose over 6% after FDA briefing documents eased concerns about mFlusiva's approval prospects.
FDA staff cited supporting data and no major filing deficiencies ahead of the June 18 review.
VRBPAC will assess whether immunogenicity data support accelerated approval in older adults.
Shares of Moderna (MRNA - Free Report) rose more than 6% on Tuesday after the FDA issued briefing documents ahead of a key advisory committee meeting, easing investor concerns about the approval prospects of the company's influenza vaccine candidate, mFlusiva (mRNA-1010).
The FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) is scheduled to meet on June 18, 2026, to assess the benefit-risk profile of the company’s influenza vaccine.
The briefing documents were broadly constructive and significantly less negative than many investors had anticipated. The FDA staff did not identify any major deficiencies in Moderna's filing and acknowledged data supporting the vaccine.
However, one of the key questions raised by the agency relates to Moderna's proposed accelerated approval pathway for adults aged 65 years and older. The company is seeking approval in this population based on immunogenicity data rather than direct clinical efficacy evidence. The proposed pathway includes a required postmarketing confirmatory study to support full approval. However, the briefing documents specifically ask VRBPAC members to assess whether the available immunogenicity data provide a sufficient basis to predict clinical benefit in older adults.
MRNA Stock Performance
Year to date, the stock has surged 88% against the industry’s nearly 2% fall.
Image Source: Zacks Investment Research
Why Is the VRBPAC Meeting Important for Moderna?
Investors will now turn their attention to tomorrow’s VRBPAC meeting, which could provide additional insight into the FDA's comfort level with Moderna's proposed approval strategy ahead of the Aug. 5, 2026, target action date. While the agency is not obligated to follow the advisory committee's recommendations, it often aligns with its guidance, making the meeting’s outcome an important event for investors.
The outcome carries implications beyond mFlusiva itself. Moderna's long-term growth increasingly depends on expanding its respiratory portfolio beyond COVID-19 vaccines, with mFlusiva expected to serve as a foundational product within that strategy.
A favorable outcome could also provide greater regulatory clarity for mCombriax (mRNA-1083), Moderna's combination vaccine targeting both influenza and COVID-19. 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, investors will likely view any regulatory progress for the flu vaccine as an encouraging sign for the combination candidate as well. Moderna is currently awaiting further FDA guidance regarding a potential future filing for mCombriax. This combination vaccine recently secured approval in the EU.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 19% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
View the Zacks #1 Rank List
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MRNA Stock Jumps as FDA Briefing Docs Ease Flu Shot Approval Concerns
Key Takeaways
Shares of Moderna (MRNA - Free Report) rose more than 6% on Tuesday after the FDA issued briefing documents ahead of a key advisory committee meeting, easing investor concerns about the approval prospects of the company's influenza vaccine candidate, mFlusiva (mRNA-1010).
The FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) is scheduled to meet on June 18, 2026, to assess the benefit-risk profile of the company’s influenza vaccine.
The favorable market reaction was notable because investors had braced for a more difficult regulatory review after the FDA initially declined to review Moderna's filing for the vaccine 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 mFlusiva based on age. The regulatory filing was subsequently modified to seek traditional approval for the vaccine in adults aged 50-64 years and accelerated approval for adults aged 65 years and older.
The briefing documents were broadly constructive and significantly less negative than many investors had anticipated. The FDA staff did not identify any major deficiencies in Moderna's filing and acknowledged data supporting the vaccine.
However, one of the key questions raised by the agency relates to Moderna's proposed accelerated approval pathway for adults aged 65 years and older. The company is seeking approval in this population based on immunogenicity data rather than direct clinical efficacy evidence. The proposed pathway includes a required postmarketing confirmatory study to support full approval. However, the briefing documents specifically ask VRBPAC members to assess whether the available immunogenicity data provide a sufficient basis to predict clinical benefit in older adults.
MRNA Stock Performance
Year to date, the stock has surged 88% against the industry’s nearly 2% fall.
Image Source: Zacks Investment Research
Why Is the VRBPAC Meeting Important for Moderna?
Investors will now turn their attention to tomorrow’s VRBPAC meeting, which could provide additional insight into the FDA's comfort level with Moderna's proposed approval strategy ahead of the Aug. 5, 2026, target action date. While the agency is not obligated to follow the advisory committee's recommendations, it often aligns with its guidance, making the meeting’s outcome an important event for investors.
The outcome carries implications beyond mFlusiva itself. Moderna's long-term growth increasingly depends on expanding its respiratory portfolio beyond COVID-19 vaccines, with mFlusiva expected to serve as a foundational product within that strategy.
A favorable outcome could also provide greater regulatory clarity for mCombriax (mRNA-1083), Moderna's combination vaccine targeting both influenza and COVID-19. 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, investors will likely view any regulatory progress for the flu vaccine as an encouraging sign for the combination candidate as well. Moderna is currently awaiting further FDA guidance regarding a potential future filing for mCombriax. This combination vaccine recently secured approval in the EU.
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 Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 19% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.