The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 18 to assess the benefit-risk profile of mFlusiva.
- The open session will focus on the safety and effectiveness of the vaccine.
- A favorable committee vote would not guarantee approval but would provide important input ahead of the FDA’s target action date of August 5.
- Separately, Moderna announced organizational changes to prepare for multiple product launches expected in 2027 and 2028.
Shares of Moderna closed up 6% on Tuesday as investors await an FDA committee meeting on mFlusiva, Moderna’s investigational mRNA-based trivalent seasonal influenza vaccine.
The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 18 to assess the benefit-risk profile of mFlusiva.
The open session will focus on the safety and effectiveness of the vaccine. Moderna submitted the Biologics License Application for the vaccine on Dec. 5, and the FDA filed it on Feb. 17 after a brief refusal, which was resolved with a revised application. The vaccine is aimed at preventing influenza disease caused by the virus subtypes represented in the vaccine in adults 50 years of age and older.
Wall Street Weighs In On Moderna
Jefferies described the FDA’s tone and analyses in the documents ahead of the committee meeting as “balanced” and “not harsh.” The firm stated that meaningful flu-related revenues are unlikely before 2027 but said a U.S. approval would help expand Moderna’s topline.
Jefferies models $750 million in combined U.S. sales from the standalone flu vaccine and potential flu/covid combination products by 2030. The firm holds a ‘Hold’ rating and a $45 price target on Moderna shares.
BofA Securities, which also reviewed the VRBPAC briefing documents, said the overall tone and proposed discussion points should foster debate but appear supportive of approval. The analyst views the clinical profile of mFlusiva as largely established, suggesting the advisory committee meeting will function more as a vote on regulatory acceptability than a fresh evaluation of data strength.
BofA highlighted several evidence gaps noted in the documents, including efficacy data limited to a single flu season, limited information in immunocompromised and frailer patients, a lack of safety data on co-administration with other vaccines, and limited case accrual for the B/Victoria strain. Despite these points, BofA expects a positive VRBPAC outcome while maintaining an ‘Underperform’ rating on the stock and a $34 price target.
The June 18 meeting represents a key regulatory milestone for Moderna as it seeks to bring the first mRNA-based seasonal influenza vaccine to the U.S. market. A favorable committee vote would not guarantee approval but would provide important input ahead of the FDA’s target action date of Aug. 5. If approved, the vaccine could potentially become available for the 2026–2027 flu season.
Organizational Changes
Separately, Moderna announced organizational changes to prepare for multiple product launches expected in 2027 and 2028. President Stephen Hoge will take on an expanded role with operational oversight of the company’s Infectious Disease, Intismeran personalized cancer therapy and Rare Disease franchises, the company said.
Ester Banque has been appointed Chief Commercial Officer, effective June 15, to build Moderna’s global commercial organization and lead upcoming product launches.
CEO Stéphane Bancel said the moves will strengthen execution as the company prepares to manage three commercial franchises while advancing its mRNA pipeline. Potential launches during this period include the seasonal flu vaccine, a flu-COVID combination vaccine, and a norovirus vaccine.
How Did MRNA Retail Traders React?
On Stocktwits, retail sentiment around MRNA stock jumped from ‘neutral’ to ‘bullish’ over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels.
A Stocktwits user said that there are more catalysts for the MRNA stock going forward.
Another user highlighted increasing skepticism about vaccination in general.
MRNA stock has gained about 80% this year.
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