Moderna (MRNA) stock jumps 9% as FDA clears major hurdle for mRNA Flu Shot vaccine

TLDR

• Moderna stock jumped as much as 9.1% after FDA briefing documents showed there were no “significant deficiencies” in its mFlusiva mRNA flu vaccine.
• The FDA’s VRBPAC advisory panel is scheduled to vote on June 18 on whether mFlusiva’s benefits outweigh its risks in adults aged 50 or older.
• If approved, mFlusiva will be the first mRNA-based seasonal influenza vaccine in the United States, and a final decision from the FDA is expected by August 5.
• Moderna is seeking traditional approval for adults ages 50 to 64 and accelerated approval for adults 65 and older
• Moderna also announced a leadership restructuring, appointing Ester Banque as chief commercial officer ahead of the launch of up to three new products in 2027-2028.

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Moderna (MRNA) stock rose as much as 9.1% on Tuesday after FDA staff reviewers released briefing documents saying data for the flu vaccine mFlusiva may support effectiveness in adults 65 and older. The stock traded at $56.12, close to its 52-week high of $57.80.

Moderna, Inc., mRNA

The documents were released ahead of Thursday’s meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which will vote on whether mFlusiva’s benefits outweigh its risks in adults aged 50 or over.

Importantly, FDA staff found no “significant deficiencies” in the application. This was the green light investors had been waiting for.

The road here was bumpy. In February, the FDA issued a “deny submission” letter, citing concerns about the trial design, specifically that the control arm for adults 65 and older used the standard-dose flu vaccine instead of the higher dose the CDC prefers for this age group. The FDA reversed course days later accident He agreed to amend his application.

That shook the market back and forth. The briefing documents released Tuesday marked a clear change in tone.

Jefferies analyst Andrew Tsai described the assessment as positive, predicting $750 million in combined flu and COVID vaccine sales in the United States by 2030.

What the FDA staff actually said

FDA reviewers noted that mFlusiva demonstrated superior relative vaccine efficacy versus standard-dose influenza vaccine in adults ages 50 to 64 years. For the 65 and older group, the app is based on immunogenicity data rather than direct efficacy data versus a high-dose comparison.

Staff reported some limitations. The vaccine was studied during only one flu season, and immunocompromised people and very frail older people were excluded from the trials, leaving questions about effectiveness in those groups.

accident It agreed to conduct an additional study and provide more data for the over-65 age group if it received accelerated approval for this group.

The company is seeking traditional approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older. A final decision from the Food and Drug Administration is expected by August 5.

If approved, mFlusiva will be the first mRNA-based seasonal influenza vaccine in the United States.

Moderna is making adjustments to its leadership before advancing the pipeline

On the same day, Moderna announced an internal reorganization. The company has appointed Ester Banque as chief commercial officer, a move aimed at preparing the business for up to three product launches – including a combination flu/Covid vaccine and a norovirus vaccine – targeted for 2027 and 2028.

The combination of a cleaner regulatory picture and a concrete business roadmap gave investors enough reason to push the stock higher.

Moderna shares are up 81.8% year to date. Despite this run, investors who invested $1,000 in MRNA five years ago would be sitting on just $283.65 today.

The VRBPAC vote is scheduled for June 18.