Moderna Pulls Application For Seasonal Flu, Covid Combination Vaccine: But Retail Gets More Bullish

Vaccine maker Moderna, Inc. (MRNA) said on Wednesday that it has withdrawn its application to the U.S. Food and Drug Administration (FDA) for approval of its seasonal flu-COVID combination vaccine candidate.

The decision to withdraw the application was in consultation with the FDA, the company said. Moderna will resubmit the application later this year after data from its ongoing late-stage trial of its seasonal flu vaccine is available. Interim data from the trial is expected to be available in summer 2025.

Earlier this month, Moderna said that it now expects regulatory approval for its combination vaccine only in 2026 after the FDA confirmed the need for more data demonstrating its efficacy. The company applied for approval of the vaccine in adults aged 50 years and older in 2024.

The decision to withdraw its application comes a day after FDA leaders said it would adopt a new COVID-19 vaccination regulatory framework, requiring new clinical trials to approve annual vaccine booster shots in healthy individuals under 65.

For the first quarter (Q1) of fiscal 2025, Moderna reported revenue of $108 million, down from $167 million in the corresponding period of 2024 and below an analyst estimate of $115.32 million, according to FinChat data.

The company said the revenue decline was primarily driven by lower net product sales due to lower vaccination rates as COVID-19 normalized. The firm, however, reported $84 million in Spikevax COVID-19 vaccine sales in the quarter.

On Stocktwits, retail sentiment around Moderna rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours while message volume jumped from ‘high’ to ‘extremely high’ levels.

According to data from Koyfin, 17 of 27 analysts covering MRNA stock have a ‘Hold’ rating on it, six rate it a ‘Buy’ or ‘Strong Buy,’ while four rate it a ‘Sell’ or ‘Strong Sell.’

MRNA stock is trading over 5% lower on Wednesday morning. The stock is down by about 37% this year and has fallen about 82% over the past 12 months.

Also See: Medtronic Announces Split Of Diabetes Business As Standalone Public Company: Retail’s Unmoved

For updates and corrections, email newsroom[at]stocktwits[dot]com.