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Modanya said on Wednesday it had withdrawn its application to await efficacy data from late-stage trials of flu shots, seeking approval for a combined vaccine candidate for the flu and Covid-19.
The delay was largely anticipated after Moderna said earlier this month that he didn't expect approval for the shot until 2026, as more data on the flu vaccine is needed.
Stocks, which fell more than 30% this year, were slightly higher at $24.20 in pre-market trading.
However, the withdrawal of applications is the latest indication of increased regulatory scrutiny in the vaccine approval process since Robert F. Kennedy Jr. took up a US health job earlier this year.
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Modanya's decision comes the day after the US Food and Drug Administration said it would require a new clinical trial to approve the annual COVID-19 booster for healthy people under the age of 65.
The combination shot includes the new covid and influenza vaccines that Moderna is currently developing.
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The company previously said it did not expect the FDA's decision to be delayed on the next-generation covid vaccine.
The company's shares were spurred by the appointment of vaccine skeptic Kennedy as secretary to the U.S. Department of Health and Human Services, while being hit by Covid's decline in revenue and investor concerns.
Moderna is banking the bank to revenue from new mRNA shots to make up for lower sales of the Covid vaccine and more than expected to ingest respiratory syncytial virus vaccines.
The FDA approved the Covid-19 vaccine from rival Novavax more than a month after missing the deadline for approval for the shot last week, restricting its use to people at risk due to the illness.
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