Moderna Inc (NASDAQ:MRNA) is up 3.6% at $58.30 ahead of the open, after the U.S. Food and Drug Administration (FDA) approved the company's mRNA-based seasonal flu vaccine , mFluvis, for adults ages 50 and older.
"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform,” Moderna CEO Stéphane Bancel said.
The decision caps a seven-month review that included a rare refusal to consider the shot at all.
The U.S. Food and Drug Administration has approved Moderna's flu vaccine for people aged 50 and older, the company said on Wednesday, marking the first approval of a messenger RNA-based vaccine for seasonal flu.
Moderna's vaccine candidate targets a species of ebolavirus behind a deadly outbreak in the Democratic Republic of the Congo.
Moderna's Q2 revenue tops estimates, but shares fall after its phase III norovirus vaccine study misses early success criteria.
Moderna, Inc. (MRNA) Q2 2026 Earnings Call Transcript
Moderna is navigating a post-COVID transition, shifting focus to a diversified vaccine and therapeutics pipeline amid weak current demand. MRNA guides for up to 10% revenue growth in 2026 but remains deeply loss-making with heavy reliance on future pipeline catalysts and product launches. The recent Phase 3 norovirus vaccine setback highlights execution risk, reinforcing that valuation and sentiment hinge on pipeline progress, not near-term earnings.
Moderna NASDAQ: MRNA reported second-quarter revenue of $145 million, exceeding the high end of its prior guidance range, while continuing to reduce costs and advance programs spanning respiratory vaccines, oncology and rare diseases.
Moderna (MRNA) came out with a quarterly loss of $1.97 per share in line with the Zacks Consensus Estimate. This compares to a loss of $2.13 per share a year ago.
The drugmaker's top line continues to be heavily influenced by Covid vaccine sales.
MRNA is likely to face a key Q2 test as investors await results, FDA updates on mRNA-1010 and commercialization plans that could shape its post-COVID growth.