Moderna stock jumped about 6% after the FDA reversed a refusal-to-file and agreed to review the company’s seasonal flu vaccine application, setting an Aug. 5 target decision date. The agency accepted an amended filing that seeks full approval for adults 50 to 64 and accelerated approval for those 65 and older, with a planned post-approval study to gather extra data on seniors. The move follows a Type A meeting between Moderna and FDA officials, and comes as the company posted narrower-than-expected Q4 losses while advancing other programs including an experimental skin cancer vaccine.

Market reaction and recent results

Moderna shares jumped after the FDA said it would take the company’s flu shot application up for review. The stock moved higher on the news, trading up a reported $2.57 to $46.50 in one report, a roughly 5.9% increase on the day. Other market note trackers showed a gain above 6% in early trading.

Investors have already pushed Moderna higher this year. The company’s shares are up more than 55% since the start of 2026. The rise reflects several catalysts. One was a quarter that beat some expectations. Moderna reported an adjusted fourth-quarter loss of $2.11 per share and revenue of $678 million, figures that compared favorably to analyst estimates of a wider loss and lower sales. Another catalyst was clinical progress in the pipeline, including positive data on an experimental skin cancer vaccine that sent the stock up about 15% on Jan. 21.

What the FDA change means for the flu shot bid

The FDA’s reversal turns a previous refusal-to-file into a full review. Moderna had received a refusal-to-file letter after regulators questioned aspects of its pivotal trial. The trial enrolled about 40,000 people and showed the mRNA-based candidate, mRNA-100, outperformed one standard flu vaccine in adults 50 and older. The agency’s initial objections included trial design issues for the 65-and-older population, where regulators said another comparator vaccine recommended for that age group wasn’t included.

In response, Moderna and the FDA held a Type A meeting. Moderna adjusted its regulatory approach. The company proposed seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older. The amended application includes a post-approval study to gather extra data on older adults. This FDA accepted that approach and agreed to review the submission, setting a target action date of Aug. 5.

Regulatory friction and CEO comments

Moderna’s chief executive, Stéphane Bancel, framed the outcome as a constructive step. "We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," Bancel said in the company statement.

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He added that, pending approval, Moderna looks forward to making the flu vaccine available later this year so seniors have a new option to protect themselves against flu.

On the company’s most recent earnings call, Bancel flagged a wider point about the regulatory environment. He said the current uncertainty in the U.S. Regulatory regime "creates real challenges for businesses, patients and the broader innovation ecosystem." That line came as company executives discussed the implications of the FDA's earlier refusal-to-file and the pathway the company proposed to address the agency’s concerns.

Pipeline progress beyond flu

The flu vaccine bid is one part of a broader pipeline push that has helped lift Moderna’s shares. The company reported positive clinical results for an experimental skin cancer vaccine developed with Merck. Those results were cited as a reason the stock spiked in late January. Moderna has also been expanding strategic deals, including a five-year agreement with the Mexican government to supply respiratory vaccines.

Those developments matter because they diversify Moderna’s revenue and reduce reliance on any single product. The company’s financials for the quarter showed revenue of $678 million, helping narrow the adjusted net loss per share versus street expectations. Investors have rewarded that mix of improving top-line and pipeline momentum with a strong start to 2026.

Moderna’s amended filing targets approval by age group rather than a single, broad approval. That was a practical answer to the FDA’s trial-design concerns. For 50- to 64-year-olds, the company asked for full licensure. For adults 65 and older, Moderna sought accelerated approval tied to a commitment to study the vaccine further after approval. Regulators accepted the age-based pathway, which preserves the trial data showing better performance in the 50-plus cohort while allowing regulators to gather extra evidence for older adults through post-marketing study requirements.

The vaccine, mRNA-100, uses the same messenger RNA platform Moderna used for its COVID-19 vaccine. Moderna and regulators will now proceed through the FDA’s standard review and potential licensure stages. The company said it aims to have the vaccine available to U.S. Adults 50 and older for the 2026-27 flu season if the FDA approves.

If the FDA licenses the vaccine, adults 50 and older would gain a new mRNA-based option for seasonal flu. For Moderna, approval would mean the first seasonal flu product added to its commercial portfolio. That would broaden the company’s marketed vaccines beyond respiratory syncytial virus and COVID-related products it has pursued in recent years.

For investors, the FDA’s reversal reduces a regulatory overhang that had weighed on the stock after the refusal-to-file. The company’s near-term valuation will still hinge on whether the FDA grants approval and on sales uptake if approved. For public-health officials and older adults, a new vaccine option would create another choice for seasonal immunization programs, subject to the agency’s final efficacy and safety findings.

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The FDA set Aug. 5 as its target date for an approval decision on Moderna’s amended flu vaccine application.

This article was created with AI assistance.