Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission
Rhea-AI Summary
Moderna (NASDAQ:MRNA) announced the FDA has accepted its biologics license application for seasonal influenza vaccine candidate mRNA-1010 and set a PDUFA goal date of August 5, 2026.
The company proposed a regulatory pathway seeking full approval for adults 50–64 and accelerated approval for adults 65+, with a post‑marketing study in older adults. Moderna says mRNA-1010 is also accepted for review in Europe, Canada, and Australia, and expects potential first approvals in 2026 pending regulatory reviews.
Positive
- BLA accepted for FDA review
- PDUFA goal date Aug 5, 2026
- Age-based regulatory pathway proposed (full approval 50–64; accelerated 65+)
- Regulatory submissions accepted in EU, Canada, Australia
Negative
- Prior Refusal-to-File required additional FDA engagement
- Post-marketing study required in older adults
- Approval remains pending subject to ongoing regulatory reviews
News Market Reaction – MRNA
On the day this news was published, MRNA gained 6.08%, reflecting a notable positive market reaction. Argus tracked a peak move of +10.3% during that session. Our momentum scanner triggered 60 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $1.13B to the company's valuation, bringing the market cap to $19.71B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
MRNA gained 4.03% while momentum scanners showed modest upside in peers like ROIV and ABVX, both moving up but without same-day news, suggesting today’s move is more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 17 | COVID vaccine approval | Positive | +4.0% | EU marketing authorization for mNEXSPIKE with favorable Phase 3 efficacy data. |
| Feb 13 | Earnings and guidance | Positive | +5.3% | Q4 and 2025 results with cost cuts, strong cash, and 2026 growth targets. |
| Feb 10 | Flu BLA RTF | Negative | +0.1% | FDA Refusal-to-File for mRNA-1010 BLA over comparator choice only. |
| Feb 10 | Mexico agreement | Positive | +0.1% | Five-year strategic deal with Mexico for vaccine access and tech transfer. |
| Jan 30 | Leadership change | Positive | -6.0% | Appointment of new Chief Development Officer overseeing late-stage pipeline. |
Recent news has often driven positive price reactions for MRNA, especially around regulatory wins and strategic updates, though there are notable divergences where leadership or regulatory setbacks did not align with price moves. Overall, the stock has shown a tendency to react positively to major pipeline and earnings disclosures, while some operational or management changes have coincided with selling pressure, indicating selective market enthusiasm depending on the nature of the catalyst.
Over the past weeks, Moderna has reported several key developments. On Feb 17, the EU granted marketing authorization for its COVID-19 vaccine mNEXSPIKE, with the stock rising afterward. On Feb 13, earnings showed 2025 revenue of $1.9B and a narrowed GAAP net loss of $2.8B, alongside cost cuts and pipeline progress. Earlier, the FDA issued an RTF for mRNA-1010, while EU, Canada, and Australia reviews continued. A Mexico strategic agreement and a new Chief Development Officer highlighted geographic expansion and leadership evolution, though the CDO news saw a negative reaction.
Market Pulse Summary
The stock moved +6.1% in the session following this news. A strong positive reaction aligns with Moderna’s pattern of favorable responses to major regulatory milestones, as seen after recent EU authorization and earnings updates. The FDA’s acceptance of the mRNA-1010 BLA with a August 5, 2026 PDUFA date firmed up U.S. flu timelines. Investors should weigh this against past regulatory uncertainty, including the prior Refusal-to-File, and monitor upcoming reviews and post-marketing study obligations for older adults.
Key Terms
type a meeting regulatory
center for biologics evaluation and research regulatory
biologics license application regulatory
prescription drug user fee act regulatory
pdufa regulatory
accelerated approval regulatory
post-marketing requirement regulatory
AI-generated analysis. Not financial advice.
Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review
Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026
CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.
"We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," said Stéphane Bancel, Chief Executive Officer of Moderna. "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."
mRNA-1010 has now been accepted for review in the United States, Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews.
About Moderna
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the FDA's review of mRNA-1010 and the potential for FDA approval; mRNA-1010's PDUFA goal date; the availability of mRNA-1010 for adults 50 years of age and older for the 2026/2027 flu season, pending FDA approval; Moderna's pending regulatory submissions for mRNA-1010 in Europe, Canada and Australia; Moderna's submissions in additional countries planned for 2026; and timing for the earliest potential approvals for mRNA-1010, subject to regulatory reviews. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire