Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Rhea-AI Summary

Moderna (NASDAQ:MRNA) said the FDA's CBER issued a Refusal-to-File (RTF) for its BLA for investigational influenza vaccine mRNA-1010, citing the choice of a licensed standard-dose comparator as the sole reason and not identifying safety or efficacy concerns.

Moderna requested a Type A meeting to clarify the path forward and notes mRNA-1010 is under review in the EU, Canada and Australia; the company does not expect an impact to its 2026 financial guidance.

Positive

• mRNA-1010 met pre-specified Phase 3 primary endpoints
• Submissions accepted for review in EU, Canada, Australia
• Company expects no impact to 2026 financial guidance

Negative

• FDA issued a Refusal-to-File over comparator choice
• U.S. BLA review delayed pending Type A meeting outcome

News Market Reaction – MRNA

-3.54%

87 alerts

-3.54% News Effect

+4.4% Peak Tracked

-15.9% Trough Tracked

-$652M Valuation Impact

$17.78B Market Cap

0.7x Rel. Volume

On the day this news was published, MRNA declined 3.54%, reflecting a moderate negative market reaction. Argus tracked a peak move of +4.4% during that session. Argus tracked a trough of -15.9% from its starting point during tracking. Our momentum scanner triggered 87 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $652M from the company's valuation, bringing the market cap to $17.78B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Regulation cited: 21 C.F.R. § 314.126 Older adult cutoff: 65 years

2 metrics

Regulation cited 21 C.F.R. § 314.126 Standard for adequate and well-controlled studies referenced in FDA letter

Older adult cutoff 65 years Age threshold for using preferentially recommended influenza vaccines in Phase 3 study

Market Reality Check

Price: $53.57 Vol: Volume 9623844 vs 20-day ...

low vol

$53.57 Last Close

Volume Volume 9623844 vs 20-day average 14278639 (relative 0.67x) indicates subdued trading ahead of this FDA update. low

Technical Price 41.995 is trading above the 200-day MA at 29.15, showing a pre-news recovery from prior lows despite being below the 52-week high of 55.2.

Peers on Argus

MRNA was modestly positive at +0.11% while key biotech peers such as ROIV, HALO,...

MRNA was modestly positive at +0.11% while key biotech peers such as ROIV, HALO, and MDGL showed small declines. No peers appeared in the momentum scanner and only HALO had routine earnings-date news, pointing to a stock-specific regulatory event rather than a sector-wide move.

Historical Context

5 past events · Latest: Jan 30 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 30	Executive appointment	Positive	-6.0%	Named new Chief Development Officer joining executive committee in March 2026.
Jan 29	Strategic collaboration	Positive	-6.0%	Global commercialization deal for mRNA-3927 with upfront and milestone payments.
Jan 26	Earnings date notice	Neutral	-1.5%	Announced date and webcast details for Q4 2025 financial results.
Jan 20	Clinical data update	Positive	+2.8%	Five-year Phase 2b melanoma data showing reduced risk of recurrence or death.
Jan 12	Business update	Positive	-1.3%	J.P. Morgan showcase of 2025 revenue, expense outlook, cash and 2026 catalysts.

Pattern Detected

Recent history shows frequent negative or muted price reactions, even to seemingly positive strategic, partnership, and clinical updates, with only one clear aligned positive move.

Recent Company History

Over the past month, Moderna reported multiple corporate and pipeline developments. A new Chief Development Officer appointment on Jan 30 and a strategic collaboration on Jan 29 both saw shares fall about 5.95%, despite constructive business implications. Positive melanoma Phase 2b data on Jan 20 produced a smaller 2.8% gain. Guidance and pipeline updates at the J.P. Morgan conference on Jan 12 and an earnings-date announcement also met with mild declines. Today’s FDA RTF letter fits into a backdrop of fragile sentiment.

Market Pulse Summary

This announcement details an FDA Refusal-to-File letter for the mRNA-1010 BLA, focused on the choice...

Analysis

This announcement details an FDA Refusal-to-File letter for the mRNA-1010 BLA, focused on the choice of influenza vaccine comparator rather than identified safety or efficacy concerns. Historically, Moderna’s stock often reacted weakly even to positive business and clinical updates. Investors may watch upcoming interactions with CBER, including the requested Type A meeting, as well as parallel reviews in the EU, Canada and Australia, and any updates to regulatory or development timelines for mRNA-1010.

Key Terms

refusal-to-file, biologics license application, priority review voucher, center for biologics evaluation and research, +4 more

8 terms

refusal-to-file regulatory

"has issued a Refusal-to-File (RTF) letter."

A refusal-to-file is a formal notice from a securities regulator saying a company’s required filing — such as a registration statement for a securities sale or a periodic financial report — cannot be accepted because it has problems or missing information. Think of it like a bank refusing to accept an application until the paperwork is fixed; it matters to investors because it delays or blocks transactions, raises questions about disclosure or compliance, and can signal increased regulatory or business risk.

biologics license application regulatory

"will not initiate a review of the biologics license application (BLA) for its investigational"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

priority review voucher regulatory

"Moderna had exercised a Priority Review Voucher to facilitate a timely review"

A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.

center for biologics evaluation and research regulatory

"the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER)"

The Center for Biologics Evaluation and Research (CBER) is the U.S. regulatory unit that reviews and approves biological medicines and vaccines, similar to a safety and quality inspector for complex medical products made from living cells. Investors watch CBER because its decisions on approvals, safety alerts, or production standards can quickly affect a company’s ability to sell products, generate revenue, or face costly delays and recalls.

type A meeting regulatory

"Moderna has requested a Type A meeting with CBER to understand the basis"

A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.

adequate and well-controlled regulatory

"the lack of an "adequate and well-controlled" study with a comparator arm"

A regulatory standard describing a clinical study that provides convincing evidence a treatment works because it was designed and run properly: it enrolled enough people, used a fair comparison (such as a placebo or existing therapy), measured the right outcomes, and followed scientific procedures to avoid bias. For investors, this matters because regulators rely on such studies when deciding approvals and labeling, which directly affect a drug’s commercial prospects.

informed consent form regulatory

"we agree with your plan to include statements in the Informed Consent Form."

A document given to people before they join a medical study that explains the study’s purpose, what will happen, possible risks and benefits, and their rights, and asks them to agree in writing. For investors, the form is a key sign that a trial is being run ethically and legally—like a permission slip that protects participants and helps prevent delays, regulatory problems, or lawsuits that could affect a drug or device’s development timeline and value.

acip medical

"recommended for use in older adults by the ACIP (i.e., Fluzone HD, Fluad or Flublok)"

A federal advisory panel that reviews data on vaccines and makes recommendations used by public health agencies to guide immunization policy. Its guidance can act like a traffic signal for vaccine demand—when it endorses a shot or schedule, uptake, insurance coverage and public confidence often rise, which can meaningfully affect sales forecasts, regulatory expectations and stock valuations for companies in vaccines, diagnostics and related healthcare sectors.

AI-generated analysis. Not financial advice.

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forward

mRNA-1010 has been submitted and accepted for review in the EU, Canada and Australia

Company does not expect any impact on its 2026 financial guidance

CAMBRIDGE, MA / ACCESS Newswire / February 10, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has notified the Company that it will not initiate a review of the biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File (RTF) letter. Moderna had exercised a Priority Review Voucher to facilitate a timely review of the application.

CBER's RTF letter, signed by Center Director Vinayak Prasad, MD, MPH, identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna's application. Specifically, the letter cited the lack of an "adequate and well-controlled" study with a comparator arm that "does not reflect the best-available standard of care." Neither the relevant regulation, 21 C.F.R. § 314.126 (Adequate and well-controlled studies), nor the FDA's guidance for industry on seasonal influenza vaccines contain any reference to the use of a comparator reflecting the "best-available standard of care." The letter did not identify any specific safety or efficacy concerns regarding mRNA-1010.

The letter is inconsistent with previous written communications from CBER to Moderna. In April 2024, Moderna submitted the Phase 3 study protocol to CBER for review during a pre-Phase 3 consultation. CBER provided written guidance noting that "while we agree it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study, we recommend you use a vaccine preferentially recommended for use in older adults by the ACIP (i.e., Fluzone HD, Fluad or Flublok) for participants >65 years of age in the study. Data on comparative efficacy of your vaccine against an influenza vaccine preferentially recommended for use in the >65 years age group may help inform ACIP's recommendation for the use of your vaccine in the older adult population. If you proceed with using a standard dose influenza vaccine comparator in participants ≥65 years of age, we agree with your plan to include statements in the Informed Consent Form." CBER did not raise any objections or clinical hold comments about the adequacy of the Phase 3 trial after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024.

In August of 2025, following the successful completion of the Phase 3 efficacy trial in which mRNA-1010 met all agreed upon pre-specified primary endpoints, Moderna held a pre-submission meeting with CBER. In its written feedback, CBER requested that supportive analyses on the comparator be included in the submission and indicated that the data would be a "significant issue during review of your BLA." Moderna provided the additional analyses requested by CBER in its submission, including data from a separate Phase 3 trial (P303 Part C) comparing mRNA-1010 against a licensed high-dose influenza vaccine. At no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.

"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines," said Stéphane Bancel, Chief Executive Officer of Moderna. "It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting. We look forward to engaging with CBER to understand the path forward as quickly as possible so that America's seniors, and those with underlying conditions, continue to have access to American-made innovations."

Moderna has requested a Type A meeting with CBER to understand the basis for the RTF letter. In the interest of transparency, the Company has posted the full letter on its website, linked here.

mRNA-1010 has been accepted for review in the EU, Canada and Australia. Submissions in additional countries are planned for 2026. Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to those ongoing regulatory reviews.

The Company does not expect an impact to its 2026 financial guidance based on the RTF from CBER.

About Moderna's mRNA-1010 Submission

Moderna's mRNA-1010 BLA submission includes two positive Phase 3 studies that enrolled a total of 43,808 participants and met all pre-specified primary endpoints. Both Phase 3 designs were reviewed by FDA prior to study initiation. P303 Part C was a safety and immunogenicity study that compared mRNA-1010 against a high-dose comparator in adults aged 65 years or older. P304 was a safety and relative efficacy study that compared mRNA-1010 against a licensed standard-dose comparator in adults aged 50 years and older. In both Phase 3 studies, the primary endpoints showed statistical superiority of mRNA-1010 compared with the respective comparators. P303 has been published in a peer-reviewed publication and P304 has been submitted for publication.

The trial design for the P304 efficacy study, showing superiority over a licensed standard-dose influenza vaccine, is similar to that used to approve two licensed influenza vaccines that are preferentially recommended for adults aged 65 years or older in the U.S. Those approved products demonstrated a similar degree of statistically superior relative efficacy over a standard-dose influenza vaccine comparator as was achieved by mRNA-1010 in P304.^[1][2] One of these products used the same licensed standard-dose comparator (Fluarix®), which is licensed in the U.S. for all adults, including for adults aged 65 years or older. Approximately 2 million U.S. adults aged 65 years or older received a standard-dose influenza vaccine in the most recent influenza season.^[3][4]

Many countries outside the U.S. do not preferentially recommend high-dose influenza vaccines over standard-dose influenza vaccines for adults aged 65 or older.^[5]

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.

Fluarix® is a registered trademark of the GlaxoSmithKline group of companies.

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 status of Moderna's pending regulatory submissions for mRNA-1010 in the EU, Canada and Australia; Moderna's submissions in additional countries planned for 2026; timing for the earliest potential approvals for mRNA-1010, subject to regulatory reviews; Moderna's requested Type A meeting with CBER; and Moderna's expectation of no impact on its 2026 financial guidance. 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
Head of Global Media Relations
+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

^[1] Sanofi Pasteur. Package Insert - Fluzone High-Dose Quadrivalent. U.S. Food and Drug Administration, revised Jan. 2019, www.fda.gov/media/132238/download

^[2] Fluzone High-Dose Quadrivalent Package Insert. U.S. Food and Drug Administration, Jan. 2019, www.fda.gov/media/132238/download

^[3] Moderna analysis of commercially available pharmacy and medical claims data.

^[4] Centers for Disease Control and Prevention. Influenza Vaccinations Administered in Pharmacies and Physician Medical Offices, Adults, United States. FluVaxView, 3 Dec. 2025, www.cdc.gov/fluvaxview/dashboard/adult-vaccinations-administered.html

^[5] Ku JH, et al. Comparative Effectiveness of Licensed Influenza Vaccines in Preventing Influenza-related Medical Encounters and Hospitalizations in the 2022-2023 Influenza Season Among Adults ≥65 Years of Age. Clin Infect Dis. 2024 Nov 22;79(5):1283-1292. doi: 10.1093/cid/ciae375.

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

Why did the FDA issue a Refusal-to-File for Moderna's mRNA-1010 (MRNA) on February 10, 2026?

The FDA cited Moderna's choice of a licensed standard-dose influenza comparator as the sole reason for the RTF. According to Moderna, CBER did not identify any safety or efficacy concerns and asked for a comparator reflecting the "best-available standard of care."

Does the Refusal-to-File affect Moderna's 2026 financial guidance for MRNA?

Moderna says the RTF does not affect its 2026 financial guidance. According to Moderna, the company continues to expect no impact to guidance while it seeks clarification from CBER via a Type A meeting.

Has mRNA-1010 completed Phase 3 and met its endpoints, and what does Moderna report?

Moderna reports mRNA-1010 met all agreed pre-specified Phase 3 primary endpoints. According to Moderna, supportive analyses including a separate trial versus a high-dose vaccine were included in the BLA submission.

What regulatory reviews are ongoing for mRNA-1010 outside the U.S. for Moderna (MRNA)?

mRNA-1010 has been accepted for review in the EU, Canada and Australia. According to Moderna, additional country submissions are planned for 2026 with potential approvals earliest in late 2026 or early 2027.

What immediate steps will Moderna take after the FDA Refusal-to-File for mRNA-1010 (MRNA)?

Moderna has requested a Type A meeting with CBER to understand the RTF basis and next steps. According to Moderna, the company posted the full RTF letter and seeks rapid engagement to clarify the path forward.