Moderna

Company MRNA

Last mentioned: Mar 21, 2026

Timeline

  1. Anticipated PDUFA

    Expected deadline for the FDA's final approval decision.

  2. Court Ruling

    Judge Brian Murphy issues a stay, halting the implementation of the vaccine overhaul.

  3. Settlement Reached

    Moderna agrees to pay up to $2.25 billion to resolve all outstanding claims.

  4. Legal Challenge

    The AAP and ACP file suit in Massachusetts federal court to block the changes.

  5. Thursday Pre-Market

    Key reports from Moderna, Newmont, Keurig Dr Pepper, Cheniere Energy, and Viatris.

  6. FDA U-Turn

    FDA agrees to review the application after resolving the public dispute.

  7. FDA U-Turn

    Moderna confirms the FDA has resolved the dispute and will now consider the vaccine for approval.

  8. Regulatory Reversal

    FDA agrees to review the application after Moderna addresses concerns.

  9. Regulatory U-Turn

    The FDA officially agrees to consider the application after resolving the internal and public dispute.

  10. Wednesday Pre-Market

    Key reports from Analog Devices, Kraft Heinz, Garmin, Wix.com, and Wingstop.

  11. Public Dispute

    Moderna and administration officials engage in a public disagreement over the regulatory path forward.

  12. Public Dispute

    Reports emerge that career FDA scientists were overruled, leading to a public standoff between Moderna and the agency.

  13. Political Controversy

    Reports emerge that the vaccine chief overruled career scientists to block the shot.

  14. Initial Rejection

    Reports emerge that the FDA vaccine chief overruled scientists to reject Moderna's flu shot filing.

  15. Initial Rejection

    Trump administration vaccine chief refuses to review Moderna's mRNA flu shot application.

  16. Refusal to File

    FDA issues a shocking rejection of the application, sparking a public dispute.

  17. Refusal to File

    FDA issues an RTF citing deficiencies in the initial application.

  18. Initial BLA Submission

    Moderna submits its Biologics License Application for mRNA-1010.

  19. BLA Submission

    Moderna submits Biologics License Application for mRNA-1010.

  20. ACIP Restructuring

    HHS replaces existing ACIP members with figures aligned with the administration's views.

Stories mentioning Moderna 19

regulation Neutral

Federal Court Halts RFK Jr.’s Vaccine Policy Shift Amid Public Health Concerns

A federal judge has issued a temporary injunction against the vaccine policy agenda proposed by Robert F. Kennedy Jr., citing potential risks to public health infrastructure. While the ruling provides a reprieve for existing immunization standards, experts warn that the ongoing legal and political battle could further erode public confidence in scientific institutions.

6 sources
pharma Neutral

Federal Judge Halts RFK Jr.’s Sweeping Vaccine Policy Overhaul

A Massachusetts federal judge has blocked the Trump administration's attempts to dismantle the standard U.S. vaccine schedule. The ruling halts Robert F. Kennedy Jr.’s efforts to reduce recommended pediatric immunizations, citing a failure to follow established scientific and procedural laws.

2 sources
pharma Neutral

CDC Data Reveals Suboptimal Flu Vaccine Efficacy for 2025-2026 Season

Preliminary reports from US health officials indicate that this season's influenza vaccines provided lower-than-expected protection against circulating strains. The findings underscore the persistent challenge of viral mismatch and are expected to accelerate the industry's shift toward next-generation mRNA and recombinant vaccine technologies.

2 sources
pharma Bullish

Egg Prices Plunge as Avian Flu Recedes, Shifting Focus to Vaccine R&D

Wholesale egg prices have dropped significantly as the poultry industry recovers from devastating H5N1 outbreaks. However, the biotech sector remains on high alert as researchers and regulators weigh the long-term necessity of mass poultry vaccination and human pandemic preparedness.

2 sources
market-trends Bullish

Wix and PAR Technology Lead Retail Tech Surge Amid SaaS Market Rally

Wix and PAR Technology shares surged on March 4, 2026, signaling a robust appetite for e-commerce and unified commerce infrastructure. The rally, supported by broader gains in the SaaS sector including Cloudflare, highlights a shift toward high-margin digital enablement tools in the retail and restaurant landscapes.

6 sources
pharma Bullish

Moderna Leads Biotech Rally as Market Sentiment Shifts Toward Growth

Moderna (MRNA) shares rose significantly on March 4, 2026, as part of a broader market rally that lifted high-growth technology and clean energy stocks. The move highlights a renewed investor appetite for innovative platforms, signaling a potential recovery for the biotech sector following a period of macro-induced volatility.

5 sources
market-trends Bullish

Moderna and SaaS Infrastructure Lead Broad Health-Tech Market Rally

A significant market rally on March 4, 2026, saw shares of Moderna, Wix, and Cloudflare surge as investors prioritized biotech innovation and the digital infrastructure powering modern healthcare delivery. These gains reflect a growing convergence between clinical breakthroughs and the secure, scalable platforms required to manage patient engagement at scale.

5 sources
pharma Neutral

Moderna to Pay Roivant $2.25 Billion to Settle mRNA Patent Litigation

Moderna has reached a landmark $2.25 billion settlement with Roivant Sciences and Arbutus Biopharma to resolve long-standing patent disputes over lipid nanoparticle technology used in its COVID-19 vaccine. The agreement provides a massive capital infusion for Roivant while removing a significant legal overhang for Moderna's future mRNA pipeline.

2 sources
market-trends Neutral

Moderna Settles mRNA Patent Dispute with Roivant for Up to $2.25 Billion

Moderna has agreed to pay Roivant Sciences up to $2.25 billion to settle long-standing patent infringement claims regarding the Lipid Nanoparticle (LNP) technology used in its COVID-19 vaccine. The settlement provides a massive capital windfall for Roivant and Arbutus Biopharma while removing a major legal risk for Moderna.

2 sources
earnings Neutral

Mid-Week Earnings Pulse: Tech, Consumer Staples, and Energy in Focus

A diverse slate of market leaders across semiconductors, consumer goods, and energy are set to report results, providing a critical pulse check on industrial demand and consumer spending. Key reports from Analog Devices, Moderna, and Kraft Heinz will highlight the divergent paths of the tech recovery and the healthcare sector's post-pandemic transition.

2 sources
regulation Bullish

FDA Reverses Course on Moderna mRNA Flu Shot Following Public Dispute

The FDA has agreed to review Moderna’s mRNA-based influenza vaccine after a high-profile rejection by the Trump administration's vaccine chief. The reversal follows a public dispute where scientific staff were reportedly overruled, marking a significant shift for the first-of-its-kind vaccine candidate.

13 sources
markets Neutral

Midweek Market Pulse: Moderna and SanDisk Lead Sector-Specific Volatility

Investors are navigating a complex Wednesday session as major players in biotech, semiconductors, and leisure release pivotal updates. Market attention is centered on Moderna's pipeline diversification and SanDisk's recovery in the memory sector, signaling a shift toward fundamental-driven trading.

6 sources
fda-approval Bullish

FDA Reverses Course, Agrees to Review Moderna’s mRNA Flu Vaccine

The FDA has rescinded its initial refusal to file Moderna’s Biologics License Application for its seasonal flu vaccine, mRNA-1010. This rare regulatory pivot clears the path for a formal review of the first mRNA-based influenza shot, a critical milestone for Moderna’s post-pandemic growth strategy.

2 sources
regulation Bullish

FDA Reverses Stance on Moderna’s mRNA Flu Shot, Clearing Path for Review

The U.S. Food and Drug Administration has unexpectedly reversed its previous position, agreeing to review Moderna’s mRNA-based influenza vaccine candidate. This regulatory pivot marks a critical victory for Moderna as it seeks to diversify its portfolio beyond COVID-19 and challenge the traditional seasonal flu market.

3 sources
markets Neutral

YieldMax Declares Monthly Distributions Across Single-Stock Option ETFs

YieldMax has announced its latest round of monthly distributions for its suite of single-stock synthetic covered call ETFs, including those tracking MicroStrategy, Tesla, and Microsoft. The payouts reflect the varying volatility levels of the underlying assets, with MRNA and MSTR leading the distribution amounts.

8 sources
regulation Bullish

FDA Reverses Course on Moderna mRNA Flu Shot After Controversial Rejection

The U.S. Food and Drug Administration has agreed to review Moderna’s experimental mRNA flu vaccine, reversing a previous decision that sparked a public dispute. The initial rejection, which reportedly saw political appointees overrule career scientists, had briefly cast doubt on the regulatory path for the company's post-COVID pipeline.

6 sources