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FDA reversals leave investors worrying about the fates of other experimental drugs
Published: March 06, 2026 by: CNBC
Sentiment: Negative
The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. The agency initially refused to review Moderna's flu shot before reversing course.
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The Sun Will Shine On Moderna Again - Initiating With A Buy
Published: March 04, 2026 by: Seeking Alpha
Sentiment: Positive
Moderna is initiated at a buy rating, as multiyear growth drivers and robust 2026 guidance signal a turnaround. mNEXSPIKE approvals, flu and combo vaccines, and mRNA therapeutics expansion underpin Moderna's growth prospects for the coming years. Revenue declines are slowing, cost controls are effective, and losses are narrowing, with 2026 guidance targeting up to 10% revenue growth.
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Why Moderna's $950M Patent Bill Is A Small Price For Pipeline Freedom
Published: March 04, 2026 by: Seeking Alpha
Sentiment: Neutral
Moderna, Inc. settles its LNP patent dispute with Arbutus and Genevant for a $950 million upfront payment, eliminating a major litigation overhang. MRNA secures royalty-free access to critical LNP technology, ensuring freedom to operate for its infectious disease and vaccine pipeline, including future combo vaccines. The settlement preserves MRNA's strong balance sheet, with projected 2026 liquidity of $5.4–$5.9 billion, supporting pipeline expansion and breakeven target by 2028.
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MRNA Stock Gains on $2.25B Deal to Settle Patent Dispute With ROIV, ABUS
Published: March 04, 2026 by: Zacks Investment Research
Sentiment: Neutral
Moderna jumps after $2.25B settlement with Genevant and Arbutus over LNP patents tied to its COVID-19 and RSV vaccines, ending global litigation.
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Moderna to pay up to $2.25B to settle COVID vaccine patent matter
Published: March 04, 2026 by: Proactive Investors
Sentiment: Positive
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) stock added almost 9% after it was announced that the drugmaker has agreed to pay up to $2.25 billion to settle a global patent infringement lawsuit brought by Arbutus Biopharma and Genevant Sciences over the use of lipid nanoparticle (LNP) delivery technology in its COVID-19 and RSV vaccines. The settlement resolves all US and international enforcement actions related to Moderna's use of Arbutus' and Genevant's LNP technology in Spikevax, its COVID-19 vaccine, and mRESVIA, its RSV vaccine.
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2 High-Flying Stocks With More Upside to Buy and Hold
Published: March 04, 2026 by: The Motley Fool
Sentiment: Positive
Walmart is expertly navigating a challenging retail environment while continuing to grow its dividend. Moderna has a promising candidate that could hit the market in the near future.
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Moderna's Covid-Flu Vaccine Recommended for Approval in EU
Published: February 27, 2026 by: WSJ
Sentiment: Positive
The recommendation from regulators paves the way for the shot's approval in the European Union at a time the company is facing scrutiny in the U.S.
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European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19
Published: February 27, 2026 by: Accesswire
Sentiment: Neutral
mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX® (mRNA-1083), Moderna's combination vaccine indicated for …
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Moderna gets EU regulator nod for combined COVID, flu vaccine
Published: February 27, 2026 by: Reuters
Sentiment: Positive
Europe's medicines regulator on Friday recommended granting marketing authorisation to mCombriax, making Moderna's messenger RNA vaccine the world's first combined shot for people aged 50 and older against COVID and seasonal influenza in a single dose.
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Moderna Stock: How Far Can The Flu Shot Fly?
Published: February 24, 2026 by: Forbes
Sentiment: Positive
Moderna (MRNA) – a developer of mRNA-focused therapeutics and vaccines – has recorded a 6-day winning streak, accumulating gains of 25% during this time. The company's market capitalization has increased by approximately $4.0 billion over the past 6 days and now sits at $20 billion.
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BioNTech sues Moderna for patent infringement over COVID-19 shots
Published: February 19, 2026 by: Reuters
Sentiment: Negative
Biopharmaceutical company BioNTech sued Moderna in Delaware federal court on Thursday, alleging that Moderna's COVID-19 vaccine mNexspike infringes a patent related to BioNTech and Pfizer's competing shot Comirnaty.
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Moderna Stock Jumps After FDA Reverses Course on Flu Shot
Published: February 19, 2026 by: Zacks Investment Research
Sentiment: Positive
MRNA stock rises 6% as the FDA agrees to review its flu vaccine filing after a surprise reversal, with a decision expected by Aug. 5, 2026.
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FDA Makes U-Turn Again On Moderna New Flu Vaccine Review, Stock Soars
Published: February 18, 2026 by: Benzinga
Sentiment: Positive
The stock's movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.
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Moderna's investigational flu vaccine moves forward in FDA review
Published: February 18, 2026 by: Proactive Investors
Sentiment: Positive
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its investigational seasonal influenza vaccine, mRNA-1010, following a Type A meeting between the company and the agency. Shares of Moderna added 6.5% at about $47 on the update.
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Moderna Shares Rally 6% After FDA Reverses Decision Not To Review Flu Vaccine
Published: February 18, 2026 by: Forbes
Sentiment: Positive
The FDA's “refuse-to-file” letter sent to reject Moderna's application is a rarity: A 2021 study found that 4% of the nearly 2,500 applications submitted to the agency receive such letters, many of which cited drug efficacy, safety and quality.
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Moderna got the FDA to change its mind and review its flu vaccine after some concessions
Published: February 18, 2026 by: Market Watch
Sentiment: Positive
Moderna's stock was surging after the FDA said it would review the biotech's flu-vaccine candidate, a week after it had refused to do so.
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Moderna Stock Pops as FDA Application Moves Forward
Published: February 18, 2026 by: Schaeffers Research
Sentiment: Positive
Pharma giant Moderna Inc (NASDAQ:MRNA) is enjoying a boost today, after the U.S. Food & Drug Administration (FDA) accepted the company's flu vaccine application for review.
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FDA reverses decision not to review Moderna's new flu vaccine
Published: February 18, 2026 by: New York Post
Sentiment: Neutral
The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday.
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Moderna Says FDA Will Review Its Flu Vaccine. The Stock Is Rising.
Published: February 18, 2026 by: Barrons
Sentiment: Positive
The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier this month.
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The FDA reversed course and agreed to begin a review of Moderna's seasonal flu shot
Published: February 18, 2026 by: WSJ
Sentiment: Positive
The company's mRNA flu shot, if approved, could be available for the 2026-27 flu season.
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Moderna's Shares Climb 5.3% as Investors Revisit Biotech Leaders
Published: February 16, 2026 by: Zacks Investment Research
Sentiment: Positive
MRNA shares jumped 5.3% as investors rotated into large-cap biotech, betting on its expanding pipeline in volatile trade.
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Moderna, Inc. (MRNA) Q4 2025 Earnings Call Transcript
Published: February 13, 2026 by: Seeking Alpha
Sentiment: Neutral
Moderna, Inc. (MRNA) Q4 2025 Earnings Call Transcript
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Moderna Q4 Loss Narrower-Than-Expected, Sales Beat Estimates
Published: February 13, 2026 by: Zacks Investment Research
Sentiment: Positive
MRNA posts a narrower Q4 loss and beats sales estimates, despite a 30% revenue drop, while advancing its pipeline and reaffirming 2026 outlook.
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CPI Increased in Line With Expectations
Published: February 13, 2026 by: Zacks Investment Research
Sentiment: Positive
As far as economic reports go, the good news just keeps on coming. Seemingly running on a separate track from investor fears about AI's future role in the economy, today's latest inflation read came in as well as anyone has the right to expect.
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Moderna shares pop on strong guidance, smaller-than-expected loss
Published: February 13, 2026 by: Proactive Investors
Sentiment: Positive
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) reported fourth quarter 2025 results that exceeded Wall Street expectations, sending its shares up about 11% on Friday. The company posted a net loss of $2.11 per share on revenue of $678 million, compared with analysts' consensus of a $2.60 loss on revenue near $660 million.
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Moderna (MRNA) Reports Q4 Loss, Beats Revenue Estimates
Published: February 13, 2026 by: Zacks Investment Research
Sentiment: Neutral
Moderna (MRNA) came out with a quarterly loss of $2.11 per share versus the Zacks Consensus Estimate of a loss of $2.6. This compares to a loss of $2.5 per share a year ago.
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Moderna Pops On Fourth-Quarter Report, But Can It Overcome Recent FDA Setbacks?
Published: February 13, 2026 by: Investors Business Daily
Sentiment: Positive
Moderna stock popped Friday after the company reported better-than-expected fourth-quarter sales and reiterated its 2026 outlook.
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Moderna Stock Sports Technical Support Ahead Of Earnings
Published: February 12, 2026 by: Forbes
Sentiment: Negative
Pharma stock Moderna (MRNA) is experiencing a sharp pullback from its Jan. 22, 52-week high of $55.20. Last seen down 3.5% at $39.08, the shares are headed for their third-straight weekly loss.
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FDA blindsides Moderna with refusal to review flu vaccine application: ‘We're pretty confused'
Published: February 11, 2026 by: New York Post
Sentiment: Neutral
The new shot was not compared to “the best-available standard of care in the United States at the time of the study,” an FDA official told Moderna.
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Moderna's investigational flu vaccine denied FDA review, shares drop
Published: February 11, 2026 by: Proactive Investors
Sentiment: Negative
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) shares fell almost 6% after the drugmaker announced that the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has issued a Refusal-to-File (RTF) letter for the company's biologics license application for its investigational seasonal influenza vaccine, mRNA-1010. According to the company, the FDA cited the choice of a licensed standard-dose influenza vaccine as the comparator in Moderna's Phase 3 trial as the reason for the refusal.
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About Moderna, Inc. (MRNA)
- IPO Date 2018-12-07
- Website https://www.modernatx.com
- Industry Biotechnology
- CEO Stéphane Bancel
- Employees 5800