News

Moderna’s FDA U-Turn: Stock Rockets Amid mRNA-1010 Review

Moderna’s FDA U-Turn: Stock Rockets Amid mRNA-1010 Review

The FDA just flipped the script on Moderna by advancing its mRNA-1010 biologics license application to review status, sending shares up 5.77% to $46.46 amid otherwise mixed market vibes. This latest move comes hot on the heels of a prior refusal-to-file letter that left many traders scrambling. You know how it goes—news hits, desks react, and if you blinked, you missed the surge.

U-Turn Drama: From Refusal to Review

Just last week, the FDA was stonewalling, rejecting mRNA-1010 due to its standard-dose seasonal flu vaccine comparator choice. Fast forward a few days and it’s now all systems go with a PDUFA goal date set for August 5, 2026, aimed squarely at adults aged 50 and over—including those 65+. If it gets across the finish line in time for the upcoming flu season? That's a game-changer.

On top of this rollercoaster ride, Moderna reported a fourth-quarter loss of $2.11 per share but managed to beat expectations by around 48 cents; analysts were bracing for an even worse hit of $2.59. The cherry on top? Quarterly sales came in at $678 million—way above forecasts of $626 million—which has got desks buzzing about potential revenue growth trajectories.

Market Signals: Strength or Stumble?

Diving deeper into technicals reveals some mixed signals amidst this volatility storm. The stock is perched 6.6% above its 20-day simple moving average (SMA) and an eye-popping 49.6% above its longer-term SMA—a bullish sign on paper, right? But hold up; while shares are sitting pretty near their year-long highs with a nifty increase of nearly 23%, other indicators tell a less rosy story.

The RSI sits at a neutral zone of 58.53—neither screaming 'buy' nor 'sell'. Meanwhile, MACD is below its signal line—suggesting bearish undertones lurking beneath that shiny surface.

This cocktail of neutral RSI with bearish MACD throws cold water on any outright confidence in sustained upward momentum ahead—traders should tread carefully here as they navigate these murky waters.

About The Author

About Investors Hangout

Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/

The content of this article is based on factual, publicly available information and does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice, and the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. This article should not be considered advice to purchase, sell, or hold any securities or other investments. If any of the material provided here is inaccurate, please contact us for corrections.

Top 10 Most Recent News Articles

Huion Kamvas Pad 12: A Creative Power Tool

Updated Category News Views 4

The Kamvas Pad 12 Hits the Market In a crowded tablet market that's fierce with innovation, Huion tossed their latest tool into the ring—the Kamvas Pad 12. Now, anyone who’s been watching the digital art scene won't be surprised that Huion, with its decade and a half of digital prowess, is pulling another tablet trick out of its hat. Key Features and Innovations If...

Continue Reading
Multiconsult-Rejlers Merger Revs Up Nordic Market Power

Updated Category News Views 2

A New Powerhouse in the Nordic Consultancy Space September 7, 2026, will likely be etched into the annals of stock market moves, marking the day two titans, Multiconsult and Rejlers, decided to tie the knot. This isn't your average merger. We're talking about a calculated Pan-Nordic push that's been building, and now, well, it's paying off with a potential powerhouse of...

Continue Reading
PBC 2026 Forum: Philanthropic Titans Collide in HK

Updated Category News Views 1

A Decade of Philanthropic Discourse The winds of change blew through Hong Kong’s West Kowloon Cultural District today, marking the tenth anniversary of the PBC 2026 forum—an event that’s got everyone from government bigwigs to sports icons chatting. Convened by The Hong Kong Jockey Club Charities Trust alongside the Institute of Philanthropy, this two-day journey is...

Continue Reading
UST Grabs Italdesign: Driving Future Mobility with AI

Updated Category News Views 3

UST's Strategic Move Into Automotive's Future Wake up and smell the coffee, because UST is shaking up the automotive scene. They've just pulled off a major play by grabbing a majority stake in Italdesign. If that doesn't scream the next leap forward for the auto world, I don't know what does. UST isn't just buying a company; it's marrying Italdesign's legendary design...

Continue Reading
GBC 2026 Wraps Up: Korea Eyes Bio Industry Leadership

Updated Category News Views 3

GBC 2026: Korea's Giant Leap in Bio Innovation Well, there wasn't a dull moment at the 'Global Bio Conference 2026' in Seoul. Picture a melting pot where 5,600 participants from 19 countries converged to chat about the latest and greatest in biopharma innovation and regulatory strategies. That's not a setup you see every day, mind you. This event packed the room with...

Continue Reading
Coastal Property Realities: A Deep Dive into Ownership

Updated Category News Views 2

Buying Coastal Property: A Balancing Act Ah, the dream of owning a piece of the beach in sunny South Florida. It sounds glamorous—something to brag about at the next family gathering. But let me tell you, diving into coastal property ownership isn't just about sipping cocktails by the ocean. It's about handling a fair share of headaches most folks don't anticipate....

Continue Reading
DNOW Faces Class Action: Proxy Missteps Under Fire

Updated Category News Views 1

DNOW's Rough Patch: Investors, Beware Here's a tangled mess for you: DNOW Inc., a name that should've been cruising post-merger, now finds itself smack in the middle of a class action lawsuit. Blame it on some botched acquisition moves with MRC Global Inc. The suits claim DNOW's management may have played fast and loose with the truth during their big merger spiel. When...

Continue Reading
Jixingfeng Advances Smart Manufacturing for Socks Market

Updated Category News Views 3

Socks Evolve: From Feet Covers to Tech Gear Once upon a time, socks were merely foot covers, destined to vanish beneath pants and shoes. But not anymore. In the bustling halls of the sock world, Jixingfeng built up a robust repertoire of producing high-performance hosiery for a modern market that demands more than just warmth. They’ve turned socks into a tech-infused...

Continue Reading
Fosun Reaches New Heights in Hang Seng Sustainability

Updated Category News Views 2

Fosun International's Sustainability Milestone Now, you don't often see a company's sustainability rating climbing the ladder like a homesick angel, but Fosun International just nailed it. On September 7, 2026, their Hang Seng Sustainability Rating bumped up a notch from AA- to AA+, now at an all-time high. It's the sort of financial footnote that grabs the attention....

Continue Reading
Reliable Safety & Flow: A New Era in Infrastructure

Updated Category News Views 1

Seismic Merger: Reliable Sprinkler and ASC Join Forces When two companies with roots stretching back to the 1800s decide to merge, it's not just a business move—it's a bold statement. Reliable Automatic Sprinkler and ASC Engineered Solutions, with over 175 years of combined innovation, have officially become Reliable Safety & Flow Corporation. This ain't just a...

Continue Reading

Top 5 Most Recently Viewed Articles

HEI Finalizes ASB Sale, Paving the Way for Future Growth

Updated Category News Views 222

HEI Concludes Major Sale of American Savings Bank Hawaiian Electric Industries, Inc. (HEI) recently finalized the significant sale of 90.1% of the common stock of American Savings Bank (ASB), which previously functioned as its wholly owned subsidiary. This remarkable transaction, valued at $450 million, saw independent investors acquire the majority stake for a total cash...

Continue Reading
Malta Explores Safe Cannabis Consumption and New Regulations

Updated Category News Views 179

Malta Considers Designated Cannabis Consumption Spaces Malta is making significant strides in cannabis legislation as its cannabis authority explores options for establishing designated places where individuals can safely consume cannabis. Currently, the law permits cannabis use solely in private settings, which presents challenges, especially for families with children....

Continue Reading
Exploring Free Spins No Deposit Bonuses in Online Casinos

Updated Category News Views 287

The Rise of Free Spins No Deposit Bonuses in Online Casinos The online gambling industry has embraced the free spins no deposit casino model as a pivotal promotional strategy. It attracts players looking to explore new platforms without any upfront financial commitment. This approach not only enhances user experience but also generates a buzz in the competitive landscape...

Continue Reading
DIRTT Environmental Solutions Prepares for Major Investor Events

Updated Category News Views 118

DIRTT Environmental Solutions to Showcase at Key Investor Conferences DIRTT Environmental Solutions Ltd. (TSX: DRT) and (OTCQX: DRTTF), recognized as a frontrunner in the realm of industrialized construction, is gearing up to participate in two vital investor conferences. This marks a significant opportunity for the company to connect with investors and present its...

Continue Reading
Thriving Dividend Stocks to Watch for Future Growth Prospects

Updated Category News Views 107

Exciting Developments in Dividend Stocks In a remarkable trend among several prominent stocks, dividends are gaining significant traction. Notably, two companies within the energy sector have doubled their quarterly dividends, while a major player in the global payments industry has initiated a double-digit increase amidst rising buybacks. Such growth in...

Continue Reading