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FDA reversals on UniQure, Moderna approvals worry investors
Investors are concerned about the fates of multiple experimental drugs for hard-to-treat diseases following a string of recent rejections from the U.S. Food and Drug Administration.
The FDA in the past year has denied or discouraged the applications of at least eight drugs, according to RTW Investments, including a gene therapy for Huntington’s disease from UniQure, a gene therapy for Hunter syndrome from Regenxbio and a drug for a blood condition from Disc Medicine. The agency initially refused to review Moderna‘s flu shot before reversing course.
In each case, the FDA took issue with the evidence the companies were using to support their applications. Some of the studies didn’t test the drugs against a placebo. Some companies didn’t directly measure the drug’s efficacy, instead relying on other factors like biomarkers to predict how well the treatment might work.
And in every case, the companies have accused the FDA of reversing its previous guidance. That’s making investors wary that a more unpredictable FDA could jeopardize the future of other treatments for hard-to-treat diseases.
“What investors and key stakeholders are hoping to see from the FDA is consistency, and it does feel that that seems to be lacking at the moment,” said RBC Capital Markets analyst Luca Issi.
In recent years, the FDA appeared willing to accept drugs for rare diseases that showed promise in less rigorous studies than the gold standard randomized, double-blind placebo controlled trials. That meant helping bring treatments more quickly to patients who have conditions where time passing could mean the loss of functions like walking or talking, or even death. It also drew controversy from critics who said that policy brought false hope to patients.
The FDA’s recent decisions has left investors wondering whether the agency’s bar has changed for other drugs in the pipeline. In the case of UniQure, the FDA asked the company to run a new study that directly compares its treatment to placebo. UniQure said that contradicts the agency’s past guidance that the company could seek approval with trial data that compared UniQure’s treatment to an external database of people with Huntington’s disease.
One former FDA official who spoke to CNBC on the condition of anonymity to speak freely called this the worst type of regulatory uncertainty, because companies say they are being told one thing then experiencing another.
In a statement, an FDA spokesperson said there was “no regulatory uncertainty,” adding the agency “makes decisions based on the evidence, but does not make assurances about outcomes.” The spokesperson said the FDA is “conducting rigorous, independent reviews and not rubber-stamping approvals.”
Analysts point to several other companies they’re watching, including Dyne Therapeutics, which is advancing a drug for Duchenne muscular dystrophy; Taysha Gene Therapies, which is developing a gene therapy for Rett syndrome; Wave Life Sciences, which is working on a treatment for a liver condition; and Lexeo Therapeutics, which is developing a gene therapy for Friedreich Ataxia. All of those companies’ stocks are down this year.
A Dyne spokesperson said the company has maintained a frequent, positive and collaborative dialogue with a consistent set of reviewers over the past 18 months, and that it’s confident in its development strategy and path forward based on the strength of its clinical results, rigor of its trial design and continued engagement with the FDA. Taysha, Wave and Lexeo declined to comment.
One looming decision that Stifel analyst Paul Matteis is tracking is a drug candidate from Denali Therapeutics for Hunter syndrome, a rare disease that causes physical defects like hearing loss and joint problems, as well as cognitive issues. The company’s application for accelerated approval relies on a trial that wasn’t randomized and data showing the drug decreases levels of a biomarker associated with the condition.
To Matteis, the dataset is harder to argue with than UniQure’s, and there’s not much risk with the technology used.
“So if they don’t approve that, I don’t know,” Matteis said. “I mean, I already think there’s been a pretty significant change in the regulatory standard of rare disease, but if they don’t approve Denali, if I was at a company I’d almost be saying to myself, ‘Can we really be confident in running an open-label study?’”
In a statement to CNBC, Denali Therapeutics CEO Ryan Watts said the company continues having constructive discussions with the FDA, and it’s confident in the strength of the data package it submitted. The FDA delayed its review of the application by three months and is now expected to decide by April 5.
Some investors feel a clash between the flexibility FDA leaders like Commissioner Marty Makary are pledging publicly and the recent decisions the agency has made, said RBC Capital Markets’ Issi. That’s leading some to discount the probability of success for companies whose paths to the market rely on some level of flexibility in the data the agency will accept, said Stifel’s Matteis.
For companies whose data are straightforward, the path looks clear, said Christiana Bardon, managing partner of MPM BioImpact. The question to her is how much the FDA should accelerate the process to bring drugs to patients as rapidly as possible for diseases with massive unmet needs.
One senior FDA official, speaking to reporters Thursday on the condition of anonymity to speak freely, said the FDA hasn’t changed its position that biomarkers reasonably likely to predict efficacy can and will get accelerated approval, and that non-randomized data can get full approval. To this official, the bar is clear.
“If you make a treatment for Alzheimer’s or Huntington’s, and you take someone who’s severely ill and you give them that therapy, and they start doing better immediately and dramatically,” the official said. “You take someone in a nursing home with Alzheimer’s, and then they walk out of it, or somebody with end-stage Huntington’s, and they suddenly have no symptoms of Huntington’s, you will get a full regulatory approval with two or three patients.
“We only ask for randomized data when a condition is heterogeneous, when the will to believe is strong, when the therapy is invasive or potentially harmful, when the effect size is difficult to detect, and when the possibility you are fooling yourself is high,” the official added.
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Nektar Therapeutics (NKTR) Presents at TD Cowen 46th Annual Health Care Conference – Slideshow
Nektar Therapeutics (NKTR) Presents at TD Cowen 46th Annual Health Care Conference – Slideshow
Form 4 Columbia Sportswear Company For: 6 March
Shares of Airbnb Inc. (NASDAQ: ABNB) declined about 2% in midday trading Friday, March 6, 2026, falling to around $132.93-$133 from Thursday’s close near $135.85, reflecting a modest pullback after recent gains tied to robust fourth-quarter results and upbeat guidance for accelerated growth in 2026.
The San Francisco-based home-sharing platform opened near $133.89 and traded in a range from lows around $130.98 to highs of $133.90-$134.52, with volume approaching 1-5 million shares by mid-morning. The dip comes amid broader market caution from geopolitical tensions and rising energy costs, though Airbnb’s fundamentals remain solid following its February earnings report.
Airbnb released fourth-quarter and full-year 2025 results on February 12, 2026, posting revenue of $2.78 billion — up 12% year-over-year and beating analyst expectations by about 2.3%. Gross booking value surged 16% to $20.4 billion, while nights and experiences booked grew 10%, marking the strongest quarterly growth in over two years despite tough comparisons.
Adjusted EBITDA reached $786 million, delivering a 28% margin, and the company achieved positive net income. Earnings per share came in at $0.56 (adjusted figures varied), slightly missing some estimates of $0.65-$0.67, but the top-line beat and strong bookings overshadowed the miss.
CEO Brian Chesky highlighted momentum from product innovations like flexible payment options, eco-tourism focus and expansions into new markets such as Japan and India. “Healthy demand” across regions drove the acceleration, with gross bookings showing particular strength.
Guidance fueled optimism: First-quarter 2026 revenue is projected at $2.59 billion to $2.63 billion (14-16% growth), topping Wall Street’s $2.54 billion consensus. For the full year, Airbnb anticipates at least low double-digit revenue growth — aligning with or exceeding analyst views of around 10%. Management emphasized scalable profitability, with forecasts pointing to operating income nearing $3 billion in 2026.
The results sparked a rally, with shares rising as much as 17.5% in the weeks following the report before recent softening. Analysts responded positively: Mizuho raised its price target to $175 from $156 in early March, citing sustained demand and innovation. Consensus targets hover around $144-$149, implying 8-12% upside from current levels, with highs up to $200 and lows near $107. Ratings lean Buy, with 34-50 analysts tracking the stock.
Airbnb’s market capitalization stands around $80-82 billion. The stock trades at a forward P/E in the mid-20s, reasonable for a growth-oriented travel tech name with expanding margins. Year-to-date in 2026, performance has been mixed but positive overall, with shares up roughly 10-15% from January lows near $100, though down from February highs near $144.
The company continues investing in AI for personalized recommendations, dynamic pricing and host tools, alongside expansions like Airbnb Experiences and co-hosting features. Challenges include regulatory pressures in some cities, competition from hotels and short-term rental platforms, and macro sensitivity to consumer spending amid inflation.
Despite headwinds, Airbnb’s asset-light model — no property ownership — supports high margins and cash flow. Free cash flow remains strong, funding share repurchases and growth initiatives without debt reliance.
Analysts see 2026 as pivotal for Airbnb, with gross bookings momentum, user growth and profitability scaling key watchpoints. Expansion into emerging markets and AI-driven efficiencies could drive faster-than-expected gains.
As trading continues, the modest decline appears technical rather than fundamental. With earnings next expected in late April 2026, investors eye sustained demand signals amid travel recovery and economic uncertainty.
Airbnb’s blend of network effects, brand strength and innovation positions it well in the evolving travel landscape, though near-term volatility persists.
Financial analyst by day and a seasoned investor by passion, I’ve been involved in the world of investing for over 15 years and honed my skills in analyzing lucrative opportunities within the market.I specialize in uncovering high quality dividend stocks and other assets that offer potential for long term-growth that pack a serious punch for bill-paying potential. I use myself as an example that with a solid base of classic dividend growth stocks, sprinkling in some Business Development Companies, REITs, and Closed End Funds can be a highly efficient way to boost your investment income while still capturing a total return that follows traditional index funds. I created a hybrid system between growth and income and manage to still capture a total return that is on par with the S&P.
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SlateStone Wealth chief market strategist Kenny Polcari discusses Wall Street’s oil dilemma on ‘Varney & Co.’
Gas prices moved higher Friday as the conflict with Iran continued to roil global energy markets, pushing crude oil sharply upward and raising concerns about fuel supplies.
The national average price for regular gasoline rose to $3.32 per gallon on Friday, up from $3.25 on Thursday and $2.98 a week ago, according to AAA. Analysts say the increase reflects a surge in crude oil prices as geopolitical tensions intensify in the Middle East.
U.S. crude settled at $90.90 per barrel on Friday, a 12.2% jump on the day.
“Gasoline prices have been following crude prices higher as the closure of the Strait of Hormuz impacts supplies,” Andy Lipow, president of Lipow Oil Associates, told FOX Business in an email.
A gas station attendant pumps diesel into a car at a filling station (Sean Gallup/Getty Images / Getty Images)
Oil markets have been on edge since the U.S. and Israel launched strikes on Iran last Saturday. Iran has since moved to block tanker traffic in the Strait of Hormuz — a critical shipping lane that handles roughly 20% of global oil flows, according to Reuters.
Lipow said the disruption has prevented tankers from loading in Iraq, Kuwait and Saudi Arabia, forcing some production shut-ins.
Missile strikes have also hampered refinery operations in Israel, Bahrain and Saudi Arabia, tightening global gasoline and diesel supplies. Additional pressure is coming from China, which is limiting exports of refined petroleum products, according to Lipow.
“All this is leading to higher gasoline prices and the national average is likely to hit $3.50 per gallon [very] soon,” Lipow said.
Cars are pictured driving on the highway. (Jonas Walzberg/picture alliance via Getty Images / Getty Images)
FOX Business contributor Phil Flynn said futures markets suggest pump prices could continue rising in the near term, depending on how events unfold.
“We’re going to probably see some increases right now,” Flynn told FOX Business. “That may slow if we get good news out of Iran.”
Flynn noted that while prices have climbed quickly, the spike has not yet reached the levels seen during past geopolitical crises.
“I’m hopeful that we see the peak of gasoline next week,” Flynn said. “The reason why I say that is I have a lot of confidence in the US military and Israel, and I really think Iran is on its last legs right now.”
MAJOR TECH COMPANIES BACK TRUMP PLEDGE TO PAY MORE FOR DATA CENTER ELECTRICITY AHEAD OF SIGNING
A navy vessel is seen sailing in the Strait of Hormuz, a vital waterway through which much of the world’s oil and gas passes on March 1, 2026. (Sahar AL ATTAR / AFP via Getty Images / Getty Images)
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President Donald Trump told Reuters on Thursday he was not concerned about the rise in prices.
“I don’t have any concern about it,” Trump told Reuters. “They’ll drop very rapidly when this is over, and if they rise, they rise, but this is far more important than having gasoline prices go up a little bit.”
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Apple unveiled the MacBook Neo on March 4, 2026, its most affordable laptop ever at a starting price of $599, drawing widespread acclaim in early hands-on reviews for delivering premium aluminum construction, a vibrant Liquid Retina display and solid everyday performance powered by the A18 Pro chip — all while undercutting competitors in the sub-$600 category.
The 13-inch MacBook Neo, available for pre-order immediately and shipping March 11, targets students, first-time Mac buyers and budget-conscious users who want the Mac experience without the $1,099+ price tag of the refreshed M5 MacBook Air. Education pricing drops it to $499, positioning it aggressively against Chromebooks and entry-level Windows laptops.
Apple’s press release highlighted the Neo’s durable aluminum enclosure in four eye-catching colors — blush, indigo, silver and a new citrus — alongside a 13-inch Liquid Retina display with 2,408×1,506 resolution, 500 nits brightness and support for 1 billion colors. It supports up to 16 hours of battery life, a 1080p FaceTime HD camera with dual mics, side-firing speakers with Spatial Audio, the Magic Keyboard and a large Multi-Touch trackpad running macOS Tahoe with full Apple Intelligence features.
The core innovation lies in the processor: the A18 Pro, borrowed from the 2024 iPhone 16 Pro lineup, features a six-core CPU (two performance cores, four efficiency cores) and five-core GPU. Apple claims it’s up to 50% faster for everyday tasks like web browsing and up to 3x faster for on-device AI workloads — such as photo effects — compared to the bestselling PC with the latest Intel Core Ultra 5.
Hands-on impressions from outlets like CNET, PCMag, Ars Technica and Daring Fireball emphasized the Neo’s surprising quality for the price. Reviewers described it as feeling “every bit like a MacBook” with solid aluminum build, a comfortable (though non-backlit) keyboard using the same mechanism as recent models, a responsive trackpad and surprisingly good side-firing speakers. The display earned praise for crispness and outdoor usability at 500 nits, matching the MacBook Air.
CNET called it a “premium laptop for $599” with “just the right feature mix,” noting its nearly Air-like thinness and fun color options that make it stand out. PCMag dubbed it “2026’s breakout budget laptop,” highlighting how it fills the gap left by the discontinued low-end M1 Air while offering better value than expected.
Ars Technica noted the Neo preserves Apple’s premium feel despite compromises: base model includes 8GB unified memory and 256GB storage (no Touch ID), with a $699 option adding Touch ID and 512GB. It has two USB-C ports (one USB 3, one USB 2), a 3.5mm jack and lacks True Tone or Force Touch trackpad. The A18 Pro, while capable for browsing, streaming, light editing and AI tasks, trails the M5’s 10-core CPU and up to 10-core GPU in heavier workloads.
Daring Fireball’s John Gruber called the $599 price (or $499 education) a “slam dunk,” arguing it’s vastly superior to typical budget Windows or Chromebooks. He praised the bright display, good speakers and overall polish, suggesting the Neo could dominate the sub-$1,000 segment.
Comparisons to the M5 MacBook Air (starting $1,099 with 512GB and 16GB RAM) show clear trade-offs: the Air offers superior performance for demanding tasks, Wi-Fi 7, a slightly larger 13.6-inch screen and more ports. Yet reviewers like 9to5Mac argue the Neo suits “most people” for common uses — web, email, streaming, schoolwork and light creative hobbies — especially with Apple Intelligence integration.
Critics noted potential limitations: 8GB RAM may feel constrained for multitasking or future-proofing, and the A18 Pro’s efficiency shines in battery life but lacks the M-series’ raw power for pro apps. Some questioned longevity versus higher-end models, though Apple’s ecosystem and software updates mitigate concerns.
The launch generated buzz as Apple’s boldest entry-level play in over a decade, challenging Chromebooks head-on while maintaining Mac quality. Early sentiment across forums and YouTube leaned positive, with many calling it a “reincarnation” of the classic budget Mac ethos.
As pre-orders roll in and full reviews emerge post-March 11 launch, the MacBook Neo appears poised to reshape the budget laptop landscape, offering accessible Apple silicon performance and premium design at an unprecedented price point.
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