FDA Commissioner Makary Resigns Over E-Cigarette Concerns
Dr. Marty Makary, the commissioner of the Food and Drug Administration, resigned on Tuesday, according to multiple media reports citing administration officials. Makary ultimately resigned over concerns about the administration's decision to authorize fruit-flavored e-cigarettes, which he opposed, four people familiar with the matter told The New York Times. Kyle Diamantas, the F.D.A.'s top food regulator, was named the acting commissioner, according to The Times and Politico, which was first to report of Makary's resignation. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks that could be impacted by the news include Replimune (REPL), Moderna (MRNA), Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Novavax (NVAX) and Lexeo Therapeutics (LXEO).
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- FDA Approval: Johnson & Johnson's Dual Energy THERMOCOOL SMARTTOUCH SF Platform has received FDA approval, integrating radiofrequency and pulsed field energy into a single device, which enhances the flexibility and precision of cardiac electrophysiology treatments, expected to significantly improve outcomes for complex cases.
- Clinical Validation: Building on the THERMOCOOL SMARTTOUCH SF system, which has treated over one million patients in the U.S., the extensive clinical validation provides a solid foundation for the rollout of this new technology, boosting physician confidence.
- Commercial Rollout Plan: Johnson & Johnson plans to initiate a phased commercial rollout in the U.S. starting this summer, aiming to quickly bring this innovative technology to market to meet the growing demand for complex case management, thereby enhancing its competitive position.
- Stock Performance: JNJ shares have traded between $154.80 and $269.43 over the past year, closing at $267.24, up 3.05% from the previous trading day, indicating positive market sentiment towards the new product.
- SK Hynix IPO Surge: SK Hynix's U.S. stock listing is oversubscribed by more than seven times, aiming to raise $28 billion, reflecting strong market confidence in its growth prospects while raising concerns about potential oversupply in debt and equity that could pressure the bull market.
- PepsiCo Earnings Report: PepsiCo reported a slight earnings miss but beat revenue expectations, with its North American beverage business standing out; however, the company warned of rising input costs in the second half, which could impact future profitability.
- Five Below Rating Upgrade: Five Below was upgraded from hold to buy by Mizuho Securities, as analysts noted that despite a nearly 30% drop from its April peak, the company is retaining customers well, indicating strong future growth potential.
- AstraZeneca Drug Failure Impact: AstraZeneca's heart disease drug Wainua failed to meet targets in a late-stage clinical trial, causing its stock to drop about 8%, while shares of co-developer Ionis Pharmaceuticals fell nearly 20%, highlighting market sensitivity to new drug development risks.
- Earnings Expectations Surge: The projected earnings growth for U.S. companies in 2026 has risen to 26.4%, significantly higher than previous estimates, reflecting a robust economic backdrop and substantial investments in AI infrastructure, which may attract increased investor interest.
- Market Valuation Moderation: The forward P/E ratio for the S&P 500 has decreased to 20.1 from 22.2 at the end of 2025, indicating that while the market remains strong, the rise in earnings expectations has led to a more reasonable valuation, reducing the risk of market bubbles.
- Sector Performance Divergence: The technology sector is expected to see a 65.5% profit growth in Q2, while the energy sector could experience a staggering 115% increase, highlighting the sensitivity of different industries to AI advancements and energy price fluctuations, which may lead investors to be more selective in stock choices.
- Upcoming Earnings Season: With major banks and high-profile companies set to report Q2 earnings soon, the high expectations for profits could lead to increased volatility, necessitating investor attention on whether these optimistic projections can be met.
- Industry Performance Outlook: Major US biopharmaceutical companies are expected to underperform in the second half of the year, reflecting challenges and uncertainties that may impact investor confidence.
- Market Reaction: Increased investor focus on the biopharmaceutical sector could lead to heightened volatility in related stocks, resulting in downward pressure on share prices in the short term.
- Policy Impact: Uncertainties in industry policy changes and regulatory environments may exacerbate performance fluctuations, affecting long-term strategic planning and investment decisions for companies.
- Intensifying Competition: The rise of emerging biotech firms poses greater competitive pressure on traditional biopharmaceutical companies, necessitating accelerated innovation and R&D investments to maintain market share.
- Hip Surgery Outcomes: The new dual-mobility implant shows a dislocation rate of only 1.3% compared to 4.2% for traditional implants, indicating a 70% reduction in dislocation risk, significantly enhancing postoperative quality of life for patients.
- Study Scale and Impact: This research randomly assigned 1,600 patients aged 65 and older to compare the effects of dual-mobility versus standard implants, revealing that the new implant also performed better in reducing surgical complications, despite no significant differences in infection or mortality rates.
- Economic Analysis Outlook: Although dual-mobility implants are more expensive, researchers believe the potential reduction in complications could offset the initial costs, and a comprehensive health economic analysis is underway to assess long-term benefits.
- Clinical Implementation Feasibility: Surgeons are already familiar with both implant types, suggesting that the adoption of dual-mobility implants can be swiftly integrated into existing medical practices, thereby improving patient surgical experiences and trust in the implants.
- FDA Approval: Johnson & Johnson announced that its new cardiac ablation device, the Dual Energy THERMOCOOL SMARTTOUCH SF Platform, has received FDA approval, aimed at enhancing electrophysiologists' ability to manage complex cases by integrating radiofrequency and pulsed field energy.
- Integrated Ecosystem: This catheter solution is integrated with J&J's CARTO ecosystem, providing three-dimensional electroanatomical mapping that enhances precision and efficiency during procedures, which is expected to significantly improve patient treatment experiences.
- U.S. Market Launch: J&J plans to begin a phased launch of the platform in the U.S., with the first commercial procedures set to start this summer, a strategy that will help the company capture a larger share of the rapidly growing cardiac medical device market.
- Successful European Introduction: Following a successful introduction in Europe, J&J is rapidly expanding access to this technology in the U.S., demonstrating the company's confidence in the new technology and its growth potential in the global market.











