Acting FDA CDER Leader Expected to Step Down
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Source: seekingalpha
- Leadership Change: Following Marty Makary's resignation as FDA Commissioner on May 12, acting CDER Director Tracey Beth Hoeg is also expected to step down, indicating instability at the FDA that could impact drug approval processes.
- Tenure Background: Hoeg has served as acting director since December 2025 and joined the FDA in March 2025 as a special assistant and senior advisor to Makary, highlighting her rapid ascent and influence within the agency.
- Professional Background: Trained as a sports medicine physician and epidemiologist, Hoeg criticized school closures during the COVID-19 pandemic, suggesting her public health policy stance may influence FDA decision-making.
- Market Reaction: The leadership changes at the FDA could create uncertainty in the biopharmaceutical sector, particularly regarding partnerships and R&D with countries like China, potentially affecting future deal-making and investment strategies.
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Analyst Views on MRK
Wall Street analysts forecast MRK stock price to rise
16 Analyst Rating
11 Buy
5 Hold
0 Sell
Moderate Buy
Current: 113.410
Low
95.00
Averages
119.53
High
139.00
Current: 113.410
Low
95.00
Averages
119.53
High
139.00
About MRK
Merck & Co., Inc. is a global health care company that delivers health solutions through its prescription medicines, including biologic therapies, vaccines and animal health products. Its Pharmaceutical segment includes human health pharmaceutical and vaccine products. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers. It sells these human health vaccines primarily to physicians, wholesalers, distributors and government entities. Its Animal Health segment discovers, develops, manufactures and markets a range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all livestock and companion animal species. Its products include KEYTRUDA (pembrolizumab) injection, for intravenous use; WELIREG (belzutifan) tablets, for oral use; Ohtuvayre (ensifentrine) and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Acting FDA CDER Leader Expected to Step Down
- Leadership Change: Following Marty Makary's resignation as FDA Commissioner on May 12, acting CDER Director Tracey Beth Hoeg is also expected to step down, indicating instability at the FDA that could impact drug approval processes.
- Tenure Background: Hoeg has served as acting director since December 2025 and joined the FDA in March 2025 as a special assistant and senior advisor to Makary, highlighting her rapid ascent and influence within the agency.
- Professional Background: Trained as a sports medicine physician and epidemiologist, Hoeg criticized school closures during the COVID-19 pandemic, suggesting her public health policy stance may influence FDA decision-making.
- Market Reaction: The leadership changes at the FDA could create uncertainty in the biopharmaceutical sector, particularly regarding partnerships and R&D with countries like China, potentially affecting future deal-making and investment strategies.
See More
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- Shift in R&D Model: This collaboration represents a departure from traditional licensing agreements, as both companies will contribute resources to drug development, positioning China as a vital part of the global pharmaceutical R&D ecosystem and highlighting U.S. drugmakers' increasing focus on the Chinese market.
- Market Trend Shift: According to DealForma, over half of large pharmaceutical licensing deals this year have originated from China, up from 39% last year, indicating a growing trend among U.S. and European biopharmaceutical companies to shift early drug development to China to expedite market entry.
- Future Industry Outlook: Experts predict that early-stage drug discovery will increasingly move to China due to its ability to conduct studies at lower costs and faster timelines, potentially reshaping the U.S. pharmaceutical landscape and encouraging more companies to initiate early clinical trials in China.
See More
Bristol Myers Squibb Partners with Hengrui Pharma for Drug Development
- New Drug Collaboration: Bristol Myers Squibb has announced a potential multi-billion dollar partnership with China's Hengrui Pharma to jointly develop about a dozen drugs, including four experimental drugs that will be sent to China for early clinical trials, marking a new phase in cross-continental drug development.
- Significance of the Chinese Market: According to DealForma, over half of large pharmaceutical companies' licensing deals have originated from China this year, a significant increase from 39% last year, indicating a growing focus of American and European biopharmaceutical companies on the Chinese market, which could accelerate the introduction of new drugs.
- Shift in R&D Model: This partnership not only involves sending experimental drugs to China for development but also positions China as a crucial part of the global R&D ecosystem, reflecting the pharmaceutical industry's recognition of China's innovative capabilities and potentially altering the future landscape of drug development.
- Signal of Industry Transformation: As more companies conduct early drug development in China, industry experts believe this will enhance drug development efficiency and reduce costs, potentially challenging the traditional U.S. early drug discovery model and prompting global pharmaceutical companies to reassess their R&D strategies.
See More
Pharma and Biotech Deal-Making Trends Remain Strong
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- Expansion into New Areas: Clive Meanwell from Population Health Partners highlighted that while recent deals have focused on oncology and obesity, there is an expectation for expansion into other areas, especially central nervous system assets, showcasing the market's potential for diversification over the next few years.
- Merck's Acquisition Frenzy: Merck has spent nearly $26 billion on M&A from April 2025 to April 2026, driven by the impending patent expiration of its blockbuster oncology therapy Keytruda in 2028, prompting the company to accelerate transactions to maintain its competitive edge in the market.
- Limited Macro Impact: Despite challenges such as inflation, oil prices, and the ongoing Iran war, Tokat believes that pharma and biotech deal-making will remain active, indicating strong industry resilience capable of withstanding external shocks.
See More
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- Drug Prices vs. Innovation: PhRMA COO Lori Reilly indicated that Trump's 'Most Favored Nation' drug policy could depress funding for US drug R&D, thereby weakening the country's biopharma innovation capabilities, particularly in competition with China.
- Policy Impact Analysis: Reilly emphasized that adopting international drug policies that undervalue innovation could invite China to surpass the US in biopharma innovation, affecting future market leadership.
- Trade Tool Recommendations: She suggested that the Trump administration should leverage Section 301 of the Trade Act more to impose tariffs and import restrictions on unjustifiable trade practices, thereby protecting US intellectual property and market policies.
- Market Strategy Adjustments: Experts at the conference noted that companies might opt not to sell drugs in Europe due to profit-maximizing strategies, potentially leading to increased drug purchases from Chinese biopharma firms, further impacting US market share.
See More
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- New Stock Additions: In Q1 2026, Barrow, Hanley added 55 stocks, with the most significant being the acquisition of 1,334,140 shares of Progressive Corp, now comprising 0.87% of the portfolio valued at $264.48 million, indicating confidence in the insurance sector.
- Key Position Increases: The firm increased its stake in GE HealthCare Technologies by 5,378,190 shares, an 82.66% rise, bringing total holdings to 11,884,588 shares valued at approximately $845.94 million, reflecting strong optimism in the healthcare technology space.
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- Position Reductions: The firm reduced stakes in 105 stocks, particularly in Western Alliance Bancorp, cutting 4,087,469 shares, a 63.37% decrease, impacting the portfolio by -1.15%, highlighting uncertainty in the financial sector.
See More
Acting FDA CDER Leader Expected to Step Down
- Leadership Change: Following Marty Makary's resignation as FDA Commissioner on May 12, acting CDER Director Tracey Beth Hoeg is also expected to step down, indicating instability at the FDA that could impact drug approval processes.
- Tenure Background: Hoeg has served as acting director since December 2025 and joined the FDA in March 2025 as a special assistant and senior advisor to Makary, highlighting her rapid ascent and influence within the agency.
- Professional Background: Trained as a sports medicine physician and epidemiologist, Hoeg criticized school closures during the COVID-19 pandemic, suggesting her public health policy stance may influence FDA decision-making.
- Market Reaction: The leadership changes at the FDA could create uncertainty in the biopharmaceutical sector, particularly regarding partnerships and R&D with countries like China, potentially affecting future deal-making and investment strategies.
See More
Bristol Myers Squibb Partners with Hengrui Pharma for Drug Development
- Significant Partnership: Bristol Myers Squibb has announced a potential multi-billion dollar partnership with Hengrui Pharma, aiming to co-develop around a dozen drugs, including four that Bristol will send to China for early-stage clinical trials, marking a new phase of international collaboration in drug development.
- Shift in R&D Model: This collaboration represents a departure from traditional licensing agreements, as both companies will contribute resources to drug development, positioning China as a vital part of the global pharmaceutical R&D ecosystem and highlighting U.S. drugmakers' increasing focus on the Chinese market.
- Market Trend Shift: According to DealForma, over half of large pharmaceutical licensing deals this year have originated from China, up from 39% last year, indicating a growing trend among U.S. and European biopharmaceutical companies to shift early drug development to China to expedite market entry.
- Future Industry Outlook: Experts predict that early-stage drug discovery will increasingly move to China due to its ability to conduct studies at lower costs and faster timelines, potentially reshaping the U.S. pharmaceutical landscape and encouraging more companies to initiate early clinical trials in China.
See More
Bristol Myers Squibb Partners with Hengrui Pharma for Drug Development
- New Drug Collaboration: Bristol Myers Squibb has announced a potential multi-billion dollar partnership with China's Hengrui Pharma to jointly develop about a dozen drugs, including four experimental drugs that will be sent to China for early clinical trials, marking a new phase in cross-continental drug development.
- Significance of the Chinese Market: According to DealForma, over half of large pharmaceutical companies' licensing deals have originated from China this year, a significant increase from 39% last year, indicating a growing focus of American and European biopharmaceutical companies on the Chinese market, which could accelerate the introduction of new drugs.
- Shift in R&D Model: This partnership not only involves sending experimental drugs to China for development but also positions China as a crucial part of the global R&D ecosystem, reflecting the pharmaceutical industry's recognition of China's innovative capabilities and potentially altering the future landscape of drug development.
- Signal of Industry Transformation: As more companies conduct early drug development in China, industry experts believe this will enhance drug development efficiency and reduce costs, potentially challenging the traditional U.S. early drug discovery model and prompting global pharmaceutical companies to reassess their R&D strategies.
See More
Pharma and Biotech Deal-Making Trends Remain Strong
- Surge in Transactions: Eric Tokat from Centerview Partners noted that 34 significant transactions are expected in Q4 2025 and Q1 2026, indicating a robust trend in pharma and biotech deal-making, particularly with an increase in early-stage candidate deals compared to previous years.
- Expansion into New Areas: Clive Meanwell from Population Health Partners highlighted that while recent deals have focused on oncology and obesity, there is an expectation for expansion into other areas, especially central nervous system assets, showcasing the market's potential for diversification over the next few years.
- Merck's Acquisition Frenzy: Merck has spent nearly $26 billion on M&A from April 2025 to April 2026, driven by the impending patent expiration of its blockbuster oncology therapy Keytruda in 2028, prompting the company to accelerate transactions to maintain its competitive edge in the market.
- Limited Macro Impact: Despite challenges such as inflation, oil prices, and the ongoing Iran war, Tokat believes that pharma and biotech deal-making will remain active, indicating strong industry resilience capable of withstanding external shocks.
See More
Trump's Drug Policy May Harm US Biopharma Innovation
- Drug Prices vs. Innovation: PhRMA COO Lori Reilly indicated that Trump's 'Most Favored Nation' drug policy could depress funding for US drug R&D, thereby weakening the country's biopharma innovation capabilities, particularly in competition with China.
- Policy Impact Analysis: Reilly emphasized that adopting international drug policies that undervalue innovation could invite China to surpass the US in biopharma innovation, affecting future market leadership.
- Trade Tool Recommendations: She suggested that the Trump administration should leverage Section 301 of the Trade Act more to impose tariffs and import restrictions on unjustifiable trade practices, thereby protecting US intellectual property and market policies.
- Market Strategy Adjustments: Experts at the conference noted that companies might opt not to sell drugs in Europe due to profit-maximizing strategies, potentially leading to increased drug purchases from Chinese biopharma firms, further impacting US market share.
See More
Barrow, Hanley Investment Portfolio Insights Q1 2026
- New Stock Additions: In Q1 2026, Barrow, Hanley added 55 stocks, with the most significant being the acquisition of 1,334,140 shares of Progressive Corp, now comprising 0.87% of the portfolio valued at $264.48 million, indicating confidence in the insurance sector.
- Key Position Increases: The firm increased its stake in GE HealthCare Technologies by 5,378,190 shares, an 82.66% rise, bringing total holdings to 11,884,588 shares valued at approximately $845.94 million, reflecting strong optimism in the healthcare technology space.
- Complete Exits: In Q1 2026, Barrow, Hanley fully exited 45 holdings, notably selling all 7,482,558 shares of American International Group, resulting in a -2.13% impact on the portfolio, indicating a cautious outlook on the company’s future.
- Position Reductions: The firm reduced stakes in 105 stocks, particularly in Western Alliance Bancorp, cutting 4,087,469 shares, a 63.37% decrease, impacting the portfolio by -1.15%, highlighting uncertainty in the financial sector.
See More
