FDA Plans to Reduce Drug Approval Trials, Shares of Icon and Others Drop
Shares of companies that conduct drug trials on behalf of pharmaceutical companies, such as Icon, Iqvia, and Medpace, are trading lower following a media report stating the Food and Drug Administration is planning to reduce the number of trials required for many drug approvals.ONLY ONE CLINICAL STUDY:The FDA plans to generally require only one clinical study, rather than the traditional two, for medical product approvals, according to Commissioner Marty Makary, STAT's Lizzy Lawrence. While two trials will still be required in certain cases, the default approach will shift to a single pivotal study, reflecting current industry practices, according to the report.While historically the FDA has required two trials for added assurance of a drug's safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval, the author notes. Makary said that while the agency will still require two in some cases, the default will be one trial."You can achieve the same statistical power with one trial as you would with two trials when it's designed and controlled appropriately," Makary told STAT.Publicly traded drugmakers include AstraZeneca, Bristol Myers, Eli Lilly, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, Rocheand Sanofi, while companies conducting drug trials on behalf of pharmaceutical companies include Icon, Iqvia, and Medpace.COVERAGE INITIATION:Last month, BMO Capital analyst Sean Dodge initiated coverage of Icon with a Market Perform rating and $175 price target. The firm's analysis suggests the company's cancellations are likely to remain elevated for the next few quarters. However, it also indicates the worst is probably now behind Icon, the analyst tells investors in a research note.BMO Capital also started coverage of Medpace with a Market Perform rating and $600 price target. The firm views the stock's valuation as full in a "tepid" biotech funding backdrop. The shares at current levels leave "little cushion for additional potential macro volatility," the analyst tells investors in a research note.More bullish on the name, BMO Capital initiated Iqvia with an Outperform rating and $260 price target. The firm believes the company is past the worst of its cancelations. This paves the way for an earnings reacceleration and valuation re-rate into 2026, the analyst tells investors in a research note.STRATEGIC COLLABORATION:On Tuesday, Iqvia announced a strategic collaboration with Amazon Web Services, naming AWS as Iqvia's preferred agentic cloud provider. Under the agreement, Iqvia will deploy its AI platform on AWS. In addition, Iqvia and AWS will explore new opportunities in life science analytics.PRICE ACTION:In morning trading, shares of Icon have dropped about 6% to $176.59, while Iqvia has slipped a little over 5% to $215.15 and Medpace has plunged almost 8% to $532.
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Trinity Street Fully Exits Axalta Stake in $22.1 Million Transaction
- Full Exit: Trinity Street Asset Management LLP disclosed on January 22, 2026, that it liquidated its entire holding of 770,919 shares in Axalta Coating Systems, with an estimated transaction value of $22.06 million, indicating a lack of confidence in the company's growth prospects.
- Asset Allocation Shift: This transaction reduced Axalta's representation to 0% of Trinity's 13F AUM, while its top five holdings include Taiwan Semiconductor valued at $293.8 million, or 18.5% of AUM, reflecting a preference for companies with better growth potential.
- Poor Market Performance: As of January 21, 2026, Axalta's share price stood at $33.47, down 9.5% over the past year, significantly underperforming the S&P 500 by 23.2 percentage points, highlighting sluggish growth in the coatings sector.
- Investor Strategy: Trinity sold a small position representing about 1.5% of its assets in Q3, possibly for tax-loss harvesting or due to diminished confidence in Axalta's growth, while simultaneously increasing investments in other major holdings like Taiwan Semiconductor, indicating a shift towards companies with higher growth potential.
Unusual Volume Noted for SPWO ETF on Friday
ETF Performance: The SP Funds S&P World ex-US ETF saw significant trading activity on Friday, with Infosys rising approximately 6.3% and Wipro increasing about 7.2%.
Trading Volume: Infosys had over 80.4 million shares traded, while Wipro had over 26.6 million shares changing hands during the session.
Icon's Performance: In contrast, Icon was underperforming compared to other ETF components, trading down by about 1.3%.
Author's Disclaimer: The opinions expressed in the article are those of the author and do not necessarily represent the views of Nasdaq, Inc.
BofA Securities Changes ICON Rating from Buy to Neutral
- Company Overview: ICON (ICLR) has received an average rating of "overweight" from analysts.
- Price Target: The mean price target for ICON is set at $205.56.
ICON Releases 2025 Global Biotech Survey, 92% Executives Show Strong Confidence
- Industry Resilience: ICON's global biotech survey reveals that 92% of 163 respondents expect to reach their next investment milestone, indicating strong confidence in the industry despite funding pressures, which drives innovation and collaboration.
- Increased R&D Spending: The survey shows that 75% of biotech firms plan to increase R&D spending over the next two years, reflecting resilience and a commitment to innovation in the face of drug development complexities.
- Changing Funding Sources: APAC biotechs report that venture capital constitutes 60% of their current funding sources, compared to 32% for the US and 30% for Europe, highlighting a deepening reliance on VC in the APAC market.
- Talent Shortage Issues: In APAC, 47% of respondents identified talent shortages as an operational impact factor, nearly three times the global average, underscoring the challenges in attracting and retaining talent in the region.
ICON Reports Clinical Trial Startup Survey, 55% of Respondents Say Activation Time Exceeds 5 Months
- Survey Reveals Bottlenecks: ICON's recent industry survey indicates that 55% of respondents report activation times exceeding 5 months from site selection, highlighting significant challenges in the clinical trial startup phase that hinder timely access to new therapies.
- Prevalence of Contract and Budget Delays: 66% of respondents frequently experience contract and budget delays, with 92% identifying these as critical areas for improvement by sponsors and CROs, underscoring the urgent need for enhanced support efficiency in the industry.
- Communication Quality Needs Improvement: 47% of respondents rated sponsor and CRO communication as average or poor, emphasizing the importance of a site-centric collaborative model to address current communication gaps and accelerate trial processes.
- Whitepaper Proposes Solutions: ICON's newly released whitepaper outlines actionable strategies, including implementing site engagement approaches that balance alignment with competing priorities, to address rising site attrition rates and promote efficient clinical trial startups.
ICON Survey Highlights Rising Delays in Clinical Trial Startups, Emphasizing the Importance of Human-Centered Site Activation Solutions
Survey Findings: ICON plc's recent survey highlights significant challenges faced by clinical trial sites, including operational bottlenecks, contract and budget delays, and poor communication, with 55% of respondents reporting activation times exceeding 5 months.
Need for Improvement: A majority of respondents (66%) frequently encounter contract and budget delays, and 92% believe that sponsors and CROs need to enhance their support, particularly in communication.
Actionable Strategies: The accompanying whitepaper outlines strategies for improving trial startup processes, such as implementing site engagement approaches, utilizing predictive analytics, and adopting data-informed site selection methods.
Industry Context: The survey reflects a growing concern in the industry, with site pre-selection decline rates increasing from 35% to 47% between 2021 and 2023, emphasizing the urgency of addressing these operational challenges.
Trinity Street Fully Exits Axalta Stake in $22.1 Million Transaction
- Full Exit: Trinity Street Asset Management LLP disclosed on January 22, 2026, that it liquidated its entire holding of 770,919 shares in Axalta Coating Systems, with an estimated transaction value of $22.06 million, indicating a lack of confidence in the company's growth prospects.
- Asset Allocation Shift: This transaction reduced Axalta's representation to 0% of Trinity's 13F AUM, while its top five holdings include Taiwan Semiconductor valued at $293.8 million, or 18.5% of AUM, reflecting a preference for companies with better growth potential.
- Poor Market Performance: As of January 21, 2026, Axalta's share price stood at $33.47, down 9.5% over the past year, significantly underperforming the S&P 500 by 23.2 percentage points, highlighting sluggish growth in the coatings sector.
- Investor Strategy: Trinity sold a small position representing about 1.5% of its assets in Q3, possibly for tax-loss harvesting or due to diminished confidence in Axalta's growth, while simultaneously increasing investments in other major holdings like Taiwan Semiconductor, indicating a shift towards companies with higher growth potential.
Unusual Volume Noted for SPWO ETF on Friday
ETF Performance: The SP Funds S&P World ex-US ETF saw significant trading activity on Friday, with Infosys rising approximately 6.3% and Wipro increasing about 7.2%.
Trading Volume: Infosys had over 80.4 million shares traded, while Wipro had over 26.6 million shares changing hands during the session.
Icon's Performance: In contrast, Icon was underperforming compared to other ETF components, trading down by about 1.3%.
Author's Disclaimer: The opinions expressed in the article are those of the author and do not necessarily represent the views of Nasdaq, Inc.
BofA Securities Changes ICON Rating from Buy to Neutral
- Company Overview: ICON (ICLR) has received an average rating of "overweight" from analysts.
- Price Target: The mean price target for ICON is set at $205.56.
ICON Releases 2025 Global Biotech Survey, 92% Executives Show Strong Confidence
- Industry Resilience: ICON's global biotech survey reveals that 92% of 163 respondents expect to reach their next investment milestone, indicating strong confidence in the industry despite funding pressures, which drives innovation and collaboration.
- Increased R&D Spending: The survey shows that 75% of biotech firms plan to increase R&D spending over the next two years, reflecting resilience and a commitment to innovation in the face of drug development complexities.
- Changing Funding Sources: APAC biotechs report that venture capital constitutes 60% of their current funding sources, compared to 32% for the US and 30% for Europe, highlighting a deepening reliance on VC in the APAC market.
- Talent Shortage Issues: In APAC, 47% of respondents identified talent shortages as an operational impact factor, nearly three times the global average, underscoring the challenges in attracting and retaining talent in the region.
ICON Reports Clinical Trial Startup Survey, 55% of Respondents Say Activation Time Exceeds 5 Months
- Survey Reveals Bottlenecks: ICON's recent industry survey indicates that 55% of respondents report activation times exceeding 5 months from site selection, highlighting significant challenges in the clinical trial startup phase that hinder timely access to new therapies.
- Prevalence of Contract and Budget Delays: 66% of respondents frequently experience contract and budget delays, with 92% identifying these as critical areas for improvement by sponsors and CROs, underscoring the urgent need for enhanced support efficiency in the industry.
- Communication Quality Needs Improvement: 47% of respondents rated sponsor and CRO communication as average or poor, emphasizing the importance of a site-centric collaborative model to address current communication gaps and accelerate trial processes.
- Whitepaper Proposes Solutions: ICON's newly released whitepaper outlines actionable strategies, including implementing site engagement approaches that balance alignment with competing priorities, to address rising site attrition rates and promote efficient clinical trial startups.
ICON Survey Highlights Rising Delays in Clinical Trial Startups, Emphasizing the Importance of Human-Centered Site Activation Solutions
Survey Findings: ICON plc's recent survey highlights significant challenges faced by clinical trial sites, including operational bottlenecks, contract and budget delays, and poor communication, with 55% of respondents reporting activation times exceeding 5 months.
Need for Improvement: A majority of respondents (66%) frequently encounter contract and budget delays, and 92% believe that sponsors and CROs need to enhance their support, particularly in communication.
Actionable Strategies: The accompanying whitepaper outlines strategies for improving trial startup processes, such as implementing site engagement approaches, utilizing predictive analytics, and adopting data-informed site selection methods.
Industry Context: The survey reflects a growing concern in the industry, with site pre-selection decline rates increasing from 35% to 47% between 2021 and 2023, emphasizing the urgency of addressing these operational challenges.
