CROs Decline as FDA Chief Makary Indicates Fewer Trials Needed for Drug Approvals
Written by Emily J. Thompson, Senior Investment Analyst
Source: SeekingAlpha
FDA Announcement Impact: FDA Commissioner Marty Makary stated that pharmaceutical companies will only need to submit results from one pivotal trial for most new drug approvals, which has negatively affected contract research organizations (CROs) like Charles River Laboratories, ICON, and IQVIA.
Market Reaction: Following the announcement, Medpace experienced the largest decline among CROs, dropping approximately 4%, while IQVIA and Fortrea saw a decrease of around 2%.
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Analyst Views on CRL
Wall Street analysts forecast CRL stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for CRL is 202.10 USD with a low forecast of 170.00 USD and a high forecast of 225.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
12 Analyst Rating
8 Buy
4 Hold
0 Sell
Moderate Buy
Current: 216.880
Low
170.00
Averages
202.10
High
225.00
Current: 216.880
Low
170.00
Averages
202.10
High
225.00
About CRL
Charles River Laboratories International, Inc. is a drug development company. It provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and academic institutions around the globe accelerate their research and drug development efforts. Its Research Models and Services segment includes three businesses that provide foundational tools that enable its clients to discover new molecules: Research Models, Research Model Services, and Cell Solutions. Its Discovery and Safety Assessment segment provides regulated and non-regulated DSA services to support the research, development, and regulatory-required safety testing of potential new drugs, including therapeutic discovery and optimization plus in vitro and in vivo studies, laboratory support services, and strategic non-clinical consulting and program management to support product development. Its Manufacturing Solutions segment includes Microbial Solutions and Biologics Solutions.
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.
Charles River Laboratories to Release Q4 2025 Results and 2026 Guidance on February 18
- Earnings Release Schedule: Charles River Laboratories is set to announce its Q4 and full-year 2025 financial results along with 2026 guidance on February 18, 2025, before market open, aiming to provide investors with a clear outlook for the future.
- Conference Call Details: A conference call is scheduled for February 18, 2025, at 8:30 a.m. ET to discuss the financial results and guidance, enhancing communication and transparency with investors.
- Live Webcast Opportunity: Investors will have the opportunity to listen to a live webcast of the conference call through the Investor Relations section of the company's website, ensuring timely access to key information for all stakeholders.
- Replay Access: Following the call, a replay will be available on the same website, further improving the accessibility and transparency of information for investors.
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Charles River Laboratories Under Investigation, Revenue Growth Expected to Decline by 400 Basis Points
- Investigation Launched: Former Louisiana Attorney General Charles C. Foti announces that Kahn Swick & Foti, LLC is investigating Charles River Laboratories for potential breaches of fiduciary duties to shareholders.
- Legal Action: Charles River and its executives are facing a securities class action lawsuit for failing to disclose material information, which could further impact the company's reputation and stock price.
- Revenue Growth Decline: The company disclosed in February 2023 that it suspended shipments of non-human primates from Cambodia due to a subpoena from the U.S. Department of Justice, leading to an expected revenue growth decline of 200 to 400 basis points, directly affecting annual financial performance.
- Compliance Risks: Kahn Swick & Foti's investigation will assess whether Charles River violated state or federal laws, and if confirmed, could lead to more severe legal consequences and financial losses.
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