Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to alleged misstatements regarding the development of its prostate cancer drug TLX591 and deficiencies in its third-party manufacturing processes, leading to significant investor losses [2][3][6]. Regulatory Issues - The lawsuit follows regulatory setbacks, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, which resulted in a 21% decline in Telix's stock price [2][6]. - The SEC is reportedly questioning the accuracy of Telix's development disclosures, while the FDA rejected a Biologics License Application (BLA) due to serious deficiencies in Chemistry, Manufacturing, and Controls (CMC) [3][6]. Allegations of Misrepresentation - The complaint claims that Telix and its executives materially overstated the progress of their therapeutic candidates and misrepresented the reliability of their supply chain and manufacturing partners [2][3]. - Documented failures in regulatory compliance were allegedly concealed, contradicting the company's claims of significant progress and global manufacturing capabilities [3][6]. Investor Impact - The cumulative effect of the regulatory disclosures has led to substantial financial losses for investors who purchased Telix's American Depositary Shares (ADSs) during the class period from February 21, 2025, to August 28, 2025 [6]. - Following the final regulatory news, Telix's ADSs experienced a sharp decline, highlighting the impact of the alleged misstatements on investor confidence [2][6].

SAN FRANCISCO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- National shareholder rights law firm Hagens Berman reminds investors that the deadline to move the Court for appointment as lead plaintiff in the securities class action lawsuit against Telix Pharmaceuticals Ltd. (NASDAQ: TLX) is January 9, 2026. The lawsuit follows a series of regulatory setbacks and steep stock declines, including a 21% drop after the final regulatory news. The complaint alleges that Telix and its executives materially overstated the develo ...

Core Viewpoint - The article discusses a securities class action lawsuit against Telix Pharmaceuticals Ltd, alleging that the company and its executives misrepresented the progress of their prostate cancer drug candidates TLX591 and TLX592, as well as the reliability of their third-party manufacturing partners, leading to significant stock declines [1]. Regulatory Failures - On July 22, 2025, Telix disclosed an SEC subpoena related to the development of TLX591 and TLX592, raising questions about misleading disclosures regarding drug development progress [1]. - On August 28, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the Zircaix (TLX250-CDx) application due to deficiencies in Chemistry, Manufacturing, and Controls (CMC), along with documented Form 483 deficiencies at third-party manufacturers [1]. Stock Impact - Following the regulatory revelations, Telix's American Depositary Shares (ADSs) experienced a sharp decline, including a 21% drop after the final regulatory news [1]. - The lawsuit claims that investors who purchased TLX ADSs during the class period (February 21, 2025 – August 28, 2025) may be entitled to damages due to the undisclosed issues [1]. Legal Proceedings - The deadline for investors to move the court for appointment as lead plaintiff in the class action lawsuit is January 9, 2026 [1]. - Hagens Berman, the law firm leading the litigation, is actively advising affected investors and has a history of securing substantial recoveries for investors [1].

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Charles River Laboratories (NYSE:CRL) FY Conference December 03, 2025 10:00 AM ET Company ParticipantsElizabeth Anderson - Senior Managing DirectorJim Foster - Chairman, President and CEOElizabeth AndersonMorning, everybody. Thanks so much for joining us. I'm Elizabeth Anderson. I'm the Health Care Services and CRO analyst here at Evercore. I am very happy to be joined by a man who needs no introduction, Jim Foster, Chairman, President, and CEO of Charles River. And so, you know, let's start with the 8-K th ...

Core Insights - The Madison Small Cap Fund experienced a challenging third quarter in 2025, with a decline of 1.3%, underperforming its benchmarks due to stock selection and a speculative market environment [1] Company Analysis: Charles River Laboratories International, Inc. (NYSE:CRL) - Charles River Laboratories operates in the drug discovery and development outsourcing sector, providing a range of services including drug discovery, non-clinical development, and safety testing [2] - The stock of Charles River Laboratories saw a one-month return of -14.15% and a 52-week decline of 16.72%, closing at $167.64 with a market capitalization of $8.25 billion on November 21, 2025 [2] - The Madison Small Cap Fund initiated a position in Charles River Laboratories in Q3 2025, highlighting its high-quality service offerings and strong operating margins of 20% or more [3] - Despite recent challenges in the drug development space, Charles River Laboratories has shown a 12% compound annual growth rate over the past decade, indicating resilience [3] - The management team is experienced, and the company is expected to achieve earnings power of approximately $15 by 2028, with a conservative intrinsic value estimate of $228 based on a sum of the parts analysis at ~12x EBITDA [3] - Revenue growth is anticipated at 4% from 2024 to 2028, supported by restructuring and cost management efforts [3]

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Core Insights - Charles River Laboratories International, Inc. (CRL) is a contract research organization with a market cap of approximately $8 billion, providing drug discovery, non-clinical development, and safety testing services [1] Financial Performance - CRL's stock has underperformed the broader market, declining 13.7% over the past 52 weeks and 12.2% year-to-date, while the S&P 500 Index gained 10.5% over the same period [2] - The company's stock prices dropped 5.7% following the release of its Q3 results, where the topline dipped 49 basis points year-over-year to $1 billion, but exceeded expectations by 2.1% [4] - Adjusted EPS for Q3 declined 6.2% year-over-year to $2.43, surpassing consensus estimates by 4.7% [4] - For the full fiscal 2025, analysts expect CRL to deliver an adjusted EPS of $10.21, down 1.1% year-over-year [5] Analyst Ratings and Price Targets - Among 16 analysts covering CRL, the consensus rating is a "Moderate Buy," with 10 "Strong Buys" and six "Holds" [5] - Morgan Stanley analyst Ricky Goldwasser maintained an "Equal-Weight" rating and raised the price target from $170 to $185, with a mean price target of $192.93 representing a 19% premium to current price levels [7] - The street-high target of $211 suggests a notable 30.2% upside potential [7]

Group 1 - David Windley from Jefferies LLC has over 25 years of experience covering Contract Research Organizations (CROs) [1] - Charles River Laboratories is represented by COO Birgit Girshick and lead IR Todd Spencer at the event [2]

Summary of Charles River Laboratories Conference Call Company Overview - **Company**: Charles River Laboratories (NYSE: CRL) - **Industry**: Contract Research Organizations (CROs) Key Points Demand Environment - The company reported a net book-to-bill ratio of 0.82, unchanged from Q2, primarily due to a lull in biotech during Q3 [4][5] - There has been an improvement in bookings in biotech over the last few months, indicating a positive trend moving into the fall and winter [4][5] - Proposal volume in both biotech and global segments has been strong, providing confidence for future quarters [4] Pricing Strategy - Charles River holds approximately 30% market share in the safety assessment market, with competitors significantly smaller [7] - The company is strategically using pricing to maintain market share and attract new clients, especially in a softer demand environment [8][9] - Pricing has stabilized, with no significant headwinds anticipated in the safety assessment business [10] Discovery Services - Discovery services represent about 10% of the DSA segment and have been soft due to tight biotech funding [11] - The company expects a rebound in discovery services as biotech funding improves [11] Sales Strategy - The DSA business operates holistically, allowing for better utilization of resources and maximizing client wallet share [14][15] - The sales strategy is not heavily dependent on pull-through from discovery services due to the small size of the discovery segment [13] China Market Dynamics - About 30% of all programs are now in-licensed from China, which poses minimal preclinical work for Charles River [18] - The company is monitoring the trend of drug discovery moving to China and the competitive landscape with local providers [19][20] - Charles River is interested in both servicing Western companies and the domestic Chinese market, but is cautious due to geopolitical pressures [21] Non-Human Primate (NHP) Market - NHP shipments were pulled forward from Q4 to Q3, with stable supply chains established [22][23] - The company has closed investigations by the DOJ and SEC, indicating no concerns regarding animal welfare [24] Research Models Segment - North America has seen a decline in research model volumes, primarily driven by the biotech segment, while Europe and China have held up better [28][30] - The company believes that research model volumes will rebound with improved biotech funding [30] Cost-Saving Initiatives - Charles River announced an additional $70 million in cost savings, building on a previous $225 million initiative [31] - Cost-saving measures include site consolidations, efficiency improvements in G&A, and digital automation [31] Acquisition Strategy - The company has a clear roadmap for acquisitions, focusing on core business areas to enhance client wallet share, particularly in bioanalytical services and potential opportunities in China [36] Additional Insights - The company is committed to refining its service portfolio to remain competitive [12] - The strategic review may lead to share repurchases or acquisitions, depending on market conditions [34][36]