Latest news with #NAMs
Yahoo
03-07-2025
- Business
- Yahoo
Craig-Hallum Trims Simulations (SLP) Price Target, Maintaining a Buy Rating
Simulations Plus, Inc. (NASDAQ:SLP) is one of the top 10 healthcare AI stocks to buy according to hedge funds. Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of modeling and simulation software for pharmaceutical research, saw its price target lowered by Craig-Hallum to $36 from $45 following a cautious Q3 pre-release and a downward revision of its fiscal year 2025 guidance. Despite maintaining a Buy rating, the firm highlighted growing macroeconomic headwinds that are weighing on the company's services segment. Clients have reportedly been slow to initiate new contracts, delay clinical trials, and hold off on major spending decisions—a trend that's been broadly felt across the healthcare landscape. A close-up view of a scientist's hand pressing keys on a laptop as another looks closely at a 3-D model on a large monitor. However, Simulations Plus' core software segment remains resilient. Known for its predictive modeling platforms used in drug discovery and development, the company plays a key role in advancing New Approach Methodologies (NAMs), which aim to modernize and reduce reliance on traditional clinical trials. These technologies, essential in streamlining the drug development process, are gaining broader acceptance across regulators and pharmaceutical companies, solidifying Simulations Plus' role in a rapidly evolving healthcare ecosystem. Craig-Hallum sees long-term potential in this structural shift. While near-term disruptions may cloud visibility, the firm notes that Simulations Plus continues to operate in a growing, innovation-driven market. For investors looking to align with the digital transformation of drug development, the company represents a compelling opportunity rooted in both regulatory trends and scientific advancement. While we acknowledge the potential of SLP to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SLP and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 13 Best Biotech Stocks To Invest In Now and 12 Best Healthcare Stocks to Buy Now. Disclosure: None. Sign in to access your portfolio
Newsweek
03-07-2025
- Health
- Newsweek
The Bulletin June 21, 2025
The rundown: The issue of animal testing is something most Americans agree on: it needs to change and gradually be stopped. Since President Donald Trump began his second term, his administration has been making moves to transform and reduce animal testing in country. Find out what steps are being taken. Why it matters: In April, the Food and Drug Administration (FDA) said that its animal testing requirement will be "reduced, refined, or potentially replaced" with a range of approaches, including artificial intelligence-based models, known as New Approach Methodologies or NAMs data. The Trump administration's efforts to tackle the issue of animal testing appear to be a step in the right direction, according to experts who spoke with Newsweek. Read more in-depth coverage: Over 300 Animals Removed From US Safari After Decade of Red Flags TL/DR: Millions of animals each year are killed in U.S. laboratories as part of medical training and chemical, food, drug and cosmetic testing. What happens now? A Department of Health and Human Services (HHS) official told Newsweek: "The agency is paving the way for faster, safer, and more cost-effective treatments for American patients.' Deeper reading How Animal Testing in US Could Be Transformed Under Trump
Associated Press
12-06-2025
- Business
- Associated Press
Predictive Oncology Develops Functional 3D Organoid Models Exclusively for Labcorp
PITTSBURGH, June 12, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery, announced today the company has successfully developed 3D organoid models exclusively for Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. As part of an ongoing agreement, Predictive Oncology recently developed two distinct and unique 3D liver toxicity models exclusively for Labcorp, including a human and rat model. Both models represent the liver microenvironment and can be used for the evaluation of both drug metabolism and liver toxicity related to drugs. 'The intention of these 3D organoid models is to enable the prediction of in vivo drug clearance, drug transport and hepatotoxicity related to drugs,' said Dr. Arlette Uihlein, Senior Vice President Translational Medicine and Drug Discovery for Predictive Oncology. 'These models provide highly relevant, species-specific data based on their physiologic hepatic microenvironments while also capturing hepatic cellular heterogeneity.' These and other 3D organoid models developed by Predictive Oncology substantially complement its AI-driven 2D platform and 3D spheroids, which utilize human tumor samples to accelerate drug discovery and identify relevant biomarkers across thousands of patients. The platform relies on Predictive Oncology's vast biobank of over 150,000 frozen tumor samples. 'Labcorp is committed to developing and using new approach methodologies (NAMs) in preclinical studies. These models show great promise to enable more rapid evaluation of new potential medicines and help accelerate their availability to patients,' said John Kendrick, Ph.D., NAMs scientific strategy lead at Labcorp. 'With this foundation in place, Labcorp will consider expanding this work into other species to support wider preclinical analyses and translate between animal and human models for these new alternative approaches.' According to Grand View Research, with the growing investment in personalized medicine and biotechnology, organoid-based platforms are key drivers to disrupting healthcare, accelerating drug development, reducing reliance on animal models, and paving the way for next-generation therapeutic solutions. Organoids are transforming disease modeling, drug discovery, and regenerative medicine, offering cost-effective and high-fidelity alternatives to traditional research methods. The functional 3D organoid models developed for Labcorp with specialized matrices and media supplements provide insights into cancer therapeutic behavior in patients. Data sets demonstrating optimal liver morphology and function were generated, including cell junction formation (ZO-1 staining); transferrin staining within hepatocytes; DCFDA staining for hepatotoxicity measurements; canalicular structure visualization; and cell viability confirmation (up to 14 days). About Predictive Oncology Predictive Oncology is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early drug discovery and enable drug development for the benefit of cancer patients worldwide. The company's scientifically validated AI platform, PEDAL, is able to predict with 92% accuracy if a tumor sample will respond to a certain drug compound, allowing for a more informed selection of drug/tumor type combinations for subsequent in-vitro testing. Together with the company's vast biobank of more than 150,000 assay-capable heterogenous human tumor samples, Predictive Oncology offers its academic and industry partners one of the industry's broadest AI-based drug discovery solutions, further complimented by its wholly owned CLIA laboratory facility. Predictive Oncology is headquartered in Pittsburgh, PA. Investor Relations Contact: Mike Moyer LifeSci Advisors, LLC [email protected] Forward-Looking Statements Certain statements made in this press release are 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These forward- looking statements reflect Predictive Oncology's current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about Predictive Oncology's operations and the investments Predictive Oncology makes. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, changes in management, plans and objectives of management are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'would,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Predictive Oncology's actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading 'Risk Factors' in Predictive Oncology's filings with the SEC. Except as expressly required by law, Predictive Oncology disclaims any intent or obligation to update these forward-looking statements. Predictive Oncology does not give any assurance that Predictive Oncology will achieve its expectations described in this press release.
Associated Press
12-06-2025
- Business
- Associated Press
Infinimmune Launches GLIMPSE-1 AI Model Trained Exclusively on Human Antibody Sequences for Advanced Therapeutic Engineering
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun 12, 2025-- Infinimmune, a biotechnology company pioneering human-first antibody discovery and design, today announced the launch of GLIMPSE-1, a protein language model trained solely on native human antibody sequences. Developed using millions of paired heavy and light chains from human memory B cells, GLIMPSE-1 represents a new paradigm for therapeutic antibody engineering that applies the design principles of the human adaptive immune system. Infinimmune published results in a new bioRxiv preprint, demonstrating that GLIMPSE-1 can humanize clinical antibodies, engineer for affinity and developability parameters, and generate highly divergent functional variants, all through in silico design guided by the biology of the human adaptive immune system. 'Fully human antibodies carry the evolutionary fingerprints of the human immune system, optimized over millions of years,' said Wyatt McDonnell, Ph.D., Co-Founder and CEO, Infinimmune. 'With GLIMPSE-1, we can decode and encode that logic directly from immune repertoires to discover and design better, safer biologics from day one. This approach complements the FDA's recent focus on assessing human-relevant methods for therapeutic development, which could ultimately benefit patients through more comprehensive safety assessment. We believe models like GLIMPSE-1 will remain essential in the discovery and development of modern antibody medicines.' GLIMPSE-1 was developed as a core component of Infinimmune's therapeutic development capabilities, strengthening the company's pipeline of antibody drug candidates. The model was trained using a large, diverse dataset with proprietary sequences from Infinimmune's Complete Human® and Anthrobody® technologies, which source antibodies directly from native human repertoires, allowing it to learn the biological and functional constraints of human immunity. Key results from the preprint include: GLIMPSE-1 operates entirely in human antibody sequence space, predicting viable antibody variants without 3D structure modeling, energy calculations, or experimental screening beforehand. The resulting antibodies maintain essential functional properties and characteristics consistent with clinically approved monoclonal antibodies, all guided by patterns learned from human immune systems. The development of GLIMPSE-1 aligns with recent FDA initiatives exploring human-relevant methodologies for therapeutic development. The FDA's roadmap for integrating New Approach Methodologies (NAMs) identifies monoclonal antibodies as an initial focus area, creating an environment where human-first models like GLIMPSE-1 may provide valuable complementary insights. Infinimmune has successfully integrated GLIMPSE-1 into its therapeutic antibody development pipeline, where the model has significantly contributed to the engineering and optimization of the company's lead programs. The company is currently exploring strategic partnerships with pharmaceutical and biotechnology companies to apply GLIMPSE-1's capabilities to partner's therapeutic programs. About Infinimmune Infinimmune is a biotechnology company pioneering a novel approach to antibody drug discovery and development. Founded by a world-class, multidisciplinary team of scientists and technologists, Infinimmune is reinventing antibody discovery with an end-to-end platform to deliver antibody drugs derived directly from the human immune system. These truly human antibodies are designed to drug new and existing targets with improved safety and efficacy. Infinimmune is building its own pipeline of drug candidates and partnering with pharmaceutical companies to advance their antibody programs, fill their pipelines, and reach new patients and new indications. To learn more, visit and follow us on LinkedIn and @infinimmune. View source version on CONTACT: Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: RESEARCH TECHNOLOGY GENETICS SOFTWARE BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ARTIFICIAL INTELLIGENCE OTHER SCIENCE SOURCE: Infinimmune Copyright Business Wire 2025. PUB: 06/12/2025 08:07 AM/DISC: 06/12/2025 08:05 AM
Yahoo
11-06-2025
- Business
- Yahoo
CRL Q1 Earnings Call: Regulatory Changes and Market Stabilization Shape Outlook
Lab services company Charles River Laboratories (NYSE:CRL) reported Q1 CY2025 results exceeding the market's revenue expectations , but sales fell by 2.7% year on year to $984.2 million. Its non-GAAP profit of $2.34 per share was 12.8% above analysts' consensus estimates. Is now the time to buy CRL? Find out in our full research report (it's free). Revenue: $984.2 million vs analyst estimates of $941.3 million (2.7% year-on-year decline, 4.6% beat) Adjusted EPS: $2.34 vs analyst estimates of $2.07 (12.8% beat) Management raised its full-year Adjusted EPS guidance to $9.55 at the midpoint, a 2.1% increase Operating Margin: 7.6%, down from 12.5% in the same quarter last year Organic Revenue fell 1.8% year on year (-3.3% in the same quarter last year) Market Capitalization: $7.42 billion Charles River Laboratories' first quarter results reflected a period of stabilization amid shifting regulatory and market dynamics. Management attributed performance to stronger-than-expected demand in the Drug Discovery and Safety Assessment (DSA) segment, particularly from global biopharmaceutical clients seeking quicker study starts. CEO Jim Foster emphasized the company's ongoing adaptation to regulatory developments, notably the FDA's push for New Approach Methods (NAMs) to reduce animal testing in preclinical research. Segment performance was mixed, with resilience in research models and manufacturing partially offset by declines in certain specialty areas. The leadership team acknowledged that industry headwinds, such as government funding cuts and persistent uncertainties in biotech funding, continue to weigh on near-term visibility. CFO Flavia Pease credited cost-saving initiatives and improved study mix for supporting operating margins despite the revenue decline. Looking ahead, Charles River Laboratories' outlook is shaped by cautious optimism regarding market stabilization and the gradual adoption of alternative testing methods. Management raised its full-year adjusted EPS guidance, citing improved DSA bookings and a more favorable study mix, but remains wary of potential headwinds. CEO Jim Foster explained, 'We are modestly increasing our full-year revenue guidance for the DSA segment based on improved bookings, though we are not assuming this trend will persist into the second half.' The company is closely monitoring regulatory changes, particularly the FDA's evolving stance on NAMs, as well as broader factors such as NIH funding and tariffs. Strategic investments in non-animal platforms and continued cost discipline are expected to be key contributors to future performance. Management linked the quarter's outperformance to a rebound in DSA bookings, cost savings from restructuring, and incremental progress in alternative testing methods. The company also highlighted the impact of regulatory changes and evolving client demand on its business mix. DSA bookings rebound: The DSA segment saw its net book-to-bill ratio rise above 1x for the first time in over two years, driven by improved bookings from global biopharma clients and fewer cancellations across all customer segments. Management noted that much of this activity was due to studies with faster start dates, reflecting a shift toward shorter-term project commitments. NAMs and regulatory alignment: CEO Jim Foster addressed the FDA's recent push towards New Approach Methods (NAMs), which aim to reduce animal testing in drug development. While acknowledging the gradual nature of this shift, management emphasized Charles River Laboratories' investments in NAMs platforms, such as organ-on-a-chip and in silico (computer-based) modeling, and reported approximately $200 million in annual DSA revenue from NAMs-related services. Segment-specific headwinds: The Research Models and Services (RMS) segment experienced a modest decline, primarily attributed to the timing of non-human primate (NHP) shipments in China and weaker Cell Solutions revenue. Academic and government clients presented a potential risk due to proposed NIH budget cuts, though no immediate impact was observed in the quarter. Manufacturing dynamics: Manufacturing revenue was flat year over year, with growth in Microbial Solutions offset by lower commercial revenue in the Cell and Gene Therapy CDMO business. Biologics Testing volumes started the year slowly, but management expressed confidence in a rebound as the year progresses, citing strong booking activity. Cost management and board changes: Ongoing restructuring and cost-saving initiatives contributed to operating margin stability. The company announced new board members and a strategic review in collaboration with Elliott Investment Management, aiming to identify value creation opportunities and optimize capital allocation. Management's outlook for the remainder of the year hinges on sustained DSA momentum, regulatory adaptation, and prudent cost controls, with caution around funding and regulatory shifts. Evolving regulatory landscape: The FDA's initiative to accelerate NAMs adoption will influence both client demand and Charles River Laboratories' service mix. Management believes broader adoption of NAMs will be gradual and expects hybrid models (combining NAMs with animal studies) to become more common, especially in monoclonal antibody research. Market stabilization and client mix: Leadership anticipates continued stabilization in demand from small and midsized biotech clients, despite ongoing funding challenges. However, the company remains cautious about potential pullbacks in academic and government spending if NIH budget cuts materialize later in the year or in 2026. Cost discipline and operational efficiency: Continued focus on cost-saving measures and restructuring is expected to help maintain margins. Management projects durable savings from recent initiatives while balancing investment in new capabilities and preparation for possible market headwinds. In the coming quarters, the StockStory team will track (1) whether DSA bookings and net book-to-bill ratios remain above 1x, (2) the pace of NAMs adoption and its impact on both revenue mix and client study designs, and (3) any signs of reduced spending from academic and government clients if NIH funding changes take effect. Additional attention will be given to the outcomes of the board's strategic review and progress in Manufacturing segment recovery. Charles River Laboratories currently trades at a forward P/E ratio of 15.8×. Should you double down or take your chips? The answer lies in our full research report (it's free). Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 9 Market-Beating Stocks. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025). Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. 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