Latest news with #biologics
National Post
11 hours ago
- Business
- National Post
Agenus and Zydus Lifesciences Enter $141M Strategic Collaboration to Advance BOT/BAL, Expand Zydus' Biologics Manufacturing in the US
Article content LEXINGTON, Mass. — Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as 'Zydus,' designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). Article content The strategic collaboration includes an exchange of Agenus' state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus' first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen's BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization. Article content Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus' established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. Article content In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL. Article content By uniting Agenus' pioneering research and development capabilities with Zydus' worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond. Article content 'With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,' said Dr. Garo Armen, CEO of Agenus. 'There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.' Article content 'We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer,' said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd. Article content The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days. Article content Conference Call and Webcast Article content As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations. Article content About Agenus Article content Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Article content About Zydus Lifesciences Article content Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit Article content Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Article content Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit Article content About Balstilimab (BAL) Article content Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Article content Forward-Looking Statements Article content This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words 'may,' 'believes,' 'expects,' 'anticipates,' 'hopes,' 'intends,' 'plans,' 'forecasts,' 'estimates,' 'will,' 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Yahoo
4 days ago
- Business
- Yahoo
West Pharmaceutical Services, Inc. (WST): A Bull Case Theory
We came across a bullish thesis on West Pharmaceutical Services, Inc. (WST) on Swiss Transparent Portfolio's Substack. In this article, we will summarize the bulls' thesis on WST. West Pharmaceutical Services, Inc. (WST)'s share was trading at $208.49 as of 22nd May. WST's trailing and forward P/E were 32.73 and 34.36respectively according to Yahoo Finance. A close-up of a technician working on a liquid injectable in a modern industrial lab. West Pharmaceutical Services stands out as a durable, underappreciated leader in the critical niche of injectable drug packaging. Despite recent headwinds from a post-Covid inventory glut and short-term earnings softness, the company's fundamentals remain strong. West holds a near-monopoly in a mission-critical industry with high switching costs, secular growth drivers like biologics and GLP-1 therapies, and a conservative, high-quality management team. Its financial turbulence appears transient, offering long-term investors an opportunity to accumulate shares at a fair price. While the current ~32x forward P/E may appear elevated, it's based on temporarily depressed earnings; normalized multiples suggest a more reasonable valuation. West's strategic investments during the downturn — including capacity expansion and share repurchases — reinforce its long-term potential. Risks such as customer concentration, technological disruption, execution missteps, regulatory issues, and macroeconomic volatility are real but manageable. The company's embedded role in drug delivery makes sudden disruptions unlikely, and its century-long record of quality execution offers confidence. Scenario analysis shows a compelling risk/reward balance: the bull case projects a ~15% CAGR, while even the bear case requires a confluence of major setbacks to yield sustained losses. West is not a flashy growth story but rather a compounder built on operational excellence, customer entrenchment, and resilient demand. For investors comfortable with a mid-30s P/E as a reflection of quality, West offers a rare blend of safety and growth. It's a Rolls-Royce business at a Bentley price — a quiet engine of compounding that, barring major failure, should keep running reliably for years to come. West Pharmaceutical Services, Inc. (WST) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 35 hedge fund portfolios held WST at the end of the fourth quarter which was 31 in the previous quarter. While we acknowledge the risk and potential of WST as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than WST but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Yahoo
5 days ago
- Business
- Yahoo
West Pharmaceutical Services, Inc. (WST): A Bull Case Theory
We came across a bullish thesis on West Pharmaceutical Services, Inc. (WST) on Swiss Transparent Portfolio's Substack. In this article, we will summarize the bulls' thesis on WST. West Pharmaceutical Services, Inc. (WST)'s share was trading at $208.49 as of 22nd May. WST's trailing and forward P/E were 32.73 and 34.36respectively according to Yahoo Finance. A close-up of a technician working on a liquid injectable in a modern industrial lab. West Pharmaceutical Services stands out as a durable, underappreciated leader in the critical niche of injectable drug packaging. Despite recent headwinds from a post-Covid inventory glut and short-term earnings softness, the company's fundamentals remain strong. West holds a near-monopoly in a mission-critical industry with high switching costs, secular growth drivers like biologics and GLP-1 therapies, and a conservative, high-quality management team. Its financial turbulence appears transient, offering long-term investors an opportunity to accumulate shares at a fair price. While the current ~32x forward P/E may appear elevated, it's based on temporarily depressed earnings; normalized multiples suggest a more reasonable valuation. West's strategic investments during the downturn — including capacity expansion and share repurchases — reinforce its long-term potential. Risks such as customer concentration, technological disruption, execution missteps, regulatory issues, and macroeconomic volatility are real but manageable. The company's embedded role in drug delivery makes sudden disruptions unlikely, and its century-long record of quality execution offers confidence. Scenario analysis shows a compelling risk/reward balance: the bull case projects a ~15% CAGR, while even the bear case requires a confluence of major setbacks to yield sustained losses. West is not a flashy growth story but rather a compounder built on operational excellence, customer entrenchment, and resilient demand. For investors comfortable with a mid-30s P/E as a reflection of quality, West offers a rare blend of safety and growth. It's a Rolls-Royce business at a Bentley price — a quiet engine of compounding that, barring major failure, should keep running reliably for years to come. West Pharmaceutical Services, Inc. (WST) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 35 hedge fund portfolios held WST at the end of the fourth quarter which was 31 in the previous quarter. While we acknowledge the risk and potential of WST as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than WST but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
27-05-2025
- Business
- Associated Press
Bora Biologics Expands San Diego Facility for 2000L+ Scale Biologics Manufacturing, Boosts CDMO Capacity
SAN DIEGO, CA / ACCESS Newswire / May 27, 2025 / Bora Biologics, a leading contract development and manufacturing organization (CDMO) specializing in biologics manufacturing, announced a major expansion of its U.S. FDA-registered commercial manufacturing facility in San Diego. This expansion will add state-of-the-art upstream and downstream GMP processing capabilities to meet the increasing demand for 2000L scale single-use biologics manufacturing, solidifying Bora Biologics' position as a premier biologics CDMO. The expansion adds 8,075 square feet of state-of-the-art GMP manufacturing space to the San Diego biologics manufacturing facility, comprising a cutting-edge upstream mammalian cell culture hall, harvest suite with two inoculation rooms and in-process testing room, capture suite, and a downstream processing suite. This includes 6,950 square feet of new construction and 1,125 square feet of revisions to the existing GMP space. The expanded facility will feature two 2000L Cytiva XDR bioreactors and seed train, providing Bora Biologics' clients with robust and scalable biologics manufacturing solutions. The upstream hall's design allows for future bioreactor expansion up to 5000L scale. The downstream process suite is engineered to efficiently process up to 5000L modern high-titer cell culture processes, ensuring streamlined purification. Bora Biologics' San Diego facility currently offers a comprehensive range of GMP manufacturing suites, including 50L, 250L and 1000L single-use bioreactors dedicated to mammalian cell culture, and a dedicated microbial GMP suite equipped with a 150L stainless steel fermenter and a 300L single-use fermenter expansion capability. The planned addition of the two 2000L single-use bioreactors in Q1 2026 will significantly enhance Bora Biologics' ability to provide seamless scale-up and commercial manufacturing solutions to its clients. 'With this expansion, we will be able to offer our customers 2000L commercial capacity with the ability to purify modern high-titer cell culture processes,' said John R. Mosack, General Manager & Vice President, Operations of the San Diego Site at Bora Biologics. 'In addition to the two 2000L Cytiva bioreactors we are installing now, we will have the space to grow with our customers and meet their evolving needs.' Miguel Carrion, Vice President, Process Development and MS&T at Bora Biologics, added, 'With the addition of the new Cytiva trains, we now have the ability to offer customers both Fisher Single Use and Cytiva Single Use bioreactor trains, providing greater flexibility and options for their specific manufacturing requirements.' cGMPnow, a leading provider of GMP facility design and GxP systems implementation and compliance for the biopharmaceutical industry, is providing process equipment, clean utilities, and automation/controls engineering and commissioning, qualification, and validation expertise for this expansion project. Jeff Gilmore, CEO of cGMPnow, expressed his enthusiasm for the partnership, 'We are absolutely thrilled to be partnering with Bora Biologics on this critical expansion, leveraging our expertise in biopharmaceutical engineering and cGMP compliance to deliver a state-of-the-art facility that will enable their clients to reach more patients.' Cytiva is supplying the advanced bioreactor technology for the expanded facility. Emphasizing Cytiva's support for Bora Biologics' growth, Jordan Heard, Americas Upstream and Consumable Leader (USA) at Cytiva, stated, 'Cytiva is proud to support Bora Biologics in their commitment to innovation and growth. Our XDR bioreactors will provide Bora Biologics with the scalability and flexibility needed to meet the evolving demands of the biologics market.' DPR Construction, a unique technical builder, is applying its skills and experience to the construction of the expanded facility. Scott Sass, DPR's San Diego Business Unit Leader, shared his excitement about the project. 'DPR is excited to partner with Bora Biologics on this project, bringing our expertise in advanced biomanufacturing facility construction to help them expand their capabilities and serve their clients.' This expansion underscores Bora Biologics' dedication to providing its clients with cutting-edge manufacturing capabilities and its commitment to supporting the development and commercialization of life-saving therapies. About Bora Biologics Bora Biologics is a global CDMO offering agile, comprehensive end-to-end solutions for biopharma companies worldwide. With a proven track record of over 100 successful cGMP manufacturing batches, Bora Biologics leverages its state-of-the-art, FDA-registered facility in the U.S. and deep expertise in biologics development and manufacturing - including its own FDA-licensed and Health Canada-approved product - to enhance time and cost efficiencies while ensuring effective pathways to market for its clients. Bora Biologics combines innovative early-phase development and late-stage manufacturing capabilities with the expertise and reputation of Bora Pharmaceuticals for flexible and scalable fill/finish services, including stability testing, and final packaging of clinical and commercial products. About cGMP Now cGMPnow provides turnkey GMP systems, accelerating the delivery of next-generation therapies. Specializing in GMP manufacturing facility design, GxP manufacturing and QC laboratory equipment, GxP computerized systems, commissioning/qualification/validation, and procurement services, cGMPnow utilizes a unique project delivery methodology and owner-focused involvement to bring new products to market faster. With expertise in GMP facility design, construction support, and GxP systems, cGMPnow enables clients to begin production efficiently and effectively, accelerating the delivery of life-changing products. About Cytiva Cytiva is a global biotechnology leader committed to supporting customers in the discovery and commercialization of next-generation therapeutics. As part of Danaher, a global science and technology innovator, Cytiva provides dedicated technical expertise and a comprehensive portfolio of tools, technologies, and services that enable the development, manufacture, and delivery of transformative medicines to patients. About DPR Construction DPR Construction is a forward-thinking, self-performing general contractor and construction manager specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. DPR's portfolio of work ranges from large-scale new construction to small tenant improvements and special projects. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown to a multi-billion-dollar organization with offices around the world. Strategically focused on delivering more predictable outcomes through applications of virtual design & construction, prefabrication, its team of self-perform craft, and leveraging data to learn and improve from DPR consistently ranks among the top building contractors and employs approximately 11,000 professionals across its family of companies. Contact Information Media Contact [email protected] CDMO Inquiries [email protected] SOURCE: Bora Biologics press release
Yahoo
27-05-2025
- Health
- Yahoo
Food Allergy Market Analysis and Forecasts Report 2025-2035: Growing Demand for Preventive and Therapeutic Measures, Expanding Focus on R&D Bolster Growth
The global food allergy market is experiencing pivotal growth driven by rising incidences of food allergies, increased consumer awareness, and advances in treatment technologies. Key market advancements include immunotherapy and biologics that enhance patient outcomes. The market is evolving from symptom management to preventive treatments, with substantial investments in oral immunotherapy and genetically engineered products. Segmentation by drug class and region highlights North America's lead in market share. Despite growth drivers like increased R&D focus, limitations such as lack of standardized diagnostics and potential adverse treatment reactions remain. The competitive landscape involves major pharmaceutical, healthcare, and food manufacturing players, with innovation strategies focusing on biologics and precision medicine. Dublin, May 27, 2025 (GLOBE NEWSWIRE) -- The "Food Allergy Market - A Global and Regional Analysis: Focus on Drug Class, Country, and Region - Analysis and Forecast, 2025-2035" report has been added to offering. The global food allergy market is segmented by drug class, with each class addressing different aspects of food allergies. Antihistamines as a popular treatment for mild symptoms, contributing to consistent market demand. Steroids, used for managing inflammation, and Beta-2-agonists, which help alleviate respiratory symptoms, are also important segments, with moderate growth expected driven by their complementary roles in managing food allergy symptoms. North America holds the largest share in the global food allergy market, with the U.S. being a major contributor. The food allergy market is in an evolving phase with substantial investment in new treatment options, such as oral immunotherapy, biologics, and genetically engineered products aimed at desensitizing patients to allergens. This shift from symptom management to more preventive treatments marks a pivotal point in the market's lifecycle. Rising incidences of food allergies, growing awareness among consumers, and technological advancements in diagnostic and treatment methods are the primary drivers of market growth. Food allergies are a significant concern globally, affecting millions of individuals and leading to a growing demand for effective treatment Can This Report Add Value to an Organization?Product/Innovation Strategy: This report highlights key trends in food allergy treatment and diagnostic services, helping companies innovate in biologics, immunotherapy, and precision medicine tailored to food allergy Strategy: The food allergy market is highly competitive, and pharmaceutical companies, healthcare providers, and food manufacturers can use this report to stay ahead by understanding market trends, competitors, and emerging Drivers The global rise in food allergies among children and adults is likely to drive higher demand for preventive and therapeutic measures A stronger focus on research and development is expected to significantly contribute to the demand for advanced allergy care products Increased healthcare spending and government investment in infrastructure are boosting the growth of the food allergy market Limitations: The lack of standardized diagnostic criteria limits the evidence on food allergy prevalence and management Delays in test results and the need for large blood samples, especially in children, can stifle market growth Risk of severe adverse reactions during treatment Key Market Players and Competition SynopsisThe companies profiled in this report are selected based on expert insights, evaluating company coverage, product portfolio, and market penetration. Leading players in the global food allergy market include pharmaceutical companies, healthcare providers, and food manufacturers. Companies Featured Novartis Pharmaceuticals F. Hoffmann-La Roche Ltd DBV Technologies Vedanta Biosciences, Inc Regeneron Pharmaceuticals Camallergy Key Topics Covered: Executive Summary1. Global Food Allergy Market: Industry Outlook1.1 Market Overview and Ecosystem1.2 Epidemiological Analysis of Food Allergy1.2.1 U.S.1.2.2 EU51.2.3 Rest-of-the-World1.3 Market Trends1.4 Clinical Trials1.4.1 By Phase1.5 Regulatory Landscape Analysis1.5.1 Legal Requirement and Framework in U.S.1.5.2 Legal Requirement and Framework in E.U.1.5.3 Legal Requirement and Framework in Asia-Pacific1.5.4 Legal Requirement and Framework in Rest-of-the-World1.6 Market Dynamics1.6.1 Impact Analysis1.6.2 Market Drivers1.6.3 Market Restraints1.6.4 Market Opportunities2. Global Food Allergy Market, by Drug Class, $Million, 2023-20352.1 Epinephrine2.2 Antihistamines2.3 Steroids2.4 Others3. Global Food Allergy Market, by Region, $Million, 2023-20353.1 North America3.1.1 Key Findings3.1.2 Market Dynamics3.1.3 Market Sizing and Forecast3.1.3.1 North America Food Allergy Market (by Country)3.1.3.1.1 U.S.3.2 Europe3.2.1 Key Findings3.2.2 Market Dynamics3.2.3 Market Sizing and Forecast3.2.3.1 Europe Food Allergy Market (by Country)3.2.3.1.1 Germany3.2.3.1.2 France3.2.3.1.3 Italy3.2.3.1.4 U.K.3.3 Asia-Pacific3.3.1 Key Findings3.3.2 Market Dynamics3.3.3 Market Sizing and Forecast3.3.3.1 Asia-Pacific Food Allergy Market (by Country)3.3.3.1.1 Japan4. Global Food Allergy Market - Competitive Benchmarking and Company Profiles4.1 Competitive Landscape4.1.1 Key Strategies and Developments by Company4.1.1.1 Funding Activities4.1.1.2 Mergers and Acquisitions4.1.1.3 Regulatory Approvals4.1.1.4 Partnerships, Collaborations and Business Expansions4.1.2 Key Developments Analysis4.2 Company Profiles4.2.1 Company Overview4.2.2 Product Portfolio4.2.3 Target Customers / End Users4.2.4 Key Personnel4.2.5 Analyst View For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
