Latest news with #clinicaldevelopment
Yahoo
10 hours ago
- Health
- Yahoo
Structure Therapeutics Announces Two Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671
SAN FRANCISCO, June 20, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, today announced two upcoming late-breaking poster presentations at the American Diabetes Association 85th Scientific Sessions, being held from June 20-23 in Chicago, IL. 'The amylin receptor is rapidly gaining clinical validation as a key target in obesity, driven by encouraging data from injectable peptide programs. We believe ACCG-2671 is well-positioned and differentiated as an oral small molecule frontrunner that is expected to enter clinical development by the end of 2025,' said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. 'The preclinical data being presented at ADA include the robust weight-loss effects of ACCG-2671 alone and in combination with a GLP-1 receptor agonist underscoring ACCG-2671's potential as a future small molecule backbone treatment for obesity. In addition, we will present data demonstrating the neuroprotective effects of GLP-1 receptor agonism in preclinical models of Parkinson's disease, reinforcing the broad role of the GLP-1 receptor across different diseases.' Presentation Details: Title: Novel Oral Small Molecule ACCG-2671: A Dual Amylin and Calcitonin Receptor Agonist Development Candidate for Obesity TherapyPoster #: 2184-LBSession: Late Breaking Poster SessionDate: Sunday, June 22Time: 12:30 p.m. – 1:30 p.m. CT Summary: ACCG-2671 demonstrated high binding affinity and balanced potency in human calcitonin receptor (CTR) and amylin receptor (AMY3R) functional assays. In diet-induced obese rats, oral administration of ACCG-2671 resulted in significant, dose-dependent body weight reductions. Combination therapy with semaglutide (both as add-on and concurrent treatment) resulted in superior weight loss compared to monotherapy. Title: Oral Small Molecule GLP-1 Receptor Agonist Demonstrates Beneficial Effects in Parkinson's Disease–Like Model Using Humanized GLP-1R MicePoster #: 1985-LBSession: Late Breaking Poster SessionDate: Sunday, June 22Time: 12:30 p.m. – 1:30 p.m. CT Summary: In a Parkinson's disease mouse model, oral administration of GSBR-5595, a small molecule GLP-1 receptor agonist distinct from Structure Therapeutics' clinical asset aleniglipron (GSBR-1290), significantly improved motor coordination and movement in both the rotarod and open field tests. Additionally, histopathological analyses revealed a significant increase in dopaminergic neurons. These findings suggest this GLP-1 receptor agonist showed neuroprotective effects by mitigating motor deficits and preserving dopaminergic neurons, highlighting a potential benefit in Parkinson's disease. About Structure TherapeuticsStructure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit Forward Looking StatementsThis press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company's future plans and prospects; the belief that ACCG-2671 is well-positioned and differentiated as an oral small molecule frontrunner; the planned initiation of the ACCG-2671 Phase 1 study and the timing thereof; the belief that the oral small molecule approach gives Structure Therapeutics the opportunity to create more scalable, cost-effective treatments to meet the needs of patients with obesity and other related diseases, without compromising on efficacy or safety; the belief that Structure Therapeutics is well-positioned with one of the most robust oral small molecule metabolic franchises in the industry; and any expectations regarding the safety, efficacy or tolerability of ACCG-2671and other candidates under development. In addition, when or if used in this press release, the words and phrases 'anticipated,' 'expect,' 'on track,' 'plan,' 'potential,' 'to be,' and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company's forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the results from earlier clinical studies not necessarily being predictive of future results, potential delays in the commencement, enrollment and completion of the Company's planned clinical studies, the Company's ability to advance ACCG-2671 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company's therapeutic candidates, competitive products or approaches limiting the commercial value of the Company's product candidates, the timing and results of preclinical and clinical studies, the Company's ability to fund development activities and achieve development goals, the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control, the impact of any global pandemics, inflation, tariffs, changes in monetary and fiscal policy, supply chain issues, rising interest rates, future bank failures and other macroeconomic factors on the Company's business, its ability to protect its intellectual property and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors:Danielle KeatleyStructure Therapeutics Media:Dan Budwick1ABDan@ 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
Globe and Mail
16 hours ago
- Business
- Globe and Mail
Lipella Pharmaceuticals Announces Delisting from Nasdaq Capital Market
PITTSBURGH, June 20, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (OTC: LIPO) ('Lipella' or the 'Company'), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, today announced that the Nasdaq Hearings Panel has determined to delist the Company's common stock from The Nasdaq Capital Market. Trading in the common stock was suspended at the open of business today. The delisting follows Nasdaq's determination that certain private placement transactions completed between December 2024 and March 2025 did not comply with Listing Rules 5100 (Public Interest Concern), 5635 (Shareholder Approval), and 5640 (Voting Rights). Specifically, Nasdaq cited the issuance of Series C voting convertible preferred stock and warrants to the Company's placement agent and advisor to those transactions, as having been structured in a way that triggered these rule violations. The Company was notified by the Hearings Panel of its determination to delist the Company's common stock effective today. Lipella is disappointed by this decision—particularly in light of the fact that it was taking immediate steps to obtain stockholder approval and address the concerns raised by Nasdaq. Lipella remains operationally sound, and its business fundamentals are intact. The Company is executing on its strategic and clinical development plans, including continued advancement of its lead product candidates LP-10 for hemorrhagic cystitis and LP-310 for oral lichen planus. In parallel, Lipella is actively exploring other markets to list its common stock and is committed to relisting its shares on a trading venue that provides the best possible liquidity and access for investors. The Company's common stock is currently quoted on the OTC Markets under the symbol 'LIPO.' 'We acknowledge Nasdaq's decision and are focused on taking swift, constructive steps accordingly,' said Dr. Jonathan Kaufman, Chief Executive Officer of Lipella. 'Our commitment to our shareholders, our mission, and our clinical goals has not changed.' The Company remains a reporting company under the Securities Exchange Act of 1934 and will continue to file periodic reports and disclosures with the U.S. Securities and Exchange Commission. Lipella will keep its stockholders informed of all material developments as it continues to assess its options. About Lipella Pharmaceuticals Inc. Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at and follow us on X and LinkedIn. Forward-Looking Statements This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, including with respect to the Company's exploration of all markets and its commitment to list its common stock, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other risks that may be included in the periodic reports and other filings that the Company files from time to time with the U.S. Securities and Exchange Commission. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein. CONTACT: Jonathan Kaufman Chief Executive Officer Lipella Pharmaceuticals Inc. Info@ 1-412-894-1853 PCG Advisory Jeff Ramson jramson@
National Post
10-06-2025
- Business
- National Post
EDETEK Engages Capgemini to Support Its Global Transformation Initiative and Accelerate AI Innovation in Clinical Development
Article content NEW YORK — EDETEK Inc., a global provider of leading AI-driven clinical development platforms and services, has engaged Capgemini to support its ongoing advancements in digital transformation within the life sciences industry. This engagement combines EDETEK's deep domain expertise and established platforms and services with Capgemini's advanced AI and engineering capabilities, to enable EDETEK to deliver innovative solutions aimed at optimizing clinical development, improving operational efficiency, and accelerating the time-to-market for new therapies. Article content A shared vision for the future of clinical R&D Article content Article content By integrating advanced digital and data capabilities—including generative AI—across all phases of clinical trials, the project will support new efficiencies for pharmaceutical companies, including: Article content Dramatically reduce time-to-market for new therapies. Enablement of self-learning, insight-driven trials for faster, more proactive decision-making. Streamlined data management and trial workflows, enhancing efficiency and precision. Significant cost reductions and boosted drug pipeline value. Article content 'Working with Capgemini signifies our continuing efforts to expand our global capabilities towards delivering more effective and faster clinical development,' Article content said Dr. Shakthi Kumar, Chief Strategy & Business Officer at EDETEK. Article content 'By bringing together our AI-driven platforms with Capgemini's leading capabilities in life science and technology, we will empower life science organizations to conduct smarter, faster, and more predictive clinical trials—ultimately improving patient outcomes at scale.' Article content Bringing innovation to clinical development at scale Article content The engagement combines EDETEK's proven technology with Capgemini's global network and deep domain knowledge to scale AI-powered clinical innovation across the pharmaceutical industry. Together, this will help make intelligent, agile, and data-driven clinical trials accessible to more life sciences organizations worldwide. In addition, Capgemini will leverage its robust engineering capabilities to help scale EDETEK's platforms globally and enable continued leadership in reliability, innovation, and performance. Article content 'Our deep expertise in next-gen clinical development methodologies and advanced AI will expand EDETEK's R&D cloud and eClinical platform, helping its clients to unlock new levels of agility, insight, and efficiency,' Article content said Thorsten Rall, Global Industry Head, Life Sciences at Capgemini. 'Together, we are committed to redefining what's possible for the industry—delivering measurable value, accelerating innovation, and shaping the future of healthcare through smarter, more predictive clinical trials.' Article content About EDETEK, Inc. Article content Founded in 2009, EDETEK delivers high-quality AI-powered platforms and clinical services to over one hundred biopharma clients worldwide. With a presence across four continents, EDETEK is redefining the future of clinical development through intelligent technology. Article content For more information about EDETEK, please visit About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Article content Article content Article content Contacts Article content Capgemini press contact: Article content Article content Julia Zimmerman Article content Article content Tel.:+1 847-922-7951 Article content Article content EDETEK press contact: Article content Article content Wei Kong Article content Article content Article content Article content
National Post
03-06-2025
- 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
Associated Press
21-05-2025
- Business
- Associated Press
Protagonist Therapeutics to Participate in the Jefferies Global Healthcare Conference 2025
NEWARK, CA / ACCESS Newswire / May 21, 2025 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference taking place June 3-5, 2025, in New York, NY. The Company will also participate in one-on-one meetings. Jefferies Global Healthcare Conference - June 3-5, 2025 Format: Company Presentation Day/Time: Wednesday, June 4 at 1:25 P.M. ET Webcast: If you are interested in meeting with the Protagonist team during the conference, please reach out to your Jefferies representative. A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage for one year following the event. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 [email protected] Media Contact Virginia Amann, Founder/CEO +1 833 500 0061 ext 1 ENTENTE Network of Companies [email protected] SOURCE: Protagonist Therapeutics press release
