Latest news with #NAMs
Business Wire
4 days ago
- Business
- Business Wire
Seyltx Expands GluN2B Antagonist Pipeline with Clinical-Stage and Small-Molecule Candidates for Chronic Cough
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seyltx, Inc., ('Seyltx', 'Company') a clinical-stage biotherapeutics company focused on developing therapies to treat chronic cough, today announced it has entered into an option agreement with NeurOp, Inc. ('NeurOp'') for a portfolio of novel GluN2B antagonists. This agreement provides Seyltx with an option to worldwide, exclusive rights to develop and commercialize a portfolio of GluN2B negative allosteric modulators (NAMs) for treating chronic cough in humans, including in refractory chronic cough (RCC) and chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). "We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx's CEO. This strategic agreement combines Seyltx's expertise in chronic cough therapeutic development with NeurOp's expertise in NMDA receptor biology and innovative GluN2B inhibitors. This combination complements and deepens Seyltx's ongoing development of Ifenprodil, a potent NMDA antagonist that is highly selective towards the GluN2B subunit, currently in Phase 2 development. The combined effort is expected to accelerate the development and commercialization of new therapies for chronic cough and solidify Seyltx's position as a leader in addressing this significant unmet medical need. The option agreement includes 8 novel compounds, including NP10679, which has completed Phase 1 and provides Seyltx with a second clinical-phase candidate, with the potential to provide differentiated performance compared to Ifenprodil. These compounds have excellent potency, selectivity, pharmacokinetics, solubility, and metabolism. Strong intellectual property exists across all optioned compounds. "We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx's CEO. "Refractory chronic cough impacts approximately 6 million people in the USA alone, representing a substantial unmet medical need. Furthermore, chronic cough associated with IPF, an orphan condition affecting up to 140,000 people in the US, is a primary driver of deteriorated quality of life for these patients. Our agreement with NeurOp for advanced GluN2B NAMs, particularly NP10679, offers a promising avenue to provide potentially superior treatment options to these patients by addressing the condition with a centrally acting non-narcotic solution." Dr. James McNamara, Executive Chairman of NeurOp added, "NeurOp has been dedicated to advancing novel GluN2B-targeted therapies. This agreement with Seyltx is a testament to the sophistication of our team's expertise in the NMDA receptor biology and the development of our GluN2B antagonists. Seyltx's deep understanding and focus on chronic cough make them an ideal partner to further develop and bring these important compounds to patients in need. We look forward to a very productive partnership." NMDA is a validated therapeutic target in cough, with the only FDA-approved cough therapy being a non-specific NMDA antagonist. Preclinical research has identified the GluN2B subunit of NMDA as a primary target for cough suppression. Traditional non-specific NMDA antagonists have demonstrated limited efficacy due to dose limiting side effects. However, specifically targeting the GluN2B subunit, provides the potential to achieve robust cough suppression, while avoiding the adverse event profile observed with non-specific NMDA antagonists. The addition of NP10679 to the portfolio provides the opportunity to effectively engage the GluN2B receptor, below the safety threshold established in Phase 1, while offering a differentiated selectivity and efficacy profile compared to Ifenprodil. The option agreement has been approved by the management of both companies with a conversion to an exclusive world-wide license agreement anticipated within 12 months. About Seyltx: Seyltx ( is a clinical stage biotherapeutics company focused on developing innovative therapies to treat chronic cough and other neuronal hypersensitivity indications. Its lead indication is refractory chronic cough, a significant unmet medical need, with a follow-on opportunity in chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). Seyltx's lead compound is Ifenprodil, an NMDA receptor inhibitor highly selective towards the GluN2B subunit, which has completed a Phase 2a trial in chronic cough associated with IPF, with statistically significant reductions in cough from baseline at 12-weeks, and statistically significant improvements on all patient reported outcomes employed. Seyltx is currently progressing into Phase 2 crossover trials. About NeurOp: NeurOp, Inc. is a privately held, clinical-stage biopharmaceutical company based in Atlanta, Georgia that is developing small-molecule therapies for central nervous system disorders, including severe pain, treatment-resistant depression, subarachnoid hemorrhage (SAH) and stroke. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors and are designed for potential therapeutic benefit with an improved safety and tolerability profile relative to other NMDA receptor antagonists. Forward-Looking Statements: Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'potential,' 'possible,' 'projects,' 'plans,' and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond Seyltx's control.
Business Insider
08-05-2025
- Business
- Business Insider
Charles River upgraded to Outperform from In Line at Evercore ISI
Evercore ISI upgraded Charles River (CRL) to Outperform from In Line with a price target of $170, up from $135, following Q1 earnings and the cooperation agreement with Elliott. Reasons for the upgrade following today's print include the fact that bookings reaccelerated quarter-over-quarter for the first time since 2022, updated disclosure on NAMs after last month's FDA recommendation to shift away from animal-based testing for mAbs, the company's 'enviable market position as a key preclinical development partner' and valuation, the analyst tells investors. Protect Your Portfolio Against Market Uncertainty
Associated Press
17-04-2025
- Business
- Associated Press
Efferent Labs Applauds FDA's Shift Away from Animal Testing
Efferent Labs' CytoComm® platform is positioned as a critical enabler of new drug evaluation standards following the FDA's shift from animal testing. 'Our CytoComm® platform provides the dynamic cell-based insight and continuous real-time wireless feedback that traditional animal models simply cannot deliver.'— Bill Rader, CEO Efferent Labs MOUNT PLEASANT, SC, UNITED STATES, April 17, 2025 / / -- Efferent Labs, Inc., a preclinical-stage biodevice company specializing in in vivo cellular data collection, celebrates the U.S. Food and Drug Administration's ( FDA ) groundbreaking move toward reducing reliance on mandatory animal testing for monoclonal antibody therapies and other drug classes. The long-awaited regulatory transformation serves to streamline development and improve patient outcomes and safety, while ultimately lowering costs. The FDA's plan outlines a strategic shift toward New Approach Methodologies (NAMs) and positions Efferent Labs' revolutionary CytoComm® biosensor platform to support the transition with a human-relevant, wireless, real-time alternative that aligns directly with the FDA's roadmap. 'This is the moment we've been building toward,' said Bill Rader, CEO of Efferent Labs. 'Our CytoComm® platform provides the dynamic cell-based insight and continuous real-time wireless feedback that traditional animal models simply cannot deliver. With today's FDA announcement, Efferent Labs moves from visionary to essential.' The FDA's pivot to AI-based toxicity and efficacy modeling relies on one critical factor: biologically meaningful, statistically reliable and clinically relevant inputs. However, many preclinical systems fall short of this standard. The CytoComm® platform addresses these limitations by capturing continuous molecular activity from engineered cell lines in vivo. This enables clean, longitudinal data that supports earlier decision-making, reduces animal use, and improves predictive accuracy—all while laying the foundation for AI modeling that regulators can trust. CytoComm® directly addresses the FDA's key aims under its new framework: Reduces animal use by replacing live models with embedded, human-relevant cellular sensors Accelerates development timelines via continuous real-time monitoring Improves predictive accuracy by capturing complex pharmacodynamic data Seamlessly integrates with AI workflows, supported by HookeCA™—Efferent's cloud-based analytics interface, which enables real-time data visualization and regulatory-aligned formatting As the first implantable cellular biosensor of its kind, CytoComm® provides continuous, high-fidelity molecular data without relying on terminal endpoints or high-stress procedures. This enables researchers to capture detailed pharmacodynamic responses using smaller cohorts, fewer animals, and statistically robust outputs. 'We are proud to be part of the solution,' said Rader. 'The science is ready. The technology is here. And with this regulatory shift, the path is now clear. CytoComm® isn't just the future—it's the answer.' For more information or partnership inquiries, visit About Efferent Labs Efferent Labs is pioneering the future of preclinical drug testing with its real-time cellular biosensor platform, CytoComm® Designed to replace static animal-based endpoints, CytoComm® delivers dynamic, high-fidelity cell-based insights—saving time, reducing costs, and elevating both human safety and ethical standards. Kerry Welch TRIO +1 8084290548 email us here Visit us on social media: Facebook LinkedIn Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Yahoo
12-04-2025
- Business
- Yahoo
Why Recursion Pharmaceuticals, Inc. (RXRX) Surged On Friday?
We recently published a list of . In this article, we are going to take a look at where Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) stands against other Friday's top performing stocks. The stock market finished the trading week on a positive note, wiping out earlier losses on Friday, as investors weighed the escalating trade tensions between the US and China. Having been battered this week, Wall Street's major indices all finished in the green, led by the Nasdaq, up 2.06 percent, followed by the S&P 500 with 1.81 percent, and the Dow Jones with 1.56 percent. Ten companies, predominantly under the mining and biopharmaceutical sectors, mimicked gains on the back of fresh industry catalysts that boosted buying appetite. In this article, let us explore Friday's top performers and the reasons behind their gains. To come up with the list, we considered only the stocks with a $2 billion market capitalization and $5 million trading volume. A pharmacist in a hospital pharmacy stands next to a row of various drug containers. Recursion Pharmaceuticals soared by 27.72 percent on Friday to finish at $5.76 apiece as investors gobbled up shares in the company following the Food and Drug Administration's (FDA) decision to replace the use of animals in testing drugs with Artificial Intelligence. RXRX is a clinical-stage biotechnology company that uses AI in its discovery and development processes. It was also one of the companies that received the backing of technology giant Nvidia Corp. According to the FDA, the initiative was designed to replace animal testing with 'more effective human-relevant methods' in the development of monoclonal antibody therapies and other drugs. The move was not only expected to improve drug safety and expedite the evaluation process, but it could also result in lower research and development costs, thereby reducing drug prices for the end consumers. According to the FDA, it will begin to encourage the inclusion of New Approach Methodologies (NAMs) data in investigational new drug applications. Overall, RXRX ranks 1st on our list of Friday's top performing stocks. While we acknowledge the potential of RXRX as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is as promising as RXRX but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
12-04-2025
- Business
- Yahoo
Why Recursion Pharmaceuticals, Inc. (RXRX) Surged On Friday?
We recently published a list of . In this article, we are going to take a look at where Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) stands against other Friday's top performing stocks. The stock market finished the trading week on a positive note, wiping out earlier losses on Friday, as investors weighed the escalating trade tensions between the US and China. Having been battered this week, Wall Street's major indices all finished in the green, led by the Nasdaq, up 2.06 percent, followed by the S&P 500 with 1.81 percent, and the Dow Jones with 1.56 percent. Ten companies, predominantly under the mining and biopharmaceutical sectors, mimicked gains on the back of fresh industry catalysts that boosted buying appetite. In this article, let us explore Friday's top performers and the reasons behind their gains. To come up with the list, we considered only the stocks with a $2 billion market capitalization and $5 million trading volume. A pharmacist in a hospital pharmacy stands next to a row of various drug containers. Recursion Pharmaceuticals soared by 27.72 percent on Friday to finish at $5.76 apiece as investors gobbled up shares in the company following the Food and Drug Administration's (FDA) decision to replace the use of animals in testing drugs with Artificial Intelligence. RXRX is a clinical-stage biotechnology company that uses AI in its discovery and development processes. It was also one of the companies that received the backing of technology giant Nvidia Corp. According to the FDA, the initiative was designed to replace animal testing with 'more effective human-relevant methods' in the development of monoclonal antibody therapies and other drugs. The move was not only expected to improve drug safety and expedite the evaluation process, but it could also result in lower research and development costs, thereby reducing drug prices for the end consumers. According to the FDA, it will begin to encourage the inclusion of New Approach Methodologies (NAMs) data in investigational new drug applications. Overall, RXRX ranks 1st on our list of Friday's top performing stocks. While we acknowledge the potential of RXRX as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is as promising as RXRX but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
