Regeneron's Lynozyfic Gains Accelerated FDA Approval for Multiple Myeloma
This bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager is approved for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 4 prior lines of therapy, including a proteasome inhibitor, which is an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality.
The accelerated approval for Lynozyfic was based on positive results from the Phase 1/2 LINKER-MM1 trial. In the efficacy population of 80 patients who had received at least four prior lines of therapy, Lynozyfic demonstrated an objective response rate of 70% and a complete response rate of 45%. The FDA had previously issued a Complete Response Letter (CRL) for linvoseltamab due to findings from a pre-approval inspection at a third-party fill/finish manufacturer.
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide.
While we acknowledge the potential of REGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the .
READ NEXT: and .
Disclosure: None. This article is originally published at Insider Monkey.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
25 minutes ago
- Yahoo
A Big Shipper Just Reported 'Historically Low' Furniture Demand
Key Takeaways JB Hunt Transport Services says demand for its "final mile" delivery has been depressed amid sluggish sales of furniture, appliances and other big purchases. Other furniture firms are being strained by what an upholstery firm executive called "historically low" demand for home furnishing. Consumers appear to have waited for Prime Day and other major retailers' sales to buy appliances, electronics and other big items, according to are holding off on furniture and other big—meaning both in terms of size and price—purchases, according to a big shipping company. JB Hunt Transport Services (JBHT) is seeing tepid demand for 'final mile' deliveries of large items, Chief Operating Officer Nick Hobbs said on a conference call Tuesday. Hobbs doesn't expect a shift toward big purchases any time this year, he added. Slow furniture sales are straining other companies, including luxury furniture retailer RH (RH) and Culp (CULP), a North Carolina-based upholstery firm. "Historically low" demand for home furnishing has weighed on fabric sales, CULP CEO Robert Culp IV said last month. 'The end markets in this business remain challenged with demand for big and bulky products still muted, with soft demand for furniture, exercise equipment and appliances,' Hobbs said, according to a transcript made available by AlphaSense. Furniture Business in 'A Bit of a Malaise' Americans were not undertaking renovations or buying many appliances and big-ticket items this fall because of the tight housing market, Home Depot (HD) and Lowe's (LOW) said. Sales have since picked up, although the growth may be coming from consumers trying to get ahead of tariffs, rather than shifts in underlying demand, experts have said. "Our industry has been in a bit of a malaise,' La-Z-Boy (LZB) CEO Melinda Whittington said on a conference call last month. 'But if the consumer is overall more strapped because of the broader macroeconomic trends, they will tend to stretch out their furniture purchases.' A number of consumers appear to have timed their purchase of appliances, electronics and other pricey items to coincide with major sales at Amazon (AMZN), Walmart (WMT) and Target (TGT), Adobe said. Meanwhile, 'off-price retail' items have been keeping JB Hunt busy, Hobbs said Tuesday. The company reported slightly stronger second-quarter revenue than expected. Read the original article on Investopedia 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
Yahoo
25 minutes ago
- Yahoo
Top Midday Stories: White House Official Says Trump Likely to Fire Powell Soon; ASML Unable to Confirm Growth in 2026
The Dow Jones and Nasdaq Composite swung to losses around midday Wednesday after Bloomberg published 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
Yahoo
25 minutes ago
- Yahoo
Zensai Named a 2025 World Future Award Winner Among Top 100 AI Tech Companies
NEW YORK, July 16, 2025 /PRNewswire/ -- Zensai, the only AI-powered learning, employee engagement, and performance management platform built on Azure and integrated into Microsoft 365 and Teams, today announced it has been named to the World Future Awards' official Top 100 AI Tech Companies of 2025 list. This prestigious recognition honors the most forward-thinking organizations advancing the field of artificial intelligence and highlights Zensai's Human Success Platform, which is redefining the future of AI-powered learning and performance management. As AI continues to transform industries worldwide, the companies recognized by the World Future Awards are setting new standards for innovation, ethics, and global relevance. Zensai has been selected as a winner for its Human Success Platform, alongside industry-leading companies like Anthropic, Databricks, Google DeepMind, Harvey, and Workday. Zensai's Human Success Platform helps organizations future-proof their workforce by driving measurable business outcomes through AI-powered insights and continuous learning, all seamlessly embedded in the Microsoft 365 applications and tools employees use every day. Curated through a rigorous global review process, the 2025 World Future Awards Top 100 AI Tech Companies list highlights companies leading AI-driven innovation across key sectors such as healthcare, finance, education, robotics, and machine learning. Zensai was carefully evaluated and selected based on its technological advancement, real-world impact, and commitment to building the future responsibly and intelligently. "This recognition from the World Future Awards is a testament to our mission at Zensai: to harness the power of AI to elevate human potential," said Robin Daniels, Chief Business Officer at Zensai. "Being named among the Top 100 AI Tech Companies of 2025 reflects our commitment to creating tools that empower individuals, foster meaningful connections, and enable teams to achieve extraordinary outcomes. This is just the beginning of what's possible when technology is designed with humanity at its core." Zensai earned its place for its groundbreaking use of generative AI to deliver personalized, impactful learning experiences that help organizations move beyond traditional, check-the-box training. Built on the belief that AI is a superpower to enhance human potential, the Human Success Platform integrates learning, engagement, and performance management into one seamless experience to create high performance company cultures. From tailored content and real-time skills mapping to performance insights embedded directly within Microsoft 365, Zensai empowers organizations to foster growth, boost retention, and build connected, engaged and successful teams. This award underscores the company's mission to ensure every employee feels equipped and empowered to thrive in the future of work. For more information on the Top 100 AI Tech Companies of 2025 list, visit: About Zensai Zensai, the only Human Success Platform, seamlessly integrates into Microsoft 365, SharePoint, and Teams and is powered by AI. Our mission? To unlock human potential worldwide. With a global presence spanning 60+ countries and millions of users, Zensai revolutionizes employee development, engagement, and performance management. As a Microsoft Preferred Solution, we redefine success metrics, offering a best-practice framework and solution for learning, engagement, and performance that is delivered in the Microsoft 365 environment. Driven by AI, designed for productivity, and aligned with your unique workflow, Zensai is a G2 leader, named a 2024 Gartner Cool Vendor, and ranked no. 94 on TIME's 2024 World's Top EdTech Companies list. Learn more at Media Contact: Lynsey Rose Head of Global Communications lrose@ View original content to download multimedia: SOURCE Zensai 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
