KYNDRYL TO SPEAK AT J.P.MORGAN INVESTOR CONFERENCE ON MAY 18 PR Newswire
NEW YORK, May 13, 2026
, /PRNewswire/ -- Kyndryl Holdings, Inc. (NYSE: KD), a leading provider of mission-critical enterprise technology services, today announced that Chairman and Chief Executive Officer Martin Schroeter will speak at the J.P.Morgan Global Technology, Media and Communications Conference on Monday, May 18, 2026 at 2:50 p.m. ET. During the event, Mr. Schroeter will discuss information regarding Kyndryl's business and/or financial performance.
To listen to the live webcast, please visit Kyndryl's investor relations website at investors.kyndryl.com. A replay of the webcast will be available approximately 24 hours after the live presentation.
About Kyndryl
Kyndryl (NYSE: KD) is a leading provider of mission-critical enterprise technology services offering advisory, implementation and managed service capabilities to thousands of customers in more than 60 countries. As the world's largest IT infrastructure services provider, the company designs, builds, manages and modernizes the complex information systems that the world depends on every day. For more information, visit www.kyndryl.com.
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New York, May 29, 2026 (GLOBE NEWSWIRE) -- The Insight Partners published its latest market intelligence report on the Global Digital Twin Market. The study finds the market, valued at US$ 13,739.99 million in 2024, is projected to reach US$ 140,938.14 million by 2031, registering a compound annual growth rate (CAGR) of 40% over the 2025 - 2031 forecast period. Research draws on primary interviews with C-suite executives, OEM engineers, procurement heads, and policy analysts across more than 15 countries, augmented by proprietary databases and third-party validation.
Market Overview
The Digital Twin market comprises software platforms and virtual simulation technologies that create real-time digital replicas of physical assets, systems, processes, and infrastructure. Key application areas include manufacturing, automotive, aerospace, energy, healthcare, smart cities, and industrial equipment monitoring. Demand is underpinned by three structural tailwinds: accelerating Industry 4.0 adoption, rapid expansion of IoT-connected devices, and growing enterprise focus on predictive maintenance and operational efficiency.
The US government is also taking various measures to boost the adoption of digital twin technology in the country. In May 2024, the Biden-Harris Administration issued a Notice of Funding Opportunity (NOFO) seeking proposals from eligible applicants for activities to establish and operate a CHIPS Manufacturing USA institute focused on digital twins for the semiconductor industry.
latest research on the Digital Twin Market, covering market size forecasts, growth drivers, regulatory trends, and competitive insights. You may access the Sample document here: https://www.theinsightpartners.com/sample/TIPRE00017045
Key Market Findings
Regional Leader: North America is forecast to account for over 35% of global market share by 2031, led by the US and Canada.Europe: Europe holds the second-largest share at over 30%, with the UK market projected to grow at a 40.8% CAGR through 2031.Dominant Segment: Asset Twins retains the largest product segment share globally.Fastest-Growing Segment: Large Enterprises registers the fastest CAGR at 39.2%%, driven by rising digital twin technology investments.Healthcare Growth: Healthcare digital twins are witnessing rapid adoption as healthcare providers increasingly seek data-driven, scalable, and cost-efficient solutions for personalized treatment, predictive care, and operational optimization. Primary Growth Driver: Increasing Adoption of IoT Devices
The Internet of Things (IoT) describes an extensively broad network of interconnected devices along with technologies that enable communications between these devices and the cloud. Recently, there has been a huge surge in the adoption of IoT technologies due to advancements in mobile and wireless connectivity technologies, and a gradual drop in the cost of sensors and other components. Several industries are using IoT to improve efficiency and reduce the costs of their operations. According to Finance Online, there were approximately 14.76 billion connected IoT devices as of November 2023, and this figure is expected to rise to ~25.44 billion by 2030. As per a forecast by IoT Analytics, 75% of the total devices in use would be IoT by 2030. Furthermore, FinleyUSA estimated the global IoT spending at US$ 1.1 trillion in 2023. The use of digital twins is increasing with the surging adoption of IoT. Digital twins require a continuous flow of data to accurately replicate their physical counterparts. IoT devices can fulfill this requirement with built-in sensors. These sensors facilitate real-time data collection from the environment, human interactions, or objects’ functions.
Manufacturing: A High-Value End-Market
The manufacturing industry has pioneered the use of digital twins. Digital twins have become ubiquitous in every stage of manufacturing, ranging from the design phase to the finishing stages. The complex operations of the manufacturing industry make it an ideal industry for implementing digital twins, as they can help manufacturers enhance product quality, improve efficiency, and lower costs. Moreover, with the emergence of smart manufacturing and Industry 4.0, digital twin technology has gained huge traction in the manufacturing sector. By creating a virtual replica connected to the physical asset, digital twins provide smart manufacturers with real-time insights to make quick production decisions. Using digital twins enables smart manufacturers to predict the quality of their end products.
Segment Analysis
Large Enterprises - Market-Leading Product Segment
The large enterprises segment is expected to grow at the highest rate during the forecast period due to an upsurge in investments by large enterprises in digital twin technology and the burgeoning adoption of IoT devices, with an inclination toward remote working augment the use of digital twins in large enterprises. For large enterprises from sectors such as construction, manufacturing, automotive, healthcare, and utilities, the implementation of digital twins is a crucial strategy to enhance operational efficiency, optimize maintenance and operations, and drive innovation.
Healthcare- Fastest-Growing at 42.0% CAGR
Digital twins in healthcare refer to the computer representations of a system, from patients to hospitals, both physical entities and processes. The technology is being increasingly used to evaluate the progress and success of processes such as organ donation and surgical training, along with procedure derisking. Digital twin systems are also developed to simulate the movement of patients through hospitals, identify potential infection hotspots, and monitor contact-related risks.
SMEs - Significant-Growing Enterprise
SMEs have lagged in the adoption of digital twins due to more dynamic and less structured environments. The deployment of digital twins is expected to increase in SMEs with the rise in competitiveness; the technology has the potential to reinforce manufacturing capabilities. and application-driven technology designs.
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Regional Analysis
Asia Pacific - Fastest-Growing Market
Asia Pacific is projected to grow at over 40% CAGR by 2031. Enterprises in the region are increasingly adopting digital twin solutions. The growing need for digital twin solutions across various industries and the rising focus of organizations on enhancing business sustainability are a few of the factors driving the digital twin market growth in the Asia Pacific. According to the Equinix Global Tech Trends Survey 2023, approximately half of IT decision-makers in the Asia Pacific are already using digital twins for operational performance optimization and quality control management. Technologies, including AI and digital twins, are gaining huge traction in the region. All such factors boost the digital twin market growth in the Asia Pacific.
North America - Sustained by Federal Investment
The North America digital twin market is segmented into the US, Canada, and Mexico. In terms of revenue, North America dominated the global digital twin market share in 2024. The region has witnessed huge adoption of technologies such as machine learning (ML), artificial intelligence (AI), and blockchain in the past three years across all the major industry verticals. With the rising penetration of digitization in various industries, the digital twin has become a vital component of business. In addition, the region is home to a majority of key market players such as IBM Corporation, Oracle; Microsoft; ANSYS, Inc; and PTC, leading to the North America digital twin market growth.
Market Dynamics: Key Opportunities and Challenges
Rising Number of Smart City Projects: The reliance on technology for a more comfortable living is increasing with the evolving lifestyles of consumers and communities worldwide. Smart cities have gained huge traction in the last few decades as they can potentially facilitate a new way of living with optimized city functions, in turn enabling economic growth and improved quality of life for consumers by using smart technologies and data analysis. According to TWI Ltd., 54% of the world’s population lives in cities, and the number is expected to rise to 66% by 2050.
High Development Costs: The average cost of digital twin development typically ranges between US$45,000 and US$60,000. However, the final investment can vary significantly based on several factors, including the size and complexity of the enterprise, the level of advanced features and integrations required, the choice of technology stack and coding language, as well as scalability, real-time analytics capabilities, and ongoing maintenance needs.
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Recent Industry Developments (2025 - 2026)
Built on Microsoft Foundry, Kyndryl’s solution helps enterprises predict, prevent and resolve technology disruptions
In April 2026, Kyndryl (NYSE: KD), a leading provider of mission-critical enterprise technology services, announced the Kyndryl Digital Twin for the Workplace, a new AI-powered capability designed to help organizations avoid workflow disruption by anticipating and resolving technology issues. Built on Microsoft Foundry, the solution combines predictive intelligence, automation, and operational insight to address one of the most critical challenges of the digital workplace — improving the employee experience through automated IT service operations.
PTC to Accelerate the Design and Simulation of AI Infrastructure and Complex Products with NVIDIA
In July 2025, PTC (NASDAQ: PTC) announced that it is expanding the scope of its collaboration with NVIDIA, the world leader in accelerated computing. PTC is integrating NVIDIA Omniverse technologies into its Creo® computer-aided design (CAD) and Windchill® product lifecycle management (PLM) solutions to transform how manufacturers and product companies design, simulate, and collaborate on complex products — including the foundational hardware of AI infrastructure, such as high-performance PCBs, advanced cooling systems, and large-scale data center equipment. In addition, PTC has joined the Alliance for OpenUSD (AOUSD), reinforcing its commitment to the OpenUSD open and interoperable 3D data standards.
Leading Digital Twin Companies
CompanyProfileGeneral ElectricIndustrial technology leader and early pioneer in Digital Twin applications for aviation, power, and industrial asset performance managementMicrosoftMajor cloud and AI provider offering the Azure Digital Twins platform for smart buildings, manufacturing, and connected infrastructureSiemens AGGlobal industrial automation leader with comprehensive Digital Twin capabilities across manufacturing, energy, and smart infrastructureDassault SystèmesLeading provider of virtual twin experiences through the 3DEXPERIENCE platform for aerospace, automotive, and life sciencesPTC Inc.Industrial software company specializing in IoT-enabled Digital Twin and product lifecycle management (PLM) solutionsRobert Bosch GmbHGerman engineering and technology company leveraging Digital Twins for smart manufacturing, mobility, and industrial automation.IBM CorporationEnterprise AI and hybrid cloud provider delivering Digital Twin solutions for asset optimization and predictive maintenanceOracle CorporationCloud infrastructure and enterprise software provider supporting Digital Twin applications in supply chain and smart operationsAnsys Inc.Engineering simulation leader enabling physics-based Digital Twins for aerospace, automotive, and industrial systems.Autodesk Inc.Design and engineering software company supporting Digital Twin adoption in architecture, construction, and infrastructure projects. About The Insight Partners
The Insight Partners is a globally recognized market research and management consulting firm specializing in technology, media, telecommunications, healthcare, and industrial sectors. Research methodology integrates primary data collection, including executive interviews, OEM surveys, and channel partner analyses, with proprietary secondary research databases and econometric modeling. Reports are used by Fortune 500 companies, private equity firms, government agencies, and institutional investors to inform strategic planning, M&A, and capital allocation decisions. The firm maintains research coverage across 50+ industries and 100+ countries.
Travelers are stuck in a traffic jam as people hit the road before the busy Thanksgiving Day weekend in Chicago, Illinois, U.S., November 21, 2017. REUTERS/Kamil Krzaczynski Purchase Licensing Rights, opens new tab
CompaniesWASHINGTON, June 3 (Reuters) - Major automakers backed the U.S. Environmental Protection Agency proposal to delay for two years enforcement of a regulation requiring significant cuts in air pollution from vehicles, but want the agency to move quickly to rewrite the rules.
The Alliance for Automotive Innovation, a trade group representing General Motors (GM.N), opens new tab, Toyota Motor (7203.T), opens new tab, Volkswagen (VOWG.DE), opens new tab, Ford (F.N), opens new tab, Stellantis (STLAM.MI), opens new tab and Hyundai (005380.KS), opens new tab, said at a public hearing that the delay is needed and called for "a reasonable, workable path forward" and for the agency to "establish realistic and durable long-term standards."
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Environmental groups criticized the delay, saying it would lead to an increase in preventable illness and premature deaths.
The EPA last month estimated that delaying former President Joe Biden's anti-pollution rule would save automakers $1.7 billion. The proposal would delay compliance deadlines for light- and medium-duty vehicles, citing the decline in U.S. sales of electric vehicles, which it said made the more stringent pollution rules unattainable for manufacturers.
The automaker group said the decline in EV sales "has already stranded billions of dollars in investments."
In April 2024, Biden's EPA finalized a rule requiring significant reductions in so-called criteria pollutants emitted from passenger and commercial vehicles from the 2027 through 2032 model years.
Environmental Defense Fund fellow Rishab Jagetia said a two-year delay will result in billions of dollars in health harms, including more serious heart and lung diseases and early deaths. "Vehicle standards save lives," he said.
The Biden rules require a 50% reduction through 2032 for light vehicles and a 58% cut for medium-duty vehicles in the six criteria pollutants: ozone, particulate matter, carbon monoxide, nitrogen dioxide, sulfur dioxide and lead.
In 2024, EPA estimated $13 billion in annualized benefits due to reduced emissions of the pollutants that contribute to the formation of soot and smog.
The Trump administration has taken a series of steps to roll back vehicle regulations.
In February, it finalized its repeal of the "endangerment finding" for vehicles, a 2009 determination that greenhouse gas emissions endanger human health, which gave the EPA authority to regulate emissions from vehicles.
In December, the Transportation Department proposed significantly reducing the fuel economy requirements from model years 2022 to 2031, requiring 34.5 miles per gallon on average by 2031, down from 50.4 miles per gallon.
Reporting by David Shepardson in Washington Editing by Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles., opens new tab
New Kyndryl Agentic AI Framework capability designed to fuel more responsive supply chains and personalized customer experiences across retail, CPG, travel and transportation industries
, /PRNewswire/ -- Kyndryl (NYSE: KD), a leading provider of mission‑critical enterprise technology services, today announced Kyndryl AI Orchestration for Business, a new capability built with the Kyndryl Agentic AI Framework designed to move enterprises beyond experimentation and siloed workflows to enterprise-wide AI impact.
As organizations in retail, consumer packaged goods (CPG), travel and transportation, and other industries struggle to leverage AI to meet customer expectations around personalized experiences, real-time responsiveness and seamless fulfillment, Kyndryl AI Orchestration for Business helps to address this challenge. The capability autonomously interacts with AI agents across supply chains, commerce, finance, IT and customer operations to enable seamless coordination, cross-functional alignment and controlled execution at scale – supporting governed, policy-driven AI agent functionality.
"Enterprises are moving fast to embrace AI, but most are stuck in isolated pilots that don't change or improve their daily operations," said Rachel Calhoun, Vice President and Global Retail, CPG, and Travel and Transportation Leader at Kyndryl. "Kyndryl AI Orchestration for Business helps companies bring order and clarity to AI complexity – coordinating how AI agents act across business functions, with clear guardrails and human oversight. That means fewer disruptions, faster decisions and the ability to protect and grow revenue and customer loyalty as AI becomes part of how the business runs."
Kyndryl AI Orchestration for Business combines data, events and AI agents from across the enterprise to support role-based decision making and real-time action. Instead of reacting to issues after they occur, leaders and frontline teams receive proactive alerts, recommended actions and embedded agentic workflows that allow them to augment their own workstreams to intervene or approve automated actions before disruptions impact customers or revenue.
Kyndryl AI Orchestration for Business supports agentic workflows for use cases across store and enterprise operations, including:
Agentic Commerce: Connects supply chain, pricing, promotions and customer engagement – allowing organizations to anticipate demand shifts, manage disruptions and personalize customer experiences without sacrificing control. Proactive supply chain disruption management: Identifies supply risks, impacted SKUs and financial exposure in real time, prompting planners and managers to act before stock‑outs reach stores or customers. Role‑based operational orchestration: Delivers alerts, recommendations and actions to the right roles – such as demand planners, supply chain leaders and pricing teams – enabling faster, more coordinated decisions across functions. Policy‑driven execution and auditability: Embeds operational, regulatory and business rules directly into agent workflows at the reasoning level using policy as code, with full transparency into how decisions are made and executed. Coordinated commerce and customer experience enablement: Aligns supply, inventory, pricing and fulfillment decisions in real time to reduce disruptions, protect revenue and deliver a more consistent customer experience. Kyndryl Consult experts will help customers design, deliver and deploy AI Orchestration for Business, while leveraging the full Kyndryl Agentic AI Framework and the company's deep experience running mission-critical systems across hybrid cloud, on-premises and edge environments. The capability is cloud and large language model-agnostic, integrates with existing enterprise platforms and can operate with or without managed services tools – giving organizations the flexibility to modernize at their own pace.
Kyndryl is uniquely positioned to be the orchestration partner of choice for these industries, recognizing that achieving enterprise-scale process transformation requires targeted modernization across varied technology landscapes. Kyndryl accelerates this journey through a catalog of workflows and AI-native industry architectures that deliver speed, consistency and quality at scale. From unlocking legacy data and transactions across mainframe and distributed environments, to re-architecting applications to enable Model Context Protocol servers and power agentic workflows, Kyndryl leverages its comprehensive services to drive efficient end-to-end transformation.
Learn more information about Kyndryl AI Orchestration for Business.
About Kyndryl
Kyndryl (NYSE: KD) is a leading provider of mission-critical enterprise technology services, offering advisory, implementation and managed service capabilities to thousands of customers in more than 60 countries. As the world's largest IT infrastructure services provider, the company designs, builds, manages and modernizes the complex information systems that the world depends on every day. For more information, visit www.kyndryl.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements often contain words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "objectives," "opportunity," "plan," "position," "predict," "project," "should," "seek," "target," "will," "would" and other similar words or expressions or the negative thereof or other variations thereon. All statements other than statements of historical fact, including without limitation statements concerning the Company's plans, objectives, goals, beliefs, business strategies, future events, business condition, results of operations, financial position, business outlook and business trends and other non-historical statements, are forward-looking statements. These statements do not guarantee future performance and speak only as of the date of this press release. Except as required by law, the Company assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Actual outcomes or results may differ materially from those suggested by forward-looking statements as a result of risks and uncertainties, including those described in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, and may be further updated from time to time in the Company's subsequent filings with the Securities and Exchange Commission.
In the latest close session, Kyndryl Holdings, Inc. (KD - Free Report) was down 2.43% at $11.25. The stock trailed the S&P 500, which registered a daily loss of 1.62%. Meanwhile, the Dow lost 1.87%, and the Nasdaq, a tech-heavy index, lost 1.98%.
Prior to today's trading, shares of the company had gained 0.44% outpaced the Business Services sector's gain of 0.29% and the S&P 500's loss of 0.03%.
The upcoming earnings release of Kyndryl Holdings, Inc. will be of great interest to investors. On that day, Kyndryl Holdings, Inc. is projected to report earnings of $0.17 per share, which would represent a year-over-year decline of 54.05%. Meanwhile, the Zacks Consensus Estimate for revenue is projecting net sales of $3.69 billion, down 1.42% from the year-ago period.
In terms of the entire fiscal year, the Zacks Consensus Estimates predict earnings of $1.98 per share and a revenue of $14.76 billion, indicating changes of +35.62% and -2.19%, respectively, from the former year.
Investors should also take note of any recent adjustments to analyst estimates for Kyndryl Holdings, Inc. Recent revisions tend to reflect the latest near-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the business outlook.
Our research demonstrates that these adjustments in estimates directly associate with imminent stock price performance. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system.
The Zacks Rank system, ranging from #1 (Strong Buy) to #5 (Strong Sell), possesses a remarkable history of outdoing, externally audited, with #1 stocks returning an average annual gain of +25% since 1988. Over the past month, there's been a 7.38% fall in the Zacks Consensus EPS estimate. Kyndryl Holdings, Inc. is holding a Zacks Rank of #5 (Strong Sell) right now.
Investors should also note Kyndryl Holdings, Inc.'s current valuation metrics, including its Forward P/E ratio of 5.83. This denotes a discount relative to the industry average Forward P/E of 16.5.
The Technology Services industry is part of the Business Services sector. At present, this industry carries a Zacks Industry Rank of 161, placing it within the bottom 35% of over 250 industries.
The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
To follow KD in the coming trading sessions, be sure to utilize Zacks.com.
Baxter International (NYSE:BAX – Get Free Report) and Zynex (NASDAQ:ZYXI – Get Free Report) are both medical companies, but which is the superior stock? We will contrast the two businesses based on the strength of their analyst recommendations, earnings, valuation, risk, institutional ownership, profitability and dividends.
Insider and Institutional Ownership 90.2% of Baxter International shares are held by institutional investors. Comparatively, 29.7% of Zynex shares are held by institutional investors. 0.2% of Baxter International shares are held by company insiders. Comparatively, 49.3% of Zynex shares are held by company insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a stock is poised for long-term growth.
Earnings and Valuation This table compares Baxter International and Zynex”s top-line revenue, earnings per share and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Baxter International $11.24 billion 0.77 -$957.00 million ($1.85) -9.01 Zynex $108.20 million 0.04 $2.99 million ($2.43) -0.05 Zynex has lower revenue, but higher earnings than Baxter International. Baxter International is trading at a lower price-to-earnings ratio than Zynex, indicating that it is currently the more affordable of the two stocks.
Analyst Recommendations This is a breakdown of recent recommendations for Baxter International and Zynex, as provided by MarketBeat.
Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Baxter International 2 9 2 0 2.00 Zynex 1 2 1 0 2.00 Baxter International currently has a consensus price target of $19.90, suggesting a potential upside of 19.36%. Zynex has a consensus price target of $4.90, suggesting a potential upside of 3,820.00%. Given Zynex’s higher possible upside, analysts plainly believe Zynex is more favorable than Baxter International.
Profitability This table compares Baxter International and Zynex’s net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets Baxter International -8.51% 16.95% 5.62% Zynex -68.35% -804.30% -36.67% Risk & Volatility Baxter International has a beta of 0.62, meaning that its stock price is 38% less volatile than the S&P 500. Comparatively, Zynex has a beta of 0.99, meaning that its stock price is 1% less volatile than the S&P 500.
Summary Baxter International beats Zynex on 8 of the 13 factors compared between the two stocks.
About Baxter International (Get Free Report)
Baxter International Inc., through its subsidiaries, develops and provides a portfolio of healthcare products worldwide. The company operates through four segments: Medical Products and Therapies, Healthcare Systems and Technologies, Pharmaceuticals, and Kidney Care. The company offers sterile intravenous (IV) solutions; infusion systems and devices; parenteral nutrition therapies; generic injectable pharmaceuticals; surgical hemostat and sealant products, advanced surgical equipment; smart bed systems; patient monitoring and diagnostic technologies; and respiratory health devices, as well as advanced equipment for the surgical space, including surgical video technologies, precision positioning devices, and other accessories. It also provides administrative sets; adhesion prevention products; inhaled anesthesia; drug compounding; chronic and acute dialysis therapies and services, including peritoneal dialysis (PD), hemodialysis (HD), continuous renal replacement therapies (CRRT), and other organ support therapies. The company’s products are used in hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, ambulatory surgery centers, doctors’ offices, and patients at home under physician supervision. The company sells its products through direct sales force, as well as through independent distributors, drug wholesalers, and specialty pharmacy or other alternate site providers in approximately 100 countries. It has an agreement with Celerity Pharmaceutical, LLC to develop acute care generic injectable premix and oncolytic products; and a collaborative research agreement with Miromatrix Medical Inc. aiming to advance care for patients with acute liver failure. Baxter International Inc. was incorporated in 1931 and is headquartered in Deerfield, Illinois.
About Zynex (Get Free Report)
Zynex, Inc., together with its subsidiaries, designs, manufactures, and markets medical devices to treat chronic and acute pain; and activate and exercise muscles for rehabilitative purposes with electrical stimulation. The company offers NexWave, a dual channel, multi-modality interferential current, transcutaneous electrical nerve stimulation, and neuromuscular electrical stimulation (NMES) device that is marketed to physicians and therapists by field sales representatives; NeuroMove, an electromyography and electric stimulation technology device; InWave, an electrical stimulation product for the treatment of female urinary incontinence; E-Wave, an NMES device; M-Wave, an NMES device. It also supplies private labeled products, including electrodes for the delivery of electrical current to the body, and batteries for use in electrotherapy products. In addition, the company distributes Comfortrac/Saunders for cervical traction, JetStream for hot/cold therapy, LSO Back Braces for lumbar support, and braces for rehabilitation support. Further, it offers Zynex Fluid Monitoring System (CM-1500); Zynex Wireless Fluid Monitoring System (CM-1600), a noninvasive monitoring device designed to measure relative changes in fluid volume in adult patients; NiCO CO-Oximeter, a laser-based noninvasive co-oximeter; and HemeOx tHb Oximeter, a laser-based total hemoglobin pulse oximeter. The company provides its products for use in pain management and control; stroke and spinal cord injury rehabilitation; hemodynamic monitoring and intravascular volume monitoring; and pulse oximetry monitoring. It sells its products through direct sales force primarily in the United States. Zynex, Inc. was founded in 1996 and is headquartered in Englewood, Colorado.
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Shares of Baxter International Inc. (NYSE:BAX – Get Free Report) have been assigned a consensus rating of “Hold” from the thirteen analysts that are presently covering the firm, Marketbeat reports. Two research analysts have rated the stock with a sell rating, nine have assigned a hold rating and two have assigned a buy rating to the company. The average twelve-month price objective among brokerages that have issued a report on the stock in the last year is $19.80.
Several equities analysts have recently weighed in on BAX shares. Weiss Ratings reiterated a “sell (d)” rating on shares of Baxter International in a report on Wednesday, January 21st. The Goldman Sachs Group dropped their price objective on shares of Baxter International from $21.00 to $17.00 and set a “neutral” rating on the stock in a report on Friday, February 13th. Citigroup dropped their price objective on shares of Baxter International from $21.00 to $19.00 and set a “neutral” rating on the stock in a report on Wednesday, March 11th. Wells Fargo & Company dropped their price objective on shares of Baxter International from $21.00 to $19.00 and set an “equal weight” rating on the stock in a report on Friday, December 12th. Finally, Evercore dropped their price objective on shares of Baxter International from $23.00 to $22.00 and set an “outperform” rating on the stock in a report on Monday.
Check Out Our Latest Stock Report on BAX
Institutional Investors Weigh In On Baxter International A number of institutional investors and hedge funds have recently made changes to their positions in BAX. Greenhaven Associates Inc. acquired a new stake in shares of Baxter International in the 3rd quarter worth about $143,186,000. Dodge & Cox raised its holdings in shares of Baxter International by 10.1% in the 3rd quarter. Dodge & Cox now owns 57,396,370 shares of the medical instruments supplier’s stock worth $1,306,915,000 after acquiring an additional 5,274,750 shares during the last quarter. SG Americas Securities LLC raised its holdings in shares of Baxter International by 477.6% in the 4th quarter. SG Americas Securities LLC now owns 1,725,251 shares of the medical instruments supplier’s stock worth $32,970,000 after acquiring an additional 1,426,547 shares during the last quarter. Geode Capital Management LLC raised its holdings in shares of Baxter International by 7.8% in the 4th quarter. Geode Capital Management LLC now owns 13,510,205 shares of the medical instruments supplier’s stock worth $257,174,000 after acquiring an additional 972,891 shares during the last quarter. Finally, Russell Investments Group Ltd. raised its holdings in shares of Baxter International by 35.6% in the 4th quarter. Russell Investments Group Ltd. now owns 3,410,689 shares of the medical instruments supplier’s stock worth $65,216,000 after acquiring an additional 894,761 shares during the last quarter. Institutional investors and hedge funds own 90.19% of the company’s stock.
Baxter International Price Performance BAX stock opened at $16.62 on Wednesday. The company’s fifty day simple moving average is $18.87 and its 200 day simple moving average is $19.71. Baxter International has a 12-month low of $15.73 and a 12-month high of $32.68. The firm has a market cap of $8.58 billion, a price-to-earnings ratio of -8.98, a PEG ratio of 1.18 and a beta of 0.62. The company has a quick ratio of 1.56, a current ratio of 2.31 and a debt-to-equity ratio of 1.55.
Baxter International (NYSE:BAX – Get Free Report) last announced its quarterly earnings data on Thursday, February 12th. The medical instruments supplier reported $0.44 earnings per share for the quarter, missing the consensus estimate of $0.53 by ($0.09). Baxter International had a negative net margin of 8.51% and a positive return on equity of 16.95%. The company had revenue of $2.97 billion for the quarter, compared to analyst estimates of $2.82 billion. During the same quarter in the prior year, the company posted $0.58 EPS. Baxter International’s revenue for the quarter was up 8.0% on a year-over-year basis. Baxter International has set its FY 2026 guidance at 1.850-2.050 EPS. On average, analysts expect that Baxter International will post 2.48 earnings per share for the current year.
Baxter International Dividend Announcement The business also recently disclosed a quarterly dividend, which was paid on Wednesday, April 1st. Stockholders of record on Friday, February 27th were issued a dividend of $0.01 per share. The ex-dividend date was Friday, February 27th. This represents a $0.04 annualized dividend and a dividend yield of 0.2%. Baxter International’s dividend payout ratio is currently -2.16%.
Baxter International Company Profile (Get Free Report)
Baxter International Inc is a global healthcare company that develops, manufactures and markets a broad portfolio of medical products, pharmaceutical therapies and biotechnology-based solutions. The company’s primary business activities are organized around renal care, medication delivery, acute therapies, pharmacy automation, surgical care and biotechnology. Baxter’s offerings are designed to support patient care in hospitals, dialysis centers, nursing homes and other healthcare facilities worldwide.
In the renal care segment, Baxter provides hemodialysis and peritoneal dialysis systems, water treatment equipment and related disposables, including dialyzers, bloodlines and catheters.
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DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a leading global medtech company, will host a conference call to discuss its first-quarter 2026 financial results on Thursday, April 30, 2026 at 7:30 a.m. Central Time. To participate in this conference call please follow this link https://registrations.events/direct/Q4I946023356 to pre-register for the call and receive the call information. This call is also being webcast and can be accessed through Baxter's website at www.
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global medtech leader, is highlighting recent additions to its Global Surgical Solutions and Patient Support Systems portfolios, as well as its broad Advanced Surgery portfolio of hemostatic and sealing agents, at the Association of periOperative Registered Nurses (AORN) Global Surgical Conference & Expo, taking place April 11-14, 2026 in New Orleans. New offerings include the AAT XR spine surgical table and the Dynam.
Baxter International (BAX - Free Report) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The earnings report, which is expected to be released on April 30, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis drug and medical device maker is expected to post quarterly earnings of $0.31 per share in its upcoming report, which represents a year-over-year change of -43.6%.
Revenues are expected to be $2.6 billion, down 0.8% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 1.72% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Baxter?For Baxter, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -0.60%.
On the other hand, the stock currently carries a Zacks Rank of #4.
So, this combination makes it difficult to conclusively predict that Baxter will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Baxter would post earnings of $0.53 per share when it actually produced earnings of $0.44, delivering a surprise of -16.98%.
Over the last four quarters, the company has beaten consensus EPS estimates two times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Baxter doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Baxter International (NYSE:BAX – Get Free Report) and GN Store Nord (OTCMKTS:GNNDY – Get Free Report) are both mid-cap medical companies, but which is the superior stock? We will contrast the two businesses based on the strength of their valuation, risk, profitability, institutional ownership, dividends, earnings and analyst recommendations.
Risk and Volatility Baxter International has a beta of 0.62, meaning that its share price is 38% less volatile than the S&P 500. Comparatively, GN Store Nord has a beta of 1.86, meaning that its share price is 86% more volatile than the S&P 500.
Analyst Recommendations This is a summary of current ratings for Baxter International and GN Store Nord, as reported by MarketBeat.com.
Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Baxter International 2 9 2 0 2.00 GN Store Nord 1 3 2 0 2.17 Baxter International currently has a consensus target price of $19.80, indicating a potential upside of 8.99%. Given Baxter International’s higher probable upside, equities research analysts clearly believe Baxter International is more favorable than GN Store Nord.
Insider and Institutional Ownership 90.2% of Baxter International shares are held by institutional investors. 0.2% of Baxter International shares are held by insiders. Strong institutional ownership is an indication that endowments, large money managers and hedge funds believe a company is poised for long-term growth.
Profitability This table compares Baxter International and GN Store Nord’s net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets Baxter International -8.51% 16.95% 5.62% GN Store Nord 3.97% 6.31% 2.29% Earnings and Valuation This table compares Baxter International and GN Store Nord”s top-line revenue, earnings per share and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Baxter International $11.24 billion 0.83 -$957.00 million ($1.85) -9.82 GN Store Nord $2.54 billion 0.91 $98.86 million $2.06 22.33 GN Store Nord has lower revenue, but higher earnings than Baxter International. Baxter International is trading at a lower price-to-earnings ratio than GN Store Nord, indicating that it is currently the more affordable of the two stocks.
Summary GN Store Nord beats Baxter International on 7 of the 13 factors compared between the two stocks.
About Baxter International (Get Free Report)
Baxter International Inc., through its subsidiaries, develops and provides a portfolio of healthcare products worldwide. The company operates through four segments: Medical Products and Therapies, Healthcare Systems and Technologies, Pharmaceuticals, and Kidney Care. The company offers sterile intravenous (IV) solutions; infusion systems and devices; parenteral nutrition therapies; generic injectable pharmaceuticals; surgical hemostat and sealant products, advanced surgical equipment; smart bed systems; patient monitoring and diagnostic technologies; and respiratory health devices, as well as advanced equipment for the surgical space, including surgical video technologies, precision positioning devices, and other accessories. It also provides administrative sets; adhesion prevention products; inhaled anesthesia; drug compounding; chronic and acute dialysis therapies and services, including peritoneal dialysis (PD), hemodialysis (HD), continuous renal replacement therapies (CRRT), and other organ support therapies. The company’s products are used in hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, ambulatory surgery centers, doctors’ offices, and patients at home under physician supervision. The company sells its products through direct sales force, as well as through independent distributors, drug wholesalers, and specialty pharmacy or other alternate site providers in approximately 100 countries. It has an agreement with Celerity Pharmaceutical, LLC to develop acute care generic injectable premix and oncolytic products; and a collaborative research agreement with Miromatrix Medical Inc. aiming to advance care for patients with acute liver failure. Baxter International Inc. was incorporated in 1931 and is headquartered in Deerfield, Illinois.
About GN Store Nord (Get Free Report)
GN Store Nord A/S provides hearing, audio, video, and gaming solutions in Denmark, rest of Europe, North America, and internationally. The company operates through GN Hearing and GN Audio segments. The GN Hearing segment produces and sells hearing instruments and products. The GN Audio segment supplies headsets, video cameras, and speakerphones for professional use and consumer products. It offers its products under the ReSound, Jabra, Beltone, Interton, Danavox, BlueParrott, FalCom, and SteelSeries brands. GN Store Nord A/S was founded in 1869 and is based in Ballerup, Denmark.
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Key Takeaways Baxter expects Q1 revenues near $2.60B and EPS of 31 cents, reflecting a sharp fall YoY.BAX faces pressure from weak infusion system demand, product disruptions and hospital volume softness.Advanced Surgery and HST offer some stability, but margin and growth challenges persist. Baxter International Inc. (BAX - Free Report) is scheduled to release first-quarter 2026 results on April 30, before the opening bell. In the last reported quarter, the company’s earnings missed the Zacks Consensus Estimate by 16.9%. BAX’s earnings beat estimates in two of the trailing four quarters and missed twice, delivering an average surprise of 2.73%.
BAX’s Q1 EstimatesThe consensus estimate for revenues is pegged at $2.60 billion, indicating a decline of 0.8% from the prior-year quarter’s reported figure. The consensus mark for earnings is pinned at 31 cents per share, implying a 43.6% year-over-year decline.
Our model estimates total revenues from continuing operations to decline 1.5% at constant currency (cc) to $2.60 billion. Adjusted earnings per share are expected to decline 44.2% to 31 cents.
Important Factors to Note Ahead of BAX’s Q1 ResultsBaxter’s first-quarter 2026 results are expected to reflect a continuation of near-term operational pressures, with management already signaling that the quarter will likely be the most challenging of the year. While the company remains in the early stages of a broader turnaround, execution headwinds, unfavorable comparisons and lingering product-related disruptions are likely to weigh on both revenue growth and profitability.
Total revenues are likely to have remained under pressure, indicating a modest year-over-year decline. This expected softness largely reflects continued challenges within hospital-facing product categories, particularly in infusion systems, alongside a normalization in demand trends that had previously benefited from temporary factors. Lower volumes, coupled with limited operating leverage, are likely to constrain overall top-line performance in the quarter.
Within the Medical Products & Therapies (“MPT”) segment, Infusion Therapies & Technologies (“ITT”) is expected to have been a key drag. ITT is likely to have faced a tough comparison in the first quarter due to the one-time distributor build in the prior year, along with near-term margin pressure from higher-cost inventory. However, performance is expected to improve later in the year, supported by cost optimization actions.
The ongoing shipment and installation hold on the Novum IQ large-volume pump should have disrupted sales, with customers adopting a wait-and-see approach amid uncertainty around resolution timelines. IV fluid conservation practices across U.S. hospitals are also expected to have weighed on IV solutions’ demand, reinforcing volume headwinds.
Advanced Surgery, however, is likely to have remained a relatively bright spot, supported by sustained demand for hemostats and sealants, steady procedural volumes and solid commercial execution. While growth in this business may not fully offset ITT-related weakness, it should provide some support to overall segment performance.
Healthcare Systems & Technologies (“HST”) is expected to have delivered relatively stable performance, backed by strength in Care & Connectivity Solutions and resilient hospital capital spending trends. Rising momentum in patient support systems and care communications, along with contributions from recent product launches, may help sustain modest growth, although margin expansion is likely to have been constrained by unfavorable mix, tariff-related costs and elevated corporate allocations.
Within Pharmaceuticals, sales of Injectables & Anesthesia are likely to be impacted by softer demand, shifts toward IV push administration and supply-related challenges, resulting in an unfavorable product mix. While Drug Compounding may have continued to show growth, the sustainability of prior-quarter strength remains uncertain, particularly given normalization trends.
Adjusted EPS is likely to have remained under pressure in the first quarter, impacted by lower volumes, absorption headwinds and higher interest expense, even as underlying operating performance remains subdued.
What the Zacks Model Unveils for BAX StockOur proven model does not conclusively predict an earnings beat for Baxter this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the chances of an earnings beat. But this is not the case here, as you will see below.
BAX’s Earnings ESP: Earnings ESP, which represents the difference between the Most Accurate Estimate and the Zacks Consensus Estimate, is -0.60% for Baxter. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter.
Zacks Rank of BAX: Baxter currently has a Zacks Rank #5 (Strong Sell).
Stocks Worth a LookHere are some medical product stocks worth considering, as these have the right combination of elements to post an earnings beat this reporting cycle.
Fresenius Medical Care AG & Co. (FMS - Free Report) has an Earnings ESP of +3.39% and a Zacks Rank #3 at present. The company is set to release first-quarter 2026 results on May 5. You can see the complete list of today’s Zacks #1 Rank stocks here.
FMS’ earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 9.67%. The Zacks Consensus Estimate for FMS’ first-quarter EPS indicates an improvement of 34.1% from the year-ago reported figure.
Intuitive Surgical (ISRG - Free Report) has an Earnings ESP of +0.06% and a Zacks Rank of 2 at present. The company released its first-quarter 2026 results on April 21.
ISRG’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 16.82%. The Zacks Consensus Estimate for ISRG’s second-quarter EPS implies an improvement of 13.2% from the year-ago reported figure.
Hims & Hers Health (HIMS - Free Report) has an Earnings ESP of +150.94% and a Zacks Rank of 3 at present. The company is slated to release first-quarter 2026 results on May 11.
HIMS’ earnings surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 69.45%. The Zacks Consensus Estimate for HIMS’ first-quarter EPS calls for a decline of 70% from the year-ago reported figure.
Wall Street expects a year-over-year decline in earnings on lower revenues when QuidelOrtho (QDEL - Free Report) reports results for the quarter ended March 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.
The earnings report, which is expected to be released on May 5, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis medical diagnostics company is expected to post quarterly earnings of $0.24 per share in its upcoming report, which represents a year-over-year change of -67.6%.
Revenues are expected to be $618.07 million, down 10.8% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 58.33% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for QuidelOrtho?For QuidelOrtho, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -54.17%.
On the other hand, the stock currently carries a Zacks Rank of #5.
So, this combination makes it difficult to conclusively predict that QuidelOrtho will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that QuidelOrtho would post earnings of $0.43 per share when it actually produced earnings of $0.46, delivering a surprise of +6.98%.
Over the last four quarters, the company has beaten consensus EPS estimates three times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
QuidelOrtho doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
An Industry Player's Expected ResultsAmong the stocks in the Zacks Medical - Products industry, Baxter International (BAX - Free Report) , is soon expected to post earnings of $0.31 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of -43.6%. This quarter's revenue is expected to be $2.6 billion, down 0.8% from the year-ago quarter.
The consensus EPS estimate for Baxter has been revised 1.7% lower over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -0.60%.
This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Baxter will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a global medtech leader, today reported results for the first quarter of 2026. “Financial results for the quarter overall were in line with our expectations, and we are making progress to stabilize the business, embed a culture of continuous improvement, and strengthen execution,” said Andrew Hider, president and CEO. “Although more work remains to achieve our full potential, Baxter continues to take the decisive steps nec.
On April 30, 2026, Baxter International Inc BAX released its 8-K filing detailing first-quarter 2026 results. Sales from continuing operations were $2.7 billion, up 3% on a reported basis and down 1% organically. U.S. GAAP diluted EPS from continuing operations was a loss of $0.03. Adjusted diluted EPS from continuing operations was $0.36. Baxter offers a variety of medical supplies and equipment to providers. From its legacy operations, Baxter sells injectable therapies for use in care settings, including IV pumps, administrative sets, and solutions; nutritional products; and surgical sealants and hemostatic agents. Baxter expanded its portfolio of hospital-focused offerings by acquiring Hillrom in late 2021, which added basic equipment like hospital beds, operating room equipment, and patient monitoring tools to the portfolio. Baxter also sold its kidney care tools in early 2025.
Headline results and estimate comparison Revenue was $2.70 billion. This is higher than the analyst estimate of $2.62 billion.
Adjusted diluted EPS from continuing operations was $0.36. This is higher than the analyst estimate of $0.11.
GAAP diluted EPS from continuing operations was a loss of $0.03. This is lower than the analyst estimate of $0.11.
For reference, current annual estimates call for EPS of $0.83 and revenue of $11,350.58 million.
Management commentary“Financial results for the quarter overall were in line with our expectations, and we are making progress to stabilize the business, embed a culture of continuous improvement, and strengthen execution,” said Andrew Hider, president and CEO. “Although more work remains to achieve our full potential, Baxter continues to take the decisive steps necessary to fulfill our commitment to delivering better and more consistent results for our shareholders. I want to thank our colleagues for their resilience, dedication and mission-driven focus to support the more than 350 million patients around the world who rely on us annually."Performance, challenges, and why they matter Top-line growth benefited from international strength and momentum in Advanced Surgery and Drug Compounding. U.S. revenue declined due to softer demand in infusion pumps and timing-related headwinds in Front Line Care. Segment operating margins compressed across all three operating groups. This reflects higher tariff and manufacturing costs, including lower absorption, which weighed on profitability.
The temporary shipment and installation hold of the Novum IQ Large Volume Pump reduced Infusion Therapies & Technologies sales. This matters because infusion pumps are a key component of Baxter’s recurring capital and disposables ecosystem. Persistent quality or regulatory issues could constrain placements and pull-through of related consumables, pressuring margins and cash generation in an industry where scale, product reliability, and service networks are competitive differentiators.
Metric Q1 2026 YoY Change / Notes Net sales (continuing) $2,701 million +3% reported; -1% organic U.S. sales $1,435 million -4% reported; -4% organic International sales $1,266 million +12% reported; +3% organic GAAP diluted EPS (cont.) $(0.03) vs $0.13 prior year Adjusted diluted EPS (cont.) $0.36 -35% year over year Adjusted operating income $297 million -24% year over year Analyst est. revenue $2,615.77 million Actual exceeded estimate Analyst est. EPS $0.11 Adjusted EPS exceeded estimateSegment trends and mix Medical Products & Therapies revenue was $1.285 billion. Reported growth was 2%. Organic growth declined 2%. Infusion Therapies & Technologies decreased 5% organically on lower infusion pump sales tied to the Novum IQ LVP shipment and installation hold and a tough comparison due to a one-time distributor build after Hurricane Helene last year. Advanced Surgery grew 10% organically on continued global demand.
Healthcare Systems & Technologies revenue was $705 million. Reported growth was flat. Organic growth declined 2%. Front Line Care decreased on order timing and planned portfolio exits. Care & Connectivity Solutions was approximately flat organically.
Pharmaceuticals revenue was $621 million. Reported growth was 7%. Organic growth was 1%. Drug Compounding rose 20% organically, partially offset by lower Injectables & Anesthesia, which declined 13% organically.
Profitability, cash, and key financial metrics On a GAAP basis, gross margin was $891 million, or 33.0% of sales, up 0.2 points year over year. Operating income was $66 million for a 2.4% margin. Interest expense was $66 million. The company reported a net loss from continuing operations of $17 million.
On an adjusted basis, diluted EPS from continuing operations was $0.36, down 35% year over year. Management cited an unfavorable prior-year comparison from an expense reclassification, along with higher tariffs and manufacturing costs, including lower absorption.
Segment operating margins contracted: Medical Products & Therapies to 14.5% from 19.3%, Healthcare Systems & Technologies to 9.4% from 13.2%, and Pharmaceuticals to 7.4% from 10.8%. Margin pressure is a focal metric for medical device companies, as it reflects pricing power, manufacturing efficiency, and product mix. Sustained cost inflation or lower plant utilization can dampen returns on invested capital in a capital-intensive industry.
The filing includes a reconciliation framework for free cash flow. The company defines free cash flow as operating cash flow less capital expenditures. This measure is widely watched in MedTech for funding R&D, quality remediation, and deleveraging, but specific cash flow figures were not included in the provided schedules.
Why this quarter matters for value investors Revenue exceeded expectations while adjusted EPS remained above consensus despite pronounced year-over-year compression. The divergence between GAAP and adjusted earnings underscores the impact of noncore items, tariffs, and manufacturing absorption. International growth and Advanced Surgery and Drug Compounding strength provided balance to U.S. declines tied to infusion pump constraints and order timing. Investors will likely focus on operational execution, cost controls, segment margin recovery, and the resolution of infusion pump-related constraints as key catalysts for fundamentals and valuation.
Selected segment and geography details Sales ($ millions) Q1 2026 Q1 2025 Reported YoY Organic YoY Medical Products & Therapies $1,285 $1,262 +2% -2% Healthcare Systems & Technologies $705 $704 0% -2% Pharmaceuticals $621 $581 +7% +1% U.S. sales $1,435 $1,490 -4% -4% International sales $1,266 $1,135 +12% +3%Analysis Baxter International Inc BAX delivered a revenue beat driven by international markets and resilient demand in Advanced Surgery and Drug Compounding. At the same time, margin compression across all segments and a GAAP loss highlight the cost environment and product-specific headwinds. Interest expense matched operating income on a GAAP basis, amplifying the sensitivity of net results to margin swings. The company’s adjusted figures point to core operating profitability but also to the urgency of cost containment and returning infusion pump volumes to normalized levels. For value-oriented investors, the quarter offers evidence of top-line stability with identifiable paths to improve margins, but execution on manufacturing efficiencies and product remediation appears central to closing the gap between adjusted and GAAP performance.
GuruFocus Valuation Check Based on GuruFocus’s proprietary valuation, Baxter International Inc BAX has a GF Value of $35.98 versus a current price of $16.90, implying the shares appear 53.0% undervalued. This suggests potential upside if fundamentals stabilize and margins improve toward historical norms.
The company’s GF Score is 57/100, which is classified as Average. Financial Strength is 4/10, indicating a moderate balance sheet with leverage and interest costs that investors should monitor. Profitability ranks 6/10, which points to reasonable core earnings power even as reported GAAP results were pressured. Growth ranks 3/10, reflecting subdued organic expansion and product-specific headwinds. Predictability is 1 star, signaling higher variability in results and lower earnings consistency. The Moat Score is 6/10, suggesting competitive advantages in core franchises but not insurmountable, especially amid cost and quality pressures.
Insider Activity shows no insider transactions in the last three months. A lack of notable buys or sells provides no incremental signal. For a deeper dive, visit the Baxter International Inc stock page on GuruFocus.
Explore the complete 8-K earnings release (here) from Baxter International Inc for further details.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
CompaniesApril 30 (Reuters) - Baxter (BAX.N), opens new tab on Thursday stuck to its annual forecast after it beat Wall Street estimates for first-quarter results, and said it is closely monitoring the conflict in the Middle East and rising oil prices, sending its shares 5% higher.
Baxter said its Middle East exposure accounts for less than 2% of total revenue.
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"We continue to monitor the direct and broader macroeconomic effects of higher oil prices and conflict in the Middle East," said CEO Andrew Hider.
He said the situation remains fluid, adding that any shift in conditions would not be specific to Baxter. "We are prepared to navigate any unforeseen dynamic with rigor and agility."
"Our exposure to fuel today is less than half of what it was historically, given the divestiture of the kidney business," he added.
Evercore ISI analyst Vijay Kumar said a steady print by Baxter and forecast reiteration should provide some relief given nervousness around Middle East and inflation risks.
"If oil stays flat as it is today, we do see this as something we can manage and mitigate and will not have a material impact in 2026," CEO Hider said.
"Following a series of misses and guide-downs last year, many of which came as surprises, we believe today's delivery and reiterated guidance will be welcomed by investors," said Citi analyst Joanne Wuensch.
Quarterly revenue came in at $2.70 billion, ahead of estimates of $2.62 billion.
On an adjusted basis, Baxter earned a profit of 36 cents per share for the quarter ended March 31, above analysts' estimate of 31 cents per share, according to LSEG data.
Baxter reiterated its full-year adjusted earnings forecast of $1.85 to $2.05 per share.
Reporting by Kamal Choudhury in Bengaluru; Editing by Shailesh Kuber
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Baxter International (BAX - Free Report) reported $2.7 billion in revenue for the quarter ended March 2026, representing a year-over-year increase of 2.9%. EPS of $0.36 for the same period compares to $0.55 a year ago.
The reported revenue compares to the Zacks Consensus Estimate of $2.6 billion, representing a surprise of +3.74%. The company delivered an EPS surprise of +15.42%, with the consensus EPS estimate being $0.31.
While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.
As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately.
Here is how Baxter performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
Net Sales- Pharmaceuticals- International: $441 million versus the two-analyst average estimate of $412.19 million. The reported number represents a year-over-year change of +14.3%.Geographic Net Sales- United States: $1.44 billion compared to the $1.42 billion average estimate based on two analysts.Net Sales- Other- International: $39 million compared to the $29.43 million average estimate based on two analysts. The reported number represents a change of +30% year over year.Net Sales- Infusion Therapies and Technologies- International: $455 million compared to the $434.6 million average estimate based on two analysts. The reported number represents a change of +11% year over year.Net Sales- Pharmaceuticals: $621 million compared to the $582.11 million average estimate based on four analysts. The reported number represents a change of +6.9% year over year.Net Sales- Advanced Surgery: $304 million versus the four-analyst average estimate of $291.29 million. The reported number represents a year-over-year change of +13.4%.Net Sales- Other: $90 million versus $80.06 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +15.4% change.Net Sales- Front Line Care: $270 million compared to the $282.71 million average estimate based on four analysts. The reported number represents a change of -2.5% year over year.Net Sales- Drug Compounding: $320 million versus $274.25 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +30.1% change.Net Sales- Care and Connectivity Solutions: $435 million compared to the $439.46 million average estimate based on four analysts. The reported number represents a change of +1.9% year over year.Net Sales- Medical Products and Therapies: $1.29 billion versus the four-analyst average estimate of $1.24 billion. The reported number represents a year-over-year change of +1.8%.Net Sales- Healthcare Systems and Technologies: $705 million versus $722.17 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +0.1% change.View all Key Company Metrics for Baxter here>>>
Shares of Baxter have returned +0.7% over the past month versus the Zacks S&P 500 composite's +12.2% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term.
Key Takeaways Baxter reported Q1 EPS of 36 cents, beating estimates, though earnings fell 35% year over year.BAX posted 3% revenue growth, with international sales up 12% but U.S. sales down 4%.BAX saw margins contract sharply, with gross margin down 500 bps and operating margin down 390 bps. Baxter International Inc. (BAX - Free Report) reported first-quarter 2026 adjusted earnings per share (EPS) from continuing operations of 36 cents, which beat the Zacks Consensus Estimate of 31 cents by 16.1%. The bottom line declined 35% from the year-ago quarter’s level.
On a GAAP basis, the company reported a loss per share from continuing operations of 3 cents against EPS of 13 cents in the prior-year quarter.
The company’s continuing operations exclude its Kidney Care business, which was acquired by Carlyle in January 2025.
Baxter’s Revenue DetailsRevenues from continued operations totaled $2.7 billion, up 3% on a reported basis but declined 1% on an organic basis. The figure beat the Zacks Consensus Estimate by 3.8%.
U.S. sales from continuing operations were $1.44 billion, down 4% on a reported as well as an organic basis. International sales from continuing operations totaled $1.27 billion, reflecting an increase of 12% on a reported basis and 3% on an organic basis.
Shares of BAX gained 6.5% in pre-market trading following better-than-expected quarterly earnings. The company’s shares have declined 11.5% so far this year compared with the industry’s fall of 21.5%. The broader S&P 500 Index has increased 4.5% in the same period.
The segment includes Advanced Surgery and Infusion Therapies & Technologies categories. Sales in this segment totaled $1.29 billion, up 2% reportedly but down 2% on an organic basis. The decline was led by lower infusion pump sales due to the previously disclosed shipment and installation hold of the Novum IQ LVP. Moreover, distributor increased their stock amid Hurricane Helene disruption last year, leading to unfavorable comparisons. The decline was partially offset by continued strong global demand for Advanced Surgery products.
Infusion Therapies and Technologies’ sales totaled $981 million, down 1% year over year, reportedly and 5% on an organic basis. Advanced Surgery category sales amounted to $304 million, up 13% year over year reportedly and 10% on an organic basis.
Healthcare Systems and Technologies
The segment includes the Front Line Care category. It also consists of the Patient Support Systems and Surgical Solutions categories, which are clubbed as Care & Connectivity Solutions. Total sales in this segment were $705 million, flat year over year reportedly and down 2% on an organic basis. The performance reflected reduced sales within the Front Line Care division, driven by the timing of orders and the impact of planned global portfolio exits.
Front Line Care category sales totaled $290 million, down 3% year over year, reportedly and 4% on an organic basis. Care & Connectivity Solutions category sales amounted to $537 million, up 2% year over year, reportedly and flat on an organic basis.
Pharmaceuticals
The segment presently includes two product categories — Injectables & Anesthesia and Drug Compounding. Total sales during the first quarter were $621 million, up 7% year over year reportedly and 1% on an organic basis. The growth was driven by continued strength in Drug Compounding, partially offset by reduced sales within Injectables & Anesthesia.
Injectables and Anesthesia category sales totaled $301 million, down 10% year over year reportedly and 13% on an organic basis. The Drug Compounding category sales amounted to $320 million, up 30% year over year reportedly and 20% on an organic basis.
Other
Revenues in the segment amounted to $51 million, up 15% year over year reportedly.
Margin AnalysisBaxter reported an adjusted gross profit of $993 million, down 18.9% year over year. As a percentage of revenues, the adjusted gross margin contracted 500 basis points (bps) to 36.8%.
Selling, general and administrative expenses amounted to $728 million, up 4% year over year. Research and development expenses totaled $139 million, down 1%.
Adjusted operating income from continuing operations totaled $188 million, down 34% year over year. As a percentage of revenues, the adjusted operating margin contracted 390 bps to 7%.
2026 GuidanceBaxter maintained its sales and EPS guidance for 2026.
Continuing operational sales are estimated to reflect flat to 1% growth on a reported basis. Sales are expected to be flat organically. The Zacks Consensus Estimate is pegged at $11.33 billion, implying 0.8% growth.
Adjusted EPS from continuing operations is projected to be in the band of $1.85-$2.05. The Zacks Consensus Estimate is pegged at $1.9.
Zacks Rank and Stocks to ConsiderCurrently, Baxter carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are Globus Medical (GMED - Free Report) , Phibro Animal Health (PAHC - Free Report) and Cardinal Health (CAH - Free Report) . While Globus Medical sports a Zacks Rank #1 (Strong Buy), Phibro Animal Health and Cardinal Health carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Globus Medical shares have gained 4% in the year-to-date period. Estimates for the company’s first-quarter 2026 EPS have increased 1 cent to 90 cents in the past 30 days. GMED’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 18.79%. In the last reported quarter, it posted an earnings surprise of 20.75%.
Estimates for Phibro Animal Health’s third-quarter fiscal 2026 EPS have remained constant at 72 cents in the past 30 days. Shares of the company have risen 45.3% in the year-to-date period against the industry’s 18.8% decline. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 20.15%. In the last reported quarter, it delivered an earnings surprise of 26.09%.
Cardinal Health shares have remained flat in the year-to-date period. Estimates for the company’s third-quarter 2026 EPS have decreased 1 cent to $2.80 in the past 30 days. CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 9.30%. In the last reported quarter, it posted an earnings surprise of 10.04%.
In recent years, stocks like Baxter International have underperformed: most low-growth, high-debt, struggling names have been bad investments at basically any price. Concerns are real, and early missteps under new CEO Andrew Hider haven't helped. But valuation is attractive not just on an absolute basis but also relative to the outlook, and Q1 results seemed helpful to the bull case.
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Almitas Capital LLC trimmed its position in Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) by 71.4% during the third quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The firm owned 457,322 shares of the company's stock after selling 1,141,944 shares during the quarter. Almitas Capital
March 17, 2026 16:30 ET | Source: ZENTALIS PHARMACEUTICALS
Preclinical evidence supports azenosertib ADC combinations as potential promising therapeutic strategies for Triple-Negative Breast Cancer Demonstration of Cyclin E1 protein overexpression as an indicator for poor prognosis in ovarian cancer patients with real world data SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
“We are excited to highlight the potential to expand the opportunity for azenosertib as a combination therapy with cytotoxic agents, including antibody drug conjugates (ADC) and chemotherapy, for Triple-Negative Breast Cancer, a subtype of breast cancer with elevated Cyclin E1 expression. These data support clinical study of azenosertib in tumor types beyond ovarian cancer,” said Julie Eastland, Chief Executive Officer. “In addition, the Cyclin E1 biomarker findings in ovarian cancer based on real world data reinforce the high unmet need for this biomarker-selected patient population with poor prognosis. Our biomarker-driven strategy for azenosertib monotherapy in Cyclin E1-positive platinum-resistant ovarian cancer has potential to address this unmet need.”
AACR poster presentation details are below:
Title: “WEE1 Inhibition as a Therapeutic Strategy in Triple-Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models”
Abstract Number: 2012
Date/Time: Monday, April 20, 2026, 2:00 p.m. - 5:00 p.m. PDT
Presenting Author: Alexandra Levy, MS
Title: “Real-World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1-Positive Ovarian Cancer”
Abstract Number: 1708
Date/Time: Sunday, April 19, 2026, 2:00 p.m. - 5:00 p.m. PDT
Presenting Author: Jinkil Jeong, PhD
The posters can be accessed on the Supporting Publications page of the Zentalis website at the time of each presentation’s session.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer, triple negative breast cancer or other indications; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; and our participation in poster presentations. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “expect,” “intent,” “look forward,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “target,” “upcoming,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
On track for DENALI Part 2a dose confirmation in 1H 2026 DENALI Part 2 trial topline readout expected by year end 2026; potential to support accelerated approval On track to initiate the ASPENOVA Phase 3, randomized, confirmatory trial in 1H 2026 Expanding azenosertib potential in ovarian cancer with the ongoing MUIR Part 2 trial evaluating the combination of azenosertib and bevacizumab as maintenance therapy $245.9 million cash, cash equivalents and marketable securities balance as of December 31, 2025, with projected cash runway into late 2027 SAN DIEGO, March 26, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced financial results for the year ended December 31, 2025, and highlighted recent corporate accomplishments and milestones expected for 2026. “The completion of enrollment for DENALI Part 2a represented a key milestone to enable dose confirmation in the first half of 2026, with topline DENALI Part 2 trial readout anticipated by year-end.
April 01, 2026 17:00 ET | Source: ZENTALIS PHARMACEUTICALS
SAN DIEGO, April 01, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that on April 1, 2026, the Compensation Committee of Zentalis’ Board of Directors granted non-qualified stock options to purchase an aggregate of 36,000 shares of the Company’s common stock to two newly hired employees. The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to each such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).
The 2022 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zentalis, or following a bona fide period of non-employment, as an inducement material to each such individual’s entering into employment with Zentalis, pursuant to Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $2.57 per share, which is equal to the closing price of Zentalis’ common stock on The Nasdaq Global Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter.
Vesting of the stock options is subject to the employees’ continued service to Zentalis on each vesting date.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Planned interim analysis from DENALI Part 2a showed a clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 and comparable safety profiles between the two dose groupsAzenosertib therapeutic profile supports Phase 2 DENALI and Phase 3 ASPENOVA advancement as well as initiation of pre-commercial activitiesDENALI Part 2 topline readout expected by year end 2026 SAN DIEGO, April 09, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced the selection of 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the optimal monotherapy dose of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC) based on the prespecified interim data analysis from DENALI Part 2a. This dose will be carried forward in the ongoing potentially pivotal DENALI Phase 2 clinical trial as well as the confirmatory ASPENOVA Phase 3 clinical trial.
"Selecting the pivotal monotherapy dose for azenosertib is a key inflection point that supports our registration-intended path. Beyond executing on DENALI and ASPENOVA, we are initiating launch preparedness by adding commercial capabilities to our organization, scaling manufacturing capacity, and advancing companion diagnostic development," said Julie Eastland, Chief Executive Officer of Zentalis. "Importantly, the therapeutic profile of the selected dose from the DENALI Part 2a interim analysis provides us confidence to further pursue expansion of the clinical pipeline for azenosertib into first-line maintenance, or platinum sensitive, ovarian cancer and explore combinations in new tumor types."
“The emerging DENALI Part 2a data from the planned interim analysis provide a favorable benefit-risk profile at the 400mg QD 5:2 dose over 300mg QD 5:2. A meaningful, differentiated response rate with the selected dose and comparable safety profiles across both dose groups were observed in this interim analysis,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “While DENALI is an ongoing trial, we are encouraged by the interim Part 2a data and continued momentum of the clinical study. As an oral monotherapy, azenosertib may offer Cyclin E1-positive PROC patients an efficacious, convenient alternative to current standard-of-care intravenous chemotherapy, if approved.”
DENALI Part 2a Interim Analysis
A comprehensive review of the interim data from DENALI Part 2a informed the selection of the 400mg QD 5:2 dose over 300mg QD 5:2. A prespecified interim analysis showed:
A meaningful and clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 doseComparable safety profiles across the two dose groups and observed improvements in several key measures, such as a discontinuation rate due to adverse events at approximately half of the rate reported in DENALI Part 1b and no treatment-related deaths. Consistent with the seamless design of the registration-intended DENALI Part 2 trial, data from Part 2a will be included in the ongoing, full Part 2 dataset after the trial is completed, rather than reported separately. This approach is intended to preserve the integrity of the overall pivotal dataset and support the potential accelerated approval pathway.
DENALI Part 2 Trial Design Updated to Address Evolving PROC Landscape
The treatment landscape in PROC is evolving. The DENALI Part 2 study has been expanded to maintain alignment between the study population and available approved treatment options.
A new DENALI cohort that broadens inclusion to patients previously treated with a taxane-containing regimen for PROC, called Part 2c, intends to further align the study with the evolving treatment landscape. Enrollment in Part 2c is planned to initiate in Q2 2026.
Together, all three DENALI Part 2 cohorts are designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker selected patient population, subject to regulatory review. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.
Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff.
Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:
Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.Part 2b: Enrollment expansion at the selected dose up to approximately 100 patients, including patients at the 400mg QD 5:2 dose in Part 2a. This cohort is currently enrolling.Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. Enrollment is expected to initiate in this cohort in Q2 2026. For physician and patient information about the DENALI trial, please visit www.denalitrial.com.
About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial will enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The trial design was aligned with the U.S. FDA to meet requirements for the accelerated approval pathway and potential conversion to full approval. ASPENOVA is expected to initiate in Q2 2026.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib; the potential for azenosertib to be first-in-class; the significance of the referenced data on the late-stage development of azenosertib; the potential benefits of azenosertib, including the potential for azenosertib to meaningfully improve outcomes for Cyclin E1-positive PROC patients; the Company’s biomarker-driven strategy for azenosertib; the potential to pursue expansion of the clinical pipeline for azenosertib outside PROC; our anticipated milestones and the timing thereof, including the anticipated timing of the completion of enrollment in all cohorts of, and topline readout from, DENALI Part 2; the initiation, design, conduct and timing of DENALI Part 2c and our confirmatory ASPENOVA Phase 3 trial; our planned regulatory strategy for azenosertib and the timing thereof, including the potential for DENALI Part 2 to support an accelerated approval; and our initiation of pre-commercial activities. The terms “add,” “anticipate,” “advance,” “aim,” “believe,” “continued,” “design,” “develop,” “encouraged,” “expect,” “intent,” “look forward,” “may,” “mission,” “momentum,” “on track,” “pivotal,” “plan,” “position,” “potential,” “pursue,” “scale,” “strategy,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of early clinical trials may not be predictive of the success of later stage clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; if our confirmatory trials do not verify clinical benefit, the FDA may seek to withdraw accelerated approval; our ability to establish effective sales or marketing capabilities; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) shares are surging Friday after a Guggenheim analyst raised the price target from $6 to $10.
Zentalis Pharmaceuticals stock is challenging resistance. Why did ZNTL hit a new high? Zentalis Sees Price Target AdjustmentGuggenheim analyst Michael Schmidt maintained Zentalis Pharmaceuticals with a Buy and raised the price target from $6 to $10. Traders are also chasing a sharp biotech momentum move that's standing out against a weak tape in healthcare.
The stock is also riding high on news that it had selected an optimal dose for an ovarian cancer treatment the company is currently focused on producing. This dose will be carried forward in the ongoing potentially pivotal DENALI Phase 2 clinical trial as well as the confirmatory ASPENOVA Phase 3 clinical trial.
Zentalis Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on developing treatments for patients with ovarian cancer. Because it's clinical-stage, the stock can move sharply when traders reprice the probability of future trial and regulatory outcomes.
Stock Soars Above Key AveragesAt $6.11, Zentalis is trading 133.4% above its 20-day simple moving average (SMA), the stock's average price over the last 20 sessions, which indicates an unusually stretched short-term trend. It's also 181% above its 100-day SMA, suggesting the intermediate trend is firmly controlled by buyers.
The relative strength index (RSI), a momentum gauge, is 78.05, and it entered overbought territory on 2026-04-09, which often lines up with "hot" momentum that can cool quickly. In January, the golden cross (50-day SMA moving above the 200-day SMA) signaled a longer-term trend shift, while the death cross in November highlights how quickly this name can flip regimes.
Key Resistance: $6.00 — a round-number area where breakouts often get retested. Key Support: $2.50 — near the 50-day SMA zone where trend buyers have recently anchored. Earnings & Analyst OutlookLooking further out, the next major catalyst for the stock arrives with the May 13, 2026 (estimated) earnings report.
EPS Estimate: Loss of 50 cents (Up from Loss of 67 cents YoY) st of the talking right now. With momentum extremely elevated, the key question is whether the stock can hold above recently reclaimed breakout areas if the broader tape stays choppy.
Shares Soar FridayZNTL Stock Price Activity: Zentalis Pharmaceuticals shares were up 31.90% at $5.82 at the time of publication on Friday, according to Benzinga Pro data.
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This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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April 17, 2026 15:15 ET | Source: ZENTALIS PHARMACEUTICALS
Preclinical data show encouraging activity of azenosertib combinations in ADC-resistant TNBC, supporting the potential for pipeline expansion beyond ovarian cancer Real-world data demonstrate Cyclin E1-positive ovarian cancer patients have significantly worse outcomes, independent of CCNE1 gene amplification status, reinforcing the potential for azenosertib to address the unmet need for these patients
SAN DIEGO, April 17, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced data from two posters being presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA. The data show encouraging preclinical activity of azenosertib in triple-negative breast cancer (TNBC) and highlight the poor prognosis of Cyclin E1-positive ovarian cancer patients with currently available treatments in a real-world data analysis.
Compelling Preclinical Activity in Triple-Negative Breast Cancer with Azenosertib
"The preclinical data in triple-negative breast cancer being presented at AACR showed that azenosertib combinations can induce complete tumor responses in a model resistant to emerging ADC therapies, supporting the potential to broaden the impact of azenosertib beyond ovarian cancer," said Julie Eastland, Chief Executive Officer of Zentalis. "This includes potential development of azenosertib through differentiated combination strategies with antibody-drug conjugates (ADCs) and chemotherapy. As ADCs advance toward first-line use in TNBC, effective post-ADC treatment strategies represent a growing unmet need that azenosertib combinations may be uniquely positioned to fill. Our data suggest azenosertib may achieve this through multiple mechanisms – possibly resensitizing tumors to chemotherapy, enhancing the responses to ADC, and extending the duration of response – which is an exciting potential future direction for our pipeline."
Preclinical evidence supports azenosertib as a therapeutic strategy in TNBC:
TNBC cell lines showed higher Cyclin E1 expression and greater sensitivity to WEE1 inhibition compared to other breast cancer cell lines Azenosertib monotherapy demonstrated meaningful antitumor activity across a diverse panel of 12 TNBC in vivo xenograft models (42-99% tumor growth inhibition) In a patient-derived xenograft model of TNBC with clinical resistance to sacituzumab govitecan, an approved topoisomerase 1 inhibitor (TOPO1i) ADC, azenosertib + enfortumab vedotin (EV): Induced complete responses in 7 of 8 mice (87.5%); 5 mice did not progress after treatment discontinuationPrevented tumor progression in 8 of 8 mice for more than 52 days compared to 100% progression observed within 30 days with EV aloneDrove deep tumor regression in mice models refractory to sacituzumab govitecan or trastuzumab deruxtecan with large tumor volumes (average ~900mm3) Combinations of azenosertib with TOPO1i-payload ADCs (sacituzumab govitecan, datopotamab deruxtecan, or trastuzumab deruxtecan) enhanced both depth and duration of response compared to ADC monotherapy in ADC-naïve modelsAzenosertib + paclitaxel restored substantial sensitivity to paclitaxel in a model resistant to both paclitaxel and TOPO1i ADCs (51% tumor growth inhibition vs. 16% with paclitaxel alone) Cyclin E1 Protein Overexpression Characterizes Ovarian Cancer Patients with Poor Prognosis
"The real-world data being presented at AACR provide important validation that Cyclin E1-positive ovarian cancer patients face a particularly challenging disease trajectory with standard-of-care therapies," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "The consistency of worse outcomes across independent cohorts and multiple treatment settings underscores the significant unmet need in this population. These findings provide important context for Zentalis' registration-intended DENALI and ASPENOVA studies, which are evaluating WEE1 inhibition with azenosertib monotherapy as a targeted approach for the Cyclin E1-positive population that currently has limited effective treatment options."
Real-world data from two independent cohorts (Tempus Lens Ovarian cancer dataset and Zentalis' historical clinical trials) consistently demonstrated that Cyclin E1-positive ovarian cancer patients experience worse clinical outcomes:
After first-line treatment, Cyclin E1-positive patients, with or without CCNE1 gene amplification, had shorter time to next treatment compared to Cyclin E1-negative patients (13.2 months and 14.9 months, respectively, compared to 19.5 months, p=0.002)Cyclin E1-positivity is associated with a trend toward reduced clinical benefit from standard-of-care PROC treatments AACR Poster Details
Title: “WEE1 Inhibition as a Therapeutic Strategy in Triple-Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models”
Abstract Number: 2012
Date/Time: Monday, April 20, 2026, 2:00 p.m. - 5:00 p.m. PDT
Presenting Author: Alexandra Levy, MS
Title: “Real-World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1-Positive Ovarian Cancer”
Abstract Number: 1708
Date/Time: Sunday, April 19, 2026, 2:00 p.m. - 5:00 p.m. PDT
Presenting Author: Jinkil Jeong, PhD
The posters can be accessed on the Supporting Publications page of the Zentalis website.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib; the potential for azenosertib to be first-in-class; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer, triple negative breast cancer or other indications, the mechanisms through which azenosertib may fill unmet needs, and the ability of azenosertib combinations to induce complete tumor responses; the unmet need for treatments in ovarian cancer, triple negative breast cancer or other indications; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the future direction of our pipeline, including the potential for pipeline expansion; and our participation in poster presentations. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “encouraging” “expect,” “future,” “intent,” “look forward,” “may,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “target,” “upcoming,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Results from Part 1 of the Phase 1b MUIR trial to be presented at annual meeting in June April 21, 2026 10:27 ET | Source: ZENTALIS PHARMACEUTICALS
SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that the American Society of Clinical Oncology (ASCO) has accepted an abstract for presentation at the 2026 ASCO Annual Meeting, which will be held June 1-5, 2026, in Chicago, IL.
"We are pleased that data from Part 1 of the MUIR trial focusing on azenosertib in combination with paclitaxel in platinum-resistant ovarian cancer (PROC) have been accepted for presentation at ASCO," said Julie Eastland, Chief Executive Officer of Zentalis. "Paclitaxel is a commonly used agent across multiple tumor types, including in ovarian cancer. The azenosertib-paclitaxel data from MUIR Part 1 will showcase combinability and activity in an all-comer setting, which we believe indicates the broad potential for azenosertib in multiple lines of ovarian cancer and other tumor types. With our core strategic focus on advancing azenosertib in registration-intended trials as a monotherapy in the biomarker-selected Cyclin E1-positive PROC population through our DENALI and ASPENOVA trials, the MUIR trial represents an important part of our broader pipeline strategy.”
Accepted Abstract Title: Azenosertib Plus Paclitaxel for Platinum-Resistant Ovarian Cancer: Results From a Phase 1b Study
Abstract Number: 5529
Session Type / Title: Poster Session – Gynecologic Cancer
Poster Board: 195
Date/Time: June 1, 2026; 9am-12pm CDT
About MUIR Clinical Trial
MUIR (ZN-c3-002) is a multi-part, open-label Phase 1b clinical trial (NCT04516447) evaluating the safety, efficacy, and preliminary clinical activity of azenosertib in combination in patients with ovarian cancer.
Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.
Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib; the potential for azenosertib to be first-in-class; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer and other tumor types; the combinability of azenosertib with other agents and the potential benefits thereof; the importance of the MUIR trial to the Company’s broader pipeline strategy; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; and the Company’s participation at ASCO. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “expect,” “focus,” “intent,” “look forward,” “objective,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “target,” “upcoming,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
May 01, 2026 17:30 ET | Source: ZENTALIS PHARMACEUTICALS
SAN DIEGO, May 01, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that on May 1, 2026, the Compensation Committee of Zentalis’ Board of Directors granted non-qualified stock options to purchase an aggregate of 26,000 shares of the Company’s common stock to one (1) newly hired employee. The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).
The 2022 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zentalis, or following a bona fide period of non-employment, as an inducement material to each such individual’s entering into employment with Zentalis, pursuant to Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $4.09 per share, which is equal to the closing price of Zentalis’ common stock on The Nasdaq Global Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter.
Vesting of the stock options is subject to the employee’s continued service to Zentalis on each vesting date.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Global Phase 3, randomized, controlled trial comparing azenosertib to standard-of-care chemotherapy now enrollingASPENOVA designed as confirmatory study to support DENALI Phase 2 accelerated approval pathway, pending FDA feedback SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
"Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and ASPENOVA now enrolling to evaluate azenosertib versus standard-of-care chemotherapy to support full approval, we are executing on a comprehensive development and regulatory strategy designed to bring this therapy to patients as quickly as possible. We are deeply grateful to the patients participating in this important trial and to our collaborators at The GOG Foundation, Inc. (GOG-F), ENGOT, and APGOT for their partnership in advancing this research."
"Cyclin E1-overexpressing ovarian cancers are associated with platinum-resistance and poor outcomes, representing a clinical unmet need," said Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the ASPENOVA trial and GOG-F. "This biomarker has yet to be exploited therapeutically and azenosertib, a WEE1 inhibitor, is an oral, targeted treatment that is showing exciting activity in Cyclin E1-overexpressing ovarian cancer (SGO Annual Meeting, 2025). The biomarker-driven approach now being studied in this Phase 3 randomized trial has the potential to identify patients most likely to benefit while sparing them from the inconvenience of intravenous regimens. On behalf of GOG Foundation, we are pleased to collaborate with Zentalis, ENGOT, and APGOT on this important trial for this underserved patient population."
ASPENOVA is a randomized, controlled Phase 3 trial designed to confirm the clinical benefit of azenosertib and support full approval as part of Zentalis' dual-track regulatory strategy. The company is pursuing accelerated approval based on the ongoing registration-intended DENALI Phase 2 trial, with a topline readout expected by year-end 2026, while simultaneously advancing ASPENOVA as the confirmatory study to satisfy FDA requirements for conversion to full approval. Both trials are evaluating azenosertib at 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2), the dose selected based on the DENALI Part 2a interim analysis announced in April 2026. The planned interim analysis showed a meaningful, clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 and comparable safety profiles between the two dose groups.
The ASPENOVA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), and Asia-Pacific Gynecologic Oncology Trials Group (APGOT), reflecting the global clinical and scientific community's recognition of the significant unmet need in this patient population.
About ASPENOVA Clinical Trial
ASPENOVA (NCT07546500, GOG-3147, ENGOT-ov109) is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was aligned with the U.S. Food and Drug Administration (FDA) to meet requirements for the accelerated approval pathway and potential conversion to full approval.
About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.
Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff.
Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:
Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by year-end 2026.
For physician and patient information about the DENALI trial, please visit www.denalitrial.com.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the continued development of azenosertib; the clinical and therapeutic potential of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other indications; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the potential to advance research on additional areas of opportunity for azenosertib outside PROC; the Company’s anticipated milestones and the timing thereof, including the anticipated timing of the topline readout from DENALI Part 2; and the Company’s planned regulatory strategy for azenosertib and the timing thereof, including the potential for DENALI Part 2 to support an accelerated approval and the potential for ASPENOVA to support full approval. The terms “anticipate,” “advance,” “believe,” “could,” “design,” “develop,” “expect,” “intent,” “look forward,” “may,” “on track,” “pending,” “plan,” “position,” “potential,” “runway,” “strategy,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
400mg QD 5:2 selected as azenosertib monotherapy pivotal study dose based on favorable benefit-risk profile in DENALI Part 2a, supporting advancement in registration-intended trialsDENALI Phase 2 trial topline readout expected by year-end 2026, with potential to support accelerated approval pathway, pending data outcomes and FDA feedbackASPENOVA Phase 3 confirmatory trial in Cyclin E1-positive PROC initiated with first patient dosed; designed to support conversion to PROC full approval and ex-US registrations$211.8 million in cash, cash equivalents and marketable securities as of March 31, 2026, providing runway into late 2027 with funding to support execution of key milestones SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent clinical progress.
"This quarter, we built momentum with achievement of key milestones advancing azenosertib in our registration-intended Phase 2 and Phase 3 trials for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC),” said Julie Eastland, Chief Executive Officer of Zentalis. "Our core focus is on bringing a convenient, oral, non-chemotherapy treatment option to approximately 50% of PROC patients who are Cyclin E1-positive and may experience poorer prognosis and limited benefit from standard-of-care therapies. Pivotal dose selection supports our regulatory strategy, positioning us to pursue accelerated approval through the DENALI Part 2 trial while simultaneously advancing ASPENOVA as our confirmatory trial—together charting a pathway to bring a potential first-in-class therapy to market for this underserved patient population. Following dose selection, we initiated pre-commercial launch preparedness activities to add commercial capabilities to the organization, scale manufacturing capacity and advance Cyclin E1 companion diagnostic market development. Beyond the lead indication, we see substantial opportunity for strategic expansion of azenosertib into platinum-sensitive or first-line maintenance settings of ovarian cancer, additional tumor types, and combination approaches."
"With a cash position of $211.8 million as of March 31, 2026, we have runway into late 2027 and the resources to support execution of key milestones, most importantly the DENALI Part 2 topline readout, and ongoing trials,” Ms. Eastland continued.
Clinical Development Progress
Pivotal Dose Selected for Registration-Intended Azenosertib Monotherapy Program in Cyclin E1-Positive PROC: In April 2026, selected 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the pivotal study dose for azenosertib monotherapy in patients with Cyclin E1-positive PROC based on a pre-specified interim analysis from DENALI Part 2a that showed a meaningful, clearly differentiated response rate at 400mg QD 5:2 and comparable safety profiles across both dose groups. The analysis revealed observed improvements in several key measures, including a discontinuation rate due to adverse events at approximately half the rate reported in DENALI Part 1b and no treatment-related deaths. Concurrently, the Company expanded DENALI Part 2 to include Part 2c, a new cohort broadening inclusion to approximately 40 patients previously treated with a taxane-containing regimen for PROC, to maintain alignment between the study population and the evolving treatment landscape. DENALI Parts 2b and 2c are currently enrolling. DENALI Part 2 is designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker-selected patient population, subject to regulatory review. The Company expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.ASPENOVA Phase 3 First Patient Dosed: In May 2026, announced the first patient was dosed in the Phase 3 ASPENOVA confirmatory trial designed to satisfy FDA requirements for potential conversion to full approval and to support approval in major ex-US markets. ASPENOVA is a randomized, controlled Phase 3 trial that is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan) in patients with Cyclin E1-positive PROC. The trial is currently enrolling.MUIR Part 2 dose expansion evaluating azenosertib in combination with bevacizumab as maintenance therapy in ovarian cancer. MUIR is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy and preliminary clinical activity of azenosertib as a combination therapy in patients with ovarian cancer. The dose expansion cohort of Part 2 is currently open for enrollment of azenosertib in combination with bevacizumab in second-line platinum-sensitive ovarian cancer (PSOC) patients for maintenance treatment, whose disease progressed while on a PARP inhibitor. Medical Meeting Presentations Supporting Pipeline Strategy
AACR 2026: Presented two posters at the American Association for Cancer Research (AACR) Annual Meeting featuring: (1) compelling preclinical data showing azenosertib combinations can induce complete tumor responses in a model resistant to emerging antibody-drug conjugate (ADC) therapies in triple-negative breast cancer (TNBC), supporting the potential for pipeline expansion beyond ovarian cancer; and (2) real-world data from two independent cohorts demonstrating that Cyclin E1-positive ovarian cancer patients experience significantly worse clinical outcomes, independent of CCNE1 gene amplification status, reinforcing the potential for azenosertib to address the unmet need for these patients.ASCO 2026 Abstract Acceptance: Announced that the American Society of Clinical Oncology (ASCO) has accepted an abstract for presentation at the 2026 ASCO Annual Meeting featuring results from Part 1 of the Phase 1b MUIR trial, focusing on an evaluation of azenosertib in combination with paclitaxel in platinum-resistant ovarian cancer (PROC). The data will showcase combinability and activity in an all-comer setting, demonstrating the broad potential for azenosertib in multiple lines of ovarian cancer and other tumor types. First Quarter 2026 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $211.8 million as of March 31, 2026, compared to $245.9 million as of December 31, 2025. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operating expenses and capital expenditure requirements into late 2027.Research and Development Expenses: Research and development (R&D) expenses for the three months ended March 31, 2026 were $28.7 million, compared to $27.2 million for the three months ended March 31, 2025. The increase of $1.5 million was primarily due to an increase of $6.8 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. This increase was partially offset by decreases of $3.9 million for personnel expense, of which $1.2 million was non-cash stock-based compensation, a decrease of $1.2 million related to a one-time impairment charge recorded in Q1 2025, and a decrease of $0.2 million for allocated overhead.General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2026 were $9.1 million, compared to $10.6 million during the three months ended March 31, 2025. This decrease of $1.5 million was attributable to a decrease of $2.0 million in personnel expense, of which $1.2 million was non-cash stock-based compensation. The decrease was partially offset by an increase of $0.5 million related to consulting, outside services and other allocated costs.Total Operating Expenses: Total operating expenses were $37.9 million for the three months ended March 31, 2026, compared to $45.6 million for the three months ended March 31, 2025. Total operating expenses for the first quarter of 2025 included a non-recurring $7.8 million expense associated with the strategic restructuring announced in January 2025. About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.
Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff.
Part 2, in total, is designed to support accelerated approval, pending positive study outcomes and further discussions with the FDA. The study design consists of the following parts:
Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.Part 2c: Broadening study population, which is expected to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by year-end 2026.
For physician and patient information about the DENALI trial, please visit www.denalitrial.com.
About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval.
About MUIR Clinical Trial
MUIR (NCT04516447) is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy and preliminary clinical activity of azenosertib combinations in patients with ovarian cancer. Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.
Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion. The dose expansion portion is currently open for enrollment.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the continued development of azenosertib; the clinical and therapeutic potential of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other indications; the Company’s biomarker-driven strategy for azenosertib; the potential to advance research on additional areas of opportunity for azenosertib as maintenance therapy in ovarian cancer and to explore additional tumor types; the Company’s anticipated milestones and the timing thereof, including the anticipated enrollment completion of DENALI Part 2, the topline readout from DENALI Part 2, and the design, conduct and timing of our confirmatory APSENOVA Phase 3 and MUIR Phase 1b trials; the Company’s anticipated cash runway; and the Company’s planned regulatory strategy for azenosertib and the timing thereof, including the potential for DENALI Part 2 to support an accelerated approval and for ASPENOVA to support conversion to a full approval and ex-US approval. The terms “anticipate,” “advance,” “believe,” “continue,” “design,” “develop,” “expect,” “focus,” “intend,” “plan,” “potential,” “runway,” “strategy,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of a companion diagnostic; risks relating to the regulatory approval process or ongoing regulatory obligations; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data;; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Zentalis Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except per share amounts)Three Months Ended March 31,
2026 2025 Operating Expenses Research and development$28,716 $27,247 General and administrative 9,139 10,580 Restructuring — 7,796 Total operating expenses 37,855 45,623 Loss from operations (37,855) (45,623)Other Income (Expense) Investment and other income (expense), net 2,623 (2,656)Net loss before income taxes (35,232) (48,279)Income tax expense 120 — Net loss$(35,352) $(48,279)Net loss per common share outstanding, basic and diluted$(0.50) $(0.67)Common shares used in computing net loss per share, basic and diluted 70,264 71,678 Zentalis Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance Sheets Data
(unaudited)
(In thousands) March 31, 2026 December 31, 2025Cash, cash equivalents and marketable securities$211,758 $245,893Working capital(1) 182,860 216,632Total assets 253,066 288,967Total liabilities 70,386 72,763Total Zentalis equity$182,680 $216,204 (1)The Company defines working capital as current assets less current liabilities.
Contact:
Aron Feingold
VP, Investor Relations & Corporate Communications [email protected]
May 13, 2026 16:05 ET | Source: ZENTALIS PHARMACEUTICALS
SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that members of the management team will participate in the following upcoming investor conferences:
H.C. Wainwright 4th Annual BioConnect Conference at Nasdaq, New York, NY. Fireside discussion, May 19, 2026, 2:30p.m. ET.Stifel 2026 Virtual Oncology Forum, Virtual. Fireside discussion, May 20, 2026, 4:30p.m. ET.TD Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA, Virtual. Fireside discussion, May 26, 2026, 10:00a.m. ET.Jefferies Global Healthcare Conference, New York, NY. Fireside discussion, June 3, 2026, 3:45p.m. ET. Access to a live webcast of each of the H.C. Wainwright, Stifel, TD Cowen, and Jefferies events, as well as an archived recording, will be available under the “Events & Presentations” tab on the Investors & Media section of the Company’s website.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
May 21, 2026 17:39 ET | Source: ZENTALIS PHARMACEUTICALS
In an all-comer PROC population, across multiple dose cohorts, manageable safety profile of the combination was observed with low frequency of high-grade adverse eventsActivity of the combined regimen across all dose cohorts achieved 39% ORR and 7.3-month median PFSIn the 250 mg QD 5:2 intermittent dose cohort, 50% ORR, 9.2-month median DOR, and low frequency of high-grade adverse events was observed, suggesting a potential optimal dose combination SAN DIEGO, May 21, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois. The poster, titled "Azenosertib Plus Paclitaxel for Platinum-Resistant Ovarian Cancer: Results From a Phase 1b Study," will be presented in the Gynecologic Cancer Poster Session (Abstract #5529, Poster Board #195) on June 1, 2026, from 9:00am–12:00pm CDT.
"Paclitaxel is one of the most widely used chemotherapy agents across tumor types, including in ovarian cancer, and these Phase 1b data show encouraging clinical activity and tolerability of adding azenosertib to paclitaxel in an all-comer platinum-resistant ovarian cancer (PROC) setting," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis Pharmaceuticals. "Establishing the safety, combinability, and efficacy signal of azenosertib with paclitaxel is an important proof of concept — one that we believe speaks to the broad potential of azenosertib across multiple lines of ovarian cancer and other tumor types where taxanes are commonly used. With our core strategic focus on advancing azenosertib in registration-intended trials as a monotherapy in the Cyclin E1-positive PROC population, the MUIR trial represents an important and complementary part of our broader indication expansion strategy."
"In a heavily pre-treated, all-comer patient PROC population where all patients had received prior paclitaxel, we observed meaningful tumor reductions and durable responses with this azenosertib paclitaxel combination, with an overall response rate of 39% and a median PFS of 7.3 months" said Joyce F. Liu, M.D., MPH, Associate Professor at Dana-Farber Cancer Institute and a study investigator. "At the 250 mg 5:2 intermittent dose — the dose thought to offer the optimal therapeutic index — half of patients achieved a response with a median duration of response of 9.2 months. Interestingly, the clinical activity appears similar in both Cyclin E1-positive and Cyclin E1-negative tumors, suggesting that Cyclin E1 status may not be as important in the azenosertib combination setting where the combination agent is inducing replication stress. These results support continued evaluation of azenosertib-taxane combinations in broader ovarian cancer settings and other tumor types where taxanes are part of the standard of care."
MUIR is a multi-part, open-label Phase 1b clinical trial evaluating azenosertib in combination with chemotherapy in patients with ovarian cancer. Part 1 evaluated azenosertib in combination with four chemotherapy regimens in patients with PROC, with data from the paclitaxel arm presented at ASCO as paclitaxel is commonly used across multiple tumor types, including ovarian cancer. Data from the other combination arms will be presented separately at a later date. The findings reflect a December 1, 2025 data cutoff and include 46 patients who received azenosertib across four dose cohorts — 200 mg QD continuously or 200 mg, 250 mg, or 300 mg QD intermittently (5 days on, 2 days off) — in combination with paclitaxel 80 mg/m². All patients had received prior paclitaxel.
Encouraging Activity in All-Comer PROC Population with Activity Across 4 Dose Groups (n=46)
Overall Response Rate (ORR): 39.1% (95% CI: 25.1–54.6)Clinical Benefit Rate (CBR): 58.7% (95% CI: 42.2–73.0)Median Duration of Response (DOR): 5.6 months (95% CI: 5.6–9.2)Median Progression-Free Survival (PFS): 7.3 months (95% CI: 3.7–7.5) These results are encouraging in the context of the historical efficacy of paclitaxel monotherapy in PROC, with an ORR of approximately 30% and a median PFS of approximately 4 months.
Clinical activity was broadly comparable in Cyclin E1-positive patients (ORR: 41.4% [95% CI: 23.5-61.1]; median PFS: 7.3 months [95% CI: 3.7-9.1]) and Cyclin E1-negative patients (ORR: 35.7% [95% CI: 12.8-64.9]; median PFS: 5.4 months [95% CI: 1.7-NE]), suggesting that Cyclin E1-positive biomarker status may not be required to derive benefit when azenosertib is combined with a cytotoxic agent.
At the 250 mg intermittent (5:2) dose cohort (n=12), which demonstrated the potential optimal therapeutic index:
ORR: 50.0% (95% CI: 21.1–78.9), including one complete responseCBR: 66.7% (95% CI: 34.9-90.1)Median DOR: 9.2 months (95% CI: 3.8–NE)Median PFS: 5.5 months (95% CI: 1.7–12.9) Manageable Safety Profile with Low Rate of High-Grade Events Across 4 Dose Cohorts (n=46)
Most common all-grade treatment-related adverse events (TRAEs): fatigue (60.9%), anemia (58.7%), nausea (52.2%), and neutropenia (50.0%).Most frequent Grade ≥3 TRAEs: neutropenia (30.4%) and anemia (19.6%); rates of high-grade fatigue and nausea were less than 10%.Serious TRAEs occurred in approximately 20% of patients; the most frequent were fatigue, diarrhea, and neutropenia, each occurred in 2 patients.Of 15 patients (32.6%) who discontinued due to adverse events, approximately half discontinued paclitaxel only and were able to continue on azenosertib monotherapy until disease progressionOne G5 event due to sepsis was assessed as related to azenosertib by the investigator (previously reported in June 2024). While the role of azenosertib cannot be excluded, the event may have been attributable to the patient's advanced disease, given the absence of neutropenia and negative blood cultures at the time of the event. The poster will be available at https://zentalis.com/science/scientific-publications/ after ASCO.
About MUIR Clinical Trial
MUIR (ZN-c3-002) is a multi-part, open-label Phase 1b clinical trial (NCT04516447) evaluating the safety, efficacy, and preliminary clinical activity of azenosertib in combination in patients with ovarian cancer.
Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.
Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib as a monotherapy and as a combination agent; the potential for azenosertib to be first-in-class; the potential benefits of azenosertib across multiple lines of ovarian cancer and other tumor types the combinability of azenosertib with other agents, including paclitaxel, and the potential benefits thereof; the significance of the referenced results; the presentation of data from other combination arms; the importance of the MUIR trial to the Company’s broader pipeline strategy; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; and the Company’s presentation at ASCO. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “encouraging,” “expect,” “focus,” “intent,” “look forward,” “may,” “objective,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “suggest,” “target,” “upcoming,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
May 27, 2026 16:05 ET | Source: ZENTALIS PHARMACEUTICALS
Appointments enhance commercialization readiness as Zentalis advances registrational program for azenosertib in Cyclin-E1 positive platinum-resistant ovarian cancer
SAN DIEGO, May 27, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced the appointments of Shannon Campbell to its Board of Directors and Sarah Kelly as the Company’s Senior Vice President of Commercial Strategy. These appointments reflect Zentalis’ continued commitment to developing commercial and operational capabilities as the Company advances registration-intended Phase 2 and Phase 3 trials of azenosertib for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
“Shannon Campbell brings deep experience helping oncology companies successfully navigate the transition from clinical to commercial-stage,” said Julie Eastland, Chief Executive Officer of Zentalis. “Shannon’s commercial scale-up leadership will help us achieve our vision as we continue advancing azenosertib through late-stage development for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Simultaneously, the appointment of Sarah Kelly brings a broad set of experience in building launch readiness for both companion diagnostics and therapeutics. Together, these roles provide the strategic, operational, and commercial foundation needed to support launch readiness and long-term growth.”
Ms. Campbell is a seasoned biopharmaceutical executive with more than 30 years of experience, leading global commercial strategy and building oncology franchises. Her proven track record will support Zentalis as it advances toward the potential commercialization of azenosertib for Cyclin E1 positive PROC patients, as well as, evaluating azenosertib in earlier lines of ovarian cancer, as a combination therapy, and in other tumor types.
Most recently, Ms. Campbell served as Executive Vice President and Chief Commercial Officer at Merus, where she led the company’s evolution toward becoming a commercial-stage organization, including launch preparedness efforts for its portfolio of multiclonic antibodies. Prior to Merus, she held senior oncology leadership roles at Novartis Pharmaceuticals and Bayer Healthcare Pharmaceuticals, where she supported the launch and growth of innovative therapies across solid tumors and rare diseases. Ms. Campbell currently serves on the board of Black Diamond Therapeutics and is an advisory board member for Verix.
“I am excited to join Zentalis’ Board at an important time for the Company as it prepares to bring a potential first-in-class therapy to market for patients with platinum-resistant ovarian cancer, a population with significant unmet need,” said Ms. Campbell. “I look forward to working with the Zentalis Board and the leadership team to help build the strategic and commercial infrastructure needed to ultimately bring this important potential new treatment option to the community.”
Sarah Kelly joins Zentalis as Senior Vice President of Commercial Strategy to lead launch readiness. Throughout Ms. Kelly’s 30-year career, she has held senior leadership positions in commercial and business development at companies including Amgen, Turning Point, Spectrum and Agilent. Ms. Kelly’s extensive experience in oncology includes building and leading commercial organizations in preparation for therapeutic and companion diagnostic launches. Ms. Kelly’s focus on commercial strategy, market access, companion diagnostics, field leadership, and business development provides operational expertise to prepare Zentalis for the potential to bring azenosertib to patients.
Zentalis is advancing azenosertib through a late-stage registrational development program in Cyclin E1-positive PROC, with an anticipated year-end 2026 topline readout from the DENALI Phase 2 trial, which is designed to support a potential accelerated approval pathway, pending data outcomes and U.S. FDA feedback. Additionally, Zentalis recently announced dosing of the first patient in the ASPENOVA Phase 3 confirmatory trial in Cyclin E1-positive PROC, which is designed to support conversion from accelerated to full approval, as well as potential ex-U.S. registrations.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib as a monotherapy and as a combination agent; the potential for azenosertib to be first-in-class; the potential benefits of azenosertib across multiple lines of ovarian cancer and other tumor types; the combinability of azenosertib with other agents and the potential benefits thereof; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the potential regulatory approval and commercialization of azenosertib; the Company’s anticipated milestones and the timing thereof, including the anticipated timing of the topline readout from DENALI Part 2; the Company’s launch readiness and long-term growth; and the building of the Company’s the strategic and commercial infrastructure. The terms “achieve,” “anticipate,” “advance,” “build,” “design,” “develop,” “expect,” “focus,” “growth,” “look forward,” “potential,” “strategy,” “strengthen,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
June 01, 2026 17:00 ET | Source: ZENTALIS PHARMACEUTICALS
SAN DIEGO, June 01, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that on June 1, 2026, the Compensation Committee of Zentalis’ Board of Directors granted non-qualified stock options to purchase an aggregate of 191,000 shares of the Company’s common stock to two (2) newly hired employees. The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to each such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).
The 2022 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zentalis, or following a bona fide period of non-employment, as an inducement material to each such individual’s entering into employment with Zentalis, pursuant to Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $3.98 per share, which is equal to the closing price of Zentalis’ common stock on The Nasdaq Global Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter.
Vesting of the stock options is subject to the employee’s continued service to Zentalis on each vesting date.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Mirae Asset Global Investments Co. Ltd. increased its holdings in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) by 764.3% during the 4th quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The institutional investor owned 78,492 shares of the biopharmaceutical company’s stock after acquiring an additional 69,410 shares during the period. Mirae Asset Global Investments Co. Ltd.’s holdings in Insmed were worth $13,661,000 at the end of the most recent reporting period.
Several other hedge funds have also bought and sold shares of INSM. EverSource Wealth Advisors LLC boosted its stake in Insmed by 65.6% during the second quarter. EverSource Wealth Advisors LLC now owns 664 shares of the biopharmaceutical company’s stock worth $67,000 after acquiring an additional 263 shares in the last quarter. First Trust Advisors LP lifted its stake in shares of Insmed by 80.8% in the second quarter. First Trust Advisors LP now owns 47,392 shares of the biopharmaceutical company’s stock worth $4,770,000 after buying an additional 21,176 shares in the last quarter. Baird Financial Group Inc. bought a new position in shares of Insmed in the second quarter worth approximately $2,589,000. Amundi lifted its stake in shares of Insmed by 21,194.4% in the second quarter. Amundi now owns 11,499 shares of the biopharmaceutical company’s stock worth $1,130,000 after buying an additional 11,445 shares in the last quarter. Finally, Natixis bought a new position in shares of Insmed in the second quarter worth approximately $1,072,000.
Analyst Ratings Changes INSM has been the topic of several analyst reports. Roth Mkm reiterated a “buy” rating and issued a $212.00 target price on shares of Insmed in a research note on Friday. Wells Fargo & Company dropped their target price on shares of Insmed from $208.00 to $175.00 and set an “overweight” rating on the stock in a research note on Monday, March 23rd. Raymond James Financial initiated coverage on shares of Insmed in a research note on Friday, April 10th. They issued an “outperform” rating and a $200.00 target price on the stock. Guggenheim reiterated a “buy” rating and issued a $230.00 target price on shares of Insmed in a research note on Thursday. Finally, Leerink Partners upped their target price on shares of Insmed from $210.00 to $215.00 and gave the stock an “outperform” rating in a research note on Tuesday, March 24th. Two equities research analysts have rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and one has assigned a Sell rating to the company’s stock. Based on data from MarketBeat, the company presently has an average rating of “Buy” and an average price target of $213.23.
Get Our Latest Research Report on Insmed
Insider Activity at Insmed In related news, CEO William Lewis sold 13,396 shares of the stock in a transaction that occurred on Monday, February 9th. The shares were sold at an average price of $147.79, for a total transaction of $1,979,794.84. Following the transaction, the chief executive officer owned 301,185 shares in the company, valued at $44,512,131.15. This represents a 4.26% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at the SEC website. Also, COO Roger Adsett sold 88,060 shares of the stock in a transaction that occurred on Wednesday, April 1st. The shares were sold at an average price of $164.63, for a total transaction of $14,497,317.80. Following the transaction, the chief operating officer owned 106,810 shares in the company, valued at approximately $17,584,130.30. This trade represents a 45.19% decrease in their position. The disclosure for this sale is available in the SEC filing. Insiders have sold a total of 190,476 shares of company stock worth $29,953,112 over the last quarter. Company insiders own 2.10% of the company’s stock.
Insmed Price Performance Shares of Insmed stock opened at $144.48 on Monday. The company has a market cap of $31.19 billion, a price-to-earnings ratio of -22.54 and a beta of 1.10. The company’s 50 day moving average is $149.95 and its 200 day moving average is $167.61. Insmed, Inc. has a twelve month low of $63.81 and a twelve month high of $212.75. The company has a quick ratio of 3.54, a current ratio of 3.83 and a debt-to-equity ratio of 0.76.
Insmed (NASDAQ:INSM – Get Free Report) last issued its quarterly earnings data on Thursday, February 19th. The biopharmaceutical company reported ($1.54) earnings per share for the quarter, missing analysts’ consensus estimates of ($1.07) by ($0.47). The company had revenue of $263.84 million for the quarter, compared to the consensus estimate of $263.97 million. Insmed had a negative net margin of 210.54% and a negative return on equity of 168.36%. The firm’s revenue for the quarter was up 152.6% on a year-over-year basis. During the same quarter last year, the company earned ($1.32) EPS. Research analysts anticipate that Insmed, Inc. will post -4.56 EPS for the current year.
Insmed Company Profile (Free Report)
Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.
The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.
Featured Articles Five stocks we like better than Insmed Want to see what other hedge funds are holding INSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Insmed, Inc. (NASDAQ:INSM – Free Report).
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Asset Management One Co. Ltd. acquired a new position in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) in the 4th quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The institutional investor acquired 80,887 shares of the biopharmaceutical company’s stock, valued at approximately $14,260,000.
A number of other hedge funds and other institutional investors also recently made changes to their positions in INSM. Vanguard Group Inc. lifted its holdings in shares of Insmed by 13.0% during the third quarter. Vanguard Group Inc. now owns 19,935,820 shares of the biopharmaceutical company’s stock valued at $2,870,957,000 after acquiring an additional 2,291,328 shares during the period. Artisan Partners Limited Partnership lifted its holdings in shares of Insmed by 49.0% during the third quarter. Artisan Partners Limited Partnership now owns 4,937,683 shares of the biopharmaceutical company’s stock valued at $711,076,000 after acquiring an additional 1,623,342 shares during the period. Orbis Allan Gray Ltd bought a new position in shares of Insmed during the second quarter valued at $153,389,000. Darwin Global Management Ltd. lifted its holdings in shares of Insmed by 5.8% during the third quarter. Darwin Global Management Ltd. now owns 20,457,445 shares of the biopharmaceutical company’s stock valued at $2,897,797,000 after acquiring an additional 1,112,824 shares during the period. Finally, Bank of Nova Scotia bought a new position in shares of Insmed during the third quarter valued at $72,904,000.
Wall Street Analyst Weigh In A number of research analysts have issued reports on the company. Truist Financial set a $205.00 price objective on Insmed in a report on Monday, January 12th. Weiss Ratings reissued a “sell (d-)” rating on shares of Insmed in a report on Thursday, January 22nd. UBS Group cut their price objective on Insmed from $223.00 to $215.00 and set a “buy” rating for the company in a report on Tuesday, January 6th. Roth Mkm reissued a “buy” rating and issued a $212.00 price objective on shares of Insmed in a research note on Friday. Finally, Guggenheim reissued a “buy” rating and issued a $230.00 price objective on shares of Insmed in a research note on Thursday. Two analysts have rated the stock with a Strong Buy rating, twenty-two have given a Buy rating and one has given a Sell rating to the company’s stock. According to MarketBeat, Insmed currently has a consensus rating of “Buy” and an average target price of $213.23.
Check Out Our Latest Report on Insmed
Insider Transactions at Insmed In other news, CEO William Lewis sold 10,699 shares of the business’s stock in a transaction on Thursday, April 16th. The stock was sold at an average price of $143.97, for a total transaction of $1,540,335.03. Following the completion of the sale, the chief executive officer owned 301,185 shares in the company, valued at $43,361,604.45. The trade was a 3.43% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the SEC, which is available through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, COO Roger Adsett sold 88,060 shares of the business’s stock in a transaction on Wednesday, April 1st. The stock was sold at an average price of $164.63, for a total value of $14,497,317.80. Following the sale, the chief operating officer owned 106,810 shares of the company’s stock, valued at approximately $17,584,130.30. The trade was a 45.19% decrease in their position. The SEC filing for this sale provides additional information. Insiders sold a total of 179,777 shares of company stock worth $28,252,720 over the last 90 days. 2.10% of the stock is owned by insiders.
Insmed Price Performance Insmed stock opened at $142.82 on Tuesday. The company has a debt-to-equity ratio of 0.76, a quick ratio of 3.54 and a current ratio of 3.83. The firm has a market cap of $30.83 billion, a P/E ratio of -22.28 and a beta of 1.10. The business’s fifty day moving average is $149.82 and its two-hundred day moving average is $167.54. Insmed, Inc. has a 52 week low of $63.81 and a 52 week high of $212.75.
Insmed (NASDAQ:INSM – Get Free Report) last posted its quarterly earnings data on Thursday, February 19th. The biopharmaceutical company reported ($1.54) EPS for the quarter, missing analysts’ consensus estimates of ($1.07) by ($0.47). The business had revenue of $263.84 million during the quarter, compared to analyst estimates of $263.97 million. Insmed had a negative return on equity of 168.36% and a negative net margin of 210.54%.Insmed’s revenue for the quarter was up 152.6% compared to the same quarter last year. During the same period in the prior year, the firm posted ($1.32) EPS. Equities research analysts forecast that Insmed, Inc. will post -2.51 earnings per share for the current fiscal year.
Insmed Profile (Free Report)
Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.
The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.
Recommended Stories Five stocks we like better than Insmed Want to see what other hedge funds are holding INSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Insmed, Inc. (NASDAQ:INSM – Free Report).
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GraniteShares Advisors LLC purchased a new position in shares of Insmed, Inc. (NASDAQ:INSM – Free Report) in the fourth quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The fund purchased 3,905 shares of the biopharmaceutical company’s stock, valued at approximately $680,000.
A number of other large investors also recently modified their holdings of the business. EULAV Asset Management bought a new stake in shares of Insmed in the 3rd quarter worth approximately $12,961,000. Artisan Partners Limited Partnership lifted its position in shares of Insmed by 49.0% in the 3rd quarter. Artisan Partners Limited Partnership now owns 4,937,683 shares of the biopharmaceutical company’s stock worth $711,076,000 after acquiring an additional 1,623,342 shares during the period. Atika Capital Management LLC bought a new stake in shares of Insmed in the 3rd quarter worth approximately $13,681,000. Nisa Investment Advisors LLC lifted its position in shares of Insmed by 374.6% in the 3rd quarter. Nisa Investment Advisors LLC now owns 10,466 shares of the biopharmaceutical company’s stock worth $1,507,000 after acquiring an additional 8,261 shares during the period. Finally, Nordea Investment Management AB bought a new stake in shares of Insmed in the 4th quarter worth approximately $3,492,000.
Insmed Trading Down 1.1% INSM opened at $142.82 on Tuesday. The company has a current ratio of 3.83, a quick ratio of 3.54 and a debt-to-equity ratio of 0.76. The stock has a market capitalization of $30.83 billion, a PE ratio of -22.28 and a beta of 1.10. Insmed, Inc. has a 1-year low of $63.81 and a 1-year high of $212.75. The firm has a 50-day moving average price of $149.82 and a two-hundred day moving average price of $167.54.
Insmed (NASDAQ:INSM – Get Free Report) last posted its quarterly earnings data on Thursday, February 19th. The biopharmaceutical company reported ($1.54) earnings per share for the quarter, missing the consensus estimate of ($1.07) by ($0.47). The company had revenue of $263.84 million during the quarter, compared to analyst estimates of $263.97 million. Insmed had a negative net margin of 210.54% and a negative return on equity of 168.36%. The company’s revenue was up 152.6% compared to the same quarter last year. During the same quarter in the previous year, the business posted ($1.32) EPS. As a group, equities analysts anticipate that Insmed, Inc. will post -2.51 earnings per share for the current fiscal year.
Analyst Ratings Changes A number of brokerages have commented on INSM. Weiss Ratings reiterated a “sell (d-)” rating on shares of Insmed in a research report on Thursday, January 22nd. Raymond James Financial began coverage on Insmed in a research report on Friday, April 10th. They issued an “outperform” rating and a $200.00 price objective for the company. Roth Mkm reiterated a “buy” rating and issued a $212.00 price objective on shares of Insmed in a research report on Friday. Jefferies Financial Group initiated coverage on Insmed in a research report on Monday, March 16th. They issued a “buy” rating and a $228.00 price objective for the company. Finally, Stifel Nicolaus lifted their price objective on Insmed from $205.00 to $208.00 and gave the company a “buy” rating in a report on Tuesday, March 24th. Two research analysts have rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and one has assigned a Sell rating to the company’s stock. According to data from MarketBeat, the stock presently has a consensus rating of “Buy” and a consensus target price of $213.23.
View Our Latest Research Report on Insmed
Insiders Place Their Bets In other Insmed news, CEO William Lewis sold 10,699 shares of the business’s stock in a transaction dated Thursday, April 16th. The stock was sold at an average price of $143.97, for a total transaction of $1,540,335.03. Following the completion of the sale, the chief executive officer directly owned 301,185 shares of the company’s stock, valued at approximately $43,361,604.45. The trade was a 3.43% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, COO Roger Adsett sold 88,060 shares of the business’s stock in a transaction dated Wednesday, April 1st. The stock was sold at an average price of $164.63, for a total value of $14,497,317.80. Following the sale, the chief operating officer directly owned 106,810 shares of the company’s stock, valued at $17,584,130.30. This represents a 45.19% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last three months, insiders sold 179,777 shares of company stock valued at $28,252,720. 2.10% of the stock is currently owned by insiders.
About Insmed (Free Report)
Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.
The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.
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, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it will release its first-quarter 2026 financial results on Thursday, May 7, 2026.
Insmed management will host a conference call for investors beginning at 8:00 a.m. ET on Thursday, May 7, 2026, to discuss financial results and provide a business update.
Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.
A replay of the conference call will be accessible approximately 1 hour after its completion through May 14, 2026, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two therapies approved to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.
Contact:
Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected]
, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that management will present at the following investor conferences:
BofA Securities 2026 Healthcare Conference in Las Vegas on Tuesday, May 12, 2026, at 1:40 p.m. PT. 2026 RBC Capital Markets Global Healthcare Conference in New York City on Wednesday, May 20, 2026, at 10:30 a.m. ET. These events will be webcast live and can be accessed by visiting the investor relations section of the Company's website at www.insmed.com. Webcasts will be archived for a period of 30 days following the conclusion of the live events.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.
Wall Street expects a year-over-year increase in earnings on higher revenues when Insmed (INSM - Free Report) reports results for the quarter ended March 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.
The earnings report, which is expected to be released on May 7, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis biopharmaceutical developing inhaled treatments for patients battling rare lung diseases is expected to post quarterly loss of $0.92 per share in its upcoming report, which represents a year-over-year change of +35.2%.
Revenues are expected to be $308.1 million, up 231.9% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 2.65% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Insmed?For Insmed, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +3.34%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination indicates that Insmed will most likely beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Insmed would post a loss of$1.07 per share when it actually produced a loss of -$1.54, delivering a surprise of -43.93%.
The company has not been able to beat consensus EPS estimates in any of the last four quarters.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Insmed appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Expected Results of an Industry PlayerAnother stock from the Zacks Medical - Biomedical and Genetics industry, Halozyme Therapeutics (HALO - Free Report) , is soon expected to post earnings of $1.54 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +38.7%. Revenues for the quarter are expected to be $357.66 million, up 35% from the year-ago quarter.
The consensus EPS estimate for Halozyme Therapeutics has been revised 0.6% lower over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -6.00%.
This Earnings ESP, combined with its Zacks Rank #3 (Hold), makes it difficult to conclusively predict that Halozyme Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
—New Data in Non-Cystic Fibrosis Bronchiectasis Further Define Impact of BRINSUPRI® on Respiratory Symptoms—
—Findings from a Pharmacokinetic Study Continue to Support Further Evaluation of Treprostinil Palmitil Inhalation Powder Phase 3 Development Program—
—Additionally, Insmed Provides Independent Research Grant to the American Thoracic Society for a Landmark Quality Initiative to Improve Diagnosis of Bronchiectasis across the U.S.—
, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida.
Notably, data will be presented from the Phase 3b ENCORE study evaluating ARIKAYCE® (amikacin liposome inhalation suspension) with multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once-daily versus placebo with multidrug therapy once-daily in diagnosed adult patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. Additional presentations include a post-hoc analysis from the Phase 3 ASPEN trial of BRINSUPRI® (brensocatib), real-world experience data in patients with non-cystic fibrosis bronchiectasis (NCFB), a pharmacokinetic analysis of investigational treprostinil palmitil inhalation powder (TPIP), and data highlighting disease burden in pulmonary hypertension associated with interstitial lung disease (PH-ILD).
"At Insmed, our work in respiratory disease is guided by the experiences of people living with serious and rare pulmonary conditions, where meaningful treatment advances are still urgently needed," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "The research we're presenting at ATS 2026 reflects the strength of Insmed's respiratory portfolio and pipeline, and our unwavering commitment to patients. Additionally, we're honored to present the Phase 3b ENCORE study findings as a late breaker, which will highlight compelling evidence of ARIKAYCE's potential use earlier in the treatment journey for patients living with Mycobacterium avium complex lung disease."
Presentations:
Late Breaking Science A71, Sunday, May 17, 11:30 AM – 1:15 PM EDT
Amikacin Liposome Inhalation Suspension for Newly Diagnosed Mycobacterium Avium Complex Lung Disease: Efficacy and Safety From a Phase 3b Study (ENCORE) Poster Session B45, Monday, May 18, 11:30 AM – 1:15 PM EDT
Effect of Brensocatib on Patient-Reported Symptoms in Patients with Non-Cystic Fibrosis Bronchiectasis: A Post Hoc Analysis of QOL-B RSS Individual Items from the ASPEN Phase 3 Trial Poster Session B106, Monday, May 18, 2:15 – 4:15 PM EDT
Population Pharmacokinetics Analysis of Treprostinil Using Data From Phase 1 and 2 Studies of Treprostinil Palmitil Inhalation Powder Poster Session B107, Monday, May 18, 2:15 – 4:15 PM EDT
Patient and Caregiver Survey of Burden of Bronchiectasis in the US and Europe Poster Session C58, Tuesday, May 19, 11:30 AM – 1:15 PM EDT
Long-term Hospitalizations, Comorbidities, and Survival in Patients with Pulmonary Hypertension Associated With Interstitial Lung Disease in Real-World Settings Using the NorstellaLinQ Claims Database Mini Symposium D92, Wednesday, May 20, 11:00 AM – 1:00 PM EDT
Exposure-response Relationships of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis In addition to its scientific presentations, Insmed will also host a Medical Affairs exhibit booth (location #937) at the ATS conference.
American Thoracic Society (ATS) Bronchiectasis Diagnosis Quality Initiative
As announced by the ATS, Insmed is supporting the organization with an independent research grant for a landmark quality improvement initiative aimed at addressing the widespread underdiagnosis of bronchiectasis across the United States. Working with seven academic medical systems, the ATS will independently conduct a large-scale electronic health record study to identify patients misdiagnosed with asthma or COPD, pilot scalable diagnostic interventions, and disseminate findings nationally, with the goal of ensuring patients receive timely, accurate diagnoses and guideline-directed care.
About ARIKAYCE
ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).
About BRINSUPRI
BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.
Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.
Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.
Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.
Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
U.S. INDICATION
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
BRINSUPRI® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION
Indication in the U.S.
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
Important Safety Information in the U.S.
WARNINGS AND PRECAUTIONS
Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.
Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.
Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
ADVERSE REACTIONS
The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
Less Common Adverse Reactions
Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.
Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.
Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.
Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.
Please see full US Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage, or for brensocatib in NCFB in Japan; and failure to successfully commercialize our marketed products and product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our marketed products and product candidates, if approved.
The Company may not actually achieve the results, plans, intentions, or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
— Insmed's Educational Initiative, Suspect Bronchiectasis (Suspect BE), Aims to Elevate Recognition and Diagnosis of Bronchiectasis and Encourage Conversations with a Pulmonologist —— Bronchiectasis Symptoms Often Overlap with COPD or Asthma and May Go Unrecognized for Years, Highlighting the Need to Look Deeper at Respiratory Symptoms —
— TV Personality, Ty Pennington, Brings Visibility to the Chronic Lung Condition Through His Experience Caring for His Mother, Who is Living with Bronchiectasis —
, /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced a collaboration with Emmy® Award–winning TV host, designer, and carpenter, Ty Pennington, to launch Suspect Bronchiectasis (Suspect BE). The educational initiative focuses on increasing awareness and proper diagnosis of bronchiectasis, a serious and chronic lung disease that may worsen over time and lead to lung damage. It encourages people with unresolved respiratory symptoms – such as cough, excess mucus, and recurrent lung infections, which may overlap with other respiratory conditions like chronic obstructive pulmonary disease (COPD) or asthma – to talk with a pulmonologist to see if additional testing, like a computed tomography (CT) scan, is the right next step to rule out or confirm bronchiectasis.
Insmed and Ty Pennington Team Up to Drive Awareness and Proper Diagnosis of Bronchiectasis
Insmed and Ty Pennington Team Up to Drive Awareness and Proper Diagnosis of Bronchiectasis
Insmed and Ty Pennington Team Up to Drive Awareness and Proper Diagnosis of Bronchiectasis
Insmed and Ty Pennington Team Up to Drive Awareness and Proper Diagnosis of Bronchiectasis Experience the full interactive Multichannel News Release here: https://www.multivu.com/insmed/9396851-en-insmed-ty-pennington-launch-suspect-bronchiectasis-awareness-initiative
For the first time, Pennington is opening up to the public about his experience as a caregiver to his mother who has lived with bronchiectasis for nearly two decades. Her journey living with unresolved respiratory symptoms for more than 40 years, along with the extended time it took for her to receive a bronchiectasis diagnosis, motivated Pennington to team up with Insmed to help raise awareness about the disease. As part of the initiative, Pennington draws on his home improvement expertise to highlight an important parallel: whether in a home or the lungs, taking a deeper look means exploring beyond the surface and suspecting when more could be going on.
"When I begin a renovation, I start by scanning the home – the foundation, the walls, and the attic – because looking deeper can give you a full picture. I believe the same is true with your health – taking a closer look could help with getting the answers you need," Pennington shares. "Watching my mom cope with breathing challenges, hospital visits, and the uncertainty of not always knowing what was going on had a big impact on our family. Through Suspect BE, I hope to encourage people to have deeper conversations with their healthcare providers and suspect bronchiectasis."
Bronchiectasis is a chronic lung disease where the airways become widened and damaged, making it harder for the lungs to clear mucus and bacteria. Approximately 500,000 people in the U.S. are diagnosed with bronchiectasis, but millions more people may be living with the disease without knowing it. Increasing awareness of bronchiectasis may help people better understand what could be behind their symptoms and know when it may be appropriate to have a healthcare professional take a deeper look.
"At Insmed, our hearts are with the people navigating life with serious health conditions. We believe that when patients have the right information, they feel more confident asking questions and having real, honest conversations with their doctors," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "Because bronchiectasis symptoms, like a chronic cough, recurring infections, or excess mucus, can look a lot like other lung conditions, it often takes years to get the right diagnosis, reinforcing the need for greater awareness and earlier identification, which Suspect BE is designed to help address."
For bronchiectasis information, resources, and to learn more about Pennington's story, visit SuspectBE.com or follow on Facebook and Instagram to stay up to date.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.
— Total Company Revenues of $306.0 Million for the First Quarter of 2026— —BRINSUPRI ® (brensocatib) Revenues of $207.9 Million for the First Quarter of 2026, Reflecting 44% Growth Over the Fourth Quarter of 2025— — ARIKAYCE ® (amikacin liposome inhalation suspension) Revenues of $98.1 Million for the First Quarter of 2026, Reflecting 6% Growth Over the First Quarter of 2025— —Company Reiterates 2026 BRINSUPRI Revenue Guidance of at Least $1 Billion and 2026 ARIKAYCE Revenue Guidance of $450 Million to $470 Million— — Phase 3b ENCORE Study of ARIKAYCE in Patients with MAC Lung Disease Met Primary and All Multiplicity-Controlled Secondary Culture Conversion Endpoints— —Phase 3 PALM-PAH Study of TPIP in Patients with PAH Initiated in April 2026— BRIDGEWATER, N.J., May 7, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.
Insmed (INSM - Free Report) came out with a quarterly loss of $0.76 per share versus the Zacks Consensus Estimate of a loss of $0.9. This compares to a loss of $1.42 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +15.86%. A quarter ago, it was expected that this biopharmaceutical developing inhaled treatments for patients battling rare lung diseases would post a loss of $1.07 per share when it actually produced a loss of $1.54, delivering a surprise of -43.93%.
Over the last four quarters, the company has surpassed consensus EPS estimates just once.
Insmed, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $305.96 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.7%. This compares to year-ago revenues of $92.82 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Insmed shares have lost about 21.2% since the beginning of the year versus the S&P 500's gain of 7.6%.
What's Next for Insmed?While Insmed has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Insmed was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.72 on $388.49 million in revenues for the coming quarter and -$2.41 on $1.72 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Another stock from the same industry, Oculis Holding AG (OCS - Free Report) , has yet to report results for the quarter ended March 2026.
This company is expected to post quarterly loss of $0.49 per share in its upcoming report, which represents a year-over-year change of +36.4%. The consensus EPS estimate for the quarter has been revised 0.4% lower over the last 30 days to the current level.
Oculis Holding AG's revenues are expected to be $0.32 million, up 0.6% from the year-ago quarter.
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