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.
Image: Shutterstock
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.
Read More 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).
Receive News & Ratings for Insmed Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Insmed and related companies with MarketBeat.com's FREE daily email newsletter.
, /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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Two AI Titans Flash Entries As Rocket Lab Readies For Launch Insmed (INSM) stock tanked Thursday after its new lung drug, Brinsupri, missed elevated buy-side expectations, though came in handily above the sell-side's view. Brinsupri treats non-cystic fibrosis bronchiectasis, or NCFB, a lung condition that damages the airways, causing mucus buildup, infections and difficulty breathing. The drug generated $208 million in first-quarter sales, beating expectations ranging between $198.5 million to $210…
Key Takeaways INSM posted Q1 revenue growth of 230%, but sales narrowly missed consensus estimates.Brinsupri generated $207.9M in Q1 sales, driven by strong patient uptake after launch.Insmed expects Brinsupri sales of at least $1B and reaffirmed Arikayce 2026 guidance. Insmed (INSM - Free Report) reported a first-quarter 2026 loss of 76 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 90 cents. In the year-ago quarter, the company posted a loss of $1.42.
Quarterly revenues soared 230% year over year to $306 million, entirely from the sales of its two marketed products. Yet, this figure missed the Zacks Consensus Estimate of $308.1 million.
More on Insmed’s EarningsInsmed currently has two marketed drugs in its portfolio, Arikayce and Brinsupri. While Arikayce is approved to treat refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no treatment options, Brinsupri is approved for non-cystic fibrosis bronchiectasis (NCFB).
Sales of Arikayce rose 6% year over year to $98.1 million, driven by strong growth across ex-U.S. markets.
This was the second full quarter in which Insmed generated revenues from Brinsupri sales since its approval in August 2025. The drug contributed $207.9 million to the top line during the quarter, up from $144.6 million in the previous quarter, driven by strong patient uptake.
Shares of Insmed declined 23% post the earnings announcement. Though the company’s top line registered significant year-over-year growth, investors were disappointed by the slight miss in consensus sales estimates. Sentiment was further impacted after management disclosed that part of Brinsupri’s strong initial launch demand came from “ready and waiting” (R&W) patients — those who were already aware of the drug before approval and began treatment quickly once it became available.
Management estimated that around 3,500 of the 9,000 patient additions in the fourth quarter and about 1,500 of the 7,800 starts in the first quarter came from the R&W group. This raised concerns among a few investors that some early demand may have been pulled forward from future quarters. At the conference call, however, Insmed stated that beginning in the second quarter of 2026, Brinsupri’s growth is expected to be driven primarily by organic demand rather than contributions from the R&W patient pool.
Year to date, the stock has lost 40% against the industry’s nil growth.
Image Source: Zacks Investment Research
During the reported quarter, research and development expenses rose 37% year over year to $209.5 million. This uptick was driven by a rise in employee headcount, resulting in increased compensation and benefit-related expenses as well as higher clinical expenses.
Selling, general and administrative expenses amounted to $247.3 million, up 68%. This upside was driven by higher professional and external service costs, along with increased compensation and benefit-related expenses, to support the commercial launch for Brinsupri.
As of March 31, 2026, Insmed had cash, cash equivalents and marketable securities of around $1.2 billion compared with $1.4 billion as of Dec. 31, 2025.
INSM Reiterates 2026 GuidanceINSM expects product sales for Arikayce to be between $450 million and $470 million, indicating 6% year-over-year growth at the midpoint of the range.
The company projects Brinsupri sales to be at least $1 billion.
Updates on INSM’s PipelineLast month, Insmed reported disappointing results from the phase IIb CEDAR study, which evaluated Brinsupri in adults with moderate-to-severe hidradenitis suppurativa (HS). The study failed to meet both its primary and secondary endpoints. Based on this outcome, the company discontinued the drug’s development in HS.
This marks the second setback for Insmed’s efforts to expand Brinsupri’s label. In December, the drug failed a mid-stage study that evaluated it for chronic rhinosinusitis without nasal polyps (CRSsNP), which had already raised concerns about its efficacy beyond its approved indication.
On a positive note, Insmed reported encouraging top-line results in March from the late-stage ENCORE study, which evaluated Arikayce as a potential treatment for newly infected patients with MAC lung disease. The study met its primary and key secondary endpoints. Based on these results, the company plans to submit a regulatory filing to the FDA in the second half of 2026, which could significantly expand Arikayce’s addressable market.
Beyond Arikayce and Brinsupri, Insmed continues to advance its investigational treprostinil palmitil inhalation powder (TPIP) program across multiple pulmonary indications. The company is currently enrolling patients in the phase III PALM-ILD study evaluating TPIP in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Insmed also recently initiated the phase III PALM-PAH study in pulmonary arterial hypertension (PAH). Additional late-stage studies in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) are expected to begin by the end of 2026 and in the first half of 2027, respectively.
INSM’s Zacks RankInsmed currently carries a Zacks Rank #3 (Hold).
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Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
Russell Rebalance: 3 Stocks Ready to Move HigherInsmed NASDAQ: INSM Chair and CEO Will Lewis said the company remains confident in the launch trajectory of BRINSUPRI, despite investor concerns over discontinuation rates that followed the company’s latest update. Speaking at a Bank of America healthcare conference, Lewis said the company intended to provide “anchor points” around what he described as “one of the strongest launches in recent years.”
Bank of America analyst Jason Zemansky noted that Insmed recently reported BRINSUPRI sales of $208 million, up 44% sequentially, while some investors focused on discontinuation rates. Lewis said Wall Street was “not prepared to hear that metric” and that the company could have done more to educate investors about how to interpret it.
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Stock Rotation is Underway: Here are the Winners Moving ForwardLewis said discontinuation was only one metric among many and should be viewed alongside the company’s operational performance and the growth of the bronchiectasis market. He said Insmed is “at or above” every metric in its internal models and that the company’s original pre-launch model has been “remarkably accurate.”
Lewis Says Persistence Remains Strong Lewis pushed back on the idea that persistence represents a problem for the launch. He said Insmed is “essentially best in class” on persistence and that the company is performing “exceptionally well” on the metric.
He said the drug’s profile remains predictable and consistent with clinical trial results, where discontinuation was comparable to placebo. Lewis said physicians, particularly those already familiar with the medicine, have been enthusiastic, which he said supports efforts to expand prescribing both in breadth and depth.
Lewis also highlighted Insmed’s inLighten Patient Support program, saying more than 80% of patients opt into the program, compared with an industry benchmark he described as “comfortably below 50%.” He said that level of engagement gives the company a way to support patients during treatment.
Market Growth and Prescriber Expansion Cited as Launch Drivers Lewis said the total addressable market for bronchiectasis is growing due to population trends, increased diagnosis and the fact that patients can live with the disease even as their health declines. He said Insmed’s prior estimate of the bronchiectasis market was based on data from three years ago and will need to be updated as the company learns more.
The company has previously discussed a population of about 500,000 patients, including about 250,000 with two or more exacerbations. Lewis said the diagnosis rate could continue to increase and create “a lot of wind in our sails” during the launch.
On prescribing trends, Lewis said 25% of pulmonologists had written a prescription by the end of the second quarter, which he called “fantastic.” He said prescribing is occurring not only at large institutions but also among community physicians, which he described as important for the middle phase of the launch.
Lewis said reimbursement is not a meaningful reason patients stop therapy, calling it a “very, very, very small component.” He said market access through specialty pharmacies is about 90%.
The company is focused on increasing both breadth and depth among prescribers. Lewis said that in the fourth quarter, 1,800 physicians wrote one prescription out of a total of 4,100 prescribers, and by the end of the first quarter, 900 of those 1,800 had written at least one additional prescription. He also said about 20% of reached physicians have written five or more prescriptions, leaving a large group with room to increase usage.
Insmed Holds Guidance Steady Despite Positive Trends Lewis said Insmed has tried to guide investors to first-quarter organic demand of 6,300 patient adds, a figure he said could be “straight lined” through the rest of the year and still produce more than $1 billion. He said the company is not representing that it will improve on that pace, noting that many launches plateau by the second or third quarter.
Still, Lewis said prescription data remain encouraging. He said Symphony Health total prescription data have continued to track proportionally with Insmed’s internal numbers and that April weekly TRx data moved “up and to the right.”
Asked why Insmed has not raised guidance, Lewis said the company wants to see more than one quarter of performance in the calendar year before making that kind of change. He said future updates could be provided at investor conferences to help reduce speculation and volatility around quarterly results.
TPIP Viewed as Potential Next Growth Driver Lewis also discussed TPIP, Insmed’s inhaled treprostinil prodrug program, which he described as “probably the single most overlooked item at the company.” He said Insmed is running four Phase 3 trials for TPIP, including studies in pulmonary arterial hypertension and PH-ILD, with IPF and PPF trials expected to begin later this year or potentially early next year for IPF.
Lewis said Phase 2 data showed a 34% reduction in pulmonary vascular resistance and described the results as “best in class in prostanoids.” He said Phase 3 trials are targeting a maximum tolerated dose of 1,280 micrograms, double the 640 micrograms used in Phase 2.
Open-label data are expected in the third quarter. Lewis said investors will be watching whether patients maintain benefit, what happens when placebo patients move to active drug and how patients perform at higher doses, including those who reached 1,280 micrograms.
Lewis said he expects the market to remain a combination-treatment setting, particularly with sotatercept now available. He said Insmed has not conducted combination work but expects physicians may want to use therapies together given the severity and mortality risk of the disease.
Pipeline and Cash Flow Outlook Lewis said Insmed’s broader pipeline includes several research programs, including gene therapy work and INS1033, a DPP1 inhibitor distinct from brensocatib that is targeting rheumatoid arthritis and inflammatory bowel disease. He said INS1033 is expected to enter the clinic this year.
He also said Insmed expects to become cash flow positive next year without raising additional capital. Lewis said the company will remain disciplined in research spending as it moves toward an earnings-per-share transition, adding that Insmed’s standard is to discontinue any medicine that is not first or best in class.
About Insmed NASDAQ: INSMInsmed 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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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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 management will present at the 2026 Goldman Sachs Annual Global Healthcare Conference in Miami on Tuesday, June 9, 2026, at 10:00 a.m. ET.
This event will be webcast live and can be accessed by visiting the investor relations section of the Company's website at www.insmed.com. This webcast will be archived for a period of 30 days following the conclusion of this live event.
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, 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.
, /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 the granting of inducement awards to 103 new employees. The awards were granted under the Insmed Incorporated 2025 Inducement Plan, which is intended to meet the requirements of a plan providing for inducement grants under Nasdaq Listing Rule 5635(c)(4). The awards were approved by Insmed's Compensation Committee and made as a material inducement to each employee's entry into employment with the Company.
In connection with the commencement of their employment, on May 29, 2026, the employees received 97,091 restricted stock units and options to purchase an aggregate 12,850 shares of Insmed common stock at an exercise price of $106.91 per share, the closing trading price on the Nasdaq Global Select Market on the date of grant.
The restricted stock units have a four-year vesting schedule, with 25% of the shares underlying each restricted stock unit grant vesting on each anniversary of the first day of the month immediately following the grant date, subject to the relevant employee's continued service with Insmed on the applicable vesting date.
The options have a 10-year term and a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the first day of the month immediately following the grant date and 12.5% of the shares subject to the option vesting every six months thereafter through the fourth anniversary thereof, subject to the relevant employee's continued service with Insmed on the applicable vesting 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, 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]
REIT headwinds are finally fading after years of pressure. Valuations remain deeply discounted despite improving fundamentals. Three powerful catalysts could now drive a REIT recovery.
Private equity is circling REITs as discounts to asset value remain unusually wide. Some beaten-down infrastructure names may still have meaningful upside despite recent rebounds. We think two REIT targets stand out as especially likely takeover candidates.
BOCA RATON, Fla.--(BUSINESS WIRE)--SBA Communications Corporation (NASDAQ: SBAC) (“SBA” and “Company”) announced it will release its first quarter results on Wednesday, April 29, 2026 after market close. SBA will host a conference call on Wednesday, April 29, 2026 to discuss these results. The call may be accessed as follows: When: Wednesday, April 29, 2026 at 5:00 PM (EDT) Dial-in Number: 1-202-735-3323 Access Code: 7690149 Conference Name: SBA First Quarter 2026 Results Replay Availab.
REIT ETFs look low yielding, but they can hide better income opportunities underneath. Some underfollowed REITs still offer 6 to 7% yields with room for growth. A few discounted picks could deliver both strong income and upside.
On April 21, 2026, SBA Communications Corp SBAC shares fell 3.3% today, closing at $213.10. This decline comes amidst a 52-week range where the stock has traded between $162.41 and $245.16.
GF Value™ verdict: Currently priced at $213.10, SBAC is 8.8% undervalued compared to its GF Value™ of $233.54.GF Score™: With a score of 82/100, SBAC is considered a strong investment opportunity.Most notable signal: The company has seen no insider transactions in the last three months, indicating stability in management's outlook. Is SBAC Overvalued or Undervalued? The current price of SBA Communications Corp SBAC at $213.10 is below its GF Value™ estimate of $233.54, suggesting that the stock is undervalued by 8.8%. This margin of safety offers potential for appreciation, especially considering the positive historical performance trends in the telecommunications REIT sector. The GF Valuation label indicates that the stock is fairly valued; however, the intrinsic value assessment points towards a favorable investment opportunity, provided the underlying business fundamentals remain strong.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. Investors should be cautious, as market conditions can shift, impacting valuations and stock performance.
How Does SBAC's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 21.7x 49.9x Forward P/E 27.8x N/A Currently, SBAC's P/E ratio of 21.7x is significantly below its 5-year median P/E of 49.9x, indicating that the stock is trading at a much lower valuation compared to its historical averages. This analysis aligns with the GF Value™ verdict that suggests the stock is undervalued, reinforcing the notion that there may be an opportunity for growth as the market adjusts to the intrinsic value of the company.
What Does SBAC's GF Score™ Tell Us? Metric Rating GF Score™ 82/100 Financial Strength 2/10 Profitability 9/10 Growth 8/10 Valuation 9/10 Momentum 4/10 The GF Score™ of 82/100 indicates a strong overall assessment of SBAC's investment potential. The highest scores in Profitability (9/10) and Valuation (9/10) suggest that the company maintains solid profit margins and is currently priced attractively relative to its intrinsic value. However, it is noteworthy that the Financial Strength score is a low 2/10, indicating potential concerns in the balance sheet or liquidity, which investors should consider. The Momentum score of 4/10 further suggests a mixed performance in recent price trends.
What Are Insiders Doing with SBAC Stock? Over the past three months, there have been no insider transactions reported for SBA Communications Corp. This lack of insider activity can indicate a level of confidence from management regarding the company's current valuation and future prospects. In general, when insiders are not buying or selling shares, it often reflects their belief in the stability of the company’s performance and strategic direction.
What This Means for Investors Based on the GF Value™ analysis, SBA Communications Corp SBAC appears to be undervalued at its current price of $213.10, suggesting a potential investment opportunity as it is priced below its intrinsic value of $233.54.
For the complete analysis, visit the SBA Communications Corp SBAC stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is SBAC's GF Score™?
SBAC's GF Score™ is 82/100, indicating a strong potential for long-term returns based on various fundamental factors.
Is SBAC overvalued or undervalued?
SBAC is currently considered undervalued, trading at $213.10, which is 8.8% below its GF Value™ estimate of $233.54.
What is SBAC's P/E ratio?
SBAC's P/E ratio is 21.7x, which is significantly below its 5-year median of 49.9x, indicating that the stock is trading at a much lower valuation compared to its historical averages.
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].
Key Takeaways SBAC is set to report Q1 results with revenues expected to rise, but AFFO per share projected to decline.SBA Communications may see growth from 5G spending, leasing activity and long-term contracts.Higher churn, interest expenses and a leveraged balance sheet could pressure performance. SBA Communications Corporation (SBAC - Free Report) is scheduled to report first-quarter 2026 results on April 29, after market close. While the company’s quarterly results might display a rise in revenues year over year, adjusted funds from operations (AFFO) per share is expected to decline.
In the last reported quarter, this Boca Raton, FL-based communications tower REIT reported an AFFO per share of $3.19, missing the Zacks Consensus Estimate of $3.25. Results reflected growth in revenues during the quarter. However, higher costs and interest expenses undermined the performance to some extent.
Over the preceding four quarters, SBAC’s AFFO per share surpassed the Zacks Consensus Estimate on three occasions and missed on the remaining, the average beat being 1.12%. The graph below depicts this surprise history:
SBAC: Factors at PlayIn the first quarter, SBA Communications is likely to have benefited from steady carrier spending on network expansion and 5G deployments, supporting leasing activity through new colocations and site upgrades. Its long-term contracts with built-in escalators are likely to have ensured stable site-leasing revenues, while services tied to network construction may have added to growth.
However, elevated churn — particularly Sprint-related in the United States and from carrier consolidation and restructuring internationally — may have weighed on performance. Higher interest expenses and a leveraged balance sheet could have been additional headwinds.
Projections for SBA CommunicationsThe Zacks Consensus Estimate for first-quarter site-leasing revenues, which account for the lion’s share of total revenues, is pegged at $650.8 million, indicating an increase from the year-ago quarter’s $616.2 million.
Site-development revenues are expected to remain flat in the first quarter. The consensus mark stands at $48 million, unchanged from the year-ago period.
The Zacks Consensus Estimate for total quarterly revenues is pegged at $698.8 million, calling for year-over-year growth of 5.2%.
The company’s activities in the to-be-reported quarter were inadequate to garner analysts’ confidence. The Zacks Consensus Estimate for quarterly AFFO per share has remained unchanged at $2.86 over the past two months. The figure also implies a year-over-year decline of 9.5%.
What Our Quantitative Model Predicts for SBA CommunicationsOur proven model does not conclusively predict a surprise in terms of AFFO per share for SBA Communications this season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the chances of an AFFO beat, which is not the case here.
SBA Communications currently has an Earnings ESP of 0.00% and a Zacks Rank of 3. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Stocks That Warrant a LookHere are two stocks from the broader REIT sector — Ventas (VTR - Free Report) and Cousins Properties (CUZ - Free Report) — you may want to consider, as our model shows that these have the right combination of elements to report a surprise this quarter.
Ventas, scheduled to report quarterly numbers on April 27, has an Earnings ESP of +0.62% and carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cousins Properties, slated to release quarterly numbers on April 29, has an Earnings ESP of +0.94% and carries a Zacks Rank of 3 at present.
Note: Anything related to earnings presented in this write-up represents FFO, a widely used metric to gauge the performance of REITs.
BOCA RATON, Fla.--(BUSINESS WIRE)--SBA Communications Corporation (Nasdaq: SBAC) ("SBA" or the "Company") today reported results for the quarter ended March 31, 2026. Highlights of the first quarter include: Net income attributable to SBA of $184.8 million or $1.74 per share Industry-leading AFFO per share of $3.03 Increased full year 2026 outlook across all key metrics Company-wide Tower Cash Flow margin of approximately 80% In addition, the Company announced today that its Board of Directors.
SBA Communications (SBAC - Free Report) came out with quarterly funds from operations (FFO) of $3.01 per share, beating the Zacks Consensus Estimate of $2.86 per share. This compares to FFO of $3.16 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an FFO surprise of +5.39%. A quarter ago, it was expected that this communications tower operator would post FFO of $3.25 per share when it actually produced FFO of $3.19, delivering a surprise of -1.85%.
Over the last four quarters, the company has surpassed consensus FFO estimates three times.
SBA Communications, which belongs to the Zacks REIT and Equity Trust - Other industry, posted revenues of $703.44 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.66%. This compares to year-ago revenues of $664.25 million. The company has topped consensus revenue estimates three times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future FFO expectations will mostly depend on management's commentary on the earnings call.
SBA Communications shares have added about 12.5% since the beginning of the year versus the S&P 500's gain of 4.3%.
What's Next for SBA Communications?While SBA Communications has outperformed 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 FFO outlook. Not only does this include current consensus FFO 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 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 estimate revisions.
Ahead of this earnings release, the estimate revisions trend for SBA Communications was unfavorable. 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 #4 (Sell) for the stock. So, the shares are expected to underperform 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 FFO estimate is $2.95 on $698.23 million in revenues for the coming quarter and $12.13 on $2.84 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, REIT and Equity Trust - Other is currently in the top 23% 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.
Clipper Realty Inc. (CLPR - Free Report) , another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 14.
This company is expected to post quarterly earnings of $0.09 per share in its upcoming report, which represents a year-over-year change of -52.6%. The consensus EPS estimate for the quarter has been revised 33.3% lower over the last 30 days to the current level.
Clipper Realty Inc.'s revenues are expected to be $39.6 million, up 0.5% from the year-ago quarter.
SBA Communications (SBAC - Free Report) reported $703.44 million in revenue for the quarter ended March 2026, representing a year-over-year increase of 5.9%. EPS of $3.01 for the same period compares to $1.77 a year ago.
The reported revenue compares to the Zacks Consensus Estimate of $698.82 million, representing a surprise of +0.66%. The company delivered an EPS surprise of +5.39%, with the consensus EPS estimate being $2.86.
While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.
Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.
Here is how SBA Communications performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
Sites owned - Domestic: 17,378 compared to the 17,393 average estimate based on three analysts.Sites owned - International: 28,980 versus 29,798 estimated by three analysts on average.Sites owned - Total: 46,358 versus 47,191 estimated by three analysts on average.Sites decommissioned - Domestic: -31 compared to the -18 average estimate based on two analysts.Sites owned previous - International: 28,934 versus 28,934 estimated by two analysts on average.Sites owned previous - Total: 46,328 compared to the 46,328 average estimate based on two analysts.Sites acquired - Total: 10 compared to the 1,124 average estimate based on two analysts.Sites built - Total: 80 versus 143 estimated by two analysts on average.Revenues- Site Development: $47.29 million versus the four-analyst average estimate of $48.01 million. The reported number represents a year-over-year change of -1.6%.Revenues- International Site Leasing: $205.85 million compared to the $205.61 million average estimate based on four analysts. The reported number represents a change of +32.6% year over year.Revenues- Domestic Site Leasing: $450.3 million versus $445.17 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a -2.3% change.Revenues- Site Leasing: $656.15 million versus the four-analyst average estimate of $650.76 million. The reported number represents a year-over-year change of +6.5%.View all Key Company Metrics for SBA Communications here>>>
Shares of SBA Communications have returned +26.4% 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.
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Published in earnings earnings-estimates-revisions earnings-surprise
SBA Communications Corp (SBAC) Q1 2026 Earnings Call Highlights: Strong Performance Boosts Full-Year Outlook SBA Communications Corp (SBAC) reports increased revenue projections and a significant dividend hike, despite challenges in international markets. Summary
Site Leasing Revenue: Increased full year outlook due to outperformance in Q1.Cash Flow: Positive outlook with plans to use free cash flow to pay down credit facility.Adjusted EBITDA: Full year outlook increased from initial 2026 guidance.AFFO and AFFO per Share: Full year outlook increased from initial 2026 guidance.Tower Cash Flow Margins: Approximately 80% in Q1.New Lease and Amendment Billings (US): Approximately $10 million increase year-over-year.New Lease and Amendment Billings (International): Approximately $4 million increase year-over-year.Total Debt: Approximately $3 billion at the end of Q1.Net Debt to Adjusted EBITDA: 6.6 times, within target range of 6 to 7 times.Dividend: $1.25 per share declared for Q1, a 13% increase over Q1 2025.New Tower Builds (Central America): Over 60 towers built in Q1.
Release Date: April 29, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points SBA Communications Corp SBAC increased its full-year outlook for key metrics, including site leasing revenue, cash flow, adjusted EBITDA, AFFO, and AFFO per share, due to strong first-quarter performance.The company achieved high Tower cash flow margins of approximately 80% by controlling direct costs efficiently.SBA Communications Corp (SBAC) declared a dividend increase of approximately 13% over the previous year, reflecting strong financial health and shareholder returns.The company is making progress in integrating Millicom assets, with colocation demand exceeding initial lease-up projections.SBA Communications Corp (SBAC) is exploring opportunities in mobile edge computing, leveraging its existing portfolio to potentially drive incremental revenue. Negative Points International churn remains elevated due to carrier consolidation, bankruptcy, and restructuring, with 2026 expected to be the peak year for international churn.The company is involved in litigation with EchoStar, which could impact financial results depending on the outcome.SBA Communications Corp (SBAC) did not repurchase meaningful shares in the first quarter, prioritizing debt repayment over share buybacks.The company faces challenges in achieving scale in certain markets, as evidenced by the decision to sell its Canadian tower portfolio.There is uncertainty regarding the timing and financial impact of mobile edge computing initiatives, which are still in the early stages. Q & A Highlights Q: Can you help us understand the advantages and disadvantages of being a public company versus a private company in terms of competing for assets, tenants, and capital?
A: Brendan Cavanagh, President and CEO, explained that the focus is on the quality of assets and customer service, regardless of being public or private. The differences lie in capitalization and public disclosures, but the business operations remain the same.
Q: How do you prioritize factors like price, ability to close, and financing when selling assets, as seen with the Canadian tower portfolio sale?
A: Brendan Cavanagh noted that the decision to sell the Canadian assets was due to the inability to achieve scale. The sale process focused on achieving an attractive price and was consistent with their approach to portfolio review across all markets.
Q: With the moderate increase in domestic leasing backlog, is this growth across the board or specific to certain companies?
A: Brendan Cavanagh mentioned that the increase was not uniform among all customers. A recent agreement with one customer contributed to the backlog increase, but activity levels are expected to be steady throughout the year.
Q: What are the investment requirements and timeline for the mobile edge compute initiative, and how will it impact financials?
A: Brendan Cavanagh stated that they are in early stages with edge compute, engaging with multiple companies. While some initial investments have been made, the financial impact is yet to be determined, but it is expected to gain traction and contribute in the future.
Q: How does SBA view the potential acquisition interest from private equity firms, and what would it take for a sale to happen?
A: Brendan Cavanagh emphasized that SBA evaluates all options in the best interest of shareholders but does not comment on speculation or rumors. Decisions are made based on what is best for shareholders at any given time.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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].
Key Takeaways SBAC posted Q1 FFO of $3.01 and revenue of $703.4M, both above consensus estimates.International site-leasing revenue jumped 32.6%, offsetting softer domestic leasing trends.SBA Communications raised 2026 revenue, EBITDA, and AFFO per share guidance. SBA Communications Corporation (SBAC - Free Report) posted first-quarter 2026 funds from operations (FFO) per share of $3.01, beating the Zacks Consensus Estimate of $2.86 by 5.24%. The figure compared unfavorably with the FFO per share of $3.16 in the prior-year period. Total revenues rose 5.9% year over year to $703.4 million and came in 0.66% above the consensus mark of $698.8 million.
Results reflected solid site-leasing momentum, led by a sharp rebound in international operations, while the company continued to operate at a company-wide tower cash flow margin of about 80%.
SBAC Posts Higher Leasing Revenue on International StrengthSite-leasing revenue increased 6.5% year over year to $656.1 million, remaining the dominant driver of the company’s quarterly performance. Site development revenues, however, edged down 1.6% to $47.3 million, modestly offsetting the leasing-led growth.
Within site leasing, domestic revenues slipped 2.3% to $450.3 million, while international site-leasing revenues surged 32.6% to $205.8 million. The mix shift underscores how international operations carried overall top-line momentum in the quarter, even as the U.S. market remained comparatively softer.
SBAC Faces Higher CostsCost pressures were evident in the core leasing business. The cost of site leasing rose 14.2% year over year to $131.9 million, while selling, general and administrative expense increased 6.5% to $70.5 million.
Those higher costs weighed on profitability metrics. Adjusted EBITDA totaled $475.4 million, up 4% from the year-ago quarter, but the adjusted EBITDA margin slipped to 68.1% from 69.0% a year earlier, highlighting the impact of higher operating expenses.
SBAC Expands Portfolio With Sites and LandSBA Communications continued investing in its asset base during the quarter. The company acquired 10 communication sites and, notably, purchased rights to land underneath approximately 3,900 communication sites in Guatemala for total cash consideration of $133 million. It also built 80 towers during the first quarter. As of March 31, 2026, the company owned or operated 46,358 communication sites, including 17,378 in the United States and its territories and 28,980 internationally.
The company also spent $10.4 million to purchase land and easements and extend lease terms. Total cash capital expenditures were $191.9 million, including $12.7 million of non-discretionary cash capital expenditures and $179.2 million of discretionary cash capital expenditures tied to new tower builds, tower augmentations, acquisitions and land-related investments.
As of April 29, 2026, SBAC purchased or was under contract to buy 56 communication sites for a total consideration of $36.9 million in cash. It expects to complete the acquisitions by the end of the third quarter of 2026.
SBAC Liquidity & LeverageLiquidity remained supported by cash generation. Net cash provided by operating activities was $255.1 million in the first quarter compared with $301.2 million in the year-ago period. Total cash, cash equivalents and restricted cash ended the quarter at $332.5 million, providing flexibility to fund ongoing investment needs.
Leverage stayed elevated but within management’s targeted range. SBAC ended the quarter with net debt of $12.6 billion, translating to net debt to annualized adjusted EBITDA of 6.6x, in the middle of its 6.0x to 7.0x range.
SBAC Lifts 2026 OutlookGiven the quarter’s performance, SBAC raised its full-year 2026 outlook across key metrics. The updated forecast indicates site-leasing revenues of $2.649-$2.674 billion and total revenues of $2.839-$2.884 billion, each up $24 million at midpoint from prior guided range. Adjusted EBITDA is now projected at $1.921-$1.941 billion, $9 million up at midpoint.
AFFO per share is expected in the range of $11.93-$12.38, up 9 cents at midpoint from previous guidance range. The Zacks Consensus Estimate is currently pegged at $12.13 per share, which is within the guided range.
SBAC’s Zacks RankThe company currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance of Other REITsW. P. Carey Inc. (WPC - Free Report) delivered first-quarter 2026 adjusted funds from operations per share of $1.30, topping the Zacks Consensus Estimate by 1.6%. Revenues of $453.02 million also came ahead of the consensus mark of $451.06 million, a 0.4% surprise, and rose 11.2% year over year.
WPC’s results reflected the accretive impact of net investment activity and contractual rent escalations across the net-lease portfolio. Contractual same-store rent registered 2.4% growth year over year on a constant-currency basis.
Digital Realty Trust (DLR - Free Report) posted first-quarter 2026 core FFO of $2.04 per share, up 15.3% from $1.77 a year ago. The results beat the Zacks Consensus Estimate of $1.94, delivering a 5.15% earnings surprise.
Total operating revenues were $1.635 billion, up 16.2% from $1.408 billion in the year-ago quarter. Revenues also topped the consensus mark of $1.609 billion by 1.6%, supported by DLR’s strong leasing activity and healthy commencements from a growing backlog.
Note: Anything related to earnings presented in this write-up represents funds from operations (FFO), a widely used metric to gauge the performance of REITs.
BOCA RATON, Fla.--(BUSINESS WIRE)--SBA Communications Corporation (NASDAQ: SBAC) (“SBA”) announces that Marc Montagner, Chief Financial Officer is scheduled to speak at the JP Morgan 2026 Global Technology, Media and Communications Conference, Monday, May 18, 2026 at 2:50 PM ET. The conference will be at The Westin Boston Seaport District in Boston, Massachusetts. The audio presentation for SBA can be accessed by visiting www.sbasite.com. About SBA Communications Corporation SBA Communications.
On a recent Morningstar Investing Insights segment unveiling the 2026 class of exceptional dividend growers, the host offered one caveat worth the entire show: “Valuation was not a component in this screen whatsoever.” A stock can clear the bar for double-digit dividend raises, a narrow or wide moat, and low or medium uncertainty, and still be priced for poor forward returns. The screen rewards capital return discipline. It says nothing about your entry point.
That gap is what should keep you reading. Buying a great dividend grower at a stretched multiple compounds the income, but a price drawdown can still erase years of payout. The fix is to overlay a valuation filter on top of the quality screen. Five names from this year’s list clear both gates: trading at 10% or deeper discounts to Morningstar fair value while raising the dividend aggressively.
The five names that pass both tests The discounts run deepest at Zoetis (NYSE: ZTS | ZTS Price Prediction) at 32%, Accenture (NYSE: ACN) at 30%, Domino’s Pizza (NASDAQ: DPZ) at 23%, Intuit (NASDAQ: INTU) at 19%, and SBA Communications (NASDAQ: SBAC) at 13%.
The fundamentals support the gap.
Accenture posted Q2 FY26 revenue of $18.04 billion, up 8%, with record bookings of $22.1 billion, and raised its quarterly dividend 10% to $1.63. Intuit grew Q2 revenue 17% to $4.651 billion and lifted the payout 15%. Both stocks are deep in the red year to date.
Why the discount math matters more than the dividend math Take a concrete example. Suppose you put $10,000 into Zoetis at $114. That buys roughly 88 shares paying $2.12 annually, an entry yield near 1.9%.
Had you bought a year ago near $154, you would own roughly 65 shares, earning the same dividend per share on a higher cost basis. Same company, same payout, permanently lower yield on cost.
That is the math the screen ignores.
The discount widens the runway for total return, too. Zoetis trades at a forward P/E of 19 against an analyst target of $150. Accenture sits at a forward P/E of 14 with a target of $251. Intuit’s forward multiple is 15 with a target of $594.
Who this list fits, and who it hurts The setup fits an investor with a 7-to-15-year horizon to fund future income. A 50-year-old building taxable retirement income can buy a 1-to-2% starter yield today and let double-digit raises do the heavy lifting. Domino’s quarterly dividend climbed from $1.51 in 2024 to $1.99 in 2026. SBA Communications raised 13% in April to $1.25, with the payout still only ~41% of AFFO. That leaves room to keep raising.
The same list hurts a 70-year-old who needs cash flow today. Zoetis, at a 1.9% yield, does not cover current bills, regardless of growth rate. Retirees drawing portfolios are usually better served pairing a sleeve of these growers with higher current-yield holdings, Treasury ladders, or covered-call funds that prioritize today’s check over tomorrow’s raise.
What to do with this Three steps.
First, pull the Morningstar fair value estimate for each name before buying and confirm the discount is still there. Gaps close. Second, project your yield on cost at year 10 using a conservative 8% annual growth assumption, well below the recent 10% to 15% raises across this group, and compare it against what a 10-year Treasury would pay you on the same dollars. Third, separate quality and valuation in your own process going forward. The host’s caveat is the lesson: a list of exceptional dividend growers is only a starting point for further research. These five names are simply where both filters happen to overlap right now.
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Investors love dividend stocks because they provide dependable passive income streams and an excellent opportunity for solid total return. Total return includes interest, capital gains, dividends, and distributions realized over time. In other words, the total return on an investment or portfolio consists of income and stock appreciation. At 24/7 Wall St., we have focused on dividend stocks for over 15 years because, despite the stock market’s ups and downs, many people need reliable passive income streams to supplement their income from employment or other sources such as Social Security and pensions.
According to the Internal Revenue Service (IRS), passive income generally includes earnings from rental activity or any trade, business, or investment in which the individual does not materially participate. It can also include income from limited partnerships, stocks, bonds, and other similar enterprises in which the investor is not actively involved. The more passive income covers rising costs—such as mortgages, insurance, taxes, and other expenses—the easier it is for investors to set aside money for future needs as they prepare for retirement. Dependable recurring dividends, paid either monthly or quarterly, are a recipe for success.
We screened our 24/7 Wall St. dividend stocks database, looking for quality companies that have been raising their payments to shareholders by double-digit percentages over the past three years. In an economy that could still be facing more inflation, owning companies that raise dividends by double digits makes sense in an era of rising prices. All five companies we found are Buy-rated by the top Wall Street firms we cover.
Why do we cover companies raising dividends by double digits?
Since 1926, dividends have accounted for approximately 32% of the S&P 500’s total return, while capital appreciation has accounted for 68%. Therefore, sustainable dividend income and the potential for capital appreciation are essential to total return expectations. A study by Hartford Funds, in collaboration with Ned Davis Research, found that dividend stocks delivered an annualized return of 9.18% over the 50 years from 1973 to 2023. Over the same timeline, this was more than double the annualized return for non-payers (3.95%).
ADP This company, founded in 1949, is a global leader in payroll and HR services and provides cloud-based software trusted by over 80% of Fortune 100 companies. Automatic Data Processing (NYSE: ADP | ADP Price Prediction) is a global technology company engaged in providing cloud-based human capital management (HCM) solutions that unite HR, payroll, talent, time, tax, and benefits administration.
ADP benefits from its dominant position in payroll and HR services, with highly recurring, subscription-like revenue, and pays a 2.94% dividend, which has increased by a double-digit amount (12.36%) each year, on average, over the past five years. Its segments include:
Employer Services Professional Employer Organization (PEO) The Employer Services segment serves clients ranging from single-employee small businesses to large enterprises with tens of thousands of employees worldwide, offering a range of technology-based HCM solutions, including its cloud-based platforms and human resource outsourcing (HRO) solutions (other than PEO).
The company’s offerings include:
Payroll Services Benefits Administration Talent Management HR Management Workforce Management Compliance Services Insurance Services Retirement Services Its PEO business, called ADP TotalSource, provides clients with employment administration outsourcing solutions. ADP serves over 1.1 million clients across 140 countries and territories.
Cantor Fitzgerald has a Buy rating with a $244 target price.
Broadcom This technology giant has been on fire. Many investors probably don’t know it has increased its payout by an average of 19.25% annually over the past five years, making it one of the most aggressive dividend growers in tech — despite its small 0.59% dividend yield — as the shares have surged over the past year. Broadcom (NASDAQ: AVGO) is a global technology firm that designs, develops, and supplies a range of semiconductors, enterprise software, and security solutions.
The company operates through two segments. The Semiconductor Solutions segment includes all of its product lines and intellectual property (IP) licensing. Broadcom provides:
Radio-frequency semiconductor devices Wireless connectivity solutions Custom touch controllers Inductive charging solutions for mobile applications The Infrastructure Software segment includes:
Private and hybrid cloud Application development and delivery Software-defined edge Application networking and security Mainframe Distributed and cybersecurity solutions FC SAN business Broadcom provides a portfolio of software solutions that enable customers to plan, develop, automate, manage, and secure applications across mainframe, distributed, mobile, and cloud platforms.
J.P. Morgan has an Overweight rating and a $500 target price.
NextEra Energy This top company is among the highest-rated utility stocks on Wall Street, which pays a dependable 2.59% dividend. NextEra Energy (NYSE: NEE) dividend payments per share have grown at an average of 10.05% over the past 36 months (three years) and 10.11% over the past 60 months. The company has recorded 32 consecutive years of dividend increases. The company has made its target explicit: NextEra Energy continues to expect to grow its dividends per share at roughly 10% per year through at least 2026, off a 2024 base.
NextEra Energy is an electric power and energy infrastructure company. It operates through its wholly owned subsidiaries, NextEra Energy Resources and NextEra Energy Transmission (collectively, NEER), and Florida Power & Light Company (FPL). The company is working with Google on developing gigawatt-scale data center campuses and will develop 2.5 GW of solar projects for Meta. NextEra also agreed to a 25-year deal with Alphabet to acquire 3 gigawatts of energy from a redeveloped nuclear facility.
The FPL segment is a rate-regulated electric utility that generates, transmits, distributes, and sells electric energy in Florida. FPL has approximately 35,052 megawatts of net generating capacity, over 91,000 circuit miles of transmission and distribution lines, and 921 substations.
The NEER segment owns, develops, constructs, manages, and operates electric generation facilities in wholesale energy markets in the United States and Canada and includes assets and investments in other businesses with a clean energy focus, such as battery storage, natural gas pipelines, and renewable fuels. It owns, develops, constructs, and operates rate-regulated transmission facilities in North America.
HSBC has a Buy rating and a $106 price target.
Parker-Hannifin This top company’s payouts have increased by an average of 14.26% annually over the past five years. With 67 years of consecutive dividend growth, Parker-Hannifin (NYSE: PH) has long since passed the Dividend King threshold of 50 years and specializes in motion and control technologies, with a current dividend yield of 0.81%.
The company designs, manufactures, and provides aftermarket support for highly engineered solutions. Its segments include:
Diversified Industrial Aerospace Systems Diversified Industrial segment, an aggregation of several business units, sells highly engineered, differentiated products to both original equipment manufacturers (OEMs) and distributors serving aftermarket replacement markets. This segment serves various markets, including:
Aerospace and defense Off-highway Plant and industrial equipment Energy and transportation HVAC and refrigeration The Aerospace Systems Segment sells highly engineered, differentiated airframe and engine components and systems to OEMs and aftermarket parts and maintenance directly to end users primarily in the commercial aerospace and defense market verticals. Its products include fuel systems and components, avionics, flight control systems, and others.
Citigroup has a Buy rating with a $1,141 target price.
SBA Communications This cell phone tower REIT was one of five new additions to Morningstar’s list of companies with five or more consecutive years of double-digit dividend increases, putting it among a very select group of consistent double-digit dividend growers. SBA Communications (NASDAQ: SBAC) is an independent owner and operator of wireless communications infrastructure, including towers, buildings, rooftops, distributed antenna systems, and small cells, and it currently pays a 2.20% dividend.
Its primary focus is the leasing of antenna space on its multi-tenant towers to a variety of wireless service providers under long-term lease contracts in the United States, South America, Central America, Canada, and Africa. Its segments include:
Domestic Site Leasing International Site Leasing Site Development The Domestic Site Leasing segment leases to T-Mobile, AT&T Wireless, and Verizon Wireless. It owns over 17,464 sites in the United States and its territories. The International Site Leasing segment owns and operates over 22,285 towers in 13 international markets throughout South America, Central America, Canada, and Africa. Site development services include network pre-design, site audits, tower and related site construction, support for leasing the location, and more.
Truist Financial has a Buy rating with a $248 price objective.
A month has gone by since the last earnings report for SBA Communications (SBAC - Free Report) . Shares have lost about 7.5% in that time frame, underperforming the S&P 500.
But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is SBA Communications due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.
SBA Communications Q1 AFFO & Revenues Beat Estimates on Higher Leasing RevenueSBA Communications posted first-quarter 2026 AFFO per share of $3.01, beating the Zacks Consensus Estimate of $2.86 by 5.24%. The figure compared unfavorably with the FFO per share of $3.16 in the prior-year period. Total revenues rose 5.9% year over year to $703.4 million and came in 0.66% above the consensus mark of $698.8 million.
Results reflected solid site-leasing momentum, led by a sharp rebound in international operations, while the company continued to operate at a company-wide tower cash flow margin of about 80%.
Higher Leasing Revenue on International StrengthSite-leasing revenue increased 6.5% year over year to $656.1 million, remaining the dominant driver of the company’s quarterly performance. Site development revenues, however, edged down 1.6% to $47.3 million, modestly offsetting the leasing-led growth.
Within site leasing, domestic revenues slipped 2.3% to $450.3 million, while international site-leasing revenues surged 32.6% to $205.8 million. The mix shift underscores how international operations carried overall top-line momentum in the quarter, even as the U.S. market remained comparatively softer.
Faces Higher CostsCost pressures were evident in the core leasing business. The cost of site leasing rose 14.2% year over year to $131.9 million, while selling, general and administrative expense increased 6.5% to $70.5 million.
Those higher costs weighed on profitability metrics. Adjusted EBITDA totaled $475.4 million, up 4% from the year-ago quarter, but the adjusted EBITDA margin slipped to 68.1% from 69.0% a year earlier, highlighting the impact of higher operating expenses.
Expands Portfolio With Sites and LandSBA Communications continued investing in its asset base during the quarter. The company acquired 10 communication sites and, notably, purchased rights to land underneath approximately 3,900 communication sites in Guatemala for total cash consideration of $133 million. It also built 80 towers during the first quarter. As of March 31, 2026, the company owned or operated 46,358 communication sites, including 17,378 in the United States and its territories and 28,980 internationally.
The company also spent $10.4 million to purchase land and easements and extend lease terms. Total cash capital expenditures were $191.9 million, including $12.7 million of non-discretionary cash capital expenditures and $179.2 million of discretionary cash capital expenditures tied to new tower builds, tower augmentations, acquisitions and land-related investments.
As of April 29, 2026, the company purchased or was under contract to buy 56 communication sites for a total consideration of $36.9 million in cash. It expects to complete the acquisitions by the end of the third quarter of 2026.
Liquidity & LeverageLiquidity remained supported by cash generation. Net cash provided by operating activities was $255.1 million in the first quarter compared with $301.2 million in the year-ago period. Total cash, cash equivalents and restricted cash ended the quarter at $332.5 million, providing flexibility to fund ongoing investment needs.
Leverage stayed elevated but within management’s targeted range. It ended the quarter with net debt of $12.6 billion, translating to net debt to annualized adjusted EBITDA of 6.6x, in the middle of its 6.0x to 7.0x range.
SBA Communications Lifts 2026 OutlookGiven the quarter’s performance, the company raised its full-year 2026 outlook across key metrics. The updated forecast indicates site-leasing revenues of $2.649-$2.674 billion and total revenues of $2.839-$2.884 billion, each up $24 million at midpoint from prior guided range. Adjusted EBITDA is now projected at $1.921-$1.941 billion, $9 million up at midpoint.
AFFO per share is expected in the range of $11.93-$12.38, up 9 cents at midpoint from previous guidance range.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a upward trend in estimates review.
VGM ScoresAt this time, SBA Communications has a poor Growth Score of F, however its Momentum Score is doing a bit better with a D. Following the exact same course, the stock has a grade of D on the value side, putting it in the bottom 40% for this investment strategy.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, SBA Communications has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Performance of an Industry PlayerSBA Communications belongs to the Zacks REIT and Equity Trust - Other industry. Another stock from the same industry, Highwoods Properties (HIW - Free Report) , has gained 7.2% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.
Highwoods Properties reported revenues of $214.03 million in the last reported quarter, representing a year-over-year change of +6.8%. EPS of $0.29 for the same period compares with $0.83 a year ago.
Highwoods Properties is expected to post earnings of $0.87 per share for the current quarter, representing a year-over-year change of -2.3%. Over the last 30 days, the Zacks Consensus Estimate has changed -1.4%.
Highwoods Properties has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D.
The build-out of 5G networks remains a massive multiyear tailwind for the real estate sector. Choosing between SBA Communications (SBAC +1.06%) and Crown Castle (CCI +1.35%) requires weighing international growth against domestic fiber strength.
Both companies operate as real estate investment trusts (REITs), owning the essential infrastructure that allows your smartphone to function. While they share similar business models, their geographic focuses and asset mixes differ significantly. One prioritizes global expansion while the other bets heavily on U.S. small cells and fiber to complement its traditional tower portfolio.
The case for SBA CommunicationsSBA Communications provides essential infrastructure by leasing tower space to wireless providers. Its primary customers include T-Mobile, AT&T, and Verizon. T-Mobile alone accounted for more than 31% of total revenue in 2024, and customer concentration like this adds a layer of risk to the business.
In FY 2025, revenue reached nearly $2.8 billion, which was a growth rate of approximately 5.1% from the previous year. The company reported net income of roughly $1.1 billion during this period. This led to a net margin of approximately 37.4%, which measures how much of each dollar earned becomes profit.
As of its December 2025 balance sheet, the debt-to-equity ratio was -3.2x, indicating that total liabilities exceed shareholder equity. The current ratio, which compares short-term assets to short-term liabilities, was roughly 0.5x. For the year, the company generated free cash flow of close to $1.1 billion.
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The case for Crown CastleCrown Castle focuses its operations on U.S. infrastructure, managing more than 40,000 towers and 90,000 miles of fiber. The big three carriers accounted for roughly 90% of site rental revenue in FY 2025, representing significant customer concentration risk. The company also builds small cell nodes to support high-density wireless demand in urban areas.
For FY 2025, revenue was nearly $4.3 billion, representing a decrease of about 35.1% over the prior year. Net income for the fiscal year was approximately $444.0 million. This resulted in a net margin of roughly 10.4%, showing how much revenue remains after all costs are paid.
According to its December 2025 balance sheet, the debt-to-equity ratio was -18.1x, which means total liabilities exceed shareholder equity. The current ratio was approximately 0.3x. Free cash flow for the year was roughly $2.9 billion, providing significant capital for reinvestment.
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Risk profile comparisonSBA Communications faces risks from a small customer base, particularly with the recent default of EchoStar. This default is expected to lead to a revenue loss of about $56.0 million in 2026. The company also deals with competition from other infrastructure providers like American Tower and must manage currency swings in international markets.
Crown Castle carries a substantial debt load of approximately $24.2 billion, which limits its flexibility to pursue new projects. The company is currently involved in a dispute with EchoStar, asserting that the carrier owes more than $3.5 billion under existing agreements. Competition in the U.S. market from firms like Equinix or carrier self-performance can also pressure lease rates.
Valuation comparisonSBA Communications currently trades at a lower forward P/E and P/S ratio than its peer based on future earnings estimates.
MetricSBA CommunicationsCrown CastleSector BenchmarkForward P/E26.9x42.9x32.2xP/S ratio7.5x9.2xn/aSector benchmark uses the SPDR XLRE sector ETF. Valuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.
SBA, Crown Castle, and American Tower are the three big publicly traded tower companies. They’re REITs, which means they operate like landlords, renting the infrastructure and physical space to providers of cell connectivity. It’s an intriguing idea for an investment, as these companies receive predictable recurring income from major telecoms and operate in an industry that is viewed as a utility.
But there are risks across the board, and the fallout from the EchoStar default and subsequent legal battle is one example. Both SBA and Crown Castle have relatively small customer bases, and if one tenant struggles financially, it can send shockwaves through the balance sheet. SBA is the smallest of the three, both in terms of market cap and in total number of towers. In April, tower stocks responded favorably to rumors that SBA Communications may be the target of an acquisition by infrastructure management companies KKR and Brookfield.
Tower stocks have been losing investments over the past five years, with SBA stock down more than 36% and Crown Castle losing about 55% in that time frame. A major acquisition in the industry could reinvigorate the investment narrative, as could interest from adjacent industries like data centers or satellite internet.
Choosing between SBA and Crown Castle may come down to your geographic preferences. SBA operates in North America, South America, Central America, and Africa, while Crown Castle is more concentrated in the United States. I think SBA’s valuation, superior financials, and potential for an acquisition make it the more interesting choice here, but prospective long-term investors should consider what they believe the industry will look like over the next five to 10 years before making a decision.
The ZacksWireless Equipment industry is poised to capitalize on the healthy demand trends driven by the rapid deployment of 5G and the transition to cloud and fiber networks. However, large-scale investments for seamless 5G evolution, margin erosion from price wars, higher customer inventory levels and inflated raw material costs owing to geopolitical conflicts, a challenging macroeconomic environment and uncertain business conditions might erode profitability.
Amid this backdrop, Motorola Solutions, Inc. (MSI - Free Report) , Ubiquiti Inc. (UI - Free Report) and Nokia (NOK - Free Report) are likely to profit from solid growth dynamics, supported by the widespread proliferation of IoT, fiber densification and shift to cloud services.
Industry Description The Zacks Wireless Equipment industry primarily comprises companies offering various networking solutions, wireless telecom products and related services for wireless voice and data communications through scalable modular platforms. Their product portfolio encompasses integrated circuit devices (chips) and system software for wireless voice and data communications, analog and digital two-way radio, satellite telecommunications, wireless networking and signal processing and end-to-end enterprise mobility solutions. The firms also provide a broad range of routing, switching and security products, video surveillance and machine-to-machine communication components that secure VPN appliances, enable intrusion detection and thwart data theft. Some firms even provide electronic warfare, avionics, robotics, advanced communications and maritime systems to the defense industry.
What's Shaping the Future of the Wireless Equipment Industry? Rapid Scaling: With operators moving toward converged or multi-use network structures, combining voice, video and data communications into a single network, the industry is increasingly developing solutions to support wireline and wireless network convergence. These investments are likely to help minimize service delivery costs to adequately support broadband competition and expand rural coverage and wireless densification in the long run. The industry players have enabled enterprises to rapidly scale communications functionalities to a vast range of applications and devices with easy-to-use software application programming interfaces. The firms support high user volumes without affecting deliverability and cost-effectively eliminate performance degradation.
Comprehensive Service Bouquet: The majority of the industry participants offer mission-critical communication infrastructure, devices, accessories, software and services that enable their customers to run businesses with increased efficiency and safety for their mobile workforce. These systems drive demand for additional device sales, software upgrades, infrastructure overhaul and expansion, as well as additional services to maintain, monitor and manage these complex networks and solutions. The comprehensive suite of services ensures continuity and reduces risks for constant critical communication operations.
Eroding Profits: Although higher infrastructure investments will eventually help minimize service delivery costs to support broadband competition and wireless densification, short-term profitability has largely been compromised. Margins are likely to be affected by the high cost of first-generation 5G products, profitability challenges in China, the Middle East war and volatility in crude oil prices. Uncertainty regarding chip shortage (albeit to a lesser extent) and supply-chain disruptions owing to tariff wars (leading to a dearth of essential fiber materials), shipping delays and scarcity of other raw materials due to geopolitical unrest are expected to affect the expansion and rollout of new broadband networks. Extended lead times for basic components might also hurt the delivery schedule and raise production costs. High customer inventory levels, owing to a challenging macroeconomic environment and volatile market conditions, pose another headwind for the companies.
Demand-Driven Operations Led by 5G, Fiber & Cloud: To maintain superior performance standards, there is a continuous need for network tuning and optimization, which creates demand for state-of-the-art wireless products and services. Moreover, a faster pace of 5G deployment is expected to augment the telecommunications industry's scalability, security and universal mobility and propel the wide proliferation of IoT. Expansion of fiber optic networks to support 4G LTE and 5G wireless standards, as well as wireline connections, is likely to act as a tailwind. The industry participants are enabling their customers to move away from an economy-of-scale network operating model to demand-driven operations and seamlessly migrate to 5G by offering easy programmability and flexible automation through steady infrastructure investments. The exponential growth of cloud networking solutions is further resulting in increased storage and computing on a virtual plane. As both consumers and enterprises use the network, there is tremendous demand for quality networking equipment.
Zacks Industry Rank Indicates Bullish Trends The Zacks Wireless Equipment industry is housed within the broader Zacks Computer and Technology sector. It carries a Zacks Industry Rank #44, which places it in the top 18% of more than 250 Zacks industries.
The group’s Zacks Industry Rank, which is basically the average of the Zacks Rank of all the member stocks, indicates bright prospects. 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.
Before we present a few wireless equipment stocks that are well-positioned to outperform the market based on a strong earnings outlook, let’s take a look at the industry’s recent stock-market performance and valuation picture.
Industry Outperforms S&P 500, Sector The Zacks Wireless Equipment industry has outperformed the S&P 500 composite and the broader Zacks Computer and Technology sector over the past year.
The industry has surged 73% over this period compared with the S&P 500 and sector’s growth of 33.9% and 49.4%, respectively.
One-Year IBM Stock Price Performance
Industry's Current Valuation On the basis of trailing 12-month Enterprise Value-to EBITDA (EV/EBITDA), which is the most appropriate multiple for valuing telecom stocks, the industry is currently trading at 32.77X compared with the S&P 500’s 17.16X. It is also trading above the sector’s trailing 12-month EV/EBITDA of 17.24X.
Over the past five years, the industry has traded as high as 35.87X, as low as 6.51X and at the median of 18.73X, as the chart below shows.
Trailing 12-Month Enterprise Value-to EBITDA (EV/EBITDA) Ratio
3 Wireless Equipment Stocks to Buy Motorola: Based in Chicago, IL, Motorola is a leading communications equipment manufacturer with a strong market position in bar code scanning, wireless infrastructure gear and government communications. As a leading provider of mission-critical communication products and services worldwide, the company has ensured a steady revenue stream from this niche market. It intends to boost its position in the public safety domain by entering into strategic alliances with other players in the ecosystem. Motorola is witnessing a robust demand for video security products and services and remains well poised to maintain this growth momentum with a diversified portfolio. The stock has gained 8.9% over the past year. The Zacks Consensus Estimate for current-year earnings has been revised 6% upward since April 2025. This Zacks Rank #2 (Buy) company has a long-term earnings growth expectation of 9.4%.
Price and Consensus: MSI
Ubiquiti: Headquartered in New York, Ubiquiti offers a comprehensive portfolio of networking products and solutions for service providers and enterprises. The company maintains a proprietary network communication platform committed to reducing operational costs by using a self-sustaining mechanism for rapid product support and dissemination of information. Ubiquiti aims to benefit from significant growth opportunities in both emerging and developed economies. These include a relentless pursuit by emerging countries to stay connected with the world through the adoption of wireless networking infrastructure, as developed economies aim to bridge the demand-supply gap for higher bandwidth. The stock has gained 198.7% over the past year. The Zacks Consensus Estimate for its current fiscal and next fiscal-year earnings has been revised 55.3% and 50.5% upward, respectively, since April 2025. Ubiquiti sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Price and Consensus: UI
Nokia: Finland-based Nokia has emerged as one of the leading players in the development of advanced 5G technology and is at the forefront of extending 5G use cases in various industries. It has laid a strong foundation of innovation through substantial infrastructure investments. This has led to the establishment of an impressive portfolio comprising approximately 26,000 patent families, including more than 8,000 patent families that are deemed crucial to 5G technology. Nokia is well-positioned for the ongoing technology cycle given the strength of its end-to-end portfolio. This Zacks Rank #2 firm has a long-term earnings growth expectation of 7.5%. The stock has gained 88.4% over the past year.