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Last update 17 Aug 2026

Abemaciclib

Last update 17 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib

+ [8]

Target

CDK4 x CDK6

Action

inhibitors

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [7]

Active Indication

ER-positive/HER2-negative/ ESR1-mutated breast cancerAdvanced breast cancerMetastatic breast cancer+ [72]

Inactive Indication

Adenocarcinoma of EsophagusAdenocarcinoma of prostateAdvanced biliary tract cancer+ [29]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly & Co.

Genentech, Inc.

Lilly Asia Shanghai Representative Office

+ [12]

Inactive Organization

Oncoinvent ASA

Clovis Oncology, Inc.

Veru, Inc.

+ [3]

License Organization

Veru, Inc.

Zentalis Pharmaceuticals, Inc.

Eli Lilly & Co.

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (28 Sep 2017),

Hormone receptor positive HER2 negative breast cancer

RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC27H32F2N8

InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N

CAS Registry1231929-97-7

267

Clinical Trials associated with Abemaciclib

NCT07441369

/ Enrolling by invitationPhase 2IIT

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy

This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of abemaciclib combined with FOLFOX/FOLFIRI regimen in patients with advanced colorectal liver metastases cancer who failed standard two or three-line therapy.

Start Date30 Jul 2026

Sponsor / Collaborator

Fudan University

NCT07410559

/ Not yet recruitingPhase 2IIT

Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)

This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.

Start Date01 Jul 2026

Sponsor / Collaborator

Fudan University

JPRN-jRCTs031260249

/ RecruitingPhase 2

A randomized study of Trastuzumab deruxtecan Against Second-line endocrine Therapy In hormone receptor-positive, HER2-low/ultralow metastatic breast cancer (TRANSITION)

Start Date29 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Abemaciclib

100 Translational Medicine associated with Abemaciclib

100 Patents (Medical) associated with Abemaciclib

1,524

Literatures (Medical) associated with Abemaciclib

31 Dec 2026·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

Author: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

01 Oct 2026·BIOORGANIC & MEDICINAL CHEMISTRY

CDK4/6-targeted therapy: From clinical inhibitors to emerging strategies to overcome resistance

Review

Author: Lu, Ying ; Yan, Zitong ; Feng, Dijing ; Sha, Wenjie ; Chen, Zhuo

The Cyclin-dependent kinase 4/6 (CDK4/6) complex orchestrates the critical G1-to-S phase transition by phosphorylating the Retinoblastoma protein (Rb), establishing it as a validated therapeutic target in oncology. The clinical deployment of ATP-competitive inhibitors-Palbociclib, Ribociclib, and Abemaciclib-has revolutionized the standard of care for hormone receptor-positive breast cancer. However, the long-term efficacy of these agents is inevitably compromised by the emergence of intrinsic and acquired resistance. This multifaceted resistance landscape is driven by genomic alterations including RB1 loss, activation of compensatory bypass signaling pathways, and the adaptive scaffolding functions of CDK6. Consequently, therapeutic strategies are evolving from simple inhibition to rational intervention. In this review, we systematically elucidate these emerging interventions. On one hand, we explore strategies grounded in the optimization of occupancy-based inhibition, specifically highlighting the synergistic combination regimens and rational design of dual-target small molecules to re-sensitize resistant tumors. On the other hand, we highlight the paradigm shift toward Proteolysis Targeting Chimera (PROTAC) technology. By recruiting the ubiquitin-proteasome system to catalytically degrade target proteins, CDK4/6-PROTACs eliminate both enzymatic activity and non-catalytic scaffolding functions, offering a mechanistically distinct strategy to overcome the structural limitations of traditional inhibitors. This review summarizes the progression from clinical inhibitors to strategies for overcoming resistance, offering insights into the future development of CDK4/6-targeted therapies.

01 Sep 2026·Journal of Geriatric Oncology

Cognitive dysfunction associated with endocrine therapy and CDK4/6 inhibitors in breast cancer: A real-world analysis of the FDA Adverse Event Reporting System (FAERS) database

Article

Author: Tao, Hong ; Li, Yuedong ; Wang, Yanan ; Hu, Zhanhong ; Shen, Zhu ; Fan, Dandan ; Han, Junping ; Liu, Hua ; Zhu, Zhu

INTRODUCTION:

Endocrine therapies (ETs) and CDK4/6 inhibitors are cornerstone treatments for hormone receptor-positive (HR+) breast cancer, but their association with cognitive dysfunction remains poorly characterized. Given the clinical significance of treatment-related cognitive impairment, we aimed to systematically assess cognitive adverse events (AEs) associated with ETs and CDK4/6 inhibitors using real-world pharmacovigilance data.

MATERIALS AND METHODS:

The FDA Adverse Event Reporting System (FAERS) database (2004-2024) was analyzed, excluding confounders (e.g., pre-existing cognitive disorders, concomitant neurotoxic medications). Reporting odds ratios (RORs) identified significant AEs; Time-to-onset analysis and Kaplan-Meier curves evaluated temporal patterns. Subgroup analyses compared monotherapies (aromatase inhibitors, SERMs, GnRHa, CDK4/6 inhibitors) and combination regimens.

RESULTS:

Among 68,832 ET/CDK4/6 inhibitor reports, 2827 cognitive AEs (4.11%) were identified. Memory impairment (31.98%), confusional state (16.98%), and amnesia (9.98%) predominated. Nine neuropsychiatric AEs showed significant associations, with SERMs having the highest risk (ROR = 2.12, 95% CI:1.76-2.55). Median time-to-onset was 88 days (IQR:1-2231); 50% occurred within three months. Abemaciclib monotherapy had the shortest onset (36 days), tamoxifen monotherapy the longest (496 days). Affected patients were primarily older (>65 years: 60.28%) and female (98.37%); most reports involved CDK4/6 inhibitor monotherapy (46.34%) or AI combinations (28.48%). Fatal outcomes occurred in 5.8% of cases.

DISCUSSION:

This study delineates the spectrum, timing, and risk profiles of cognitive dysfunction linked to ETs and CDK4/6 inhibitors, highlighting the need for proactive monitoring, particularly in older patients and combination regimens. While limitations inherent to FAERS data apply, these hypothesis-generating findings provide a foundation for mechanistic research and clinical risk stratification.

471

News (Medical) associated with Abemaciclib

16 Aug 2026

·www.biospace.com

LeonaBio Reports Second Quarter 2026 Financial Results and Provides Business Update

On Track to Complete Enrollment of Phase 3 ELAINE-3 Clinical Trial of Lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated Metastatic Breast Cancer in 4Q 2026 with Topline Data Expected in 2H 2027 BOTHELL, Wash., Aug. 14, 2026 (GLOBE NEWSWIRE) -- LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today reported financial results for the quarter ended June 30, 2026, and provided recent pipeline and business updates. “We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer,” said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. “We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027. As the treatment landscape for metastatic breast cancer continues to evolve, we believe the differentiated pro lasofoxifene positions it to address a significant unmet need as a potential endocrine therapy partner and create opportunities beyond ELAINE-3, including additional combination strategies and future label expansions. The body of clinical and scientific evidence behind lasofoxifene supports our confidence in its potential to greatly benefit patients battling this difficult-to-treat form of breast cancer.” “As we approach the completion of enrollment in this Phase 3 registrational trial, we are investing today in critical CMC, regulatory, and commercial readiness activities to ensure we are well-positioned to bring this therapy to patients as quickly as possible, if approved. With our talented team and the potential to add up to an additional $146 million upon exercise of cash-exercisable warrants issued in our December 2025 financing, we believe LeonaBio is well-positioned to deliver on multiple value-creating milestones in the years ahead,” added Dr. Litton. Clinical Development & Pipeline Programs Lasofoxifene – A third generation novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer. In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene. Lasofoxifene is being advanced in ELAINE-3, a Phase 3 clinical trial ( NCT05696626 ), in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS), as determined by blinded, independent central review (BICR). ELAINE-3 aims to establish a new standard of care for this genetically defined patient group with limited treatment options. The Company expects to complete enrollment of ~600 participants in the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027. Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2. ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits. ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade. In April 2026, LeonaBio hosted a virtual Key Opinion Leader event with two leading physicians in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant ER+, HER2-negative, ESR1-mutated metastatic breast cancer. The event titled, “Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer,” featured a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field. A replay of the event is available on the LeonaBio website under “Events & Presentations” in the “Investor Relations” section here . Brelgometon (ATH-1105) – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. Brelgometon is currently in clinical development for the potential treatment of ALS. LeonaBio’s first-in-human Phase 1 double-blind, placebo-controlled clinical trial (NCT06432647) enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of brelgometon, demonstrating a favorable safety and tolerability pro well as dose-proportional pharmacokinetics and CNS penetration and supporting its advancement into a Phase 2 proof-of-concept trial. The Company expects to provide an update on the timing of a proposed Phase 2 proof-of-concept clinical trial following completion of enrollment of the Phase 3 ELAINE-3 clinical trial as it continues to focus on its lasofoxifene program. Corporate Updates LeonaBio announced the appointment of Fred Callori, J.D., Natalie Holles and Peter B. Silverman, J.D. to its Board of Directors, effective as of May 5, 2026. The company also announced that John Fluke, Jr., who served on the Board since 2014, retired effective May 4, 2026. Fred Callori, J.D., has served as a Partner and Managing Director at Perceptive Advisors LLC, an investment firm that specializes in investing in biotechnology stocks, since January 2018. Natalie Holles has served as the Chief Executive Officer and member of the Board of Directors of Aura Biosciences, a clinical-stage biotechnology company, since April 2026. Ms. Holles served as the Chief Executive Officer of Third Harmonic Bio, a biopharmaceutical company, from August 2021 to December 2025. Peter B. Silverman, J.D., served as Chief Operating Officer of Merus N.V. (formerly, Nasdaq: MRUS), a biotechnology company, from January 2023 until its acquisition by Genmab A/S in December 2025, and prior to that, Mr. Silverman held several leadership roles at Merus. Mr. Silverman has served as a member of the board of directors of Kinaset Therapeutics, a biopharmaceutical company, since January 2026. Financial Results Cash Position. Cash, cash equivalents and investments were $51.1 million as of June 30, 2026, compared to $88.3 million as of December 31, 2025. Net cash used in operations was $37.9 million for the quarter ended June 30, 2026, compared to $21.7 million for the quarter ended June 30, 2025. In conjunction with the December 2025 Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the Series A warrants providing, if exercised in full, up to an additional $146 million to support development through key clinical and regulatory milestones. Research and Development (R&D) Expenses. R&D expenses were $12.9 million for the quarter ended June 30, 2026, compared to $3.7 million for the quarter ended June 30, 2025. The increase was driven primarily by clinical trial spend related to the ELAINE-3 trial for lasofoxifene. General and Administrative (G&A) Expenses. G&A expenses were $6.6 million for the quarter ended June 30, 2026, compared to $3.6 million for the quarter ended June 30, 2025. The increase was driven primarily by personnel-related expenses, including stock-based compensation and professional service fees. Net Loss. Net loss was $19.0 million, or $0.80 per share, for the quarter ended June 30, 2026, compared to a net loss of $7.0 million, or $1.78 per share, for the quarter ended June 30, 2025. About LeonaBio LeonaBio, headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS), with the goal of improving patients’ lives. Our lead drug candidates, lasofoxifene and brelgometon (ATH-1105), are novel, small molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most. For more information, visit . Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the beneficial characteristics, safety and efficacy of LeonaBio’s drug candidates; the potential of LeonaBio to complete the Phase 3 ELAINE-3 clinical trial for lasofoxifene and to meet the trial endpoints, potential of ELAINE-3 to serve as a registrational trial, and any subsequent clinical trials to show the clinical benefits of lasofoxifene to the satisfaction of the FDA to support its regulatory approval; the potential of any subsequent clinical trials to show the beneficial characteristics, safety and efficacy of brelgometon; LeonaBio’s drug candidates as potential treatments for metastatic breast cancer, amyotrophic lateral sclerosis and other diseases; LeonaBio’s future development plans and the timing thereof; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; the markets for LeonaBio’s drug candidates, if approved for commercial use, and LeonaBio’s ability to serve those markets; anticipated development milestone timelines, such as the initiation of clinical trials and the timing of data releases, and LeonaBio’s ability to meet such timelines; LeonaBio’s ability to obtain and maintain regulatory approval of its drug candidates in the United States and other jurisdictions and the timing thereof, and any related restrictions, limitations or warnings in the label of any approved drug candidate; LeonaBio’s ability to commercialize any approved products; and the sufficiency of LeonaBio’s capital resources to advance both its oncology and neurodegeneration programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” “target” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the possible failure to realize certain anticipated benefits of the license relating to lasofoxifene and the recent private placement financing, including with respect to future financial and operating results; the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of LeonaBio’s drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether LeonaBio’s trials are sufficiently powered to meet the planned endpoints; LeonaBio may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that may in the future be instituted against LeonaBio, its directors and officers; possible negative interactions of LeonaBio’s drug candidates with other treatments; FDA regulatory delays and uncertainty and new policies, including executive orders, changes in the leadership of federal agencies such as the FDA and SEC, staff layoffs, budget cuts to agency programs and research and changes in drug pricing controls; LeonaBio’s assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets, including as a result of tariffs; the impact of competition; the impact of drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks detailed in LeonaBio’s filings with the SEC from time to time. These forward-looking statements speak only as of the date hereof and LeonaBio undertakes no obligation to update forward-looking statements. LeonaBio may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements. Investor & Media Contact: Julie Rathbun LeonaBio julie.rathbun@leonabio.com 206-769-9219 LeonaBio, Inc. Condensed Consolidated Balance Sheets (Amounts in thousands) June 30, December 31, 2026 2025 (unaudited) Assets Cash and cash equivalents $ 32,323 $ 69,276 Short-term investments 18,744 19,055 Other short-term assets 3,741 1,127 Other long-term assets 2,086 2,693 Total assets $ 59,894 $ 92,151 Liabilities and stockholders' equity Current liabilities $ 7,817 $ 10,015 Sermonix pre-funded warrant — 37,488 Milestone liability 14,362 15,116 Long-term liabilities 1,120 1,742 Total liabilities 23,299 64,361 Stockholders' equity 33,595 27,790 Total liabilities and stockholders' equity $ 56,894 $ 92,151 LeonaBio, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, 2026 2025 Operating expenses: Research and development $ 12,702 $ 3,661 Milestone liability change in fair value 175 — General and administrative 6,576 3,630 Total operating expenses 19,453 7,291 Loss from operations (19,453 ) (7,291 ) Other income, net 446 325 Sermonix pre-funded warrant change in fair value — — Net loss $ (19,007 ) $ (6,966 ) Unrealized gain on available-for-sale securities 4 1 Comprehensive loss attributable to common stockholders $ (19,003 ) $ (6,965 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.80 ) $ (1.78 ) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 23,726,211 3,909,297

Phase 3Phase 2Phase 1Executive ChangeClinical Result

12 Aug 2026

·www.biospace.com

LeonaBio to Highlight Lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated Metastatic Breast Cancer at DAVA Oncology’s 4th Summit on Breast Cancer

On Track to Complete Enrollment of the Phase 3 ELAINE-3 clinical trial in 4Q 2026 with Topline Data Expected in 2H 2027 BOTHELL, Wash., Aug. 12, 2026 (GLOBE NEWSWIRE) -- LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today announced that its lead product candidate, lasofoxifene, will be featured in multiple presentations at Dava Oncology’s 4th Summit on Breast Cancer taking place from August 18-22, 2026, in Kona, Hawaii. “We are honored to share the body of clinical and scientific evidence supporting lasofoxifene as a potential treatment for metastatic breast cancer with many of the world's leading breast cancer experts,” said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. “Patients with metastatic breast cancer continue to face significant challenges as resistance emerges and treatment options become limited. We believe lasofoxifene has the potential to redefine the treatment paradigm for these patients through its differentiated mechanism of action and promising clinical profile. As we advance toward completion of enrollment in our pivotal Phase 3 ELAINE-3 trial, we remain focused on obtaining the data needed to bring a potential new therapeutic option to patients as quickly as possible.” Jessica Tao, M.D., a medical oncologist specializing in breast cancer at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, will present on lasofoxifene, including the Phase 3 ELAINE-3 clinical trial of lasofoxifene in combination with abemaciclib in the treatment of ER-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer on Wednesday, August 19, 2026, at 8:02 am Hawaii time. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In addition, David Portman, M.D., Founder and Chief Executive Officer of Sermonix and a consultant to LeonaBio, will lead an Industry Lunch Presentation on the development of lasofoxifene and its potential as a treatment for metastatic breast cancer on Thursday, August 20, 2026, at 12:25 pm Hawaii time. “We are excited by the opportunities that success in ELAINE-3 could create, not only in potentially establishing lasofoxifene in combination with CDK4/6 inhibition as a new standard of care in metastatic breast cancer but also informing future testing in different combination strategies and additional breast cancer settings,” concluded Dr. Litton. About LeonaBio LeonaBio, headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS), with the goal of improving patients’ lives. Our lead drug candidates, lasofoxifene and brelgometon (ATH-1105), are novel, small molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most. For more information, visit . Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the beneficial characteristics, safety and efficacy of LeonaBio’s drug candidates; the potential of LeonaBio to complete the Phase 3 ELAINE-3 clinical trial for lasofoxifene and to meet the trial endpoints, potential of ELAINE-3 to serve as a registrational trial, and any subsequent clinical trials to show the clinical benefits of lasofoxifene to the satisfaction of the FDA to support its regulatory approval; LeonaBio’s drug candidates as potential treatments for metastatic breast cancer, amyotrophic lateral sclerosis and other diseases; LeonaBio’s future development plans and the timing thereof; anticipated development milestone timelines, such as the initiation of clinical trials and the timing of data releases, and LeonaBio’s ability to meet such timelines; and LeonaBio’s ability to obtain and maintain regulatory approval of its drug candidates in the United States and other jurisdictions and the timing thereof, and any related restrictions, limitations or warnings in the label of any approved drug candidate. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” “target” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the possible failure to realize certain anticipated benefits of the license relating to lasofoxifene and the recent private placement financing, including with respect to future financial and operating results; the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of LeonaBio’s drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether LeonaBio’s trials are sufficiently powered to meet the planned endpoints; LeonaBio may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that may in the future be instituted against LeonaBio, its directors and officers; possible negative interactions of LeonaBio’s drug candidates with other treatments; FDA regulatory delays and uncertainty and new policies, including executive orders, changes in the leadership of federal agencies such as the FDA and SEC, staff layoffs, budget cuts to agency programs and research and changes in drug pricing controls; LeonaBio’s assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets, including as a result of tariffs; the impact of competition; the impact of drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks detailed in LeonaBio’s filings with the SEC from time to time. These forward-looking statements speak only as of the date hereof and LeonaBio undertakes no obligation to update forward-looking statements. LeonaBio may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements. Investor & Media Contact: Julie Rathbun LeonaBio julie.rathbun@leonabio.com 206-769-9219

Phase 3

07 Aug 2026

·www.prnewswire.com

Atossa Therapeutics Reports Second Quarter 2026 Financial Results and Provides a Corporate Update

SEATTLE, Aug. 7, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced its financial results and provided an update on recent corporate developments for the second quarter ended June 30, 2026. "During the quarter, we executed well across the business," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "We continued to advance the scientific rationale for (Z)-endoxifen's potential in rare pediatric diseases, such as Duchenne Muscular Dystrophy and McCune-Albright Syndrome, while also strengthening its clinical and scientific foundation in breast cancer, all through new data presented at important industry conferences, including ASCO and AACR, as well as publications in well-regarded peer-reviewed journals, Degenerative Neurological and Neuromuscular Disease and npj Breast Cancer." Dr. Quay continued, "These accomplishments, together with additional capital from our registered direct offering, underscore the breadth of potential we see for (Z)-endoxifen, and investors' support in our ability to continue advancing our programs." Second Quarter 2026 & Recent Highlights Rare Diseases Atossa Participated at the 2026 American Association for Cancer Research (AACR) Special Conference in Cancer Research: Cancer Evolution In a poster presentation titled, "Dual estrogen receptor and PKC-β signaling modulation by (Z)-Endoxifen: A mechanism-driven therapeutic strategy for estrogen-driven pathology in McCune-Albright Syndrome," the Company discussed a dual mechanism of action for (Z)-endoxifen in estrogen-driven pathology relevant to McCune-Albright Syndrome-associated Peripheral Precocious Puberty (MAS-PPP). The dual mechanism includes the blockade of estrogen receptor (ER)-mediated transcription downstream of autonomous estrogen production and suppression of PKC-β/AKT-associated proliferative and cell-cycle signaling. This multi-pathway profile may address a key therapeutic gap in MAS-PPP, where estrogen suppression alone may not fully mitigate downstream proliferative signaling. The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of McCune-Albright Syndrome (MAS). The Company Announced Acceptance of Manuscript Highlighting the Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD) A paper details how (Z)-endoxifen may support the expression of utrophin, a paralog of dystrophin. (Z)-Endoxifen therefore represents a potential dystrophin mutation-agnostic treatment for DMD. The paper citation is: Remmel HL, Hammer SS, Blackburn SM, Quay SC. (Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic and Transcriptomic Perspective. Degener Neurol Neuromuscular Dis. 2026;16:574524 The results support further investigation of (Z)-endoxifen in dystrophin-deficient models, as well as biomarker development. These data also build upon the Company's previously published manuscript, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy," also published in Degenerative Neurological and Neuromuscular Disease. The Company previously received Orphan Drug Designation (ODD) and RPD designation for (Z)-endoxifen from the FDA for the treatment of DMD. Oncology The Company Published Manuscript Highlighting the Anti-cancer Activity of (Z)-Endoxifen-related Compounds In the peer-reviewed journal, npj Breast Cancer, the Company published an article titled, "Novel (Z)-endoxifen-related new chemical entities exhibit potent anti-cancer activity in ERα+ breast cancer." The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen, alongside (Z)-endoxifen in a broad panel of laboratory assays, as well as in combination with the CDK4/6 inhibitor abemaciclib. The publication reported anti-estrogenic and anti-cancer activity across multiple ER-positive (ER+) breast cancer models, including models harboring clinically relevant activating mutations in ESR1. In certain experimental settings and models, selected compounds combined with abemaciclib demonstrated additive to synergistic activity that was comparable to or greater than the activity observed with abemaciclib plus (Z)-endoxifen. The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease. Atossa Participated in the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting In a poster presentation titled, "A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE)," the Company described EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/human epidermal growth factor receptor 2 negative (HER2-), cT2-3, cN0-1 breast cancer. Enrollment in this study was completed as of June 30, 2026. In an online publication titled, "Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations," the Company highlighted new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives. Corporate Atossa Strengthened its Balance Sheet with a Registered Direct Offering, Potentially Providing Up to $16.5 Million in Gross Proceeds The Company entered into a securities purchase agreement with institutional investors, which provided for the issuance and sale by the Company, in a registered direct offering of (i) 1,363,637 shares of the Company's common stock and (ii) Series A warrants to purchase up to 1,363,637 shares of common stock and short-term Series B warrants to purchase up to 1,363,637 shares of common stock, raising $4.5 million in upfront gross proceeds, with the potential to receive up to an additional $12 million, assuming the full cash exercise of the warrants. Net proceeds are designated to support the clinical development of (Z)-endoxifen and for general corporate working capital. Financial Results for the Second Quarter Ended June 30, 2026 Operating Expenses. Total operating expenses were $8.7 million and $18.6 million for the three and six months ended June 30, 2026, respectively, which was a decrease of $0.3 million and an increase of $2.1 million from total operating expenses for the three and six months ended June 30, 2025 of $9.0 million and $16.5 million, respectively. Factors contributing to the changes in operating expenses during the three and six months ended June 30, 2026 are explained below. Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands): As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate: Clinical and non-clinical trial expenses decreased $0.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in spend on preclinical trials that concluded in the prior period, partially offset by an increase in expense due to higher enrollment in clinical trials of $0.2 million and an increase in drug development costs of $0.3 million in the current period. Clinical and non-clinical trial expenses increased $0.4 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to an increase in expense related to clinical trial enrollments of $1.5 million and an increase in drug development costs of $0.7 million, partially offset by a $1.8 million decrease in expenses related to preclinical work completed in 2025. The increase in R&D compensation expenses of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million. The decrease in R&D professional fees and other of $0.1 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was primarily attributable to a decrease in regulatory consulting fees in the 2026 periods related to our (Z)-endoxifen program as compared to the same periods in the prior year. General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands): The decrease in G&A compensation expenses of $0.3 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year. The increase in G&A professional fees and other of $0.6 million and $2.6 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to higher legal fees of $0.7 million and $2.5 million, for the three and six months ended June 30, 2026, respectively, related to our patent litigation matters, which have now been settled, as well as fees associated with management of our intellectual property portfolio and legal costs related to our SEC compliance and other stock administration matters incurred during the current year periods. Interest Income. Interest income was $0.2 million and $0.5 million for the three and six months ended June 30, 2026, respectively, and decreased $0.4 million and $0.8 million compared to the three and six months ended June 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. (Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication. Atossa has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of Duchenne Muscular Dystrophy, as well as Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of both Duchenne Muscular Dystrophy and McCune-Albright Syndrome. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$220 million. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide. More information is available at . Forward Looking Statements This press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our 2026 outlook and our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential role of (Z)-endoxifen and (Z)-endoxifen-related compounds in endocrine therapies, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the Company's progress across its pipeline and potential commercialization, the strength of the Company's patent portfolio, the Company's potential eligibility for and the value of a Rare Pediatric Disease PRV, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD or MAS indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials, and research and development programs; the potential clinical significance of preclinical data and the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for MAS; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. The market value of a PRV is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements. SOURCE Atossa Therapeutics Inc 21% more press release views with Request a Demo

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative/ ESR1-mutated breast cancer	China	Eli Lilly Nederland BV	17 Jun 2026
Advanced breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
Metastatic breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
HR Positive/HER2 Negative/Node positive breast cancer	European Union	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Iceland	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Liechtenstein	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Norway	Eli Lilly Nederland BV	26 Sep 2018
Hormone receptor positive HER2 negative breast cancer	United States	Eli Lilly & Co.	28 Sep 2017

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Indication	Highest Phase	Country/Location	Organization	Date
Bone metastases	Phase 3	United States	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	China	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Japan	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Argentina	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Australia	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Belgium	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Brazil	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Canada	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	Czechia	Eli Lilly & Co.	14 Apr 2022
Bone metastases	Phase 3	France	Eli Lilly & Co.	14 Apr 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06001762 (TRADE \| TRADE study, CTgov)	Phase 2	Early Stage Breast Carcinoma \| Hormone receptor positive HER2 negative breast cancer	90	LHRH Agonist+Tamoxifen+Letrozole+abemaciclib+Exemestane+anastrozole	rghndkpjfo = zxldbktvku unaywaqzkp (tsjqofbnrs, ytjnnfmchj - uunbpkjypy) View more	-	02 Jul 2026
NCT03292250 (TRIUMPH, Pubmed \| Head Neck)	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck CDK4/6 Pathway Alteration	23	Abemaciclib	cmqdubzbrm(zippalytoh) = vswmxvhtlz pebvexggqb (lgclidhqbg )	Positive	01 Jun 2026
ASCO2026	Not Applicable	Early Stage Breast Carcinoma Adjuvant HR+ \| HER2-	39	Abemaciclib	gfunwapvdz(wwkidihtat) = xlokredjuf jmqhlimgxg (mjbfzqraxc ) View more	Negative	29 May 2026
NCT04967521 (SARC041, ASCO2026)	Phase 3	Dedifferentiated Liposarcoma	108	Abemaciclib 200 mg PO twice a day	jhxudatnsi(gmnouchyjc) = awysrfgpoc hwztemtjvc (wbubfbljuz ) View more	Positive	29 May 2026
NCT04967521 (SARC041, ASCO2026)	Phase 3	Dedifferentiated Liposarcoma	108	Placebo	jhxudatnsi(gmnouchyjc) = vxtrqxylan hwztemtjvc (wbubfbljuz ) View more	Positive	29 May 2026
NCT04469764 (ASCO2026)	Phase 2	Endometrial Carcinoma \| Recurrent ovarian cancer estrogen receptor positive (ER+)	43	Abemaciclib + hormonal therapy (ER+ EC)	rwtbssueao(iopnrthxzs) = qfettgqqfl advdgpdjzd (xhjvxhnobq, 34.5 - 77.7) View more	Positive	29 May 2026
NCT04469764 (ASCO2026)	Phase 2		43	Abemaciclib + hormonal therapy (LGSOC)	rwtbssueao(iopnrthxzs) = ovdjkbdeql advdgpdjzd (xhjvxhnobq, 47.8 - 95.1) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer Adjuvant HR+ \| HER2-	64	Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic acid0mg Denosumaby month 1, then 150mg twice daily + Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic aciditorDenosumab + Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic acid or Denosumab	vgbhxkeant(leykihfldz) = qieahgsaka cwceruwxyu (rokfcisntv ) View more	Positive	29 May 2026
NCT06001762 (TRADE, ASCO2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer Adjuvant HR+ \| HER2−	90	Abemaciclib + Abemaciclibherapy	zkbpffcuij(bsmubmjmau) = increased Bacteroidota and decreased Firmicutes abundance (p < 0.002 and p = 0.001, respectively, paired T-test) vvimgxtfyp (jvfwrrkgmy ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Hormone receptor positive breast cancer Adjuvant hormone receptor-positive (HR+)	640	Abemaciclib + Abemaciclibherapy	syjzmraers(rzeegaztji) = jzlermloea bfqnlwaaqw (nlivmjwljg ) View more	Negative	29 May 2026
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer Second line HR+/HER2-	411	Abemaciclib±ET	odtruvvzaj(xdblkvaqfb): P-Value = 0.482 View more	Positive	29 May 2026
ASCO2026	Not Applicable		411	ET monotherapy	odtruvvzaj(xdblkvaqfb): P-Value = 0.482 View more	Positive	29 May 2026
NCT05548127 (TACTIVE-U, ASCO2026)	Phase 1/2	ESR1-mutated \| ER+/human epidermal growth factor receptor 2-negative (HER2−)	37	AbemaciclibVepdegestrant + AbemaciclibVepdegestrant	vfwefnqwcg(ztcmlljvja) = mlnikcizxd fcxfkwfwfq (uholmtolbw, 18.0 - 46.9) View more	Positive	29 May 2026
NCT05548127 (TACTIVE-U, ASCO2026)	Phase 1/2		37	Abemaciclib (ESR1m)	vfwefnqwcg(ztcmlljvja) = lakvwobpky fcxfkwfwfq (uholmtolbw, 25.8 - 65.8) View more	Positive	29 May 2026

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