DelveInsight’s, “HR Positive/ HER2 Negative Breast Cancer Pipeline Insight, 2025,” report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the HR Positive/ HER2 Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HR Positive/ HER2 Negative Breast Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the HR Positive/ HER2 Negative Breast Cancer Pipeline Report
- In August 2025, Puma Biotechnology, Inc. announced a Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
- In August 2025, Merck Sharp & Dohme LLC conducted a Phase 3 study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.
- In August 2025, Relay Therapeutics, Inc. announced a Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
- DelveInsight’s HR Positive/ HER2 Negative Breast Cancer pipeline report depicts a robust space with 50+ active players working to develop 53+ pipeline therapies for HR Positive/ HER2 Negative Breast Cancer treatment.
- The leading HR Positive/ HER2 Negative Breast Cancer Companies such as Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.
- Promising HR Positive/ HER2 Negative Breast Cancer Pipeline Therapies such as TQB3616 capsule, Fulvestrant injection, Pembrolizumab, Sacituzumab Govitecan, VS-6766, Abemaciclib, Fulvestrant, Letrozole, Anastrozole, Exemestane and others.
Learn how leading HR Positive/ HER2 Negative Breast Cancer Companies are positioning themselves for success in the evolving pharmaceutical market—access the full report today!” @ HR Positive/ HER2 Negative Breast Cancer Clinical Trials Assessment
HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Profile
- Camizestrant: AstraZeneca
Camizestrant is a potent, next-generation oral SERD and pure ERα antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same.
- Dato-DXd: Daiichi Sankyo, Inc.
Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.
- CX-2009: CytomX Therapeutics
CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer.
- RGT-419B: Regor Therapeutics
RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer.
The HR Positive/ HER2 Negative Breast Cancer Pipeline report provides insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of HR Positive/ HER2 Negative Breast Cancer with aggregate therapies developed by each company for the same.
- It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HR Positive/ HER2 Negative Breast Cancer Treatment.
- HR Positive/ HER2 Negative Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- HR Positive/ HER2 Negative Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
- Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the HR Positive/ HER2 Negative Breast Cancer market.
From early-stage research to late-phase HR Positive/ HER2 Negative Breast Cancer Clinical Trials, our analysis covers key companies, innovative treatment approaches, and the next wave of Emerging Drugs. Don’t miss this opportunity to stay informed—download now! @ HR Positive/ HER2 Negative Breast Cancer Treatment Drugs
HR Positive/ HER2 Negative Breast Cancer Companies
Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.
HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
- Intra-articular
- Intraocular
- Intrathecal
- Intravenous
- Ophthalmic
- Oral
- Parenteral
- Subcutaneous
- Topical
- Transdermal
HR Positive/ HER2 Negative Breast Cancer Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
Stay updated with the latest HR Positive/ HER2 Negative Breast Cancer Pipeline Insights—download our report for a deep dive into the next generation of therapeutics! @ HR Positive/ HER2 Negative Breast Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the HR Positive/ HER2 Negative Breast Cancer Pipeline Report
- Coverage- Global
- HR Positive/ HER2 Negative Breast Cancer Companies- Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.
- HR Positive/ HER2 Negative Breast Cancer Pipeline Therapies- TQB3616 capsule, Fulvestrant injection, Pembrolizumab, Sacituzumab Govitecan, VS-6766, Abemaciclib, Fulvestrant, Letrozole, Anastrozole, Exemestane and others.
- HR Positive/ HER2 Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- HR Positive/ HER2 Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Find answers in our latest HR Positive/ HER2 Negative Breast Cancer Pipeline Insights report, featuring in-depth coverage of Clinical Trials, regulatory trends, and upcoming breakthroughs. Download now to stay at the forefront of pharmaceutical innovation!” @ HR Positive/ HER2 Negative Breast Cancer Emerging Drugs and Companies
Table of Contents
- Introduction
- Executive Summary
- HR Positive/ HER2 Negative Breast Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- HR Positive/ HER2 Negative Breast Cancer– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Dato-DXd: Daiichi Sankyo, Inc.
- Mid Stage Products (Phase II)
- CX-2009: CytomX Therapeutics
- Early Stage Products (Phase I)
- RGT-419B: Regor Therapeutics
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Inactive Products
- HR Positive/ HER2 Negative Breast Cancer- Unmet Needs
- HR Positive/ HER2 Negative Breast Cancer- Market Drivers and Barriers
- Appendix
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