HER2-Negative Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "HER2-Negative Breast Cancer Pipeline Insight" report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in HER2-Negative Breast Cancer pipeline landscape. It covers the HER2-Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2-Negative Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight's comprehensive HER2-Negative Breast Cancer Pipeline Report to explore emerging therapies, key HER2-Negative Breast Cancer Companies, and future HER2-Negative Breast Cancer treatment landscapes @ HER2-Negative Breast Cancer Pipeline Outlook Report [https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Key Takeaways from the HER2-Negative Breast Cancer Pipeline Report

* In February 2025:- AstraZeneca :- This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
* In February 2025:- Puma Biotechnology Inc.:- PUMA-ALI-1201 is a randomized, dose optimization, multicenter, 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 February 2025:- SOLTI Breast Cancer Research Group:- This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.
* DelveInsight's HER2-Negative Breast Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for HER2-Negative Breast Cancer treatment.
* The leading HER2-Negative Breast Cancer Companies such as Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.
* Promising HER2-Negative Breast Cancer Therapies such as Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and others.

Discover how the HER2-Negative Breast Cancer treatment paradigm is evolving. Access DelveInsight's in-depth HER2-Negative Breast Cancer Pipeline Analysis for a closer look at promising breakthroughs @ HER2-Negative Breast Cancer Clinical Trials and Studies [https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

HER2-Negative Breast Cancer Emerging Drugs Profile

* Giredestrant : Genentech

Giredestrant is a novel investigative small molecule that works as selective estrogen receptor degrader (SERD) by targeting the estrogen receptor (ER). The drug candidate is a new molecular entity (NME) which is administered through oral route. Preclinical studies suggest that Giredestrant is orally bioavailable and competitively inhibits the binding of estrogen to the ER. In preclinical models, Giredestrant has been shown to restrain the normally dynamic behavior of both wild-type and mutant ER, immobilizing the ER and attenuating the expression of its target genes. Currently, the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

* Inavolisib : Genentech

Inavolisib is an investigational small molecule designed to selectively inhibit mutant PI3K. In preclinical models, the molecule showed potent selective inhibition of PI3K and has increased potency to mutant PI3K cells over wild type. It is less sensitive for the other three PI3K isoforms. Inavolisib binds to the ATP-binding site of PI3K, thereby blocking phosphorylation of PIP2 to PIP3 and preventing downstream signaling as shown in preclinical models. Moreover, inavolisib specifically degrades the mutant form of PI3K, resulting in reduction of pathway activity. Currently the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

* CX-2009 : CytomX Therapeutics

CX-2009 (Praluzatamab ravtansine) is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD166-directed humanized monoclonal antibody conjugated to the maytansinoid DM4, a tubulin inhibitor. Praluzatamab ravtansine utilizes CytomX Probody Registered platform technology, which incorporates a masking peptide to cover and block the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

* H3B 6545 : H3 Biomedicine

H3B-6545 is an oral, selective estrogen receptor covalent antagonist (SERCA) for the research of metastatic ER-positive, HER2-negative breast cancer. H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ER.4 H3B-6545 activity against ER mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies. Currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

* RGT-419B : Regor Therapeutics

RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B's tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor. Currently, the drug is in Phase I stage of its development for the treatment of HER2 negative breast cancer.

The HER2-Negative Breast Cancer pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of 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 HER2-Negative Breast Cancer Treatment.
* HER2-Negative Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* 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 HER2-Negative Breast Cancer market.

Get a detailed analysis of the latest innovations in the HER2-Negative Breast Cancer pipeline. Explore DelveInsight's expert-driven report today! @ HER2-Negative Breast Cancer Unmet Needs [https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

HER2-Negative Breast Cancer Companies

Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.

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

* Oral
* Parenteral
* Intravitreal
* Subretinal
* Topical

HER2-Negative Breast Cancer Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

Download DelveInsight's latest report to gain strategic insights into upcoming HER2-Negative Breast Cancer Therapies and key HER2-Negative Breast Cancer Developments @ HER2-Negative Breast Cancer Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the HER2-Negative Breast Cancer Pipeline Report

* Coverage- Global
* HER2-Negative Breast Cancer Companies- Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs , and others.
* HER2 Negative Breast Cancer Therapies- Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin , and others.-
* HER2-Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* HER2-Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in HER2-Negative Breast Cancer drug development? Find out in DelveInsight's exclusive HER2-Negative Breast Cancer Pipeline Report-access it now! @ HER2-Negative Breast Cancer Emerging Drugs and Major Companies [https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* HER2 Negative Breast Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* HER2 Negative Breast Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Giredestrant : Genentech
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* CX-2009 : CytomX Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* RGT-419B : Regor Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* HER2 Negative Breast Cancer Key Companies
* HER2 Negative Breast Cancer Key Products
* HER2 Negative Breast Cancer- Unmet Needs
* HER2 Negative Breast Cancer- Market Drivers and Barriers
* HER2 Negative Breast Cancer- Future Perspectives and Conclusion
* HER2 Negative Breast Cancer Analyst Views
* HER2 Negative Breast Cancer Key Companies
* Appendix

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