Novartis entered into an agreement with Synnovation Therapeutics to acquire SNV4818 for HR+/HER2- breast cancer and other solid tumor indications March 24, 2026
Data from Ph 1/2 ReDiscover trial of 400mg BID zovegalisib (RLY-2608) + fulvestrant in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer announced March 24, 2026
Results from PIK3CA WT Cohort of Ph 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer Published in Journal of Clinical Oncology March 17, 2026
Zovegalisib Granted Breakthrough Therapy Designation by FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer February 9, 2026
FDA “Study May Proceed” Letter for (Z)-Endoxifen IND Application for Metastatic Breast Cancer Received January 11, 2026
FAILED TRIAL: Ph 3 ASCENT-07 study of Trodelvy® (sacituzumab govitecan-hziy) vs chemo in 1L HR+/HER2-neg metastatic breast cancer patients did not meet the primary endpoint of PFS November 10, 2025
PROs from VERITAC-2 Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy October 29, 2025
FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer September 30, 2025
HERTHENA-Breast04 Ph 3 Trial of Patritumab Deruxtecan Initiated for Metastatic HR+ve, HER2-neg Breast Cancer Previously Treated with Endocrine Therapy September 3, 2025
DATROWAY® Approved in China for Patients with Previously Treated Metastatic HR+ve, HER2-neg Breast Cancer September 3, 2025
Incyclix Bio Secures $11.25M Series B Extension for Ph 1/2 Trial of INX-315 in CDK4/6i-Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors August 26, 2025
Positive FDA Feedback and Advances Toward IND for (Z)-Endoxifen Clinical Program in ER+/HER2- Metastatic Breast Cancer Announced August 5, 2025
Clinically Meaningful Improvement in Both PFS Primary Endpoints from PIK3CA WT Cohort of Ph 3 VIKTORIA-1 Trial Announced July 29, 2025
Bria-IMT Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer July 15, 2025
NDA submitted to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer June 11, 2025
Ph 1/2 trial of AVZO-023 initiated in patients with advanced or metastatic HR+/HER2- breast cancer and select other advanced solid tumors June 10, 2025
CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer May 27, 2025
Two Ph 2 trials of Samuraciclib + SERDs in HR+ve Advanced Breast Cancer demonstrate extended PFS in patients without TP53 mutations or without liver mets May 21, 2025
DATROWAY Approved in the EU for Patients with Previously Treated Metastatic HR+ve, HER2-neg Breast Cancer April 15, 2025
Camizestrant demonstrated highly statistically significant improvement in PFS in 1L advanced HR+ve breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Ph 3 trial March 4, 2025
First Patient Dosed in the WIN-B Trial of Debio 0123 & Trodelvy® in Advanced Breast Cancer March 3, 2025
