Ataraxis AI has published details of a two-stage artificial intelligence framework designed to predict pathological complete response (pCR) to neoadjuvant therapy in breast cancer patients using routine pre-treatment biopsy slides. The system, described in a technical report from the company, pairs two AI models (MORPHEUS, which estimates gene expression from histology images, and NEO, which […]
Celcuity Inc. announced on September 30, 2026, that REVTORPYK (gedatolisib) is now commercially available in the United States for adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy […]
Bayer announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation for elinzanetant (Lynkuet) for a new indication: the treatment of moderate to severe vasomotor symptoms (VMS) in women receiving endocrine therapy for the treatment or prevention of hormone receptor–positive (HR+) breast cancer. […]
The U.S. Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio) on September 18, 2026, for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed following at least one line of endocrine therapy. Both agents are manufactured by Eli Lilly and Company. Concurrently, the FDA approved the […]
Researchers have reported preliminary findings from a prospective observational study evaluating the cerebrospinal fluid (CSF) penetration of elacestrant combined with abemaciclib in patients with hormone receptor-positive (HR+), HER2-negative breast cancer and active brain metastases. Published in Neuro-Oncology Advances, the data offer early pharmacokinetic evidence that both agents can be detected in the CSF of patients […]
On August 26, 2026, Celcuity Inc. (Nasdaq: CELC) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for REVTORPYK™ (gedatolisib) in patients with hormone receptor–positive (HR+), HER2-negative (HER2−) locally advanced or metastatic breast cancer (ABC) harboring a PIK3CA mutation, following progression on or after at least […]
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETX-19477, an investigational poly(ADP-ribose) glycohydrolase (PARG) inhibitor developed by 858 Therapeutics, for the treatment of adult patients with BRCA-mutated, HR+/HER2− unresectable or metastatic breast cancer. The designation highlights PARG as an emerging target in DNA-damage response (DDR) oncology beyond the established PARP […]
Celcuity Inc. announced on July 30, 2026, that REVTORPYK™ (gedatolisib) has been incorporated into the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a preferred Category 1 regimen for second-line and subsequent-line therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation — following the drug’s FDA […]