Celcuity Announces Positive Breast Cancer Trial Results, Triple Drug Combo Tops AstraZeneca's Treatment.

Celcuity Inc. has announced the pricing of concurrent public offerings, and its triple drug combo has shown positive results in a breast cancer trial, topping AstraZeneca's treatment in reducing disease progression. The company's shares surged on the news.

Celcuity Inc. (CELC.O) has announced the pricing of concurrent public offerings, and its triple drug combo has shown positive results in a breast cancer trial, topping AstraZeneca's treatment in reducing disease progression. The company's shares surged on the news.

The experimental combination treatment involving Celcuity's gedatolisib, Pfizer's Ibrance (palbociclib), and AstraZeneca's Faslodex (fulvestrant) demonstrated a 76% reduction in the risk of disease progression or death compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients [1]. HR+/HER2- breast cancer accounts for about 70% of all breast cancers.

The study showed "unprecedented results," according to Leerink Partners analyst Andrew Berens, who noted that gedatolisib could become a new standard of care as a second-line treatment in breast cancer, especially in community settings [1].

Celcuity's triple combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex alone [1]. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' Afinitor and AstraZeneca's Truqap [1]. The company projects revenue potential of $5 billion for the treatment in the second-line treatment setting [1].

The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth [1]. The study also showed that a double combination of gedatolisib and Ibrance increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex [1].

Celcuity plans to report full results from the late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter [1]. Shares of the Minnesota-based firm more than doubled to $38.02 in early trading [1].

References:
[1] https://www.reuters.com/business/healthcare-pharmaceuticals/celcuitys-triple-drug-combo-tops-astrazenecas-treatment-breast-cancer-trial-2025-07-28/
[2] https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3TP0X0:0-celcuity-s-triple-drug-combo-tops-astrazeneca-s-treatment-in-breast-cancer-trial/
[3] https://www.biopharmadive.com/news/celcuity-breast-cancer-gedatolisib-viktoria-study-results-shares/754197/