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COMPANY:
Celcuity

i
Other names: Celcuity LLC | Celcuity LLC. | Celcuity Inc. | Celcuity Inc | Celcuity | Celcuity, Inc. | Celcuity, Inc | CELCUITY | Celcuity, LLC | Celcuity, LLC.
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Evidence
News
28d
A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). (ASCO 2026)
P3 | "Geda has superior preclinical potency and cytotoxicity compared to alpelisib, capivasertib, and everolimus and demonstrated activity in PIK3CA-MT and wild-type (WT) breast cancer cell lines. These data demonstrate that gedatolisib combination therapies offer a potential new standard of care as 2L treatment of HR+/HER2- ABC, irrespective of PIK3CA mutation status."
Clinical • P3 data • Late-breaking abstract
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • fulvestrant • Truqap (capivasertib) • gedatolisib (PF-05212384)
11ms
Gedatolisib (geda) + fulvestrant ± palbociclib (palbo) vs fulvestrant in patients (pts) with HR+/ HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC): First results from VIKTORIA-1 (ESMO 2025)
"Hyperglycemia incidence was 9.2% and 11.5%, respectively, with grade 3 severity in 2.3% of pts in both geda groups. Conclusions These data support gedatolisib combination therapy as a potential new standard of care for the 2L treatment of pts with HR+/HER2-/PIK3CA WT ABC."
Clinical • Late-breaking abstract
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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Ibrance (palbociclib) • fulvestrant • gedatolisib (PF-05212384)
1year
Celcuity to present at upcoming TD Cowen and Jefferies investor conferences (Celcuity Press Release)
"Celcuity Inc...today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:A fireside chat at the TD Cowen: 6th Annual Oncology Innovation Summit at 9:30 a.m. ET on Wednesday, May 28, 2025. A live webcast will be available using this weblink: https://wsw.com/webcast/cowen180/celc/1978947 ; andA fireside chat at the Jefferies Global Healthcare Conference at 7:35 a.m. ET on Thursday, June 5, 2025. A live webcast will be available using this weblink: https://wsw.com/webcast/jeff319/celc/1820072 ."
Clinical
1year
Celcuity to present at upcoming Needham and Stifel Investor Conferences (Celcuity Press Release)
"Celcuity Inc...today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences...A fireside chat at the Stifel 2025 Virtual Targeted Oncology Forum at 10:00 a.m. ET on Wednesday, April 9, 2025...and...A fireside chat at the 24 th Annual Needham Virtual Healthcare Conference at 11:00 a.m. ET on Thursday, April 10, 2025...Alternatively, the live webcasts will be accessible from the Investors section of the company's website..."
Clinical