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18.10.25 - 10:33
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Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer (GlobeNewswire EN)
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MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA WT, advanced breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. As previously announced, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival (“PFS”) versus fulvestrant, reducing the risk of disease progression or death by 76%. The gedatolisib doublet reduced the risk of progression or death by 67% versus fulvestrant....
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18.10.25 - 10:33
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Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial (GlobeNewswire EN)
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MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (“MT”) tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Analysis of data from a Phase 1b clinical trial that evaluated gedatolisib combined with palbociclib and fulvestrant in the same population was also provided....
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09.09.25 - 22:03
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Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance (GlobeNewswire EN)
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MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and Oxford Finance LLC, and its affiliates (together, “Oxford”). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million....
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27.08.25 - 22:09
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Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA′s Real-Time Oncology Review Program (GlobeNewswire EN)
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MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and Drug Administration (“FDA”) agreed to accept its New Drug Application (“NDA”) for gedatolisib in HR+/HER2- advanced breast cancer (“ABC”) for review under the Real-Time Oncology Review (“RTOR”) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. Celcuity is expected to initiate in September a rolling submission to the FDA of its NDA for gedatolisib, based on topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025....
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24.07.25 - 23:54
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XFRA: NEW INSTRUMENT AVAILABLE - 25.07.2025 - EQUBF_01 (XETRA)
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Das Instrument 7VR US15102K1007 CELCUITY INC. DL -,001 EQUITY hat seinen ersten Handelstag am 25.07.2025: CONTINUOUS AUCTION SPECIALIST, PAG PAG_EQU, SettlCurr EUR, CCP N
The instrument 7VR US15102K1007 CELCUITY INC. DL -,001 EQUITY has its first trading date on 25.07.2025: CONTINUOUS AUCTION SPECIALIST, PAG PAG_EQU, SettlCurr EUR, CCP N...
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