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Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of ...
Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrantFor patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7...
Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of t...
Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract was accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) and is now available on the SABCS website. The 2025 SABCS is being held virtually and in-person from December 9-12, 2025. The presentation will inclu...
Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Confere...
Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the 8th Annual Evercore Healthcare Conference to be held in Miami, Florida on December 2-4, 2025. Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, is scheduled for a fireside chat at 7:30 a.m. ET on Wednesday, December 3, 2025. A live webcast of the event will be available using this weblin...
- Dave Nicoski
- Ross LaDuke
Vermilion Compass: Weekly Equity Strategy
Back to Near-Term Bullish on SPX and QQQ We downgraded our near-term outlook on the S&P 500 (SPX) and Nasdaq 100 (QQQ) to neutral last week (11/19/25 Compass), after being bullish since our 4/22/25 Compass, while maintaining our intermediate-term bullish outlook (as of our 5/14/25 Compass). Crucial support levels of 6480-6520 on SPX and $580-$583 on QQQ held last week, and we are right back to being near-term bullish as long as these support levels continue to hold. Just know that SPX could see...
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Celcuity Inc: 1 director
A director at Celcuity Inc sold 15,000 shares at 100.001USD and the significance rating of the trade was 71/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly s...
Celcuity Announces Completion of Submission of Its New Drug Applicatio...
Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast...
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provide...
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update Presented detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial at a late breaking oral presentation at the 2025 European Society for Medical Oncology (“ESMO”) Congress Presented updated clinical results from the Phase 1b portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) in men with metastatic castration resistant prostate cancer (“mCRPC”) at a poster session at ESMO Completed enrollment of the ...
Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Result...
Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Informatio...
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Stifel 2025 Healthcare Conference to be held in New York on November 11-13, 2025. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 10:00 a.m. ET on Tuesday, November 11, 2025. A live webcast of the event will be available using this weblink . Alternatively, ...
Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Pha...
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 PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolledAdditional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (“PFS”) of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer (“ABC”) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasda...
Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 ...
Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer (“mCRPC”) Median radiographic progression free survival (“rPFS”) was 9.1 months and the six-month rPFS rate was 67% No patients discontinued study treatment due to a treatment-related adverse event (“TRAE”) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated clinical resu...
Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Tr...
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 Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and in 11.5% of patients treated with gedatolisib + fulvestrant (“gedatolisib doublet”)Study treatment discontinuation due to treatment related adverse eve...
- Jonathan Moreland
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Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial ...
Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detail...
- Jonathan Moreland
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Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 M...
Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance 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 $...
Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type...
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 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...
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