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<title>Celcuity Llc — News on 6ix</title>
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<title>Celcuity Llc</title>
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<title>Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-inc-reports-release-of-fourth-quarter-and-full-year-2025-financial-results-and-provides-corporate-update</link>
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<pubDate>Wed, 25 Mar 2026 04:00:00 GMT</pubDate>
<description>The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee</description>
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<title>Celcuity Schedules Release of Fourth Quarter and Full Year 2025 Financial Results and Webcast/Conference Call</title>
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<pubDate>Wed, 18 Mar 2026 04:00:00 GMT</pubDate>
<description>MINNEAPOLIS, March 18, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted</description>
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<title>Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-announces-publication-of-results-from-pik3ca-wild-type-cohort-of-phase-3-viktoria-1-study-of-gedatolisib-regimens-in-hrher2-advanced-breast-cancer-in-journal-of-clinical-oncology</link>
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<pubDate>Mon, 09 Mar 2026 04:00:00 GMT</pubDate>
<description>As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the</description>
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<title>Celcuity To Participate in Upcoming Investor Conferences</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-to-participate-in-upcoming-investor-conferences</link>
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<pubDate>Wed, 25 Feb 2026 21:01:00 GMT</pubDate>
<description>MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, 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 46th Annual Healthcare Conference at 10:30 a.m. ET on Wednesday, March 4, 2026. A live webcast will be</description>
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<title>Celcuity Appoints Charles Romp to its Board of Directors</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-appoints-charles-romp-board-210500736</link>
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<pubDate>Thu, 12 Feb 2026 21:05:00 GMT</pubDate>
<description>MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting. “Chip brings a wealth of oncology-related commercial expertise t</description>
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<title>Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-present-upcoming-guggenheim-emerging-120500919</link>
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<pubDate>Wed, 04 Feb 2026 12:05:00 GMT</pubDate>
<description>MINNEAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026 to be held in New York, New York on February 11-12, 2026. Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, is scheduled for a fireside chat at 9:30 a.m. ET on Wednesday, February 11, 2026. A live webcast of the event w</description>
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<title>Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-announces-fda-acceptance-drug-123000027</link>
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<pubDate>Tue, 20 Jan 2026 12:30:00 GMT</pubDate>
<description>FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-ty</description>
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<title>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</title>
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<pubDate>Thu, 11 Dec 2025 05:00:00 GMT</pubDate>
<description>For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib +</description>
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<title>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</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-present-updated-data-pik3ca-wild-type-cohort-phase-3-viktoria-1-trial-2025</link>
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<pubDate>Wed, 26 Nov 2025 05:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-present-upcoming-8th-annual-evercore-healthcare-conference-2025-11-26</link>
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<pubDate>Wed, 26 Nov 2025 05:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>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</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-announces-completion-submission-its-new-drug-application-us-fda-gedatolisib</link>
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<pubDate>Mon, 17 Nov 2025 05:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update</title>
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<pubDate>Wed, 12 Nov 2025 05:00:00 GMT</pubDate>
<description>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</description>
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<title>Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call</title>
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<pubDate>Wed, 05 Nov 2025 05:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference</title>
<link>https://6ix.com/company/celcuity-llc/news/celcuity-present-upcoming-stifel-2025-healthcare-conference-2025-11-04</link>
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<pubDate>Tue, 04 Nov 2025 05:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>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</title>
<link>https://6ix.com/company/celcuity-llc/news/detailed-results-pik3ca-wild-type-cohort-phase-3-viktoria-1-trial-presented-2025-esmo</link>
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<pubDate>Sat, 18 Oct 2025 04:00:00 GMT</pubDate>
<description>Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with</description>
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<title>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</title>
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<pubDate>Sat, 18 Oct 2025 04:00:00 GMT</pubDate>
<description>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</description>
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<title>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”)</title>
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<pubDate>Sat, 18 Oct 2025 04:00:00 GMT</pubDate>
<description>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</description>
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<title>Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress</title>
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<pubDate>Mon, 22 Sep 2025 04:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted</description>
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<title>Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance</title>
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<pubDate>Tue, 09 Sep 2025 04:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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<title>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</title>
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<pubDate>Wed, 27 Aug 2025 04:00:00 GMT</pubDate>
<description>MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies</description>
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