$CELC News
Last published 2d ago
- 2d agoCELCCelcuity Announces FDA Acceptance of sNDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast CancerGlobeNewswireFDA assigned a PDUFA goal date of June 25, 2027
- 2d agoCELCCelcuity Announces FDA Acceptance of sNDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast CancerGlobeNewswireMINNEAPOLIS, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid
- 6d agoCELCCelcuity Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 6d agoCELCCelcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswireREVTORPYK became commercially available on September 30th for the treatment of patients with HR+/HER2- PIK3CA wild-type locally advanced or metastatic breast cancer 91% of U.S. commercial and Medicare lives are in
- 1w agoCELCCelcuity To Participate in Upcoming Investor ConferencesGlobeNewswireMINNEAPOLIS, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications,
- 1w agoCELCCelcuity Schedules Release of Third Quarter 2026 Financial Results and Webcast/Conference CallGlobeNewswireMINNEAPOLIS, Oct. 29, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid
- 2w agoCELCCelcuity Presents Updated Results from the PIK3CA MT Cohort of the Phase 3 VIKTORIA-1 Study in Patients with HR+/HER2- Advanced Breast Cancer at the ESMO Congress 2026GlobeNewswireMedian PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases ORR and median duration of
- 2w agoCELCCelcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026GlobeNewswireMedian radiographic progression free survival ("rPFS") was 15.7 months and the six-month rPFS rate ("rPFS6") was 82.2% in patients who received prior abiraterone Median rPFS was 9.1 months and rPFS6 was
- 2mo agoCELCCelcuity To Participate in Upcoming Investor ConferencesGlobeNewswireMINNEAPOLIS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications,
- 2mo agoCELCCelcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast CancerGlobeNewswireIf approved, REVTORPYK would be the first and only therapy for advanced breast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 MINNEAPOLIS, Aug.
- 3mo agoCELCCelcuity Second Quarter 2026 Financial Results Call - CELCUITY INCEarnings Call TranscriptsGood afternoon, ladies and gentlemen. Welcome to Securities Second Quarter 2026 Financial Results Conference Call and Webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduc
- 3mo agoCELCCelcuity Second Quarter 2026 Financial Results Call Webcast/Conference Call - CELCUITY INCEarnings Call TranscriptsGood afternoon, ladies and gentlemen. Welcome to Securities Second Quarter 2026 Financial Results Conference Call and Webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduc
- 3mo agoCELCCelcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswireREVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late third quarter
- 3mo agoCELCCelcuity Schedules Release of Second Quarter 2026 Financial Results and Webcast/Conference CallGlobeNewswireMINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid
- 3mo agoCELCNewly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast CancerGlobeNewswireMINNEAPOLIS, July 30, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced
- 4mo agoCELCCelcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast CancerGlobeNewswireREVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and
- 4mo agoCELCApproval of Revtorpyk, Nda #219908 (Type 1 - New Molecular Entity)FDA Approved DrugsApproval Date: 07/14/2026; Drug Name: Revtorpyk, Nda #219908; Active Ingredients: GEDATOLISIB; Company: Celcuity Inc..; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 219908
- 5mo agoCELCCelcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032GlobeNewswireMINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC) ("Celcuity" or the "Company"), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of
- 5mo agoCELCCelcuity Inc. Announces Public Offering of Convertible Senior Notes Due 2032GlobeNewswireMINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC) ("Celcuity" or the "Company"), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of
- 5mo agoCELCCelcuity's Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast CancerGlobeNewswireGedatolisib plus fulvestrant and palbociclib (the "gedatolisib-triplet") reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median
- 5mo agoCELCCelcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib Regimens in HR+/HER- Advanced Breast Cancer on June 2, 2026GlobeNewswireMINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications,
- 5mo agoCELCCelcuity To Participate in Upcoming Investor ConferencesGlobeNewswireMINNEAPOLIS, May 28, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications,
- 6mo agoCELCCelcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswirePhase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant cohort; detailed data for gedatolisib regimens will be presented at the 2026 ASCO
- 6mo agoCELCCelcuity's Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive PatientsGlobeNewswireMINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications,
- 6mo agoCELCCelcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference CallGlobeNewswireMINNEAPOLIS, May 07, 2026 (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
- 6mo agoCELCCelcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant CohortGlobeNewswireMINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from
- 7mo agoCELCCelcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate UpdateGlobeNewswireThe U.S. Food and Drug Administration ("FDA") accepted Celcuity's New Drug Application ("NDA") and granted Priority Review with a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026, for gedatolisib in
- 8mo agoCELCCelcuity 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 OncologyGlobeNewswireAs previously presented, gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and gedatolisib + fulvestrant ("gedatolisib doublet") reduced the risk of disease progression or death versus fulvestrant by 76%
- 8mo agoCELCCelcuity To Participate in Upcoming Investor ConferencesGlobeNewswireMINNEAPOLIS, 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
- 9mo agoCELCCelcuity Appoints Charles Romp to its Board of DirectorsGlobeNewswireMINNEAPOLIS, 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
- 9mo agoCELCCelcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026GlobeNewswireMINNEAPOLIS, 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
- 9mo agoCELCCelcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast CancerGlobeNewswireFDA 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
- 10mo agoCELCONCYRNXTSLSThe $170B Survival Race: Why Big Pharma is Snapping Up Late-Stage Cancer TechGlobeNewswireIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, British Columbia, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – Biopharma M&A is entering a fever pitch, with precision oncology
- 11mo agoCELCCelcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer SymposiumGlobeNewswireFor 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
- 11mo agoCELCCelcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer SymposiumGlobeNewswireMINNEAPOLIS, 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
- 11mo agoCELCCelcuity To Present at Upcoming 8th Annual Evercore Healthcare ConferenceGlobeNewswireMINNEAPOLIS, 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
- 11mo agoCELCCelcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast CancerGlobeNewswireMINNEAPOLIS, 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
- 12mo agoCELCCelcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswirePresented 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
- 1y agoCELCCelcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference CallGlobeNewswireMINNEAPOLIS, 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
- 1y agoCELCCelcuity To Present at Upcoming Stifel 2025 Healthcare ConferenceGlobeNewswireMINNEAPOLIS, 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
- 1y agoCELCPhase 3 VIKTORIA-1 Additional Results Presentation - CELCUITY INCEarnings Call TranscriptsHello and thank you for standing by. My name is Bella and I will be your conference operator today. At this time, I would like to welcome everyone to Phase 3 Victoria 1 Additional Results Presentation. All lines have in
- 1y agoCELCCelcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical TrialGlobeNewswirePIK3CA 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
- 1y agoCELCDetailed 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 CancerGlobeNewswireClinical 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
- 1y agoCELCCelcuity 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")GlobeNewswireMedian 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,
- 1y agoGTBPLPTXIOBTCELC+1Clinical Breakthroughs Converge as Immunotherapy Market Surges Past $136 BillionPR NewswireUSA News Group News Commentary – Major pharmaceutical companies are unveiling breakthrough cancer data at the European Society for Medical Oncology...
- 1y agoCELCCelcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) CongressGlobeNewswireMINNEAPOLIS, 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
- 1y agoCELCCelcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford FinanceGlobeNewswireMINNEAPOLIS, 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
- 1y agoCELCCelcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA's Real-Time Oncology Review ProgramGlobeNewswireMINNEAPOLIS, 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
- 1y agoCELCCelcuity Inc. (CELC) Q2 2025 Earnings Call TranscriptEarnings Call Transcripts
- 1y agoCELCCelcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswireReported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trialHazard ratios and improvements in median progression-free