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 - Celcuity ( NASDAQ:CELC )
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.
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.
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 ...
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, ...
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference - Celcuity ( NASDAQ:CELC )
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, ...
WW International, Replimune Group, Datavault AI, GRAIL And Other Big Stocks Moving Higher On Monday - American Battery Tech ( NASDAQ:ABAT ) , Amazon.com ( NASDAQ:AMZN )
U.S. stocks were higher, with the Nasdaq Composite gaining more than 1% on Monday. Shares of WW International, Inc. ( NASDAQ:WW ) rose sharply during Monday's session after announcing a partnership with Amazon.com, Inc.'s ( NASDAQ:AMZN ) Amazon Pharmacy to make weight management medications ...
Dow Jumps Over 200 Points; Cleveland-Cliffs Shares Jump After Q3 Results - Celcuity ( NASDAQ:CELC ) , Adaptimmune Therapeutics ( NASDAQ:ADAP )
U.S. stocks traded higher this morning, with the Dow Jones index gaining more than 200 points on Monday. Following the market opening Tuesday, the Dow traded up 0.47% to 46,407.15 while the NASDAQ gained 0.93% to 22,890.22. The S&P 500 also rose, gaining, 0.61% to 6,704.61.
Why Delcath Systems Shares Are Trading Higher By Over 14%; Here Are 20 Stocks Moving Premarket - Beyond Meat ( NASDAQ:BYND ) , Addex Therapeutics ( NASDAQ:ADXN )
Shares of Delcath Systems Inc ( NASDAQ:DCTH ) rose sharply in pre-market trading after the company announced preliminary third quarter 2025 financial results. The company's Phase 2 CHOPIN study achieved primary endpoint, with PHP plus immunotherapy extending median PFS to 12.8 months versus ...
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
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 ...
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 - Celcuity ( NASDAQ:CELC )
PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional 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 ...
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" )
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 results from the Phase 1 portion of a clinical trial evaluating gedatolisib in ...
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" ) - Celcuity ( NASDAQ:CELC )
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" )
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
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 ...
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 - Celcuity ( NASDAQ:CELC )
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 ...
Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology ( ESMO ) Congress - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, Sept. 22, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc.
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 ...
Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance - Celcuity ( NASDAQ:CELC )
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 ...
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 - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, Aug. 27, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. CELC, a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S.
Celcuity Q2 Results Highlight Cash Surge
Celcuity ( NASDAQ:CELC ) reported second quarter 2025 results on Aug. 14, 2025, highlighted by top-line Phase III data for gedatolisib in second-line HR-positive, HER2-negative advanced breast cancer. The company ended the quarter with $455 million in pro forma cash after raising $286.5 million ...
Celcuity ( CELC ) Q2 2025 Earnings Call Transcript
Image source: The Motley Fool.Thursday, August 14, 2025 at 4:30 p.m. ETChief Executive Officer and Cofounder - Brian SullivanContinue reading ...
Celcuity Expenses Jump 81 Percent
Celcuity ( NASDAQ:CELC ) , a clinical-stage biotechnology company developing targeted therapies for cancer, released its second quarter 2025 earnings on August 14, 2025. The highlight was topline Phase 3 data for lead drug gedatolisib, which showed unprecedented results in advanced breast cancer ...
Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, Aug. 07, 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 second quarter 2025 after the market closes on ...
Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants
MINNEAPOLIS, July 30, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. ( Nasdaq: CELC ) ( the "Company" ) , a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal ...
Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, July 28, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc.
Crude Oil Gains 2%; CEA Industries Shares Spike Higher - AIM ImmunoTech ( AMEX:AIM ) , Adaptimmune Therapeutics ( NASDAQ:ADAP )
U.S. stocks traded mostly higher midway through trading, with the Nasdaq Composite gaining more than 50 points on Monday. The Dow traded up 0.07% to 44,932.70 while the NASDAQ rose 0.28% to 21,167.71. The S&P 500 also rose, gaining, 0.09% to 6,394.33. In trading on Monday, materials stocks ...
Alerus Financial Posts Better-Than-Expected Earnings, Joins Celcuity, SES AI, Abercrombie & Fitch And Other Big Stocks Moving Higher On Monday - Alerus Financial ( NASDAQ:ALRS ) , Abercrombie & Fitch ( NYSE:ANF )
U.S. stocks were higher, with the Nasdaq Composite gaining around 50 points on Monday. Shares of Alerus Financial Corporation ALRS rose sharply during Monday's session following better-than-expected quarterly results.
US Stocks Mixed; Enterprise Products Partners Posts Upbeat Earnings - AIM ImmunoTech ( AMEX:AIM ) , Adaptimmune Therapeutics ( NASDAQ:ADAP )
U.S. stocks traded mixed this morning, with the Dow Jones index falling around 50 points on Monday. Following the market opening Tuesday, the Dow traded down 0.14% to 44,837.21 while the NASDAQ rose 0.35% to 21,181.60. The S&P 500 also rose, gaining, 0.07% to 6,393.09.
US Stocks Mixed; Enterprise Products Partners Posts Upbeat Earnings - AIM ImmunoTech ( AMEX:AIM ) , Adaptimmune Therapeutics ( NASDAQ:ADAP )
U.S. stocks traded mixed this morning, with the Dow Jones index falling around 50 points on Monday. Following the market opening Tuesday, the Dow traded down 0.14% to 44,837.21 while the NASDAQ rose 0.35% to 21,181.60. The S&P 500 also rose, gaining, 0.07% to 6,393.09.
Celcuity Stock Skyrockets On Breakthrough Trial Data For Heavily Pretreated Breast Cancer - Celcuity ( NASDAQ:CELC )
Gedatolisib triplet cut the risk of disease progression or death by 76% vs. fulvestrant. Median progression-free survival improved to 9.3 months with the triplet vs. 2.0 months with fulvestrant. The market's back, and these 3 income stocks are thriving. See them here→ Celcuity Inc.
Why Celcuity Shares Are Trading Higher By Around 13%; Here Are 20 Stocks Moving Premarket - Anghami ( NASDAQ:ANGH ) , ATAI Life Sciences ( NASDAQ:ATAI )
Shares of Celcuity Inc CELC rose sharply in pre-market trading after the company announced it will disclose the topline results of the PIK3CA Wild-Type Cohort from the Phase 3 VIKTORIA-1 trial. Celcuity jumped 12.6% to $15.50 in the pre-market trading session.
Celcuity to Announce Topline Results for the PIK3CA Wild-Type Cohort from Phase 3 VIKTORIA-1 Trial in HR+/HER2- Advanced Breast Cancer
MINNEAPOLIS, July 25, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. ( Nasdaq: CELC ) , a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the Company will hold a conference call and webcast on Monday, July 28, 2025 at 8:00 AM ET to disclose ...
Celcuity to Announce Topline Results for the PIK3CA Wild-Type Cohort from Phase 3 VIKTORIA-1 Trial in HR+/HER2- Advanced Breast Cancer - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, July 25, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. CELC, a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the Company will hold a conference call and webcast on Monday, July 28, 2025 at 8:00 AM ET to disclose the topline ...
Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042
MINNEAPOLIS, July 14, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. ( Nasdaq: CELC ) , a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the issuance of U.S. Patent No. 12,350,276 covering the clinical dosing regimen for its lead drug ...
Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042 - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, July 14, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. CELC, a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the issuance of U.S.
Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib
• In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plusdarolutamide in men with metastatic castration resistant prostate cancer ( "mCRPC" ) ,the six-month radiographic progression free survival ( "rPFS" ) rate was ...
Celcuity To Present at Upcoming TD Cowen and Jefferies Investor Conferences
MINNEAPOLIS, May 21, 2025 ( 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 ...
Celcuity To Present at Upcoming TD Cowen and Jefferies Investor Conferences - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, May 21, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. 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 ...
Celcuity Inc. Schedules Release of First Quarter 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, May 07, 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 first quarter 2025 after the market closes on ...
Celcuity Inc. Schedules Release of First Quarter 2025 Financial Results and Webcast/Conference Call - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, May 07, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. CELC, a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2025 after the market closes on Wednesday, May 14, ...
Northrop Grumman Posts Downbeat Results, Joins Halliburton And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - Celcuity ( NASDAQ:CELC ) , Five Point Hldgs ( NYSE:FPH )
U.S. stock futures were higher this morning, with the Dow futures gaining around 300 points on Tuesday. Shares of Northrop Grumman Corporation NOC shares fell sharply in today's pre-market trading after the company reported worse-than-expected first-quarter EPS and revenues.
Parexel appoints Charlotte Moser, MD, PhD, MBA as Chief Medical Officer
DURHAM, N.C., April 15, 2025 ( GLOBE NEWSWIRE ) -- Parexel, one of the world's largest clinical research organizations ( CROs ) providing the full range of Phase I to IV clinical development services, today announced the appointment of Charlotte Moser, MD, PhD, MBA as Chief Medical Officer.
Greenbrier, RPM International, CVRx And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - Collective Mining ( AMEX:CNL ) , Celcuity ( NASDAQ:CELC )
U.S. stock futures were higher this morning, with the Dow futures gaining more than 900 points on Tuesday. Shares of The Greenbrier Companies, Inc. GBX fell sharply in today's pre-market trading as the company posted downbeat results for its second quarter.
Celcuity To Present at Upcoming Needham and Stifel Investor Conferences
MINNEAPOLIS, April 01, 2025 ( 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 ...
Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call
MINNEAPOLIS, March 24, 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 fourth quarter and full year 2024 after the market ...
Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, March 24, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. CELC, a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2024 after the market closes on ...
Celcuity to Participate at Upcoming Cowen and Leerink Investor Conferences
MINNEAPOLIS, Feb. 25, 2025 ( 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 ...
Celcuity to Participate at Upcoming Cowen and Leerink Investor Conferences - Celcuity ( NASDAQ:CELC )
MINNEAPOLIS, Feb. 25, 2025 ( GLOBE NEWSWIRE ) -- Celcuity Inc. 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 ...
Neumora Therapeutics, XPeng And Other Big Stocks Moving Lower In Thursday's Pre-Market Session - Celcuity ( NASDAQ:CELC ) , GrafTech International ( NYSE:EAF )
U.S. stock futures were higher this morning, with the Dow futures gaining more than 300 points on Thursday. Shares of Neumora Therapeutics, Inc. NMRA fell sharply in today's pre-market trading after the company reported data from KOASTAL-1 study of Navacaprant in major depressive disorder.
Mama's Creations Posts Weak Earnings, Joins EVgo, Red Cat Holdings And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - Celcuity ( NASDAQ:CELC ) , Apellis Pharmaceuticals ( NASDAQ:APLS )
U.S. stock futures were lower this morning, with the Dow futures falling around 150 points on Tuesday. Shares of Mama's Creations Inc MAMA fell sharply in today's pre-market trading after the company reported worse-than-expected third-quarter EPS results.
Why Mitek Systems Shares Are Trading Higher By Around 19%; Here Are 20 Stocks Moving Premarket - Alset ( NASDAQ:AEI ) , Cango ( NYSE:CANG )
Shares of Mitek Systems, Inc. MITK rose sharply in today's pre-market trading after reporting better-than-expected fourth-quarter results. Mitek Systems reported quarterly earnings of 33 cents per share which beat the analyst consensus estimate of 17 cents per share.
