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Celcuity Inc., a clinical stage biotechnology company, focuses on the development of molecularly targeted therapies for cancer patients in the United States. The company's CELsignia diagnostic platform uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the related targeted therapy for the treatment. Its drug candidate includes Gedatolisib, which selectively targets various class I isoforms of PI3K and mammalian target of rapamycin and focus on the treatment of patients with hormone receptor positive, HER2-negative, and advanced or metastatic breast cancer. The company is also developing CELsignia MP test, a qualitative laboratory developed test that measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. It had a license agreement with Pfizer, Inc. for the development and commercialization rights to Gedatolisib. Celcuity Inc. was founded in 2011 and is headquartered in Minneapolis, Minnesota.

Celcuity Inc.

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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 INCLUDE ADDITIONAL SUB-GROUP EFFICACY ANALYSES AND SAFETY DATA.

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 ITS PARTICIPATION IN THE 8TH ANNUAL EVERCORE HEALTHCARE CONFERENCE TO BE HELD IN MIAMI, FLORIDA ON DECEMBER 2-4, 2025.

CELCUITY TO PRESENT AT UPCOMING 8TH ANNUAL EVERCORE HEALTHCARE CONFERENCE

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 CANCER (ABC). THE NDA WAS SUBMITTED UNDER THE FDA'S REAL-TIME ONCOLOGY REVIEW (RTOR) PROGRAM, WHICH IS INTENDED TO FACILITATE SHORTER REGULATORY REVIEW PERIODS. GEDATOLISIB PREVIOUSLY RECEIVED BOTH BREAKTHROUGH THERAPY AND FAST TRACK DESIGNATIONS BASED ON PROMISING PRELIMINARY CLINICAL DATA. THE SUBMISSION IS BASED ON CLINICAL DATA FROM THEPIK3CA WILD-TYPE COHORT OF THE PHASE 3 VIKTORIA-1 CLINICAL TRIAL.

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

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 PIK3CA MUTANT COHORT OF THE PHASE 3 VIKTORIA-1 CLINICAL TRIAL AND EXPECT TOPLINE DATA TO BE AVAILABLE SOMETIME IN LATE Q1 2026 OR DURING Q2 2026 SUBMISSION OF A NEW DRUG APPLICATION (NDA) TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR GEDATOLISIB, BASED ON DATA FROM THE PIK3CA WT COHORT, IS ON TRACK TO BE COMPLETED DURING THE FOURTH QUARTER OF 2025 MANAGEMENT TO HOST WEBCAST AND CONFERENCE CALL TODAY, NOVEMBER 12, 2025, AT 4:30 P.M. ET MINNEAPOLIS, NOV. 12, 2025 (GLOBE NEWSWIRE) -- CELCUITY INC. (NASDAQ: CELC), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY PURSUING DEVELOPMENT OF TARGETED THERAPIES FOR ONCOLOGY, TODAY ANNOUNCED FINANCIAL RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2025 AND OTHER RECENT BUSINESS DEVELOPMENTS.

CELCUITY INC. REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

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.

CELCUITY INC. SCHEDULES RELEASE OF THIRD QUARTER 2025 FINANCIAL RESULTS AND WEBCAST/CONFERENCE CALL

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.

CELCUITY TO PRESENT AT UPCOMING STIFEL 2025 HEALTHCARE CONFERENCE

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.

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 UPDATED CLINICAL RESULTS FROM THE PHASE 1 PORTION OF A CLINICAL TRIAL EVALUATING GEDATOLISIB IN COMBINATION WITH NUBEQA (DAROLUTAMIDE), AN ANDROGEN RECEPTOR INHIBITOR, IN MEN WITH MCRPC WHOSE DISEASE HAD PROGRESSED ON PRIOR TREATMENT WITH A NEXT GENERATION ANDROGEN RECEPTOR INHIBITOR. THESE DATA WERE PRESENTED AT A POSTER PRESENTATION AT THE EUROPEAN SOCIETY OF MEDICAL ONCOLOGY (ESMO) TODAY, SATURDAY, AT 6:00 A.M. ET/12:00 P.M. CEST.

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 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.

DETAILED RESULTS FROMPIK3CA 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, 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 DETAILED EFFICACY AND SAFETY DATA FROM THE PIK3CA WILD-TYPE COHORT OF THE 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. 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.

CELCUITY ANNOUNCES UPSIZED SENIOR SECURED TERM LOAN FACILITY OF $500 MILLION WITH INNOVATUS CAPITAL PARTNERS AND OXFORD FINANCE

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.

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 Inc.

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