Company news
Celcuity Inc. (NASDAQ:CELC) news
Every Celcuity Inc. press release and news update in one place — announcements, filings coverage, and company updates for investors.
Press releases & updates
Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
August 26, 2026
Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update
August 13, 2026
Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines f...
July 30, 2026
Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastat...
July 14, 2026
Celcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032
June 3, 2026
Celcuity Inc. Announces Public Offering of Convertible Senior Notes Due 2032
June 3, 2026
Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib...
June 2, 2026
Celcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib ...
June 1, 2026
Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include En...
May 14, 2026
Celcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference Call
May 7, 2026
Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3...
May 1, 2026
Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
March 25, 2026
Celcuity Schedules Release of Fourth Quarter and Full Year 2025 Financial Results and Webcast/Conference Call
March 18, 2026
Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- A...
March 9, 2026
Celcuity To Participate in Upcoming Investor Conferences
February 25, 2026
Celcuity Appoints Charles Romp to its Board of Directors
February 12, 2026
Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026
February 4, 2026
Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
January 20, 2026
Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer ...
December 11, 2025
Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference
November 26, 2025
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 S...
November 26, 2025
Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Adv...
November 17, 2025
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
November 12, 2025
Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call
November 5, 2025
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference
November 4, 2025
Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Ph...
October 18, 2025
Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedat...
October 18, 2025
Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastat...
October 18, 2025
Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress
September 22, 2025
Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance
September 9, 2025
Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time O...
August 27, 2025
Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update
August 14, 2025
Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call
August 7, 2025
Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funde...
July 30, 2025
Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Co...
July 28, 2025
Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Co...
July 28, 2025
Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock
July 28, 2025
Celcuity to Announce Topline Results for the PIK3CA Wild-Type Cohort from Phase 3 VIKTORIA-1 Trial in HR+/HER2- Advanced Breast Cancer
July 25, 2025
Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanc...
July 24, 2025
Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042
July 14, 2025
Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib
June 30, 2025
Celcuity To Present at Upcoming TD Cowen and Jefferies Investor Conferences
May 21, 2025
Celcuity Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update
May 14, 2025
Celcuity Inc. Schedules Release of First Quarter 2025 Financial Results and Webcast/Conference Call
May 7, 2025
Celcuity To Present at Upcoming Needham and Stifel Investor Conferences
April 1, 2025
Celcuity Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
March 31, 2025
Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call
March 24, 2025
Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call
March 24, 2025
Celcuity to Participate at Upcoming Cowen and Leerink Investor Conferences
February 25, 2025
Celcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy ...
December 11, 2024