Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update Celcuity (NASDAQ: CELC) reported Phase 3 and corporate updates on March 25, 2026. Key clinical milestones include FDA acceptance of the gedatolisib NDA with Priority Review and a PDUFA date of July 17, 2026, and publication of PIK3CA WT VIKTORIA-1 results showing PFS 16.6 vs 1.9 months (HR=0.14).Financially, 2025 operating expenses and net loss widened versus 2024; cash and short-term investments were $441.5M, expected to fund operations through 2027.

#CELC Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

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Biotech Celcuity schedules March 25 call on 2025 results Investors get Celcuity’s Q4 and full-year 2025 numbers after markets close March 25, with a webcast and teleconference at 4:30 p.m. ET.

#CELC Celcuity Schedules Release of Fourth Quarter and Full Year 2025 Financial Results and Webcast/Conference Call

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Celcuity Stock Soars 700% in a Year as One Investor's $17 Million Buy Helps Create Top Two Position | The Motley Fool Celcuity develops targeted cancer therapies and diagnostic platforms, with a focus on advancing precision medicine in oncology.

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Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer 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

#CELC Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

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Breaking News: ( NASDAQ: #CELC ) 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

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 For 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 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months

#CELC 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

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This Fund Bought $38 Million of Celcuity as Stock Surges on Investigational Cancer Drug Results | The Motley Fool One clinical-stage biotech is defying gravity—here’s why its record-breaking run is catching institutional attention.

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JUST IN: ( NASDAQ: #CELC ) 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

Breaking News: ( NASDAQ: #CELC ) Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference

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) announced on November 17, 2025 the completion of its New Drug Application (NDA) submission to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the FDA’s Real-Time Oncology Review (RTOR) program.The submission is supported by Phase 3 VIKTORIA-1 PIK3CA wild-type cohort data: the gedatolisib-triplet showed a HR 0.24 (PFS 9.3 vs 2.0 months, +7.3 months) and the gedatolisib-doublet showed a HR 0.33 (PFS 7.4 vs 2.0 months, +5.4 months). Gedatolisib holds prior Breakthrough Therapy and Fast Track designations.

#CELC 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

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Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update 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

#CELC Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call Celcuity (Nasdaq: CELC) will release its third quarter 2025 financial results after market close on Wednesday, November 12, 2025.Management will host a webcast and teleconference the same day at 4:30 p.m. Eastern Time to discuss results and provide a corporate update. Domestic callers may dial 1-800-717-1738, international callers 1-646-307-1865, and a live webcast is available at the provided link. A replay will be posted on the Celcuity website following the event.

#CELC Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call

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BREAKING NEWS: ( NASDAQ: #CELC ) Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference

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News; ( NASDAQ: #CELC ) 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 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) announced the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is fully enrolled and that topline data are expected in late Q1 2026 or Q2 2026.Celcuity also released updated analysis from a Phase 1b trial of gedatolisib plus fulvestrant and palbociclib: for PIK3CA-mutated advanced HR+/HER2- breast cancer (n=30) median PFS was 14.6 months with an ORR of 48%; in the subgroup receiving the intermittent dose (n=11) median PFS was 19.7 months with ORR 64%. For PIK3CA wild-type (n=60) median PFS was 9.0 months and ORR 41%.

#CELC 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

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76% Disease Progression Risk Reduction: Celcuity's Breast Cancer Drug Heads for FDA Fast-Track Review Celcuity's gedatolisib shows 76% reduction in disease progression risk for HR+/HER2- breast cancer. Phase 3 trial achieved 9.3-month PFS vs 2.0 months. NDA submission starts September 2025.

#CELC 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

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Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update Celcuity (NASDAQ:CELC) reported significant Q2 2025 milestones for its cancer drug gedatolisib. The company announced breakthrough results from the PIK3CA wild-type cohort of Phase 3 VIKTORIA-1 trial in HR+/HER2- advanced breast cancer, showing a 76% reduction in disease progression risk with the gedatolisib triplet therapy and a 67% reduction with the doublet therapy.The company plans to submit an NDA to FDA in Q4 2025. Additionally, Celcuity raised $286.5 million through offerings, bringing total cash position to $455 million on a proforma basis. Q2 operating expenses increased to $44.0 million from $24.3 million year-over-year, with a net loss of $45.3 million. The company's cash runway extends through 2027.

#CELC Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update

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Celcuity Announces Q2 2025 Earnings Date: Biotech's Financial Results and Conference Call Details Revealed Oncology biotech Celcuity schedules Q2 2025 earnings release for August 14, with management webcast at 4:30 PM ET. Get conference call details.

#CELC Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call

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Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants Celcuity (NASDAQ:CELC), a clinical-stage biotechnology company, has announced the pricing of two concurrent public offerings. The company is offering $175 million of 2.750% convertible senior notes due 2031, along with 1,836,842 shares of common stock at $38.00 per share and pre-funded warrants for up to 400,000 shares.The convertible notes will have an initial conversion rate of 19.4932 shares per $1,000 principal amount, equivalent to a conversion price of $51.30 per share. The company expects to raise approximately $248.7 million in net proceeds, which will be used for working capital and general corporate purposes, including clinical trials, commercial launch, and R&D expenditures.The offerings are expected to close on July 31 and August 1, 2025, with Jefferies, TD Cowen, and Leerink Partners acting as joint book-running managers.

#CELC Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants

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Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company, has announced two concurrent public offerings: $150 million in convertible senior notes due 2031 and $75 million in common stock shares. The company is also granting underwriters 30-day options to purchase additional amounts of up to $22.5 million in convertible notes and $11.25 million in common stock.The convertible notes will be senior unsecured obligations maturing on August 1, 2031, with semi-annual interest payments. The company plans to implement capped call transactions to reduce potential dilution. The net proceeds will fund capped call transactions costs and general corporate purposes, including clinical trials, commercial launch preparations, and R&D expenditures.Jefferies, TD Cowen, and Leerink Partners are serving as joint book-running managers for both offerings, with LifeSci Capital acting as lead manager for the notes offering and passive bookrunner for the stock offering.

#CELC Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock

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News; ( NASDAQ: #CELC ) Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival ("PFS") Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial  Celcuity (NASDAQ:CELC) announced breakthrough topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial evaluating gedatolisib combinations for HR+/HER2- advanced breast cancer. The gedatolisib triplet therapy showed a 76% reduction in disease progression risk (HR=0.24) with 9.3 months median PFS vs. 2.0 months for fulvestrant alone. The gedatolisib doublet demonstrated a 67% reduction (HR=0.33) with 7.4 months median PFS.These results represent unprecedented efficacy in HR+/HER2- advanced breast cancer treatment, with both combinations showing better safety profiles than previous trials. Treatment discontinuation rates were lower than observed in Phase 1b and other Phase 3 trials. Celcuity plans to submit a New Drug Application to the FDA in Q4 2025, with full data presentation scheduled for later this year.

#CELC Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial 

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Major Phase 3 Breast Cancer Trial Results: Celcuity Reveals VIKTORIA-1 Data Next Week Key Phase 3 trial data for HR+/HER2- advanced breast cancer treatment to be unveiled. Breakthrough findings from VIKTORIA-1 study. Get insights Monday.

#CELC Celcuity to Announce Topline Results for the PIK3CA Wild-Type Cohort from Phase 3 VIKTORIA-1 Trial in HR+/HER2- Advanced Breast Cancer

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Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Celcuity (NASDAQ:CELC) has initiated patient dosing in its Phase 3 VIKTORIA-2 clinical trial, evaluating gedatolisib combination therapy as a first-line treatment for HR+/HER2- advanced breast cancer (ABC) patients with endocrine therapy resistance. Gedatolisib, a novel multi-target PI3K/AKT/mTOR inhibitor, demonstrated promising results in a Phase 1b trial when combined with palbociclib and letrozole, achieving a median progression-free survival of 48.6 months, median overall survival of 77.3 months, and an objective response rate of 79%.The VIKTORIA-2 study aims to evaluate gedatolisib's efficacy in combination with CDK4/6 inhibitor and fulvestrant, regardless of patients' PIK3CA status or metabolic profile.

#CELC Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer

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Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042 Celcuity (Nasdaq: CELC) has secured a new U.S. patent (No. 12,350,276) for the clinical dosing regimen of gedatolisib, its lead drug candidate for ER+/HER2- breast cancer patients. This patent extends the company's exclusivity until 2042.The company's gedatolisib patent portfolio now includes 13 U.S. patents and 290 foreign patents, covering composition, formulations, and methods of use. Celcuity expects to release topline data from the VIKTORIA-1 clinical trial for the PIK3CA wild-type cohort in Q3 2025 and the PIK3CA mutant cohort in Q4 2025.

#CELC Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042

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