Annuncio • Jul 30

Celcuity Announces FDA Approval And NCCN Guidelines Inclusion For REVTORPYK In Combination With Fulvestrant With Or Without Palbociclib

Celcuity Inc. announced that REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, is recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a preferred Category 1 second-line and/or subsequent-line therapy following progression on or after treatment with at least one line of endocrine therapy. REVTORPYK was granted approval by the U.S. Food and Drug Administration on July 14, 2026, for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (a, ß, d, ?) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval. The approval of REVTORPYK is based on positive clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, an open-label, global, randomized clinical trial evaluating the efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- locally advanced or metastatic breast cancer following progression on or after CDK4/6 therapy and an aromatase inhibitor. In the VIKTORIA-1 trial, median progression free survival with the REVTORPYK triplet (REVTORPYK plus palbociclib and fulvestrant) was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35). REVTORPYK is a kinase inhibitor of class I PI3K isoforms (a, ß, d, ?) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT. REVTORPYK is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration-resistant prostate cancer. REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose. Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment. REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (=20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase, increased aspartate aminotransferase, musculoskeletal pain, decreased sodium, and increased eosinophils. REVTORPYK in Combination with Fulvestrant: The most common (=20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea. Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Advise females and males of reproductive potential that REVTORPYK may impair fertility. Please see full Prescribing Information, including Patient Information, for REVTORPYK. You may report side effects related to Celcuity products to Celcuity Medical Information or to FDA.

Annuncio • May 15

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Celcuity Inc. announced updates to the Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”). Following last year’s announcement and subsequent data presentation demonstrating clinically meaningful improvement in progression-free survival (“PFS”) for patients treated with gedatolisib combined with palbociclib and fulvestrant compared to those treated with fulvestrant in the PIK3CA wild-type (“WT”) cohort of the VIKTORIA-1 Phase 3 study, several important elements of the VIKTORIA-2 clinical trial protocol have been amended. First, in addition to evaluating patients in the first-line setting with endocrine-resistant HR+/HER2- ABC, VIKTORIA-2 will now include a separate study to evaluate the safety and efficacy of patients in the first-line setting who have endocrine-sensitive HR+/HER2- ABC. Second, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Third, efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population (combined WT and mutant type (“MT”)) enrolled in their respective study. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by blinded independent central review (“BICR”). Prior to finalizing the amended Phase 3 trial design, Celcuity conducted a Type B meeting with the U.S. Food and Drug Administration (the “FDA”) to obtain their feedback and to gain alignment on these planned amendments. For patients with endocrine-sensitive HR+/HER2- advanced breast cancer who received gedatolisib in combination with palbociclib and letrozole in our Phase 1b clinical trial, median progression free survival was 48.6 months, median overall survival was 77.3 months, and the objective response rate was 79%. Results from the PIK3CA wild-type and mutation cohort of our VIKTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in HR+/HER2- ABC in the second-line setting. Developing the gedatolisib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status, offers the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR+/HER2- ABC. To support its long-term lifecycle development plan, Celcuity also announced that it submitted to the United States Patent and Trademark Office (“USPTO”) its first patent application for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed globally in 2022. While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis. HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (“PAM”), are primary oncogenic drivers of HR+/HER2- ABC. Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Ka, AKT, or mTORC1. However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-2 is a Phase 3, global, open-label, randomized, clinical trial designed to evaluate the efficacy and safety of gedatolisib plus palbociclib and endocrine therapy as first-line treatment for patients with HR+/HER2- ABC. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control. Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B). Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D). The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by BICR. This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, and Asia-Pacific. Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.

Rendimento totale per gli azionisti	-3.0%
Rendimento futuro dei dividendi	n/a
Crescita dei dividendi	n/a
Prossima data di pagamento dei dividendi	n/a
Data di stacco del dividendo	n/a
Dividendo per azione	n/a
Rapporto di remunerazione	n/a

Segmento	Rendimento dei dividendi
Azienda (CELC)	n/a
Fondo del 25% del mercato (US)	1.3%
Top 25% del mercato (US)	4.0%
Media del settore (Biotechs)	1.9%
Analista previsionale (CELC) (fino a 3 anni)	n/a

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/08/17 08:58
Prezzo dell'azione a fine giornata	2026/08/17 00:00
Utili	2026/06/30
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Analista	Istituzione
Arlinda Lee	Canaccord Genuity
Silvan Tuerkcan	Citizens JMP Securities, LLC
Alexander Nowak	Craig-Hallum Capital Group LLC

Celcuity Dividendi e riacquisti

Criteri Dividendo verificati 0/6

Informazioni chiave

Aggiornamenti recenti su dividendi e riacquisti

Recent updates

FDA Approves REVTORPYK as Category 1 Breast Cancer Therapy Celcuity Eyes 2026 Launch

New major risk - Negative shareholders equity

Celcuity Inc. to Report Q2, 2026 Results on Aug 13, 2026

FDA Approves REVTORPYK for Metastatic Breast Cancer as Celcuity Gains NCCN Endorsement

Celcuity Announces FDA Approval And NCCN Guidelines Inclusion For REVTORPYK In Combination With Fulvestrant With Or Without Palbociclib

CELC: FDA Breast Cancer Approval Will Drive Commercial Launch Reappraisal

Celcuity Announces FDA Approval of REVTORPYK™ (Gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

Celcuity Gains FDA Approval for REVTORPYK in Advanced Breast Cancer Treatment

CELC: VIKTORIA-1 Data And Priority Review Will Drive Future Repricing

Celcuity Inc.(NasdaqCM:CELC) dropped from Russell 3000E Growth Benchmark

CELC: VIKTORIA Breast Cancer Data Will Drive Future Upside Potential

Forecast breakeven date pushed back to 2028

Celcuity Announces Detailed Efficacy and Safety Results from the PIK3CA Mutant Cohort of the Phase 3 Viktoria-1 Clinical Trial of Gedatolisib

New minor risk - Share price stability

Celcuity Shares Fall Despite Positive Phase 3 Breast Cancer Trial Results and Regulatory Plans

Forecast breakeven date pushed back to 2028

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Celcuity Inc. to Report Q1, 2026 Results on May 14, 2026

Forecast breakeven date moved forward to 2027

Priority FDA Review And Phase III Data Will Transform This Oncology Pure Play

Price target increased by 8.0% to US$131

Forecast breakeven date moved forward to 2027

Celcuity Inc., Annual General Meeting, May 14, 2026

New major risk - Shareholder dilution

Price target increased by 7.6% to US$126

Single Drug Dependence And Heavy Financing Will Shape A Challenging Future

Celcuity Inc. to Report Q4, 2025 Results on Mar 25, 2026

Celcuity Inc Announces Publication Of Results From PIK3CA Wild-Type Cohort Of Phase 3 VIKTORIA-1 Study Of Gedatolisib Regimens In HR+/HER2- Advanced Breast Cancer

Future Oncology Approvals And Pipeline Expansion Will Support A Stable Long Term Outlook

Celcuity Inc. Appoints Charles Romp to Its Board of Directors

Price target increased by 7.3% to US$114

Independent Director notifies of intention to sell stock

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

Forecast to breakeven in 2028

Celcuity: After Stellar 2025, I Predict More Success In 2026 And Beyond

Celcuity Inc. Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

Independent Director notifies of intention to sell stock

Celcuity Inc. Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild- Advanced Breast Cancer

New minor risk - Shareholder dilution

Celcuity Inc. to Report Q3, 2025 Results on Nov 12, 2025

Price target increased by 8.9% to US$81.13

Celcuity Inc. Presents Updated Data At the 2025 Esmo Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer

Co-Founder exercised options to buy US$5.8m worth of stock.

Celcuity Inc. 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. to Report Q2, 2025 Results on Aug 14, 2025

Celcuity Inc. has completed a Follow-on Equity Offering in the amount of $84.999596 million.

Price target increased by 89% to US$55.86

Celcuity Inc. Announces Clinically Meaningful Improvement in Both Progression-Free Survival Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

New major risk - Share price stability

Celcuity Inc. 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 Inc. Reports Clinical Data from Two Early Phase Studies of Gedatolisib

Celcuity Inc. to Report Q1, 2025 Results on May 14, 2025

Is Celcuity (NASDAQ:CELC) Using Debt Sensibly?

Celcuity Inc., Annual General Meeting, May 13, 2025

Celcuity Inc. to Report Q4, 2024 Results on Mar 31, 2025

New major risk - Shareholder dilution

Celcuity Presents Overall Survival Data from Phase 1B Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy At the 2024 San Antonio Breast Cancer Symposium

Celcuity Inc. to Report Q3, 2024 Results on Nov 14, 2024

Celcuity: Breast Cancer Drug Developer With Upcoming Catalysts

Is Celcuity (NASDAQ:CELC) Using Too Much Debt?

Celcuity Inc. to Report Q2, 2024 Results on Aug 14, 2024

Celcuity: Flying A Phase 3 Trial Right Under Your Nose

Celcuity Inc. has completed a Follow-on Equity Offering in the amount of $60.0005 million.

New major risk - Shareholder dilution

Celcuity Inc. Announces Plan to Initiate A Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

Celcuity Inc. to Report Q1, 2024 Results on May 15, 2024

Does Celcuity (NASDAQ:CELC) Have A Healthy Balance Sheet?

Price target increased by 7.7% to US$29.50

Celcuity Inc., Annual General Meeting, May 09, 2024

Celcuity Inc. to Report Q4, 2023 Results on Mar 27, 2024

Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer

Price target increased by 11% to US$27.40

Celcuity Appoints Eldon Mayer as Chief Commercial Officer

Celcuity Inc. Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Breast Cancer Models at the 2023 San Antonio Breast Cancer Symposium

New major risk - Revenue and earnings growth