A Phase Ib, Multicenter, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Are Sensitive or Resistant to Endocrine Therapy

The study will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-4198 when given in combination with endocrine therapy (ET) (letrozole, fulvestrant, or giredestrant) as first-line treatment to participants with locally advanced or metastatic Hormone receptor (HR)-positive, Human epidermal growth factor receptor-2 (HER2)-negative breast cancer

Start Date15 Dec 2026

Sponsor / Collaborator

Genentech, Inc.

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date15 Dec 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Australia Pty Ltd.

TCTR20260918008

/ Not yet recruitingPhase 1IIT

A bioequivalence study of a randomized, open-label, single dose, 2-way crossover design, with two-period, two treatment and two-sequence of Letrozole Film-coated Tablet 2.5 mg relative to Femara 2.5 mg in healthy non-pregnant, non-lactating post-menopausal female under fasting condition

Start Date24 Nov 2026

Sponsor / Collaborator-

100 Clinical Results associated with Letrozole

100 Translational Medicine associated with Letrozole

100 Patents (Medical) associated with Letrozole

5,108

Literatures (Medical) associated with Letrozole

01 Mar 2027·Value in Health Regional Issues

Cost-Effectiveness of Ribociclib Plus Endocrine Therapy for Premenopausal or Perimenopausal Women With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer in Thailand

Article

Author: Rattanachotphanit, Thananan ; Sittibodin, Surachai ; Waleekhachonloet, Onanong

OBJECTIVES:

To evaluate the cost-effectiveness of ribociclib plus letrozole as first-line therapy for premenopausal or perimenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in Thailand.

METHODS:

We developed a state-transition (Markov) model with 5 health states and 2 tunnel states, using 28-day cycles over a lifetime horizon from the public healthcare perspective. First-line progression-free survival was reconstructed from MONALEESA-7 Kaplan-Meier curves and fitted using log-normal parametric survival models. Transition probabilities incorporated progression and death as competing risks. Utilities came from Thai EuroQol 5-Dimension (EQ-5D) data, and direct medical costs were estimated based on primary data collection from tertiary hospitals (2025 US$). Outcomes included costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). Uncertainty was assessed using 1-way and probabilistic sensitivity analyses, whereas scenario analyses varied drug prices and incorporated Asian subgroup efficacy.

RESULTS:

Ribociclib plus letrozole yielded 5.42 QALYs at US$75 324, compared with 4.06 QALYs at US$9020 for letrozole alone, with an ICER of US$48 753 per QALY, which is above Thailand's willingness-to-pay threshold of US$4842 per QALY. The ICER was most sensitive to first-line progression-free utility, ribociclib acquisition cost, and the discount rate. Applying MONALEESA-7 Asian subgroup efficacy and a 75% ribociclib price reduction reduced the ICER to US$11 621 per QALY. Sensitivity analyses confirmed the robustness of the ICERs across all scenarios.

CONCLUSIONS:

Despite clinical benefits, ribociclib plus letrozole is not cost-effective in Thailand at the current price. Price negotiation and alternative financing or risk-sharing mechanisms are warranted to expand access while preserving budget sustainability.

01 Feb 2027·TISSUE & CELL

Ameliorative character of eugenol and propargylated eugenol against letrozole induced polycystic ovarian syndrome in in-vivo zebrafish model

Article

Author: Kumaradoss, Kathiravan Muthu ; Bharathi, S Vijaya ; Arasu, Mariadhas Valan ; Arokiyaraj, Selvaraj ; Oubella, Ali ; Kadaikunnan, Shine ; Chagaleti, Bharath Kumar ; Arockiaraj, Jesu ; Akash, G

Polycystic ovary syndrome (PCOS) is an endocrine condition that mainly affects female reproductive function and is often linked with metabolic disturbances. Letrozole (LET), though widely used for ovulation induction, may induce PCOS-like conditions with prolonged exposure. In this study, we evaluated the protective effect of eugenol (EU) and its derivative propargylated eugenol (PEU) against letrozole-induced PCOS using an in vivo zebrafish model. Molecular docking helped, that both compounds interact with key PCOS-related targets, with PEU exhibiting relatively stronger binding affinity. In vivo exposure to letrozole resulted in reduced sexual behaviour, decreased fecundity, elevated glucose levels, increased oxidative stress and delayed ovarian development. Treatment with eugenol and propargylated eugenol has improved mating behavior, restored spawning ability, normalized gonadosomatic index (GSI) and reduced fasting blood glucose levels. Antioxidant assays revealed decreased lipid peroxidation, improved SOD and CAT activity in treated groups. Furthermore, the analysis of ovarian tissue sections corroborated the resumption of ovarian follicular development and a decrease in collagen deposition validated including Masson's trichrome (MTS), Picrosirius red (PSR). Gene expression investigations demonstrated the reinstatement of steroidogenic markers such as cyp19a1a, alongside inflammatory marker. These observations suggest that the synthesized compounds exert considerable effects, with propargylated eugenol exhibiting numerically greater efficacy across most assays. Consequently, these results imply that eugenol derivatives could function as potential adjunctive agents in the management of letrozoles-induced PCOS, specifically by addressing oxidative stress, hormonal imbalances, and ovarian dysfunction.

01 Jan 2027·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Environmental endocrine disruptors activate CBX2 to disrupt cholesterol homeostasis in PCOS

Article

Author: Yang, Hong ; Qiu, Xianliang ; Zhu, Chan ; Chen, Qiu ; Wang, Yao ; Cui, Tao

Polycystic ovary syndrome (PCOS) is a common endocrine disorder influenced by genetic and environmental factors, yet the molecular mechanisms linking endocrine-disrupting chemicals (EDCs) to ovarian dysfunction remain unclear. Here, we establish a letrozole-induced PCOS-like rat model and integrate bulk RNA-seq, single-cell RNA-seq of human granulosa cells (GCs), and functional validation to identify CBX2 as a critical epigenetic regulator connecting EDC exposure to PCOS pathogenesis. Transcriptomic profiling revealed dysregulated cell cycle progression, disrupted cholesterol homeostasis, and chronic inflammation in PCOS ovaries. Of these, cholesterol biosynthesis genes (e.g., Ebp, Dhcr7) were broadly suppressed, while efflux (Abca1) and metabolism-related (Cyp27a1) genes showed opposing alterations. Cross-species analysis identified CBX2 as consistently upregulated in both rat and human PCOS GCs, where it strongly correlated with accelerated cell proliferation and impaired cholesterol homeostasis. Mechanistically, exposure to EDCs (BPA and DDT) significantly induced CBX2 expression in human GCs. ChIP-seq analysis demonstrated that CBX2 directly binds to and represses genes from cholesterol-homeostasis-associated transcriptional networks-including CSRNP1, DDIT3, and FOSL1-through H3K27me3-mediated epigenetic silencing. Functional validation showed that CBX2 knockdown suppressed GCs proliferation, reduced lipid droplet accumulation while restoring normal cell cycle distribution. Single-cell RNA-seq confirmed elevated CBX2 activity specifically in PCOS GCs, particularly during G2/M phase, where it exhibited the strongest negative correlation with cholesterol homeostasis signatures (rs = -0.23). These findings reveal a novel EDC-CBX2-H3K27me3 epigenetic axis that decouples GC proliferation from metabolic support functions, establishing CBX2 as both a molecular biomarker and potential therapeutic target for environment-associated PCOS.

273

News (Medical) associated with Letrozole

19 Oct 2026

·www.biospace.com

BeOne Medicines Highlights Rapidly Accelerating Solid Tumor Franchise at ESMO 2026

New data from four priority programs, including the GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and brain-penetrant PRMT5 inhibitor underscore the depth of BeOne ’ s solid tumor pipeline Multiple TEVIMBRA abstracts reinforce breadth of evidence across lung and gastrointestinal cancers, including data in combination with ZIIHERA in HER2+ gastroesophageal cancer SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne --BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from across its rapidly progressing solid tumor portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 on October 23-27 in Madrid. Presentations will highlight an accelerating pipeline of differentiated targeted therapies, alongside a broad body of evidence for TEVIMBRA ® (tislelizumab), including a late-breaking rapid oral presentation on TEVIMBRA in combination with ZIIHERA ® (zanidatamab) in HER2+ gastroesophageal adenocarcinoma (GEA). Priority pipeline data include an oral proffered paper presentation on BeOne’s GPC3x4-1BB bispecific antibody, currently being studied in hepatocellular carcinoma (HCC) and first-in-human data for two investigational lung cancer assets, a CEA targeting antibody-drug conjugate (ADC), in CEA-expressing non-small cell lung cancer (NSCLC), and a brain-penetrant PRMT5 inhibitor in MTAP-deleted tumors, including NSCLC. A trial-in-progress (TiP) abstract of KANDELA-302 will be presented for the Company’s CDK4 inhibitor, in front-line metastatic HR+/HER2-negative breast cancer (BC). Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said: “2026 has been an inflection year for our solid tumor portfolio. Across major medical congresses, we have demonstrated proof of concept for five priority programs, while rapidly advancing these assets toward pivotal development. At ESMO, that progress is visible in pipeline data spanning our three strategically focused disease areas, breast, lung, and gastrointestinal cancers, alongside further evidence supporting TEVIMBRA, including updated Phase 3 data in combination with ZIIHERA in HER2+ gastroesophageal adenocarcinoma. Together, the reach of TEVIMBRA and a pipeline advancing at scale position BeOne to change the game in solid tumor oncology.” Pipeline at scale: advancing priority programs with new data at ESMO The latest evidence of the progress of BeOne’s solid tumor pipeline will be presented at ESMO with abstracts being published across four investigational assets, demonstrating the speed and scale of BeOne’s global development superhighway. Priority pipeline presentations at ESMO include: BGB-B2033 (GPC3x4-1BB bispecific antibody): An oral proffered paper presentation with updated Phase 1 dose-escalation and first dose-optimization results in previously treated patients with advanced HCC. BG-C477 (CEA targeting ADC): First-in-human Phase 1 data in heavily pretreated, locally advanced NSCLC, with further analysis provided in patients with CEA-high expressing tumors. BGB-58067 (PRMT5 inhibitor): First-in-human data evaluating BeOne’s brain-penetrant, MTA-cooperative PRMT5 inhibitor in MTAP-deficient advanced tumors. BGB-43395 (CDK4 inhibitor): Trial-in-progress presentation of KANDELA-302, a global Phase 3 study evaluating BGB-43395 plus letrozole compared with investigator’s choice of a CDK4/6 inhibitor plus letrozole as first-line treatment for advanced or metastatic HR+/HER2-negative BC. Strengthening evidence base for TEVIMBRA in lung and gastrointestinal cancers In addition to pipeline data, seven abstracts at ESMO will further characterize TEVIMBRA across lung and gastrointestinal cancers, including a late-breaking, rapid oral presentation with new data from the Phase 3 HERIZON-GEA-01 trial in HER2+ gastroesophageal adenocarcinoma. Key TEVIMBRA presentations include: HERIZON-GEA-01: Second interim analysis of the Phase 3 trial of ZIIHERA plus chemotherapy, with and without TEVIMBRA, in first-line HER2-positive locally advanced or metastatic GEA. RATIONALE-312: Exploratory analysis evaluating the effect of TEVIMBRA plus platinum-etoposide on brain disease progression in first-line extensive stage small-cell lung cancer (ES-SCLC). RATIONALE-315: Analysis of clinical outcomes by adjuvant treatment cycles with perioperative TEVIMBRA plus chemotherapy in patients with resectable NSCLC. RATIONALE-305 and RATIONALE-302: New analyses further evaluating outcomes with TEVIMBRA in gastric/gastroesophageal junction (GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC), respectively. Full list of BeOne’s presentations at ESMO: Pipeline data Abstract Title Presentation Details (CET) Lead Author Phase 1 study of BGB-B2033 monotherapy: First disclosure of dose optimization and dose escalation update in advanced HCC Proffered paper 1679O ; Gastrointestinal tumour, upper digestive; Oct. 24, 10:15-11:45AM Hong Jae Chon First-in-human study of BG-C477, a novel CEA-targeting ADC, in advanced solid tumors: initial results in NSCLC Poster: 2567P ; NSCLC, locally advanced; Oct. 26, 12:00-12:45 Matthew Lee First-in-human trial of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in MTAP-deficient advanced tumors Poster: 1043P ; Translational Research and Biomarkers; Oct. 23, 3:15-4:00 PM Jordi Rodon KANDELA-302: A Phase 3, global, open-label, randomized study of the selective CDK4 inhibitor BGB-43395 + letrozole vs CDK4/6 inhibitors + letrozole for first-line treatment of advanced or metastatic HR+/HER2− breast cancer Poster: 1885TiP ; HR+ Breast Cancer; Oct. 24, 12:00-12:45 Sara M. Tolaney TEVIMBRA data Abstract Title Presentation Details (CET) Lead Author Zanidatamab + chemotherapy ± tislelizumab for first-line HER2+ advanced/metastatic GEA: second interim analysis from HERIZON-GEA-01 Rapid oral: LBA79; Gastrointestinal tumour, upper digestive Oct 23, 4:15-5:45 PM Kohei Shitara Phase 1b/2 trial of BGB-A445 (OX40 agonist) with or without tislelizumab in urothelial carcinoma, renal cell carcinoma, and melanoma Poster: 1980P ; Investigational Immunotherapy; Oct. 24, 12:00-12:45 Bin Lian Impact of progressive disease patterns on post-progression overall survival in ESCC: A post hoc analysis of RATIONALE-302 Poster: 2950P ; Oesophagogastric cancer; Oct. 25, 12:00-12:45 Jhe-Cyuan Guo RATIONALE-305: Post-treatment immuno-oncology adjustment analysis to assess tislelizumab treatment effect vs placebo Poster: 2931P ; Oesophagogastric cancer; Oct. 25, 12:00-12:45 Markus Moehler RATIONALE-312: Exploratory analysis of tislelizumab plus platinum-etoposide on brain disease progression in first-line ES-SCLC Poster: 3839P ; SCLC; Oct. 26, 12:00-12:45 Francesco Passiglia RATIONALE-315: Clinical outcomes by adjuvant treatment cycles in perioperative tislelizumab plus chemotherapy in resectable NSCLC Poster: 2594P ; NSCLC, locally advanced; Oct. 26, 12:00-12:45 Ernest Nadal Exposure-adjusted analyses of safety patterns in HERIZON-GEA-01: Zanidatamab with and without tislelizumab and chemotherapy in 1L HER2+ metastatic GEA Poster: 2946P ; Oesophagogastric cancer; Oct. 25, 12:00-12:45 Sun Young Rha About ZIIHERA (zanidatamab-hrii) ZIIHERA (zanidatamab-hrii) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo. 1 Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions. ZIIHERA is a registered trademark of Zymeworks BC Inc. About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. TEVIMBRA is the cornerstone asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2.2 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency . The information in this press release is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the advancement of BeOne’s solid tumor pipeline toward pivotal development; the potential of TEVIMBRA across multiple tumor types and disease settings; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom site. 1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com

Phase 1Phase 3ImmunotherapyDrug ApprovalLicense out/in

05 Oct 2026

·www.biospace.com

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC MINNEAPOLIS, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented. Late Breaking Rapid Oral Presentation Details: Title: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2) Presentation Number: LBA 16 Speaker: Barbara Pistilli, MD Session Title: Rapid oral 1: Breast cancer, advanced stage Room: Almeria Auditorium - Hall 9 Date: Saturday, October 24, 2026 Time: 10:15 –11:45 a.m. CEST Poster Presentation Details: Title: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) Presentation Numbe r : 2237P Presenting Author: Adam Sharp, MD, PhD Session Title: Poster Display session, Metastatic prostate cancer Date: Friday, October 23, 2026 Time: 3:15 p.m. – 4:00 p.m. CEST Title: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA) Presentation Numbe r : 1873P Presenting Author: Sara Tolaney, MD Session Title: Poster Display session, HR+ breast cancer Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy (ET) and Palbociclib vs ET and Ribociclib as First-Line (1L) Treatment in Patients With HR-Positive (HR+) HER2-Negative (HER2-) Advanced Breast Cancer (ABC) (VIKTORIA-2) Presentation Numbe r : 57TiP Presenting Author: Giuseppe Curigliano, MD, PhD Session Title: Poster Display session, Advanced breast cancer, other Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Abstracts will be published online via the ESMO website at 12:05 a.m. CEST on October 19, 2026. The posters will be presented in the Poster Area – Hall 5. Electronic versions will also be available on the ESMO 2026 virtual platform. About Celcuity Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK™ (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Contacts: For Investors: Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 For investors and media: Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Phase 1Phase 3Drug ApprovalPhase 2Clinical Result

02 Oct 2026

·www.globenewswire.com

Celcuity Appoints David Gryska To Its Board Of Directors

Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity’s BoardMINNEAPOLIS, Oct. 02, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced the appointment of David W. Gryska to its Board of Directors. Mr. Gryska is a seasoned executive who brings over 35 years of strategic and financial leadership experience in the life sciences industry to Celcuity, including advising early-stage biotechnology companies. “On the heels of our first FDA approval for REVTORPYK™, we are pleased to welcome David to our Board of Directors as we transition into a commercial-stage company,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “David's extensive experience as a Chief Financial Officer and board member of a number of pharmaceutical companies, through periods of significant clinical development and commercial growth makes him an outstanding addition to our Board. We are confident he will provide valuable expertise as we execute the launch of REVTORPYK, advance our clinical development programs, and continue building the capabilities needed to support long-term growth.” Prior to his retirement, Mr. Gryska served as Executive Vice President and Chief Financial Officer of Incyte Corporation; and Senior Vice President and Chief Financial Officer of Celgene Corporation. Mr. Gryska also served as Senior Vice President and Chief Financial Officer as well as Vice President of Finance and Chief Financial Officer at Scios, Inc. Earlier in his career, Mr. Gryska served as a partner at Ernst & Young LLP in California. Throughout the past 25 years, Mr. Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics. He previously served on the Boards of Directors of Seagen Inc. for more than 15 years, Forte Biosciences, Aerie Pharmaceuticals, and GW Pharmaceuticals. Mr. Gryska holds a B.A. in Accounting and Finance from Loyola University and an MBA from Golden Gate University. “Celcuity is entering an exciting new chapter, with the company poised for significant growth over the next few years following the FDA approval and commercial launch of REVTORPYK in advanced breast cancer,” said Mr. Gryska. “I look forward to supporting Brian and Celcuity’s experienced leadership team as we build on this momentum, advance gedatolisib in additional solid tumor indications, and work to bring meaningful benefits to more patients.” About CelcuityCelcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s supplemental New Drug Application (“sNDA”) for REVTORPYK, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for REVTORPYK; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for REVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com(415) 494-9924

100 Deals associated with Letrozole

External Link

KEGG	Wiki	ATC	Drug Bank
D00964	Letrozole	L02BG04	DB01006

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone receptor positive breast cancer	Australia	Sandoz Pty Ltd.	11 Sep 2026
Infertility	Japan	Novartis Pharma AG	25 Feb 2022
Metastatic breast cancer	United States	Novartis Pharmaceuticals Corp.	25 Jul 1997
Breast Cancer	Sweden	Novartis AG	10 Dec 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid carcinoma ovary	Phase 3	Austria	Hoffmann-La Roche, Inc.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Austria	Novartis Pharmaceuticals Corp.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Germany	Novartis Pharmaceuticals Corp.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Germany	Hoffmann-La Roche, Inc.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Switzerland	Novartis Pharmaceuticals Corp.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Switzerland	Hoffmann-La Roche, Inc.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Austria	Hoffmann-La Roche, Inc.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Germany	Hoffmann-La Roche, Inc.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Germany	Novartis Pharmaceuticals Corp.	05 Nov 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00541086 (GIM3 FATA, ESMO2026)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR-positive	3,697	Anastrozoletamoxifen (Upfront or after 2 years of tamoxifen)	izbloozuzx(niylrnzfja) = rxostssxwv xczhzpegmz (sopyxtqnzt, 76.1 - 81.7)	Negative	23 Oct 2026
				Exemestanetamoxifen (Upfront or after 2 years of tamoxifen)	izbloozuzx(niylrnzfja) = kphvhyomvt xczhzpegmz (sopyxtqnzt, 70.9 - 77.2)
NRG-GY019 (IGCS2026)	Phase 3	Ovarian Serous Adenocarcinoma First line p53 wildtype	450	Letrozole	urfodqrxuv(eusvxygffp) = The median PFS has not been reached in either treatment arm. vbohwswrgv (zjdfxbbtqp ) View more	Negative	01 Oct 2026
				Paclitaxel and carboplatin followed by letrozole
GOG-3026 (IGCS2026)	Phase 2	Recurrent ovarian cancer Ki-67 expression \| p16 expression	24	Ribociclib plus letrozole	bgxyccsxge(sazonhyjfs) = svwejtbzvc cvhdlspune (jpkmlhbmlg ) View more	Positive	01 Oct 2026
NCT02188745 (POLLY, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	20	letrozole+Exemestane+17B-estradiol+anastrozole	chhpynvfga = pdgujnecli mrxbolukwf (yqseuxgzxj, gvwrquzngo - wkbhnueaos) View more	-	25 Sep 2026
NCT01797523 (CTgov)	Phase 2	Recurrent Endometrial Cancer	62	Letrozole+Everolimus+Metformin	yppkxsbbcc = qsrzxycuxe wyjzsyhyos (lkoppjppxa, ztkhmltdqz - rsnnncyezw) View more	-	30 Jul 2026
NCT03439046 (BioItaLEE \| Phase IIIb, CTgov)	Phase 3	Leukodystrophy, Hypomyelinating, 6 \| Breast Cancer \| Locally advanced breast cancer ... View more	287	Letrozole+Ribociclib (Ribociclib+Letrozole (Core Phase))	btpzkjjcly(qzwvkjplqc) = medwguoarw welqsqdffi (lcnucikhxo, ryjkkftnyl - yoaewvaqck) View more	-	10 Jul 2026
				Fulvestrant+Alpelisib (Alpelisib+Fulvestrant (Extension Phase))	soibtdvixn = mjqaheddmi vcvihbgiyg (enynrroubd, tfwcutkfpt - iqgtlabzuj) View more
NCT04568616 (NAOMI, ASCO2026)	Phase 2	Estrogen receptor positive breast cancer Neoadjuvant estrogen receptor-positive (ER+)	121	Letrozole (ER+ breast cancer)	dorryqpanl(wbqdehnbgr) = qqmbzyffoa mzjnidgsux (bdvitguusi ) View more	Positive	29 May 2026
NCT06276868 (HELEN HER2 017, ASCO2026)	Phase 2	Hormone receptor positive HER2 positive breast cancer Neoadjuvant HR+ \| HER2+	20	Dalpiciclib + Letrozole + Trastuzumab + Pertuzumab	ebyhafaonq(icrpshaloy) = dbqcukvqtp bwcjxdqybn (iguwtwcpnj )	Positive	29 May 2026
				Dalpiciclib + Letrozole + Trasdalpicicliberletrozole (patients who continued on the dalpiciclib, letrozole, and dual HER2 blockade regimen)	ebyhafaonq(icrpshaloy) = entakmlckl bwcjxdqybn (iguwtwcpnj )
NCT02095184 (CTgov)	Not Applicable	Breast Cancer \| Obesity	42	anastrozole (Cohort 1: Normal Weight Anastrozole)	vmagwdstqf(vfgzhtzujm) = vjbomghyvn kxrkkoimcd (cxkothtpan, mdrroubxjn - ihcvwpwyrc) View more	-	15 Apr 2026
				anastrozole (Cohort 2: Overweight Anastrozole)	vmagwdstqf(vfgzhtzujm) = tsuysganvg kxrkkoimcd (cxkothtpan, kqvpnnlkxh - ryvuedqgha) View more
NCT03747042 (CTgov)	Phase 2	Breast Cancer	61	Letrozole	dyeuoevriz = aoaivkcvfp esmthqkvta (pyeuzakicl, azwcdmzvxk - yuktyhwvku) View more	-	16 Mar 2026

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