{"success":true,"data":{"pressRelease":{"id":"178521","rtpr_id":"nGNX89n42b-20261023","ticker":"CELC","exchange":"NASDAQ","all_tickers":["CELC"],"title":"Celcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026","author":"Globe Newswire","published_at":"2026-10-23T13:15:00.119Z","article_body":"Median radiographic progression free survival (“rPFS”) was 15.7 months and\nthe six-month rPFS rate (“rPFS6”) was 82.2% in patients who received prior\nabiraterone\n\nMedian rPFS was 9.1 months and rPFS6 was 62.5% in patients who received prior\nenzalutamide\n\nThe Phase 2 portion of the study evaluating gedatolisib plus darolutamide is\nexpected to begin in the first half of 2027\n\nMINNEAPOLIS, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a\nbiotechnology company focused on developing and commercializing targeted\ntherapies for the treatment of multiple solid tumor indications, today\nannounced updated clinical results from the Phase 1b/2 study evaluating\ngedatolisib in patients with metastatic castration-resistant prostate cancer\n(“mCRPC”). These data were presented at the European Society of Medical\nOncology (ESMO) Congress 2026 today, Friday, October 23, 2026, at 9:15 a.m.\nEDT/3:15 p.m. CEST at a poster presentation:\n\nPoster 2237P: A phase 1/2, open-label, randomized, dose-finding and dose\nexpansion study of gedatolisib in combination with darolutamide in metastatic\ncastration-resistant prostate cancer (mCRPC)\n(https://www.globenewswire.com/Tracker?data=NK81kDmpEXTNL5u3CqQbqgQQ4gvcMaCg9fgcXywqUE-U2qq1Dk1S1e5ArvSMF_pNIEe6h-iwjjEpIM9rSyFLBbtgJaYFJuuHufSpi9jecLISwb6ET5QmHZnXrdXaoSx6wGOfxj1OGiHYjL44YkpF-77Lad6WIhqhCVs-p5gngfWXvkMP1_AfFfPqqlfhaCmzmWl1Hmtzq0-ZMzrJXYiOs-tUPeVdZ7HXG_Avwh5LJCSDYwcX8MQR6VWvM9_06s4bXrfGO9GO-w79dPelislExtucxLbGwNFlN0pc4WMqFucWB-CUIECT1e3S9dayA5a8I1YWierOQtCeIitMjRaLPdS8ywiE1CU9Wj0kcuokxI9tQbUB56XfsST7kegNdkq71XLtRZsfYMrYVSQp8yRxQFxkfEj8Pj41urdzjbU9j0I=)\n\nIn this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to\nreceive 600 mg darolutamide twice daily combined with either 120 mg\ngedatolisib in Arm 1 (n=19), 180 mg gedatolisib in Arm 2 (n=19) and 240 mg\ngedatolisib in Arm 3 (n=7). In all arms, gedatolisib was administered\nintravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off.\nAdditionally, all patients received prophylactic treatment for stomatitis.\nBaseline characteristics were generally consistent across dose cohorts; over\n50% had bone disease, 33% had phosphatase and tensin hemolog (“PTEN”)\nloss. Data was analyzed as of an August 14, 2026 cut-off date.\n\nKey results reported included:\n* Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with\nprior abiraterone exposure (n=22).\n* Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with\nprior enzalutamide exposure (n=18).\n* PSA ≥50% decreases from baseline (“PSA50”) were observed across all\ndose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and\n240-mg gedatolisib dose levels, respectively, in patients with prior exposure\nto either abiraterone or enzalutamide.\n* Exploratory analyses of patients according to their PTEN status suggest\nactivity is independent of PTEN status.\n* Gedatolisib plus darolutamide demonstrated a manageable safety profile\nacross the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose\nlimiting toxicity (Grade 3 rash), no Grade 4/5 treatment related adverse\nevents (“TRAEs”), and no TRAEs leading to treatment discontinuation or\ndeath. Grade 3 TRAEs occurred in 9 (20%) patients with only rash (n=4) and\npruritus (n=2) occurring in more than one patient.\n“We are highly encouraged by these results and believe combining gedatolisib\nwith an androgen receptor inhibitor is a promising new approach for patients\nwith mCRPC,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity.\n“The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable\nin patients who had received prior abiraterone and compares favorably to\npublished data for AR inhibitors in this setting. We look forward to\ninitiating the Phase 2 portion of the study and further evaluating this\ncombination in more patients.”\n\nThe randomized Phase 2 study is expected to evaluate two different groups of\npatients (Groups 1 and 2) with the objective of determining the recommended\nphase 3 dose level. Subjects in Group 1 will be those who received prior\nabiraterone for either hormone sensitive or castration resistant prostate\ncancer. Subjects in Group 2 will be those who received prior enzalutamide or\napalutamide for either hormone sensitive or castration resistant prostate\ncancer. Celcuity anticipates initiating this study in the first half of 2027\nafter completion of the Phase 1b part of the study.\n\nAbout Prostate Cancer\nProstate cancer is the second most commonly occurring cancer in men with 1.5\nmillion cases diagnosed in 2024 and the fourth most commonly occurring cancer\noverall worldwide.(1) The American Cancer Society estimates approximately\n333,830 men will be diagnosed with prostate cancer in 2026 and over 36,000\nwill die annually in the U.S.(2) For men diagnosed with metastatic\ncastration-resistant prostate cancer, the 5-year survival rate is 32% and\nthere is a significant need for better treatment options, as median\nprogression-free survival is currently between 6.7 – 5.5 months in the\nsecond line setting following AR therapy.(3-5)\n\nAbout Celcuity\n\nCelcuity is a commercial-stage biotechnology company focused on developing and\ncommercializing targeted therapies for the treatment of multiple solid tumor\nindications. The company's first FDA-approved product is REVTORPYK™\n(gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively\nblockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and\npharmacokinetic properties are differentiated from other currently approved\nand investigational therapies that target PI3Kα, AKT or mTORC1 alone or\ntogether. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in\ncombination with fulvestrant with or without palbociclib in patients with\nHR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported\nU.S. Food and Drug Administration approval of REVTORPYK for use in patients\nwithout a PIK3CA mutation detected following progression on or after treatment\nwith at least one line of endocrine therapy in the metastatic setting. Results\nfor the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is\nan ongoing Phase 3 clinical trial incorporating two independent studies, Study\n1 and Study 2, in two separate cohorts of patients with ABC who are\ntreatment-naive in the advanced setting. Study 1 is evaluating gedatolisib\nplus palbociclib plus fulvestrant as first-line treatment for patients with\nendocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus\npalbociclib plus letrozole as first-line treatment for patients with\nendocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201,\nevaluating gedatolisib in combination with darolutamide in patients with\nmetastatic castration-resistant prostate cancer, is ongoing. More detailed\ninformation about Celcuity’s active clinical trials can be found at\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=jw6t09D9tWg9hwKLdUGI1sB5DgIPKM_deiej9VngySXCgrxrHN_hHDAtmqKfxY01pyB8TmJ3r7ThQ4Gq-laMH2iqkPf8uvFuALU37oQtefmOmF2JWG2np73luUPib1nn87aqJX_WXZjBLcoA7vO4R8HMM5ZF0HFOfv5sGx6JONVUzXhcklBU_J3KCpl23iK5).\nCelcuity is headquartered in Minneapolis. Further information about Celcuity\ncan be found at www.celcuity.com. Follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=SBFpf4d7p9fibXQdeqyim7r77Z7gEIww6lFLI07ChrhLlU9WIofbQ-hSOM8WhXMtk5al4QPdq3h_1HZIOrXLzvfh7Wf6QCSZACoSXZ5RfXM=)\nand X\n(https://www.globenewswire.com/Tracker?data=_-GpD8vltr4ZyOhpxEDUwfHMkgV9mCbBpzxJuq2wE4YciaNce0WqQvmf6zgEWVmv17fULNbxELZuG5UO9rUB8A==).\n\nForward Looking Statements\n\nThis press release contains statements that constitute \"forward-looking\nstatements\" within the meaning of the Private Securities Litigation Reform Act\nof 1995 including statements relating to the potential therapeutic benefits of\ngedatolisib; the size, design and timing of the Company’s clinical trials;\nthe Company’s interpretation of clinical trial data; the Company’s\nclinical strategy, including the benefits of strategic decisions regarding\nstudies and trials; and other expectations with respect to gedatolisib,\nincluding potential future indications for gedatolisib regimens. Words such\nas, but not limited to, “look forward to,” “believe,” “expect,”\n“anticipate,” “estimate,” “intend,” \"confidence,\" \"encouraged,\"\n“potential,” “plan,” “targets,” “likely,” “may,”\n“will,” “would,” “should” and “could,” and similar expressions\nor words identify forward-looking statements. The forward-looking statements\nincluded in this press release are based on management's current expectations\nand beliefs which are subject to a number of risks, uncertainties and factors,\nincluding that the Company’s topline clinical results are based on an\nongoing analysis of efficacy and safety data and such data may change\nfollowing a more comprehensive review of the data related to the clinical\ntrial; unforeseen delays in the Company’s clinical trials; and the\ndevelopment of therapies and tools competitive with gedatolisib. In addition,\nall forward-looking statements are subject to other risks detailed in the\nCompany’s Annual Report on Form 10-K for the year ended December 31, 2025,\nas such risks may be updated in its subsequent filings with the Securities and\nExchange Commission. You are cautioned not to place undue reliance on these\nforward-looking statements, which speak only as of the date hereof. All\nforward-looking statements are qualified in their entirety by these cautionary\nstatements, and the Company undertakes no obligation to revise or update this\npress release to reflect events or circumstances after the date hereof.\n\nReferences\n1. Sung H, Filho AM, Laversanne M, Ferlay J, Siegel RL, Soerjomataram I, Jemal\nA, Bray F. Global cancer statistics 2024: GLOBOCAN estimates of incidence and\nmortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026\nJul-Aug;76(4):e70090. doi: 10.3322/caac.70090. PMID: 42417444; PMCID:\nPMC13343830.\n2. American Cancer Society website; Accessed October 2026:\nhttps://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html\n3. Crabb, J Clin Oncol 2021\n4. Attard, J Clin Oncol 2018\n5. Sweeny Clin Cancer Res 2022\nContacts\n\nFor Investors: \nBrian Sullivan, bsullivan@celcuity.com\nVicky Hahne, vhahne@celcuity.com   \n(763) 392-0123\nJodi Sievers, jsievers@celcuity.com\n(415) 494-9924\n\nFor Media:\nSam Brown LLC\nLaura Morgan, lauramorgan@sambrown.com\n(951) 333-9110\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/dab74495-313f-47dd-a6cb-b42a7f024edd)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX89n42b-20261023","title":"Celcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026","author":"Globe Newswire","ticker":"CELC","created":"2026-10-23T13:15:00.119Z","tickers":["CELC"],"exchange":"NASDAQ","article_body":"Median radiographic progression free survival (“rPFS”) was 15.7 months and\nthe six-month rPFS rate (“rPFS6”) was 82.2% in patients who received prior\nabiraterone\n\nMedian rPFS was 9.1 months and rPFS6 was 62.5% in patients who received prior\nenzalutamide\n\nThe Phase 2 portion of the study evaluating gedatolisib plus darolutamide is\nexpected to begin in the first half of 2027\n\nMINNEAPOLIS, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a\nbiotechnology company focused on developing and commercializing targeted\ntherapies for the treatment of multiple solid tumor indications, today\nannounced updated clinical results from the Phase 1b/2 study evaluating\ngedatolisib in patients with metastatic castration-resistant prostate cancer\n(“mCRPC”). These data were presented at the European Society of Medical\nOncology (ESMO) Congress 2026 today, Friday, October 23, 2026, at 9:15 a.m.\nEDT/3:15 p.m. CEST at a poster presentation:\n\nPoster 2237P: A phase 1/2, open-label, randomized, dose-finding and dose\nexpansion study of gedatolisib in combination with darolutamide in metastatic\ncastration-resistant prostate cancer (mCRPC)\n(https://www.globenewswire.com/Tracker?data=NK81kDmpEXTNL5u3CqQbqgQQ4gvcMaCg9fgcXywqUE-U2qq1Dk1S1e5ArvSMF_pNIEe6h-iwjjEpIM9rSyFLBbtgJaYFJuuHufSpi9jecLISwb6ET5QmHZnXrdXaoSx6wGOfxj1OGiHYjL44YkpF-77Lad6WIhqhCVs-p5gngfWXvkMP1_AfFfPqqlfhaCmzmWl1Hmtzq0-ZMzrJXYiOs-tUPeVdZ7HXG_Avwh5LJCSDYwcX8MQR6VWvM9_06s4bXrfGO9GO-w79dPelislExtucxLbGwNFlN0pc4WMqFucWB-CUIECT1e3S9dayA5a8I1YWierOQtCeIitMjRaLPdS8ywiE1CU9Wj0kcuokxI9tQbUB56XfsST7kegNdkq71XLtRZsfYMrYVSQp8yRxQFxkfEj8Pj41urdzjbU9j0I=)\n\nIn this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to\nreceive 600 mg darolutamide twice daily combined with either 120 mg\ngedatolisib in Arm 1 (n=19), 180 mg gedatolisib in Arm 2 (n=19) and 240 mg\ngedatolisib in Arm 3 (n=7). In all arms, gedatolisib was administered\nintravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off.\nAdditionally, all patients received prophylactic treatment for stomatitis.\nBaseline characteristics were generally consistent across dose cohorts; over\n50% had bone disease, 33% had phosphatase and tensin hemolog (“PTEN”)\nloss. Data was analyzed as of an August 14, 2026 cut-off date.\n\nKey results reported included:\n* Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with\nprior abiraterone exposure (n=22).\n* Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with\nprior enzalutamide exposure (n=18).\n* PSA ≥50% decreases from baseline (“PSA50”) were observed across all\ndose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and\n240-mg gedatolisib dose levels, respectively, in patients with prior exposure\nto either abiraterone or enzalutamide.\n* Exploratory analyses of patients according to their PTEN status suggest\nactivity is independent of PTEN status.\n* Gedatolisib plus darolutamide demonstrated a manageable safety profile\nacross the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose\nlimiting toxicity (Grade 3 rash), no Grade 4/5 treatment related adverse\nevents (“TRAEs”), and no TRAEs leading to treatment discontinuation or\ndeath. Grade 3 TRAEs occurred in 9 (20%) patients with only rash (n=4) and\npruritus (n=2) occurring in more than one patient.\n“We are highly encouraged by these results and believe combining gedatolisib\nwith an androgen receptor inhibitor is a promising new approach for patients\nwith mCRPC,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity.\n“The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable\nin patients who had received prior abiraterone and compares favorably to\npublished data for AR inhibitors in this setting. We look forward to\ninitiating the Phase 2 portion of the study and further evaluating this\ncombination in more patients.”\n\nThe randomized Phase 2 study is expected to evaluate two different groups of\npatients (Groups 1 and 2) with the objective of determining the recommended\nphase 3 dose level. Subjects in Group 1 will be those who received prior\nabiraterone for either hormone sensitive or castration resistant prostate\ncancer. Subjects in Group 2 will be those who received prior enzalutamide or\napalutamide for either hormone sensitive or castration resistant prostate\ncancer. Celcuity anticipates initiating this study in the first half of 2027\nafter completion of the Phase 1b part of the study.\n\nAbout Prostate Cancer\nProstate cancer is the second most commonly occurring cancer in men with 1.5\nmillion cases diagnosed in 2024 and the fourth most commonly occurring cancer\noverall worldwide.(1) The American Cancer Society estimates approximately\n333,830 men will be diagnosed with prostate cancer in 2026 and over 36,000\nwill die annually in the U.S.(2) For men diagnosed with metastatic\ncastration-resistant prostate cancer, the 5-year survival rate is 32% and\nthere is a significant need for better treatment options, as median\nprogression-free survival is currently between 6.7 – 5.5 months in the\nsecond line setting following AR therapy.(3-5)\n\nAbout Celcuity\n\nCelcuity is a commercial-stage biotechnology company focused on developing and\ncommercializing targeted therapies for the treatment of multiple solid tumor\nindications. The company's first FDA-approved product is REVTORPYK™\n(gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively\nblockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and\npharmacokinetic properties are differentiated from other currently approved\nand investigational therapies that target PI3Kα, AKT or mTORC1 alone or\ntogether. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in\ncombination with fulvestrant with or without palbociclib in patients with\nHR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported\nU.S. Food and Drug Administration approval of REVTORPYK for use in patients\nwithout a PIK3CA mutation detected following progression on or after treatment\nwith at least one line of endocrine therapy in the metastatic setting. Results\nfor the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is\nan ongoing Phase 3 clinical trial incorporating two independent studies, Study\n1 and Study 2, in two separate cohorts of patients with ABC who are\ntreatment-naive in the advanced setting. Study 1 is evaluating gedatolisib\nplus palbociclib plus fulvestrant as first-line treatment for patients with\nendocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus\npalbociclib plus letrozole as first-line treatment for patients with\nendocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201,\nevaluating gedatolisib in combination with darolutamide in patients with\nmetastatic castration-resistant prostate cancer, is ongoing. More detailed\ninformation about Celcuity’s active clinical trials can be found at\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=jw6t09D9tWg9hwKLdUGI1sB5DgIPKM_deiej9VngySXCgrxrHN_hHDAtmqKfxY01pyB8TmJ3r7ThQ4Gq-laMH2iqkPf8uvFuALU37oQtefmOmF2JWG2np73luUPib1nn87aqJX_WXZjBLcoA7vO4R8HMM5ZF0HFOfv5sGx6JONVUzXhcklBU_J3KCpl23iK5).\nCelcuity is headquartered in Minneapolis. Further information about Celcuity\ncan be found at www.celcuity.com. Follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=SBFpf4d7p9fibXQdeqyim7r77Z7gEIww6lFLI07ChrhLlU9WIofbQ-hSOM8WhXMtk5al4QPdq3h_1HZIOrXLzvfh7Wf6QCSZACoSXZ5RfXM=)\nand X\n(https://www.globenewswire.com/Tracker?data=_-GpD8vltr4ZyOhpxEDUwfHMkgV9mCbBpzxJuq2wE4YciaNce0WqQvmf6zgEWVmv17fULNbxELZuG5UO9rUB8A==).\n\nForward Looking Statements\n\nThis press release contains statements that constitute \"forward-looking\nstatements\" within the meaning of the Private Securities Litigation Reform Act\nof 1995 including statements relating to the potential therapeutic benefits of\ngedatolisib; the size, design and timing of the Company’s clinical trials;\nthe Company’s interpretation of clinical trial data; the Company’s\nclinical strategy, including the benefits of strategic decisions regarding\nstudies and trials; and other expectations with respect to gedatolisib,\nincluding potential future indications for gedatolisib regimens. Words such\nas, but not limited to, “look forward to,” “believe,” “expect,”\n“anticipate,” “estimate,” “intend,” \"confidence,\" \"encouraged,\"\n“potential,” “plan,” “targets,” “likely,” “may,”\n“will,” “would,” “should” and “could,” and similar expressions\nor words identify forward-looking statements. The forward-looking statements\nincluded in this press release are based on management's current expectations\nand beliefs which are subject to a number of risks, uncertainties and factors,\nincluding that the Company’s topline clinical results are based on an\nongoing analysis of efficacy and safety data and such data may change\nfollowing a more comprehensive review of the data related to the clinical\ntrial; unforeseen delays in the Company’s clinical trials; and the\ndevelopment of therapies and tools competitive with gedatolisib. In addition,\nall forward-looking statements are subject to other risks detailed in the\nCompany’s Annual Report on Form 10-K for the year ended December 31, 2025,\nas such risks may be updated in its subsequent filings with the Securities and\nExchange Commission. You are cautioned not to place undue reliance on these\nforward-looking statements, which speak only as of the date hereof. All\nforward-looking statements are qualified in their entirety by these cautionary\nstatements, and the Company undertakes no obligation to revise or update this\npress release to reflect events or circumstances after the date hereof.\n\nReferences\n1. Sung H, Filho AM, Laversanne M, Ferlay J, Siegel RL, Soerjomataram I, Jemal\nA, Bray F. Global cancer statistics 2024: GLOBOCAN estimates of incidence and\nmortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026\nJul-Aug;76(4):e70090. doi: 10.3322/caac.70090. PMID: 42417444; PMCID:\nPMC13343830.\n2. American Cancer Society website; Accessed October 2026:\nhttps://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html\n3. Crabb, J Clin Oncol 2021\n4. Attard, J Clin Oncol 2018\n5. Sweeny Clin Cancer Res 2022\nContacts\n\nFor Investors: \nBrian Sullivan, bsullivan@celcuity.com\nVicky Hahne, vhahne@celcuity.com   \n(763) 392-0123\nJodi Sievers, jsievers@celcuity.com\n(415) 494-9924\n\nFor Media:\nSam Brown LLC\nLaura Morgan, lauramorgan@sambrown.com\n(951) 333-9110\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/dab74495-313f-47dd-a6cb-b42a7f024edd)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-23T13:15:00.169613386Z","server_sent_at_ms":1792761300169},"received_at":"2026-10-23T13:15:00.339Z","source_url":null},"analysis":{"id":"166433","press_release_id":"178521","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Small cohort sizes (n=19-22 per arm); data based on an August 14, 2026 cut-off and subject to change"],"eventType":"clinical_trial","narrative":"Celcuity presented updated Phase 1b/2 data at ESMO 2026 showing median rPFS of 15.7 months and a 82.2% six-month rPFS rate with gedatolisib plus darolutamide in mCRPC patients with prior abiraterone exposure.\n\nIn prior enzalutamide patients, median rPFS was 9.1 months with a 62.5% six-month rPFS rate; PSA50 response rates rose with dose, reaching 67% at the 240-mg level.\n\nThe combination showed a manageable safety profile with no Grade 4/5 treatment-related events and a randomized Phase 2 portion is expected to begin in the first half of 2027.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Gedatolisib expands beyond breast cancer into prostate cancer -- strong early mCRPC data de-risks the Phase 2 path into 2027."},"keyFigures":{"drugName":"gedatolisib (REVTORPYK) plus darolutamide","phaseOfTrial":"Phase 1b/2","customDimensions":{"grade3_trae_rate":"20%","patients_enrolled":45,"phase2_initiation":"first half of 2027","rpfs6_prior_abiraterone":"82.2%","rpfs6_prior_enzalutamide":"62.5%","median_rpfs_prior_abiraterone":"15.7 months","median_rpfs_prior_enzalutamide":"9.1 months"}},"quotedText":"The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable in patients who had received prior abiraterone and compares favorably to published data for AR inhibitors in this setting.","namedEntities":{"people":[{"name":"Igor Gorbachevsky","role":"Chief Medical Officer of Celcuity"}],"products":["gedatolisib","REVTORPYK","darolutamide"],"companies":[{"name":"Celcuity Inc.","ticker":"CELC","relationship":"filer"},{"name":"European Society of Medical Oncology (ESMO)","relationship":"conference venue"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Updated Phase 1b/2 data for gedatolisib plus darolutamide in mCRPC show encouraging efficacy (median rPFS 15.7 months in prior abiraterone patients) with a manageable safety profile, supporting expansion into a randomized Phase 2 in 1H 2027. Encouraging but early, non-pivotal data -- not a binary or registrational event."},"tickerRelevance":{"others":[],"primary":"CELC"},"globalImportance":35,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap biotech","eventGravity":"early-stage clinical data update at major congress","registrational":false,"commercialStage":"has first FDA-approved product (REVTORPYK)"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Celcuity presented updated Phase 1b/2 data at ESMO 2026 showing median rPFS of 15.7 months and a 82.2% six-month rPFS rate with gedatolisib plus darolutamide in mCRPC patients with prior abiraterone exposure.\n\nIn prior enzalutamide patients, median rPFS was 9.1 months with a 62.5% six-month rPFS rate; PSA50 response rates rose with dose, reaching 67% at the 240-mg level.\n\nThe combination showed a manageable safety profile with no Grade 4/5 treatment-related events and a randomized Phase 2 portion is expected to begin in the first half of 2027.","key_figures":{"drugName":"gedatolisib (REVTORPYK) plus darolutamide","phaseOfTrial":"Phase 1b/2","customDimensions":{"grade3_trae_rate":"20%","patients_enrolled":45,"phase2_initiation":"first half of 2027","rpfs6_prior_abiraterone":"82.2%","rpfs6_prior_enzalutamide":"62.5%","median_rpfs_prior_abiraterone":"15.7 months","median_rpfs_prior_enzalutamide":"9.1 months"}},"named_entities":{"people":[{"name":"Igor Gorbachevsky","role":"Chief Medical Officer of Celcuity"}],"products":["gedatolisib","REVTORPYK","darolutamide"],"companies":[{"name":"Celcuity Inc.","ticker":"CELC","relationship":"filer"},{"name":"European Society of Medical Oncology (ESMO)","relationship":"conference venue"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-23T13:15:06.084Z","global_importance":35,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap biotech","eventGravity":"early-stage clinical data update at major congress","registrational":false,"commercialStage":"has first FDA-approved product (REVTORPYK)"}},"durationMs":5703,"modelName":"glm-5.3-flashx"}}