{"success":true,"data":{"pressRelease":{"id":"128197","rtpr_id":"nGNX9vLm0m","ticker":"CELC","exchange":"NASDAQ","all_tickers":["CELC"],"title":"Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer","author":"Globe Newswire","published_at":"2026-08-26T12:30:00.948Z","article_body":"* If approved, REVTORPYK would be the first and only therapy for advanced\nbreast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms\n(α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2\nMINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a\nbiotechnology company focused on developing and commercializing targeted\ntherapies for multiple solid tumor indications, today announced the submission\nof its supplemental New Drug Application (“sNDA”) to the U.S. Food and\nDrug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the\ntreatment of patients with hormone receptor positive (“HR+”), human\nepidermal growth factor receptor 2 negative (“HER2-”), locally advanced or\nmetastatic breast cancer (“ABC”) with a PIK3CA mutation, following\nprogression on or after treatment with at least one line of endocrine therapy.\n\n“This submission allows us to potentially make REVTORPYK available to all\npatients with HR+/HER2- locally advanced or metastatic breast cancer,\nregardless of PIK3CA mutation status,” said Igor Gorbatchevsky, MD, Chief\nMedical Officer of Celcuity. “In the PIK3CA mutant cohort of the VIKTORIA-1\ntrial, REVTORPYK demonstrated compelling safety and efficacy results. Pending\nregulatory approval, we believe REVTORPYK has the potential to become an\nimportant treatment option in this indication.”\n\nThe application to the FDA is supported by positive results from the PIK3CA\nmutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In the trial,\nREVTORPYK plus fulvestrant and palbociclib (the “REVTORPYK-triplet”)\nreduced the risk of disease progression or death by 50% versus alpelisib plus\nfulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median progression-free\nsurvival (“PFS”) was 11.1 months with the REVTORPYK-triplet versus 5.6\nmonths with alpelisib plus fulvestrant. REVTORPYK plus fulvestrant (the\n“REVTORPYK-doublet”) reduced the risk of disease progression or death by\n49% versus alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79;\ndescriptive p=0.0013). Median PFS was 11.3 months with the REVTORPYK-doublet\nversus 5.6 months with alpelisib plus fulvestrant. The REVTORPYK regimens\ndemonstrated robust and durable responses: 49% objective response rate\n(“ORR”) and median duration of response (“DOR”) of 15.7 months for the\nREVTORPYK-triplet and 36% ORR and median DOR of 24.2 months for the\nREVTORPYK-doublet. The safety data for both regimens were generally consistent\nwith previously reported data from the PIK3CA wild-type cohort of the Phase 3\nVIKTORIA-1 trial.\n\nREVTORPYK in combination with fulvestrant, with or without palbociclib, was\napproved by the FDA on July 14, 2026, for the treatment of patients with\nHR+/HER2- ABC without a PIK3CA mutation detected following progression on or\nafter treatment with at least one line of endocrine therapy in the metastatic\nsetting.\n\n“The recent FDA approval of REVTORPYK marked an important milestone for\nCelcuity and for patients with PIK3CA wild-type HR+/HER2- advanced breast\ncancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We are\ndeeply committed to expanding the availability of REVTORPYK to a broader\npopulation of patients. We look forward to working collaboratively with the\nFDA on this application to potentially bring this treatment to patients with\nPIK3CA mutated locally advanced or metastatic breast cancer.”\n\nAbout HR+/HER2- Breast Cancer\nBreast cancer is the second most common cancer and one of the leading causes\nof cancer-related deaths worldwide.(1) More than two million breast cancer\ncases were diagnosed globally in 2022.(1) While survival rates are high for\nthose diagnosed with early breast cancer, only approximately 30% of patients\nwho are diagnosed with or who progress to metastatic disease are expected to\nlive five years after their diagnosis.(2) HR+/HER2- breast cancer is the most\ncommon subtype of breast cancer, accounting for approximately 70% of all\nbreast cancers.(2) Among this breast cancer subtype, approximately 40%\nhave PIK3CA mutations.(3)\n\nAbout the VIKTORIA-1 Phase 3 Trial\nVIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the\nefficacy and safety of gedatolisib in combination with fulvestrant, with or\nwithout palbociclib, in adults with HR+/HER2- ABC whose disease progressed on\nor after prior CDK4/6 therapy in combination with an aromatase inhibitor. The\ntrial enrolled 701 subjects regardless of PIK3CA status while enabling\nseparate evaluation of subjects according to their PIK3CA status. Detailed\nresults from the PIK3CA wild-type cohort of VIKTORIA-1 have been previously\nreported. For the PIK3CA mutant cohort, 350 subjects who met eligibility\ncriteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1)\nto receive a regimen of either the gedatolisib-triplet, alpelisib and\nfulvestrant, or the gedatolisib-doublet.\n\nAbout REVTORPYK (gedatolisib)\nREVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and\nmTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of\nmultiple effectors, including AKT.(4)(,)(5)(,6)\n\nREVTORPYK is in development for the first-line treatment of HR+/HER2- locally\nadvanced or metastatic breast cancer and for the second-line treatment of\nmetastatic castration resistant prostate cancer.\n\nIndication Statement\nREVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with\nfulvestrant, with or without palbociclib, for the treatment of adult patients\nwith hormone receptor (HR)-positive, human epidermal growth factor receptor 2\n(HER2)-negative locally advanced or metastatic breast cancer without\na PIK3CA mutation detected following progression on or after treatment with\nat least one line of endocrine therapy in the metastatic setting.\n\nIMPORTANT SAFETY INFORMATION\n\nWARNINGS AND PRECAUTIONS\n\nStomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral\nmucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with\nfulvestrant and palbociclib, including Grade 3 events in 22% of patients.\nStomatitis occurred in 58% of patients treated with REVTORPYK with\nfulvestrant, including Grade 3 events in 12% of patients. Initiate a\nsteroid-containing, alcohol-free mouthwash prior to starting treatment with\nREVTORPYK and continue prophylactically during treatment. Monitor patients for\nsigns and symptoms of stomatitis. Withhold, reduce dose, or permanently\ndiscontinue REVTORPYK based on severity.\n\nDermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash\noccurred in 30% of patients treated with REVTORPYK in combination with\nfulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash\noccurred in 40% of patients treated with REVTORPYK with fulvestrant, including\n5% of patients with Grade 3 events. Monitor patients for rash and infectious\nsequelae. Instruct patients to limit sun exposure during REVTORPYK treatment.\nWithhold, reduce dose, or permanently discontinue REVTORPYK based on severity.\n\nHyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting\nglucose prior to initiating treatment with REVTORPYK and periodically during\ntreatment. Monitor HbA1c level if clinically indicated. Increased fasting\nglucose occurred in 46% of patients receiving REVTORPYK in combination with\nfulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving\nREVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of\nREVTORPYK has not been established in patients with Type 1 or uncontrolled\nType 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may\nrequire intensified antihyperglycemic therapy and close monitoring of fasting\nglucose. Manage hyperglycemia with antihyperglycemic medications as clinically\nindicated. Evaluate fasting blood glucose and HbA1c levels prior to starting\nand at regular intervals during treatment. Withhold, reduce dose, or\npermanently discontinue REVTORPYK based on severity.\n\nEmbryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause\nfetal harm when administered to a pregnant woman. Advise pregnant women and\nfemales of reproductive potential of the potential risk to a fetus. Advise\nfemales of reproductive potential to use effective contraception during\ntreatment with REVTORPYK and for 2 weeks after the last dose. Advise male\npatients with female partners of reproductive potential to use effective\ncontraception during treatment and for 2 weeks after the last dose.\nAdvise women not to breastfeed during treatment with REVTORPYK and for 2 weeks\nafter the last dose. When REVTORPYK is used in combination, advise patients to\nuse effective contraception during treatment and for the longest\npost-treatment duration recommended in the Prescribing Information of any of\nthe individual products. Verify the pregnancy status of females of\nreproductive potential prior to initiating treatment.\n\nADVERSE REACTIONS\nREVTORPYK in Combination with Fulvestrant and Palbociclib: The most common\n(≥20%) adverse reactions, including laboratory abnormalities when given in\ncombination with fulvestrant and palbociclib were decreased white blood cells,\ndecreased neutrophils, decreased hemoglobin, decreased lymphocytes,\nstomatitis, nausea, decreased platelets, increased fasting glucose, fatigue,\nvomiting, rash, constipation, diarrhea, increased alanine aminotransferase\n(ALT), increased aspartate aminotransferase (AST), musculoskeletal pain,\ndecreased sodium, and increased eosinophils.\n\nREVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse\nreactions, including laboratory abnormalities when given in combination with\nfulvestrant were stomatitis, glucose increased, eosinophils increased,\nhemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal\npain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.\n\nUSE IN SPECIFIC POPULATION\nLactation: Advise women not to breastfeed during treatment with REVTORPYK and\nfor 2 weeks after the last dose. When used in combination, advise patients not\nto breastfeed during treatment and for the longest post-treatment duration\nrecommended in the Prescribing Information of any of the individual products.\n\nInfertility: Advise females and males of reproductive potential that\nREVTORPYK may impair fertility.\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=0KKNhu5vHuTTdaQYwgio2Npt3JWkqmcKcJNdWGbmPN8dUaU5ssSY-iifWWj4f3SWixgnm2unT2ngSUgQjMLU_dj2-ZIQwRufQrHYraIsUyitduBTQ6w2WCwwcSpZBmefZWRRh15QmvgAnfHnPLGbdtVJgdDtDMJnWeQyliif86A=),\nincluding Patient Information\n(https://www.globenewswire.com/Tracker?data=mq5CO3Rs10LOvQhbuWCqdGOWFfN0h-FNSMtGfmTV3eNBLVwEJxrBnBpad6V29L-oKy0C3cekRdIMFXnMI_Hn2DMl9ape9dQzx8Ze2TEK7p9M7OuwjWDt1WT_lQxJXUXUaHDxE7PSP_c30wDukGhQtTKQIr6Lhf3XmkDhuCRcyDLgEz33zh5TsSBUPcwVieT-),\nfor REVTORPYK.\n\nYou may report side effects related to Celcuity products to Celcuity Medical\nInformation at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088\nor www.fda.gov/medwatch.\n\nAbout Celcuity\n\nCelcuity is a biotechnology company focused on developing and commercializing\ntargeted therapies for the treatment of multiple solid tumor indications. The\ncompany's first FDA-approved product is REVTORPYK (gedatolisib), a potent,\npan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM\npathway. Its mechanism of action and pharmacokinetic properties are\ndifferentiated from other currently approved and investigational therapies\nthat target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial,\nVIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or\nwithout palbociclib in patients with HR+/HER2- ABC, supported FDA approval of\nREVTORPYK for use in patients without a PIK3CA mutation detected following\nprogression on or after treatment with at least one line of endocrine therapy\nin the metastatic setting. Results for the PIK3CA mutant cohort of\nVIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical\ntrial incorporating two independent studies, Study 1 and Study 2, in two\nseparate cohorts of patients with ABC who are treatment-naive in the advanced\nsetting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant\nas first-line treatment for patients with endocrine-resistant HR+/HER2- ABC.\nStudy 2 is evaluating gedatolisib plus palbociclib plus letrozole as\nfirst-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A\nPhase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination\nwith darolutamide in patients with metastatic castration-resistant prostate\ncancer, is ongoing. More detailed information about Celcuity’s active\nclinical trials can be found at ClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=N5MgmJXbgR7TIBgmrWZtrEQLOoTV-48os2i5FwLfXx4rXiz3IfDzNTEFPdgnljSBagWi0GerN6WGx7ailZQzTB9YdNC1CGDgy6siW0CFdRnUSLOdBHUibBBSTICxKAk46-SFiXZDUOVXb3nNr9EnTFd8zOTFFpvCyntBPryApfOZwBhEWDr2w2o0GW4GvCVw).\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=WZkzuuizzSPGpPRullrgFIs6ItBe0ZFNuNlocaMOi1pu42_8kWlMj5qiw0_ngeq587_9kugeiBTT9DqFYEWARUw335OhKjpiWMYsIqG92Ss=)and X\n(https://www.globenewswire.com/Tracker?data=du-jNH7xF-6DK1nr-byNbAUcDIgfJDpAda0NFtKZ-IpEsDm-mkjwXmDWTGYdHIaUV5MooOXeVmA35vnttXXknQ==).\n\nForward Looking Statements\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 REVTORPYK and the potential\ntherapeutic benefits of gedatolisib; the size, design and timing of the\nCompany’s clinical trials; the Company’s interpretation of clinical trial\ndata; the status and timing of the submission, and the FDA’s review, of the\nCompany’s sNDA for REVTORPYK, and for making comparable filings with other\nregulatory authorities outside the U.S.; the market opportunity for\ngedatolisib; the Company’s expectations regarding the timing of and its\nability to commercialize REVTORPYK; the Company’s strategy, marketing and\ncommercialization plans, including the benefits of strategic decisions\nregarding studies and trials; other expectations with respect to gedatolisib,\nincluding subcutaneous formulations to support potential future indications\nfor gedatolisib regimens; the Company’s anticipated use of cash; and the\nstrength of its balance sheet. Words such as, but not limited to, “look\nforward to,” “believe,” “expect,” “anticipate,” “estimate,”\n“intend,” \"confidence,\" \"encouraged,\" “potential,” “plan,”\n“targets,” “likely,” “may,” “will,” “would,” “should”\nand “could,” and similar expressions or words identify forward-looking\nstatements. The forward-looking statements included in this press release are\nbased on management's current expectations and beliefs which are subject to a\nnumber of risks, uncertainties and factors, including that the Company’s\ntopline clinical results are based on an ongoing analysis of efficacy and\nsafety data and such data may change following a more comprehensive review of\nthe data related to the clinical trial; unforeseen delays in the Company’s\nclinical trials or the submission, and FDA’s review of, its sNDA for\nREVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA\nand maintain regulatory approvals to commercialize REVTORPYK in the U.S. and\nobtain regulatory approval of gedatolisib outside the U.S., and the market\nacceptance of REVTORPYK; the development of therapies and tools competitive\nwith gedatolisib; and the Company’s ability to access capital upon favorable\nterms. In addition, all forward-looking statements are subject to other risks\ndetailed in the Company’s Annual Report on Form 10-K for the year ended\nDecember 31, 2025, as such risks may be updated in its subsequent filings with\nthe Securities and Exchange Commission. You are cautioned not to place undue\nreliance on these forward-looking statements, which speak only as of the date\nhereof. All forward-looking statements are qualified in their entirety by\nthese cautionary statements, and the Company undertakes no obligation to\nrevise or update this press release to reflect events or circumstances after\nthe date hereof.\n\n© 2026 Celcuity Inc. All rights reserved. REVTORPYK and its logo are\ntrademarks of Celcuity, Inc.\n\nReferences:\n1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of\nIncidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J\nClin. 2021;10.3322/caac.21660.\n2. National Cancer Institute. Surveillance, Epidemiology and End Results\nProgram (accessed July 2025).\nhttps://seer.cancer.gov/statfacts/html/breast-subtypes.html\n3. Anderson, E. et al. A Systematic Review of the Prevalence and Diagnostic\nWorkup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer, Int J\nBreast Cancer. 2020 Jun 20;2020:3759179\n4. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives:\npotent adenosine 5'-triphosphate competitive\nphosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors:\ndiscovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med\nChem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p\n5. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual\nPI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203.\nhttps://doi.org/10.1158/1078-0432.CCR-10-1694\n6. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus\nsingle-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast\nCancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0\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":"nGNX9vLm0m","title":"Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer","author":"Globe Newswire","ticker":"CELC","created":"2026-08-26T12:30:00.948Z","tickers":["CELC"],"exchange":"NASDAQ","article_body":"* If approved, REVTORPYK would be the first and only therapy for advanced\nbreast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms\n(α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2\nMINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a\nbiotechnology company focused on developing and commercializing targeted\ntherapies for multiple solid tumor indications, today announced the submission\nof its supplemental New Drug Application (“sNDA”) to the U.S. Food and\nDrug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the\ntreatment of patients with hormone receptor positive (“HR+”), human\nepidermal growth factor receptor 2 negative (“HER2-”), locally advanced or\nmetastatic breast cancer (“ABC”) with a PIK3CA mutation, following\nprogression on or after treatment with at least one line of endocrine therapy.\n\n“This submission allows us to potentially make REVTORPYK available to all\npatients with HR+/HER2- locally advanced or metastatic breast cancer,\nregardless of PIK3CA mutation status,” said Igor Gorbatchevsky, MD, Chief\nMedical Officer of Celcuity. “In the PIK3CA mutant cohort of the VIKTORIA-1\ntrial, REVTORPYK demonstrated compelling safety and efficacy results. Pending\nregulatory approval, we believe REVTORPYK has the potential to become an\nimportant treatment option in this indication.”\n\nThe application to the FDA is supported by positive results from the PIK3CA\nmutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In the trial,\nREVTORPYK plus fulvestrant and palbociclib (the “REVTORPYK-triplet”)\nreduced the risk of disease progression or death by 50% versus alpelisib plus\nfulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median progression-free\nsurvival (“PFS”) was 11.1 months with the REVTORPYK-triplet versus 5.6\nmonths with alpelisib plus fulvestrant. REVTORPYK plus fulvestrant (the\n“REVTORPYK-doublet”) reduced the risk of disease progression or death by\n49% versus alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79;\ndescriptive p=0.0013). Median PFS was 11.3 months with the REVTORPYK-doublet\nversus 5.6 months with alpelisib plus fulvestrant. The REVTORPYK regimens\ndemonstrated robust and durable responses: 49% objective response rate\n(“ORR”) and median duration of response (“DOR”) of 15.7 months for the\nREVTORPYK-triplet and 36% ORR and median DOR of 24.2 months for the\nREVTORPYK-doublet. The safety data for both regimens were generally consistent\nwith previously reported data from the PIK3CA wild-type cohort of the Phase 3\nVIKTORIA-1 trial.\n\nREVTORPYK in combination with fulvestrant, with or without palbociclib, was\napproved by the FDA on July 14, 2026, for the treatment of patients with\nHR+/HER2- ABC without a PIK3CA mutation detected following progression on or\nafter treatment with at least one line of endocrine therapy in the metastatic\nsetting.\n\n“The recent FDA approval of REVTORPYK marked an important milestone for\nCelcuity and for patients with PIK3CA wild-type HR+/HER2- advanced breast\ncancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We are\ndeeply committed to expanding the availability of REVTORPYK to a broader\npopulation of patients. We look forward to working collaboratively with the\nFDA on this application to potentially bring this treatment to patients with\nPIK3CA mutated locally advanced or metastatic breast cancer.”\n\nAbout HR+/HER2- Breast Cancer\nBreast cancer is the second most common cancer and one of the leading causes\nof cancer-related deaths worldwide.(1) More than two million breast cancer\ncases were diagnosed globally in 2022.(1) While survival rates are high for\nthose diagnosed with early breast cancer, only approximately 30% of patients\nwho are diagnosed with or who progress to metastatic disease are expected to\nlive five years after their diagnosis.(2) HR+/HER2- breast cancer is the most\ncommon subtype of breast cancer, accounting for approximately 70% of all\nbreast cancers.(2) Among this breast cancer subtype, approximately 40%\nhave PIK3CA mutations.(3)\n\nAbout the VIKTORIA-1 Phase 3 Trial\nVIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the\nefficacy and safety of gedatolisib in combination with fulvestrant, with or\nwithout palbociclib, in adults with HR+/HER2- ABC whose disease progressed on\nor after prior CDK4/6 therapy in combination with an aromatase inhibitor. The\ntrial enrolled 701 subjects regardless of PIK3CA status while enabling\nseparate evaluation of subjects according to their PIK3CA status. Detailed\nresults from the PIK3CA wild-type cohort of VIKTORIA-1 have been previously\nreported. For the PIK3CA mutant cohort, 350 subjects who met eligibility\ncriteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1)\nto receive a regimen of either the gedatolisib-triplet, alpelisib and\nfulvestrant, or the gedatolisib-doublet.\n\nAbout REVTORPYK (gedatolisib)\nREVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and\nmTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of\nmultiple effectors, including AKT.(4)(,)(5)(,6)\n\nREVTORPYK is in development for the first-line treatment of HR+/HER2- locally\nadvanced or metastatic breast cancer and for the second-line treatment of\nmetastatic castration resistant prostate cancer.\n\nIndication Statement\nREVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with\nfulvestrant, with or without palbociclib, for the treatment of adult patients\nwith hormone receptor (HR)-positive, human epidermal growth factor receptor 2\n(HER2)-negative locally advanced or metastatic breast cancer without\na PIK3CA mutation detected following progression on or after treatment with\nat least one line of endocrine therapy in the metastatic setting.\n\nIMPORTANT SAFETY INFORMATION\n\nWARNINGS AND PRECAUTIONS\n\nStomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral\nmucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with\nfulvestrant and palbociclib, including Grade 3 events in 22% of patients.\nStomatitis occurred in 58% of patients treated with REVTORPYK with\nfulvestrant, including Grade 3 events in 12% of patients. Initiate a\nsteroid-containing, alcohol-free mouthwash prior to starting treatment with\nREVTORPYK and continue prophylactically during treatment. Monitor patients for\nsigns and symptoms of stomatitis. Withhold, reduce dose, or permanently\ndiscontinue REVTORPYK based on severity.\n\nDermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash\noccurred in 30% of patients treated with REVTORPYK in combination with\nfulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash\noccurred in 40% of patients treated with REVTORPYK with fulvestrant, including\n5% of patients with Grade 3 events. Monitor patients for rash and infectious\nsequelae. Instruct patients to limit sun exposure during REVTORPYK treatment.\nWithhold, reduce dose, or permanently discontinue REVTORPYK based on severity.\n\nHyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting\nglucose prior to initiating treatment with REVTORPYK and periodically during\ntreatment. Monitor HbA1c level if clinically indicated. Increased fasting\nglucose occurred in 46% of patients receiving REVTORPYK in combination with\nfulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving\nREVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of\nREVTORPYK has not been established in patients with Type 1 or uncontrolled\nType 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may\nrequire intensified antihyperglycemic therapy and close monitoring of fasting\nglucose. Manage hyperglycemia with antihyperglycemic medications as clinically\nindicated. Evaluate fasting blood glucose and HbA1c levels prior to starting\nand at regular intervals during treatment. Withhold, reduce dose, or\npermanently discontinue REVTORPYK based on severity.\n\nEmbryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause\nfetal harm when administered to a pregnant woman. Advise pregnant women and\nfemales of reproductive potential of the potential risk to a fetus. Advise\nfemales of reproductive potential to use effective contraception during\ntreatment with REVTORPYK and for 2 weeks after the last dose. Advise male\npatients with female partners of reproductive potential to use effective\ncontraception during treatment and for 2 weeks after the last dose.\nAdvise women not to breastfeed during treatment with REVTORPYK and for 2 weeks\nafter the last dose. When REVTORPYK is used in combination, advise patients to\nuse effective contraception during treatment and for the longest\npost-treatment duration recommended in the Prescribing Information of any of\nthe individual products. Verify the pregnancy status of females of\nreproductive potential prior to initiating treatment.\n\nADVERSE REACTIONS\nREVTORPYK in Combination with Fulvestrant and Palbociclib: The most common\n(≥20%) adverse reactions, including laboratory abnormalities when given in\ncombination with fulvestrant and palbociclib were decreased white blood cells,\ndecreased neutrophils, decreased hemoglobin, decreased lymphocytes,\nstomatitis, nausea, decreased platelets, increased fasting glucose, fatigue,\nvomiting, rash, constipation, diarrhea, increased alanine aminotransferase\n(ALT), increased aspartate aminotransferase (AST), musculoskeletal pain,\ndecreased sodium, and increased eosinophils.\n\nREVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse\nreactions, including laboratory abnormalities when given in combination with\nfulvestrant were stomatitis, glucose increased, eosinophils increased,\nhemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal\npain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.\n\nUSE IN SPECIFIC POPULATION\nLactation: Advise women not to breastfeed during treatment with REVTORPYK and\nfor 2 weeks after the last dose. When used in combination, advise patients not\nto breastfeed during treatment and for the longest post-treatment duration\nrecommended in the Prescribing Information of any of the individual products.\n\nInfertility: Advise females and males of reproductive potential that\nREVTORPYK may impair fertility.\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=0KKNhu5vHuTTdaQYwgio2Npt3JWkqmcKcJNdWGbmPN8dUaU5ssSY-iifWWj4f3SWixgnm2unT2ngSUgQjMLU_dj2-ZIQwRufQrHYraIsUyitduBTQ6w2WCwwcSpZBmefZWRRh15QmvgAnfHnPLGbdtVJgdDtDMJnWeQyliif86A=),\nincluding Patient Information\n(https://www.globenewswire.com/Tracker?data=mq5CO3Rs10LOvQhbuWCqdGOWFfN0h-FNSMtGfmTV3eNBLVwEJxrBnBpad6V29L-oKy0C3cekRdIMFXnMI_Hn2DMl9ape9dQzx8Ze2TEK7p9M7OuwjWDt1WT_lQxJXUXUaHDxE7PSP_c30wDukGhQtTKQIr6Lhf3XmkDhuCRcyDLgEz33zh5TsSBUPcwVieT-),\nfor REVTORPYK.\n\nYou may report side effects related to Celcuity products to Celcuity Medical\nInformation at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088\nor www.fda.gov/medwatch.\n\nAbout Celcuity\n\nCelcuity is a biotechnology company focused on developing and commercializing\ntargeted therapies for the treatment of multiple solid tumor indications. The\ncompany's first FDA-approved product is REVTORPYK (gedatolisib), a potent,\npan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM\npathway. Its mechanism of action and pharmacokinetic properties are\ndifferentiated from other currently approved and investigational therapies\nthat target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial,\nVIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or\nwithout palbociclib in patients with HR+/HER2- ABC, supported FDA approval of\nREVTORPYK for use in patients without a PIK3CA mutation detected following\nprogression on or after treatment with at least one line of endocrine therapy\nin the metastatic setting. Results for the PIK3CA mutant cohort of\nVIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical\ntrial incorporating two independent studies, Study 1 and Study 2, in two\nseparate cohorts of patients with ABC who are treatment-naive in the advanced\nsetting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant\nas first-line treatment for patients with endocrine-resistant HR+/HER2- ABC.\nStudy 2 is evaluating gedatolisib plus palbociclib plus letrozole as\nfirst-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A\nPhase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination\nwith darolutamide in patients with metastatic castration-resistant prostate\ncancer, is ongoing. More detailed information about Celcuity’s active\nclinical trials can be found at ClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=N5MgmJXbgR7TIBgmrWZtrEQLOoTV-48os2i5FwLfXx4rXiz3IfDzNTEFPdgnljSBagWi0GerN6WGx7ailZQzTB9YdNC1CGDgy6siW0CFdRnUSLOdBHUibBBSTICxKAk46-SFiXZDUOVXb3nNr9EnTFd8zOTFFpvCyntBPryApfOZwBhEWDr2w2o0GW4GvCVw).\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=WZkzuuizzSPGpPRullrgFIs6ItBe0ZFNuNlocaMOi1pu42_8kWlMj5qiw0_ngeq587_9kugeiBTT9DqFYEWARUw335OhKjpiWMYsIqG92Ss=)and X\n(https://www.globenewswire.com/Tracker?data=du-jNH7xF-6DK1nr-byNbAUcDIgfJDpAda0NFtKZ-IpEsDm-mkjwXmDWTGYdHIaUV5MooOXeVmA35vnttXXknQ==).\n\nForward Looking Statements\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 REVTORPYK and the potential\ntherapeutic benefits of gedatolisib; the size, design and timing of the\nCompany’s clinical trials; the Company’s interpretation of clinical trial\ndata; the status and timing of the submission, and the FDA’s review, of the\nCompany’s sNDA for REVTORPYK, and for making comparable filings with other\nregulatory authorities outside the U.S.; the market opportunity for\ngedatolisib; the Company’s expectations regarding the timing of and its\nability to commercialize REVTORPYK; the Company’s strategy, marketing and\ncommercialization plans, including the benefits of strategic decisions\nregarding studies and trials; other expectations with respect to gedatolisib,\nincluding subcutaneous formulations to support potential future indications\nfor gedatolisib regimens; the Company’s anticipated use of cash; and the\nstrength of its balance sheet. Words such as, but not limited to, “look\nforward to,” “believe,” “expect,” “anticipate,” “estimate,”\n“intend,” \"confidence,\" \"encouraged,\" “potential,” “plan,”\n“targets,” “likely,” “may,” “will,” “would,” “should”\nand “could,” and similar expressions or words identify forward-looking\nstatements. The forward-looking statements included in this press release are\nbased on management's current expectations and beliefs which are subject to a\nnumber of risks, uncertainties and factors, including that the Company’s\ntopline clinical results are based on an ongoing analysis of efficacy and\nsafety data and such data may change following a more comprehensive review of\nthe data related to the clinical trial; unforeseen delays in the Company’s\nclinical trials or the submission, and FDA’s review of, its sNDA for\nREVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA\nand maintain regulatory approvals to commercialize REVTORPYK in the U.S. and\nobtain regulatory approval of gedatolisib outside the U.S., and the market\nacceptance of REVTORPYK; the development of therapies and tools competitive\nwith gedatolisib; and the Company’s ability to access capital upon favorable\nterms. In addition, all forward-looking statements are subject to other risks\ndetailed in the Company’s Annual Report on Form 10-K for the year ended\nDecember 31, 2025, as such risks may be updated in its subsequent filings with\nthe Securities and Exchange Commission. You are cautioned not to place undue\nreliance on these forward-looking statements, which speak only as of the date\nhereof. All forward-looking statements are qualified in their entirety by\nthese cautionary statements, and the Company undertakes no obligation to\nrevise or update this press release to reflect events or circumstances after\nthe date hereof.\n\n© 2026 Celcuity Inc. All rights reserved. REVTORPYK and its logo are\ntrademarks of Celcuity, Inc.\n\nReferences:\n1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of\nIncidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J\nClin. 2021;10.3322/caac.21660.\n2. National Cancer Institute. Surveillance, Epidemiology and End Results\nProgram (accessed July 2025).\nhttps://seer.cancer.gov/statfacts/html/breast-subtypes.html\n3. Anderson, E. et al. A Systematic Review of the Prevalence and Diagnostic\nWorkup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer, Int J\nBreast Cancer. 2020 Jun 20;2020:3759179\n4. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives:\npotent adenosine 5'-triphosphate competitive\nphosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors:\ndiscovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med\nChem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p\n5. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual\nPI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203.\nhttps://doi.org/10.1158/1078-0432.CCR-10-1694\n6. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus\nsingle-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast\nCancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0\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":"2026-08-26T12:30:00.996072566Z","server_sent_at_ms":1787747400996},"received_at":"2026-08-26T12:30:01.045Z","source_url":"https://www.globenewswire.com/news-release/2026/08/26/3351327/0/en/celcuity-submits-snda-to-fda-for-revtorpyk-gedatolisib-for-hr-her2-pik3ca-mutant-locally-advanced-or-metastatic-breast-cancer.html"},"analysis":{"id":"117114","press_release_id":"128197","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK for the treatment of HR+/HER2- advanced breast cancer with a PIK3CA mutation.\n\nThe submission is supported by Phase 3 VIKTORIA-1 data where the REVTORPYK triplet regimen reduced the risk of disease progression or death by 50% versus the control arm, achieving a median PFS of 11.1 months compared to 5.6 months.\n\nThis follows the July 2026 approval of REVTORPYK for wild-type patients, and the new submission aims to expand the label to the approximately 40% of patients with the PIK3CA mutation.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"sNDA submission backed by strong Phase 3 data could significantly expand the addressable market for Celcuity's recently approved REVTORPYK."},"keyFigures":{"drugName":"REVTORPYK (gedatolisib)","phaseOfTrial":"Phase 3","customDimensions":{"orr_doublet_percent":36,"orr_triplet_percent":49,"hazard_ratio_doublet":0.51,"hazard_ratio_triplet":0.5,"subjects_mutant_cohort":350,"median_dor_doublet_months":24.2,"median_dor_triplet_months":15.7,"median_pfs_control_months":5.6,"median_pfs_doublet_months":11.3,"median_pfs_triplet_months":11.1}},"quotedText":"This submission allows us to potentially make REVTORPYK available to all patients with HR+/HER2- locally advanced or metastatic breast cancer, regardless of PIK3CA mutation status","namedEntities":{"people":[{"name":"Igor Gorbatchevsky","role":"Chief Medical Officer"},{"name":"Brian Sullivan","role":"CEO"}],"products":["REVTORPYK","gedatolisib","fulvestrant","palbociclib","alpelisib"],"companies":[{"name":"Celcuity Inc.","ticker":"CELC"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Submission of sNDA for label expansion of recently approved drug REVTORPYK into the PIK3CA mutant population. Supported by strong Phase 3 data showing ~50% reduction in risk of progression and doubled median PFS vs control. Significant potential commercial expansion."},"tickerRelevance":{"others":[],"primary":"CELC"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"small/mid-cap_biotech","eventGravity":"sNDA_submission_with_strong_data","sectorWeight":"Health Care"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK for the treatment of HR+/HER2- advanced breast cancer with a PIK3CA mutation.\n\nThe submission is supported by Phase 3 VIKTORIA-1 data where the REVTORPYK triplet regimen reduced the risk of disease progression or death by 50% versus the control arm, achieving a median PFS of 11.1 months compared to 5.6 months.\n\nThis follows the July 2026 approval of REVTORPYK for wild-type patients, and the new submission aims to expand the label to the approximately 40% of patients with the PIK3CA mutation.","key_figures":{"drugName":"REVTORPYK (gedatolisib)","phaseOfTrial":"Phase 3","customDimensions":{"orr_doublet_percent":36,"orr_triplet_percent":49,"hazard_ratio_doublet":0.51,"hazard_ratio_triplet":0.5,"subjects_mutant_cohort":350,"median_dor_doublet_months":24.2,"median_dor_triplet_months":15.7,"median_pfs_control_months":5.6,"median_pfs_doublet_months":11.3,"median_pfs_triplet_months":11.1}},"named_entities":{"people":[{"name":"Igor Gorbatchevsky","role":"Chief Medical Officer"},{"name":"Brian Sullivan","role":"CEO"}],"products":["REVTORPYK","gedatolisib","fulvestrant","palbociclib","alpelisib"],"companies":[{"name":"Celcuity Inc.","ticker":"CELC"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-26T13:43:18.258Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small/mid-cap_biotech","eventGravity":"sNDA_submission_with_strong_data","sectorWeight":"Health Care"}},"durationMs":245041,"modelName":"glm-4.7"}}