Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

An additional FDA application seeks to extend REVTORPYK treatment to patients with PIK3CA-mutated advanced breast cancer.

Rhea-AI Summary

Celcuity (CELC) has made REVTORPYK (gedatolisib) commercially available in the United States for eligible patients with advanced breast cancer. The FDA approved it on July 14, 2026, with fulvestrant, with or without palbociclib. Eligibility covers adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one endocrine therapy in the metastatic setting.

In the Phase 3 VIKTORIA-1 cohort without PIK3CA mutations, the three-drug and two-drug combinations reduced the risk of progression or death by 76% and 67%, respectively, versus fulvestrant. Celcuity submitted an additional FDA application in August for patients with PIK3CA-mutated advanced breast cancer; that use remains conditional on approval. The company also launched REVTORPYK Support Services for insurance coverage, financial assistance and treatment enrollment.

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Positive

• Major pointREVTORPYK is commercially available in the United States, launching Celcuity’s first FDA-approved product.
• Moderate pointThree-drug combination reduced progression or death risk by 76% versus fulvestrant in VIKTORIA-1’s PIK3CA wild-type cohort.
• Moderate pointAdditional FDA application submitted in August seeks treatment eligibility for PIK3CA-mutated advanced breast cancer.
• Minor pointFDA approval on July 14, 2026 covers fulvestrant combinations with or without palbociclib for eligible patients.
• Minor pointTwo-drug combination reduced progression or death risk by 67% versus fulvestrant in VIKTORIA-1’s PIK3CA wild-type cohort.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.PIK3CA-mutated breast cancer use remains subject to FDA approval of the additional application.

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Key Figures

Triplet risk reduction: 76% Doublet risk reduction: 67% Stomatitis: 72%; Grade 3: 22% +3 more

Triplet risk reduction

76%

VIKTORIA-1 PIK3CA wild-type cohort; versus fulvestrant

Doublet risk reduction

67%

VIKTORIA-1 PIK3CA wild-type cohort; versus fulvestrant

Stomatitis

72%; Grade 3: 22%

REVTORPYK with fulvestrant and palbociclib

Stomatitis

58%; Grade 3: 12%

REVTORPYK with fulvestrant

Increased fasting glucose

46%; Grade 3: 0.9%

REVTORPYK with fulvestrant and palbociclib

Increased fasting glucose

57%; Grade 3: 1.8%

REVTORPYK with fulvestrant

Historical Context

1 past event · Latest: Aug 26

1 event

1. Aug 26

   sNDA submission

   24h Move

   +3.0%

   Phase 3 mutant-cohort results supported the sNDA for the PIK3CA-mutated population.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

PIK3CA, sNDA, mtorc1, mtorc2, +1 more

5 terms

PIK3CA medical

"without a PIK3CA mutation detected"

PIK3CA is a gene that helps control cell growth and survival by sending signals inside cells; when it carries certain mutations, those signals can become stuck in the “on” position and drive cancer growth. For investors, PIK3CA matters because its mutations are a biomarker used to identify patients for targeted drugs and diagnostics, affecting clinical trial design, approval chances, and potential market size for therapies aimed at those mutations.

sNDA regulatory

"Celcuity submitted a supplemental New Drug Application"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

mtorc1 medical

"mTOR complexes mTORC1 and mTORC2"

mTORC1 is a protein complex that acts like a cellular control center, sensing nutrient and energy levels and telling cells when to grow, divide, or conserve resources. It matters to investors because drugs or therapies that block or tweak this control center can slow cancer growth, treat metabolic and age‑related diseases, or cause side effects, so companies targeting mTORC1 can have substantial therapeutic and commercial potential.

mtorc2 medical

"mTOR complexes mTORC1 and mTORC2"

mTORC2 (mechanistic target of rapamycin complex 2) is a protein assembly inside cells that helps control cell growth, survival and metabolism by sending chemical signals that tell cells how to use nutrients and respond to stress. For investors, it matters because drugs that block or modify mTORC2 can alter cancer growth, metabolic disorders and drug resistance—think of it as a central traffic controller in a city where changing its signals can reroute outcomes, creating potential therapeutic value or risk for drug developers.

pi3k/akt/mtor pathway medical

"to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathway"

A chain of proteins inside cells that passes signals controlling cell growth, survival and energy use; think of it like a thermostat and wiring that tells a cell when to grow, divide or conserve resources. It matters to investors because drugs or tests that alter this pathway are central to many cancer and metabolic disease treatments, influencing the value and risk of biotech pipelines, trial outcomes and future sales potential.

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• REVTORPYK is indicated for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting
  
  
• REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathway
  
  
• In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant
  
  
• Healthcare providers can visit www.revtorpykhcp.com to access a comprehensive patient support program through REVTORPYK Support Services
  
  

MINNEAPOLIS, Sept. 30, 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 REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK was approved in combination with palbociclib and fulvestrant (“REVTORPYK triplet”) and in combination with fulvestrant (“REVTORPYK doublet”), by the U.S. Food and Drug Administration (“FDA”) on July 14, 2026.

“Our experienced commercial and medical affairs teams have been laying the groundwork for a successful launch with healthcare providers, payers, and patient advocacy partners since REVTORPYK was approved,” said Brian Sullivan, CEO and co-founder of Celcuity. “Now that REVTORPYK is commercially available, we are focused on working with physicians to bring this new treatment option to patients living with HR+/HER2- advanced breast cancer.”

As part of its commitment to patient access, Celcuity has launched the REVTORPYK Support Services program to provide financial assistance and treatment enrollment resources for physicians and eligible patients. The program offers support with insurance coverage, including access and reimbursement, and facilitates access to financial assistance, including Copay Assistance and Patient Assistance Programs. For more information, healthcare providers can visit www.revtorpykhcp.com or contact REVTORPYK Support Services at 877-4-CELCUITY (877-423-5284).

“There is an urgent need for new and differentiated treatment options for patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer in the second-line setting,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “REVTORPYK demonstrated unprecedented clinical benefit in the pivotal VIKTORIA-1 study, and we believe, provides an important new therapeutic option to address this need. We are excited now to make this new therapy available to physicians and their patients.”

Celcuity submitted a supplemental New Drug Application to the FDA in August for REVTORPYK to treat patients with HR+/HER2-, PIK3CA mutated, advanced breast cancer based on the results of Study 2 of the VIKTORIA-1 trial. If approved, physicians would have the option to prescribe REVTORPYK for patients with advanced breast cancer regardless of their PIK3CA tumor status.

About HR+/HER2- Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About REVTORPYK (gedatolisib)
REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.^3,4,5

REVTORPYK is in development for the first-line treatment of HR+/HER2- ABC and for the second-line treatment of metastatic castration-resistant prostate cancer.

Indication Statement
REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS

REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

USE IN SPECIFIC POPULATION

Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products.

Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility.

Please see full Prescribing Information, including Patient Information, for REVTORPYK.

You may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

© 2026 Celcuity Inc. All rights reserved. REVTORPYK and its logo are trademarks of Celcuity Inc.

About Celcuity

Celcuity 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 Statements

This 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.

References:

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025).
   https://seer.cancer.gov/statfacts/html/breast-subtypes.html
3. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
4. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
5. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
   
   

Contacts: 

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/297d1d12-584a-4733-ae4f-15748ef91345

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Who is eligible for Celcuity’s commercially available REVTORPYK?

REVTORPYK is indicated for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one endocrine therapy in the metastatic setting. It is used with fulvestrant, with or without palbociclib.

What did Celcuity’s VIKTORIA-1 trial show for REVTORPYK?

In VIKTORIA-1’s cohort without PIK3CA mutations, REVTORPYK combinations reduced the risk of disease progression or death versus fulvestrant. The reduction was 76% for REVTORPYK with palbociclib and fulvestrant, and 67% for REVTORPYK with fulvestrant.