Celcuity
Celcuity is a clinical-stage biotechnology company developing gedatolisib, a potential first-in-class pan-PI3K/mTORC1/2 inhibitor for HR+/HER2- advanced breast cancer and prostate cancer, with FDA Priority Review and a July 2026 PDUFA date.
- Company typePublic
- Founded2016
- HeadquartersHamel, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What Celcuity does
Celcuity is a clinical-stage biotechnology company headquartered in Minneapolis, Minnesota, developing gedatolisib, a potential first-in-class pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway at low nanomolar concentrations. The drug is being evaluated in three clinical programs: VIKTORIA-1 (Phase 3 second-line HR+/HER2- advanced breast cancer, approximately 701 patients), VIKTORIA-2 (Phase 3 first-line HR+/HER2- advanced breast cancer across up to 200 global sites), and CELC-G-201 (Phase 1/2 metastatic castration-resistant prostate cancer). In May 2026, VIKTORIA-1's PIK3CA mutant cohort demonstrated a 50% reduction in disease progression risk versus alpelisib plus fulvestrant, complementing the prior 76% reduction seen in the PIK3CA wild-type cohort, establishing gedatolisib's potential across the full HR+/HER2- patient population regardless of PIK3CA status.
The company's underlying technology platform centers on gedatolisib's differentiated pharmacokinetic and mechanism-of-action profile versus single-node PI3K or AKT inhibitors, supplemented by the CELSignia functional signaling diagnostics platform for identifying patient subgroups who may benefit from targeted therapy. The FDA has granted gedatolisib Priority Review, Breakthrough Therapy, and Fast Track designations and accepted the NDA under the Real-Time Oncology Review program, with a PDUFA goal date of July 17, 2026. Celcuity is also pursuing lifecycle extension through a subcutaneous formulation patent filed with the USPTO in 2026 to enable patient self-administration as an alternative to IV infusion.
Celcuity is transitioning from clinical-stage to commercial operations. The company reported its first meaningful sales of $4.7 million in Q1 2026 ahead of approval. Upon FDA approval, gedatolisib will be distributed through specialty pharmacy networks and oncology treatment centers via an enterprise field sales force targeting oncologists, supported by Medical Science Liaisons. The CEO Brian Sullivan is a serial entrepreneur with prior exits to Johnson & Johnson and Procter & Gamble, and the leadership team includes experienced biopharma operators in regulatory, clinical, and commercial functions. Cumulative funding raised exceeds $880 million, anchored by a $500 million convertible notes offering in June 2026 and a $500 million term loan facility with Innovatus Capital Partners and Oxford Finance, providing runway through 2027. Analyst projections for gedatolisib peak annual sales range from $2.1 billion (Evaluate, 2032) to $3.7-4.5 billion.
Celcuity firmographics
Firmographics- Name
- Celcuity
- Legal name
- Celcuity Inc.
- Website
- https://celcuity.com
- Company type
- Public
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Celcuity is a clinical-stage biotechnology company developing gedatolisib, a potential first-in-class pan-PI3K/mTORC1/2 inhibitor for HR+/HER2- advanced breast cancer and prostate cancer, with FDA Priority Review and a July 2026 PDUFA date.
- Ownership category
- akta.pro rank
Celcuity industry classification
Industry- Product category
- Oncology Pharmaceuticals
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
- SIC
- Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Breast Oncology (HLAKAFAJ)
- akta.pro secondary industries
- Genitourinary Oncology (HLAKAFAM), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)
Keywords
Where Celcuity is headquartered
LocationHeadquarters
- HQ city
- Hamel
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Celcuity business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Pharmaceutical Product Sales: Pre-commercial stage biotech expecting first product revenue from gedatolisib sales upon FDA approval. Peak sales projections range from $3.7 billion to $4.5 billion according to analyst estimates. Revenue model will be traditional pharmaceutical product sales through specialty pharmacies and treatment centers.
- Product Revenue: Company reported first meaningful sales of $4.7 million in Q1 2026 as it transitions from purely clinical operations toward commercialization. This represents early revenue from expanded access or initial commercial supply.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Pharmaceutical drug pricing - to be determined upon approval |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels5 records
Celcuity product offering
Product offeringCore offering
Celcuity is a clinical-stage biotechnology company developing gedatolisib, a potential first-in-class pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway for cancer treatment. The company's lead candidate is being advanced through Phase 3 clinical trials (VIKTORIA-1, VIKTORIA-2, CELC-G-201) for HR+/HER2- advanced breast cancer and metastatic castration-resistant prostate cancer, with an FDA PDUFA goal date of July 17, 2026.
Product overview
Celcuity is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumor indications. The company's core product portfolio centers on gedatolisib, a potential first-in-class pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Gedatolisib is being evaluated through three Phase 3 clinical trials: VIKTORIA-1 (2nd-line treatment for HR+/HER2- advanced breast cancer), VIKTORIA-2 (1st-line treatment for HR+/HER2- advanced breast cancer), and CELC-G-201 (metastatic castration resistant prostate cancer). The company is transitioning from clinical-stage to commercial readiness, with FDA Priority Review granted for gedatolisib in PIK3CA wild-type advanced breast cancer and a PDUFA goal date of July 17, 2026.
Differentiator
Problem solved
Functional benefit
Brands
- CELSignia: Celcuity's diagnostic platform for functional signaling analysis to identify patient subgroups who may benefit from targeted therapies
- VIKTORIA-1
- VIKTORIA-2
- CELC-G-201
Products and services
- Gedatolisib (CELC-G-100) Gedatolisib is an investigational, potential first-in-class pan-PI3K and mTORC1/2 inhibitor administered intravenously that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway by inhibiting all four Class I PI3K isoforms (p110α, p110β, p110γ, p110δ) and mTORC1/2 at low nanomolar concentrations. It is being developed for HR+/HER2- advanced breast cancer and metastatic castration-resistant prostate cancer (mCRPC).
- CELSignia Diagnostics Platform CELSignia is a functional signaling test platform that identifies cancer patients who may benefit from targeted therapies by measuring real-time pathway activity in live tumor cells. It can identify patient subgroups with hyperactive signaling who may respond to specific pathway inhibitors such as gedatolisib.
Quantifiable outcome
- 50% reduction in risk of disease progression or death vs alpelisib plus fulvestrant in PIK3CA mutant cohort (VIKTORIA-1)
- +3 more outcomes
Companies that use Celcuity
Customer profileSegments3 records
Ideal customer profiles3 records
Celcuity technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Celcuity partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- FDA (Type B Meeting)coreType B meeting held with FDA to align on amended VIKTORIA-2 trial design for expanded Phase 3 study.
- FDA (Real-Time Oncology Review Program)coreFDA accepted NDA under RTOR (Real-Time Oncology Review) program, facilitating accelerated review process for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer.
Scale indicators13 records
Recent moves7 records
Expansion highlights7 records
Celcuity competitors and assessment
Company assessmentEmerging players
- Puma Biotechnology: Commercial-stage oncology company marketing Nerlynx (neratinib) for HER2-positive breast cancer. Comparable in being a smaller, focused oncology company with a single targeted breast cancer therapy facing larger incumbents.
- G1 Therapeutics: Developed Cosela (trilaciclib), a CDK4/6-related therapy used to reduce chemotherapy-induced myelosuppression. Adjacent breast cancer oncology peer with overlapping oncology sales channels.
- MEI Pharma: Clinical-stage oncology company that has previously developed PI3Kδ and CDK inhibitors; Celcuity's CMO Igor Gorbatchevsky was previously VP of Clinical Development at MEI Pharma, indicating close comparability in development-stage oncology focus.
Broad incumbents
- Pfizer: Original developer of gedatolisib (formerly PKI-587), which it sold to Celcuity for ~$10M in 2021. Major oncology incumbent with established breast cancer franchises and direct historical relationship to the Celcuity asset.
- Bayer: Developed Aliqopa (copanlisib), a pan-PI3K inhibitor approved for follicular lymphoma. Celcuity's CMO previously led the Aliqopa clinical team at Bayer, and Bayer represents the only other company to have commercially developed a pan-PI3K inhibitor.
- Daiichi Sankyo: Major Japanese oncology drug developer with established breast cancer presence (Enhertu). Celcuity's CMO previously held Senior Medical Director role at Daiichi-Sankyo, and Daiichi competes broadly in targeted oncology.
Direct peers
- Relay Therapeutics: Clinical-stage precision oncology company developing RLY-2608, a mutant-selective PI3Kα inhibitor, with breast cancer as a lead indication. Directly comparable PI3K-focused development-stage peer.
- Novartis: Markets Piqray (alpelisib), the standard-of-care PI3Kα inhibitor that gedatolisib directly outperformed in VIKTORIA-1's PIK3CA mutant cohort. Direct head-to-head competitor in HR+/HER2- advanced breast cancer.
- AstraZeneca: Markets Truqap (capivasertib), an AKT inhibitor approved for HR+/HER2- advanced breast cancer with PIK3CA/AKT1/PTEN alterations. Competes for the same second-line patient population as gedatolisib.
- Roche: Genentech/Roche developed inavolisib, a next-generation PI3Kα inhibitor that received FDA approval in HR+/HER2- PIK3CA-mutant advanced breast cancer. Represents the most imminent competitive threat to gedatolisib's commercial launch.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Celcuity social profiles
Digital presenceCelcuity financial estimates
Financial estimateRevenue estimate
Valuation estimate
Celcuity leadership team
Management profileNumber of profiles
Profiles11 records
Celcuity funding detail
Funding detailFunding overview
Funding rounds17 records
Investors14 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Celcuity M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Celcuity
What does Celcuity do?
Celcuity is a clinical-stage biotechnology company developing gedatolisib, a potential first-in-class pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway for cancer treatment. The company's lead candidate is being advanced through Phase 3 clinical trials (VIKTORIA-1, VIKTORIA-2, CELC-G-201) for HR+/HER2- advanced breast cancer and metastatic castration-resistant prostate cancer, with an FDA PDUFA goal date of July 17, 2026.
Is Celcuity a public or private company?
Celcuity is a public company. It is classified as public and is currently operating.
When was Celcuity founded?
Celcuity was founded in 2016. It employs 51 to 100 people.
Where is Celcuity based?
Celcuity is headquartered in Hamel, United States, in the North America region.
How does Celcuity make money?
Two revenue lines are on record. Pharmaceutical Product Sales are the primary driver. The others are product Revenue.
Who are Celcuity's main competitors?
Emerging players on record are Puma Biotechnology, G1 Therapeutics and MEI Pharma. Broad incumbents are Pfizer, Bayer and Daiichi Sankyo. Direct peers are Relay Therapeutics, Novartis, AstraZeneca and Roche.
Does Celcuity have an API?
No public API is recorded for Celcuity.
What industry is Celcuity in?
Celcuity's product category is Oncology Pharmaceuticals. Its primary akta.pro industry code is HLAKAFAJ, Breast Oncology, with a secondary code of HLAKAFAM, Genitourinary Oncology. Its NAICS code is 541714 and its SIC code is 2834.