Earnings summaries and quarterly performance for Celcuity.
Executive leadership at Celcuity.
Board of directors at Celcuity.
Research analysts who have asked questions during Celcuity earnings calls.
Chase Knickerbocker
Craig-Hallum Capital Group
3 questions for CELC
Also covers: AVDL, BFLY, BVS +17 more
Gil Blum
Needham & Company
3 questions for CELC
Also covers: ABSI, AUTL, FATE +9 more
MR
Maurice Raycroft
Jefferies Financial Group
3 questions for CELC
Also covers: ABEO, AFMD, ALNY +14 more
BC
Bradley Canino
Stifel
2 questions for CELC
Also covers: ARVN, KURA, KYMR +2 more
OM
Oliver McCammon
LifeSci Capital
2 questions for CELC
TB
Tara Bancroft
TD Cowen
2 questions for CELC
Also covers: ADVM, DAWN, FATE +10 more
Amin Makarem
Jefferies
1 question for CELC
Also covers: ABEO, CMPX, RIGL
Andrew Berens
Leerink Partners
1 question for CELC
Also covers: AGIO, ARVN, BGNE +6 more
EL
Eason Lee
Leerink Partners
1 question for CELC
FD
Frances Dovell
TD Cowen
1 question for CELC
Also covers: CRNX, LNTH, TVTX
FD
Frances Duvall
TD Cowen
1 question for CELC
SW
Stephen Willey
Stifel Financial Corp.
1 question for CELC
Also covers: ABCL, CGEN, CUE +10 more
Recent press releases and 8-K filings for CELC.
Celcuity's New Drug Application for Gedatolisib Accepted by FDA
CELC
Product Launch
New Projects/Investments
- Celcuity Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer (ABC).
- The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026.
- The NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, and gedatolisib previously received both Breakthrough Therapy and Fast Track designations.
Jan 20, 2026, 12:30 PM
Celcuity Discusses Gedatolisib's Clinical Progress and Market Opportunity
CELC
New Projects/Investments
Product Launch
Guidance Update
- Celcuity's lead asset, gedatolisib (Geta), a pan-PI3K/mTOR inhibitor, demonstrated a hazard ratio of 0.24 and nearly 10 months median PFS in the triplet arm (Geta + fulvestrant + CDK4/6) for wild-type patients in the Victoria I Phase III trial. Preliminary data for mutant patients showed 14.6 months median PFS.
- The company anticipates data for mutant patients from the Victoria I trial by end of Q1 or Q2 2026, and will provide an update on the wild-type cohort at San Antonio Breast on December 11th.
- Gedatolisib exhibits a favorable tolerability profile, with only 10% all-grade hyperglycemia and 2% grade three hyperglycemia in the wild-type cohort, significantly lower than other drugs in the pathway.
- Celcuity estimates the second-line HR-positive, HER2-negative breast cancer market to be a $6 billion opportunity, encompassing approximately 37,000 patients (60% wild-type, 40% mutant).
- The company is actively preparing for a commercial launch, having initiated preparations in Q1 2024 and planning to hire a sales force of 80-90 representatives closer to the expected approval date.
Dec 3, 2025, 12:30 PM
Celcuity Provides Update on Gedatolisib Clinical Trials and Commercial Strategy
CELC
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Celcuity's lead asset, gedatolisib, a pan-PI3K/mTOR inhibitor, is progressing through three phase III programs for HR-positive, HER2-negative breast cancer, targeting both second-line and first-line settings.
- The Victoria I trial in the post-CDK4/6 setting demonstrated promising results for the triplet arm (gedatolisib + fulvestrant + CDK4/6) in wild-type patients, achieving a hazard ratio of 0.24, which is noted as a lower hazard ratio than previously reported in breast cancer.
- Gedatolisib is characterized by its 300 times greater potency compared to other PI3K alpha inhibitors, its cytotoxic action, and a favorable safety profile with significantly lower rates of hyperglycemia (10% all-grade, 2% grade 3 in the wild-type cohort).
- The company estimates the second-line market for HR-positive, HER2-negative breast cancer to encompass approximately 37,000 patients, representing a served market potential of around $6 billion.
- Celcuity is actively preparing for the commercial launch of gedatolisib, having established most of its core team, with the sales force expected to be onboarded closer to the anticipated approval date.
Dec 3, 2025, 12:30 PM
Celcuity Discusses Gedatolisib Clinical Progress and Market Opportunity
CELC
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
- Celcuity's lead asset, gedatolisib (Geta), a pan-PI3K/mTOR inhibitor, is in three Phase III programs for HR-positive, HER2-negative breast cancer, including second-line (Victoria I) and first-line (Victoria II) settings.
- In the Victoria I wild-type cohort, the triplet arm (Geta + fulvestrant + CDK4/6) showed a hazard ratio of 0.24 and a median progression-free survival (PFS) of nearly 10 months.
- Preliminary data for the Victoria I mutant cohort indicated a median PFS of 14.6 months, significantly exceeding competitors like alpelisib (~7 months) and capivasertib (~5.5 months). Results for this cohort are anticipated by end of Q1 or Q2 2026.
- Geta demonstrated a favorable tolerability profile with only 10% all-grade hyperglycemia and 2% grade 3 hyperglycemia in the wild-type cohort, without discontinuations or dose reductions.
- The second-line HR-positive, HER2-negative breast cancer market represents an estimated $6 billion served market potential, with 37,000 patients (40% mutant, 60% wild-type). Celcuity is actively preparing for the drug's launch.
Dec 3, 2025, 12:30 PM
Celcuity announces completion of NDA submission for gedatolisib
CELC
Product Launch
New Projects/Investments
- Celcuity Inc. has completed the submission of its New Drug Application (NDA) to the U.S. FDA for gedatolisib for the treatment of HR+/HER2-/PIK3CA wild-type advanced breast cancer.
- The NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program and follows prior Breakthrough Therapy and Fast Track designations for gedatolisib.
- The submission is based on positive clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, where the gedatolisib-triplet regimen reduced the risk of disease progression or death by 76% (hazard ratio of 0.24) compared to fulvestrant.
- The median progression-free survival (PFS) for the gedatolisib-triplet was 9.3 months, an incremental improvement of 7.3 months over fulvestrant alone.
Nov 17, 2025, 9:36 PM
Celcuity Reports Q3 2025 Financial Results and Advances Gedatolisib Clinical and Regulatory Milestones
CELC
Earnings
Guidance Update
New Projects/Investments
- Celcuity reported a net loss of $43.8 million, or $0.92 per share, for Q3 2025, and ended the quarter with $455 million in cash, cash equivalents, and short-term investments.
- The company significantly strengthened its balance sheet, securing $287 million in net proceeds from concurrent offerings and increasing its term loan facility to $500 million, which is expected to fund operations through 2027.
- Key clinical and regulatory milestones include the release of positive top-line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 study and the FDA's acceptance of their request for a Real-Time Oncology Review (RTOR) program for gedatolisib, with NDA submission planned for Q4 2025.
- Enrollment for the PIK3CA mutant cohort of VIKTORIA-1 is complete, with top-line data expected in late Q1 2026 or Q2 2026, and commercial launch preparations are accelerating, targeting an estimated $5 billion-$6 billion addressable market with potential peak revenues of $2.5 billion-$3 billion for a second-line wild-type indication.
Nov 12, 2025, 9:30 PM
Celcuity Inc. Reports Q3 2025 Financial Results and Provides Clinical and Regulatory Updates
CELC
Earnings
New Projects/Investments
Debt Issuance
- Celcuity Inc. reported a net loss of $43.8 million, or $0.92 loss per share, for the third quarter ended September 30, 2025.
- The company announced positive detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial for gedatolisib, where the gedatolisib-triplet reduced the risk of disease progression or death by 76% compared to fulvestrant.
- The New Drug Application (NDA) submission for gedatolisib, based on data from the PIK3CA wild-type cohort, is on track to be completed during the fourth quarter of 2025, with the FDA accepting the request for the Real-Time Oncology Review (RTOR) program.
- As of September 30, 2025, Celcuity held $455.0 million in cash, cash equivalents, and short-term investments, and expects to fund operations through 2027 following recent capital raises including $287 million net proceeds from a public offering and an increased term loan facility.
Nov 12, 2025, 9:06 PM
Celcuity Provides Update on Gedatolisib Development and Commercialization Plans
CELC
Product Launch
New Projects/Investments
Guidance Update
- Celcuity's gedatolisib regulatory filing is on track for an NDA submission, having been accepted into the RTOR program, which historically leads to a 4-5 month review process.
- The company is preparing for commercialization, with market research indicating a focus on community settings where approximately 80% of patients are treated.
- Celcuity plans to advance gedatolisib through regulatory processes in Europe and Japan and expects to submit the MAA for Europe soon after the supplemental NDA for the mutant population.
- Enrollment for the Victoria 2 study in first-line metastatic breast cancer began in late July, with the randomized portion expected to build enrollment in 2026.
- The company's current cash on hand and term loan facility are projected to provide a financial runway through 2027.
Nov 11, 2025, 3:00 PM
Celcuity discusses gedatolisib regulatory filing and commercialization plans
CELC
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Celcuity is preparing for the commercialization of gedatolisib, a drug for breast and prostate cancer, following positive top-line data in July, and anticipates achieving a majority market share in the second-line setting.
- The company is on track to file a regulatory submission under an accelerated review pathway (RTOR program), with a potential approval timeline of 4 to 6 months from submission or acceptance.
- Celcuity plans to target both community and academic settings for commercialization in the US and is advancing regulatory submissions in Europe and Japan.
- The Phase 3 Victoria 2 trial for gedatolisib in first-line metastatic breast cancer, an all-comer study, enrolled its first patient in late July, with the randomized portion expected to begin in 2026.
- The company's current cash on hand and access to a term loan facility are expected to provide a cash runway through 2027.
Nov 11, 2025, 3:00 PM
CELC Reports Positive VICTORIA-one Phase 3 Results and Outlines Regulatory Path
CELC
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- CELC's Gadotelisib triplet regimen demonstrated a 7.3-month improvement in median progression-free survival (PFS) over fulvestrant, achieving 9.3 months median PFS and a 76% reduction in the risk of disease progression or death (hazard ratio 0.24) in PIK3CA wild type HR positive HER2 negative advanced breast cancer patients. The doublet regimen showed a 5.4-month improvement in PFS with a 67% reduction in risk (hazard ratio 0.33). Both regimens were generally well tolerated, with low rates of discontinuation due to treatment-related adverse events.
- These unprecedented results address a significant unmet need for an estimated 37,000 patients who have progressed on prior CDK4six inhibitors, representing a potential $5 billion addressable market.
- The company expects to submit a New Drug Application (NDA) for the PIK3CA wild type cohort indication this quarter (Q4 2025) and anticipates top-line data for the PIK3CA mutation cohort by late Q1 or Q2 2026. Patent protection for Gadotelisib's API extends through the end of 2034, with a drug formulation patent through 2041, and a dosing schedule patent to be included in the Orange Book.
Oct 20, 2025, 12:00 PM
Quarterly earnings call transcripts for Celcuity.
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