| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Oncology | ||
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Oncology | ||
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Oncology |
Recent Updates
Recently added Catalysts
Celcuity Inc.$107.58
-5.93 (-5.22%)
C 42Pipeline Score Richly Valued Biotech · Clinical
Market Cap
6.74 B
EPS
-3.90
P/E Ratio
-
Value Trade
481.85 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
33.06 M
Operating CF
-55.06 M
Total Assets
410.16 M
Total Liabilities
356.64 M
Equity
53.52 M
D/E Ratio
12,345
6.17 %
Week
9.45 %
1 Month
29.62 %
3 Month
48.81 %
6 Month
367.63 %
5 Year
1,019.27 %
All Time
Cash Data
Cash Position
387.06 M
Monthly Burn
18.36 M
Runway
19.4 mo
Burn Trend
SEC Filing
May 14, 2026
Overview
Volume
698.70 K
52 Week Range
10.26 - 151.02
% held by Insiders
20.21 %
% held by Institutions
89.79 %
Enterprise Value
6.68 B
Total Shares
48.75 M
Short %
30.12 %
Float Shares
36.41 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Celcuity Inc.
309Total events
4Upcoming
76Tier-1 (high impact)
2017 – 2026Coverage
Upcoming catalysts 4
Event history 305
Q3 2026
◆Product LaunchGedatolisibApprovedPost-Market
Commercial launch anticipated in Q3 2026 pending FDA approval
HR+/HER2- advanced breast cancersource ↗
Q3 2026
◆FDA ApprovalGedatolisibApprovedFDA Decision
Potential FDA approval in Q3 2026
HR+/HER2- advanced breast cancersource ↗
Q3 2026
●sNDA SubmissionGedatolisibApprovedRegulatory Filing
Celcuity intends to submit sNDA to FDA in Q3 2026
HR+/HER2- advanced breast cancersource ↗
Jun 10, 2026
◆Oral PresentationPresentation
Fireside chat at Goldman Sachs 47th Annual Global Healthcare Conference 2026
Jun 4, 2026
Jun 3, 2026
▼Equity OfferingCorporate
Proposed public offering of $400M convertible senior notes due 2032
Jun 2, 2026
◆Oral PresentationGedatolisibApprovedPresentation
Conference call to discuss results from PIK3CA mutant cohort of Phase 3 VIKTORIA-1 trial
HR+/HER2- advanced breast cancersource ↗
Jun 2, 2026
◆Late-BreakerGedatolisibApprovedPresentation
Late-breaking abstract oral presentation at ASCO 2026
HR+/HER2- advanced breast cancersource ↗
Jun 2, 2026
▲Topline ReadoutGedatolisibApprovedClinical Data
Topline efficacy and safety results from PIK3CA mutant cohort
HR+/HER2- advanced breast cancer with PIK3CA mutationsource ↗
Jun 2, 2026
▲Primary Endpoint MetGedatolisibApprovedClinical Data
Gedatolisib-triplet met primary endpoint of PFS
HR+/HER2- advanced breast cancer with PIK3CA mutationsource ↗
May 14, 2026
◆Quarterly UpdateCorporate
First Quarter 2026 Financial Results Release and Webcast/Conference Call
May 14, 2026
◆Type B MeetingGedatolisibApprovedFDA Meeting
Type B meeting with FDA to gain alignment on VIKTORIA-2 amendments
HR+/HER2- advanced breast cancersource ↗
Drug Pipeline Intelligence
C42
Pipeline Score $151M
Pipeline ValueRichly Valued
Valuation Signal2
Drugs Scored0.0x
rNPV / MCap Top 62%
Small Cap (rank 347 of 911)
Percentile RankCelcuity Inc. carries a moderate pipeline score (42/100), with $232M risk-adjusted pipeline value, led by Gedatolisib in Breast Cancer (Phase 3), across $51B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gedatolisib Small molecule | Breast Cancer | Phase 3 | NCT05501886 | 42% | $222M | ACTIVE NOT_RECRUITING | 842 | FAST | C (58) | Dec 31, 2026 | MODERATE_RISK | LOW May 26, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
gedatolisib Priority | HR+/HER2- advanced breast cancer | Phase 3 | 2026-06-02 | gedatolisib triplet: risk reduction 50%, median pfs 11.1 months, orr 48.9%, median dor 15.7 months; gedatolisib doublet: risk reduction 49%, median pfs 11.3 months, orr 35.7%, median dor 24.2 months; alpelisib plus fulvestrant: median pfs 5.6 months, orr 26.0%, median dor 7.5 months Read More | Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer Read More | |
gedatolisib Priority | HR+/HER2- advanced breast cancer | Phase 3 | 2026-06-02 | gedatolisib triplet: risk reduction 50%, median pfs 11.1 months, orr 48.9%, median dor 15.7 months; gedatolisib doublet: risk reduction 49%, median pfs 11.3 months, orr 35.7%, median dor 24.2 months; alpelisib plus fulvestrant: median pfs 5.6 months, orr 26.0%, median dor 7.5 months Read More | Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer Read More | |
gedatolisib Priority | HR+/HER2- advanced breast cancer | Phase 3 | 2026-06-02 | gedatolisib triplet: risk reduction 50%, median pfs 11.1 months, orr 48.9%, median dor 15.7 months; gedatolisib doublet: risk reduction 49%, median pfs 11.3 months, orr 35.7%, median dor 24.2 months; alpelisib plus fulvestrant: median pfs 5.6 months, orr 26.0%, median dor 7.5 months Read More | Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in CELC
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
CELC Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-09-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-09-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-09-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
CELCCelcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032
Celcuity Inc. has announced the pricing of its upsized public offering of $500 million in 0.250% convertible senior notes due 2032, increasing from a previously announced $400 million. The offering is set to close on June 8, 2026, and proceeds will be used for debt repayment and general corporate purposes, including clinical trials. The notes will be convertible under specific conditions, providing flexibility for investors.
Read more →CELCCelcuity Inc. Announces Public Offering of Convertible Senior Notes Due 2032
Celcuity Inc. has announced a public offering of $400 million in convertible senior notes due 2032. The proceeds will primarily be used to repay existing debts and support various corporate purposes, including clinical trials. The offering is subject to market conditions, and the company has filed a registration statement with the SEC for this offering.
Read more →CELC▼ -25.7%on this newsshared move
Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer
Celcuity's gedatolisib, in combination with fulvestrant and palbociclib, demonstrated significant efficacy in the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer. The gedatolisib-triplet reduced the risk of disease progression or death by 50% compared to alpelisib plus fulvestrant, with median progression-free survival of 11.1 months. The study results will be presented at the ASCO Annual Meeting, and Celcuity plans to submit data for FDA approval.
Read more →CELC▼ -7.5%on this news· ran to -31% by day 1shared move
Celcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib Regimens in HR+/HER- Advanced Breast Cancer on June 2, 2026
Celcuity Inc. will host a conference call on June 2, 2026, to discuss results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. The trial evaluates gedatolisib, a kinase inhibitor, in patients with HR+/HER2- advanced breast cancer. The call will provide insights into the efficacy and safety of gedatolisib in this patient population.
Read more →CELCCelcuity To Participate in Upcoming Investor Conferences
Celcuity Inc. announced its participation in upcoming investor conferences, where CEO Brian Sullivan will present and hold one-on-one meetings. The events include the Jefferies Global Healthcare Conference and the Goldman Sachs Annual Global Healthcare Conference. The company continues to advance its clinical-stage therapies for solid tumors, particularly focusing on gedatolisib.
Read more →CELC▲ +8.2%on this news
Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients
Celcuity Inc. has announced new changes to its Phase 3 VIKTORIA-2 trial for gedatolisib, now including endocrine-sensitive patients with HR+/HER2- advanced breast cancer. This adjustment follows previous promising data on progression-free survival in a related study. The trial will consist of separate analyses for both endocrine-resistant and endocrine-sensitive populations, aiming to evaluate the efficacy of gedatolisib combined with existing therapies. Additionally, Celcuity is developing a subcutaneous formulation of gedatolisib to potentially enhance treatment delivery for patients.
Read more →CELC▲ +8.2%on this news
Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update - Phase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival
Celcuity Inc. has reported financial results for the first quarter of 2026 and announced significant advancements in its clinical programs. The Phase 3 VIKTORIA-1 trial achieved its primary endpoint, demonstrating a meaningful improvement in progression-free survival among patients. The company is on track to potentially launch gedatolisib, a targeted therapy for HR+/HER2- advanced breast cancer, pending FDA approval expected in the third quarter of 2026. Additionally, Celcuity is developing a subcutaneous formulation of gedatolisib and has expanded its Phase 3 VIKTORIA-2 trial to include treatment-naive patients.
Read more →CELC▼ -6.3%on this news
Celcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference Call
Celcuity Inc. will release its financial results for Q1 2026 on May 14, 2026, after market close. A webcast and teleconference will follow at 4:30 p.m. ET to discuss the results and provide a corporate update. The company is focused on developing targeted therapies for oncology, with ongoing clinical trials for its lead candidate, gedatolisib.
Read more →CELC▲ +15.4%on this newsshared move
Celcuity’s Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort
Celcuity Inc. announced positive topline results from the Phase 3 VIKTORIA-1 trial, demonstrating a significant improvement in progression-free survival for patients with PIK3CA mutant advanced breast cancer. The trial evaluated gedatolisib combined with fulvestrant, with or without palbociclib. Detailed results will be presented at the 2026 ASCO Annual Meeting, and Celcuity plans to submit these findings to the FDA for further review.
Read more →CELCCelcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort Detailed data for the gedatolisib triplet and doublet regimens wil
Celcuity Inc. announced that its Phase 3 VIKTORIA-1 trial for gedatolisib, combined with fulvestrant, achieved its primary endpoint in the PIK3CA mutant cohort. The results demonstrated a statistically significant improvement in progression-free survival compared to the standard treatment. The company plans to submit these findings to the FDA for a supplemental New Drug Application. Furthermore, both treatment regimens were reported to be generally well tolerated, further supporting the potential of gedatolisib in improving outcomes for advanced breast cancer patients.
Read more →CELCCelcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Celcuity Inc. reported its financial results for Q4 and full year 2025, highlighting a net loss of $51 million for Q4. The company anticipates releasing topline results from its Phase 3 VIKTORIA-1 study in Q2 2026, which could enhance treatment options for advanced breast cancer. Additionally, Celcuity is preparing for the commercial launch of gedatolisib, pending FDA approval expected in Q3 2026.
Read more →CELCCelcuity Schedules Release of Fourth Quarter and Full Year 2025 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced its schedule for releasing the financial results for the fourth quarter and full year 2025. The results will be made available after market close on March 25, 2026. Following the release, the company will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide updates on corporate developments.
Read more →CELCCelcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology
Celcuity announced the publication of results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 study, showing that gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, demonstrates significant efficacy in treating HR+/HER2- advanced breast cancer. The gedatolisib triplet regimen showed a substantial improvement in median progression-free survival compared to standard treatment. The clinical trial results are seen as potentially practice-changing, particularly for patients with limited options. The FDA's Priority Review of the New Drug Application signifies a critical step forward for gedatolisib's potential approval and availability.
Read more →CELCCelcuity To Participate in Upcoming March 2026 Investor Conferences
Celcuity Inc. announced its participation in upcoming investor conferences, where CEO Brian Sullivan will present and hold one-on-one meetings. The company is focused on developing targeted therapies for oncology, with its lead candidate, gedatolisib, currently undergoing multiple clinical trials, including Phase 3 studies for breast cancer and prostate cancer. Detailed trial results and ongoing studies are accessible on their website.
Read more →CELCCelcuity Appoints Charles Romp to its Board of Directors MINNEAPOLIS
Celcuity Inc. has appointed Charles R. Romp to its Board of Directors, bringing extensive experience in the pharmaceutical industry, particularly in oncology. Romp, who is currently the CEO of Secura Bio, has held significant roles at Seagen and Genentech, which positions him to provide valuable insights as Celcuity advances its targeted therapies. The company is preparing for the potential launch of its lead therapy, gedatolisib, later this year, as it progresses through key clinical trials for breast cancer and prostate cancer indications.
Read more →CELCCelcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026
Celcuity Inc. will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026. CEO Brian Sullivan is scheduled for a fireside chat on February 11. The company is focused on developing targeted therapies for oncology, with ongoing clinical trials for its lead candidate, gedatolisib.
Read more →CELCCelcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
Celcuity Inc. announced that the FDA has accepted its New Drug Application for gedatolisib, targeting HR+/HER2- advanced breast cancer. The FDA granted Priority Review with a PDUFA goal date of July 17, 2026. This submission is based on data from the Phase 3 VIKTORIA-1 trial, highlighting gedatolisib's potential as a new treatment option.
Read more →CELCCelcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium
Celcuity Inc. announced updated results from the Phase 3 VIKTORIA-1 trial, highlighting the efficacy of gedatolisib in patients with hormone receptor positive, HER2-negative advanced breast cancer. The trial demonstrated a median progression-free survival of 16.6 months for the gedatolisib triplet therapy. Additionally, patients reported a significant delay in deterioration of well-being, with improvements seen in stomatitis management. The findings were presented at the 2025 San Antonio Breast Cancer Symposium.
Read more →CELCCelcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference
Celcuity Inc. will participate in the 8th Annual Evercore Healthcare Conference in Miami from December 2-4, 2025. CEO Brian Sullivan is scheduled for a fireside chat on December 3 at 7:30 a.m. ET. The company is focused on developing targeted therapies for oncology, with ongoing clinical trials for its lead candidate, gedatolisib.
Read more →CELCCelcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium
Celcuity Inc. has announced that an abstract was accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium. The presentation will feature updated efficacy and safety data from the PIK3CA Wild-Type cohort of the phase 3 VIKTORIA-1 trial. The event will take place from December 9-12, 2025, and highlights Celcuity's efforts in developing targeted therapies for advanced breast cancer.
Read more →CELCCelcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/ PIK3CA Wild-Type Advanced Breast Cancer MINNEAPOLIS
Celcuity Inc. has announced the completion of its New Drug Application (NDA) submission for gedatolisib to the U.S. FDA, aimed at treating hormone receptor positive, HER2-negative advanced breast cancer. The NDA was filed under the FDA's Real-Time Oncology Review program, designed to expedite the regulatory approval process. The submission is bolstered by promising clinical data from the Phase 3 VIKTORIA-1 trial, which showed notable improvements in progression-free survival compared to standard treatments. The company is optimistic about the drug's efficacy and safety profile, viewing it as a potential advancement in oncology treatment options.
Read more →CELCCelcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Celcuity Inc. reported its Q3 2025 financial results, highlighting significant clinical advancements, particularly for gedatolisib in the VIKTORIA-1 trial. The company plans to submit a New Drug Application for gedatolisib based on promising data. Despite a net loss of $43.8 million, Celcuity maintains a strong cash position of $455 million to support ongoing operations.
Read more →CELCCelcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release of its third quarter 2025 financial results, scheduled for November 12, 2025. Following the release, management will host a webcast and teleconference to discuss the results and provide updates on corporate activities. The company is focused on developing targeted therapies for oncology, with ongoing clinical trials for its lead candidate, gedatolisib.
Read more →CELCCelcuity To Present at Upcoming Stifel 2025 Healthcare Conference
Celcuity Inc. will present at the Stifel 2025 Healthcare Conference in New York from November 11-13, 2025. CEO Brian Sullivan is scheduled for a fireside chat on November 11 at 10:00 a.m. ET. The event will be available via live webcast, and Celcuity's ongoing clinical trials for its lead candidate, gedatolisib, were also highlighted.
Read more →CELC▲ +35.8%on this news
Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast
Celcuity Inc. presented detailed results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial at the ESMO Congress. Patients treated with gedatolisib regimens showed significant improvements in median progression-free survival compared to fulvestrant, with the gedatolisib triplet yielding 9.3 months versus 2.0 months for fulvestrant. The results suggest that these regimens could become the new standard of care for HR+/HER2- advanced breast cancer following CDK4/6 inhibitor treatment. Both gedatolisib triplet and doublet were generally well tolerated, with low rates of serious adverse effects reported.
Read more →CELC▲ +35.8%on this newsshared move
Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer
Celcuity Inc. presented promising results from the Phase 3 VIKTORIA-1 trial of gedatolisib for HR+/HER2- advanced breast cancer at the ESMO Congress. The gedatolisib triplet showed a 76% reduction in disease progression risk compared to fulvestrant, with a median progression-free survival of 9.3 months. The safety profile was favorable, indicating potential for changing treatment standards.
Read more →CELC▲ +35.8%on this newsshared move
Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer (“mCRPC”)
Celcuity Inc. presented updated Phase 1 trial data for gedatolisib combined with darolutamide in men with metastatic castration-resistant prostate cancer at the ESMO Congress. The trial showed a six-month rPFS rate of 67% and a median rPFS of 9.1 months. The combination therapy was well tolerated, with no significant toxicities reported, and the company is now enrolling patients for the Phase 1/1b portion of the study.
Read more →CELC▲ +35.8%on this newsshared move
Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial
Celcuity Inc. has announced that the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 trial is fully enrolled. The company expects to report topline data in late Q1 or Q2 2026. Additionally, updated results from a Phase 1b trial showed a median progression-free survival of 14.6 months for patients with PIK3CA mutations, indicating promising efficacy of gedatolisib in this population.
Read more →CELCCelcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress
Celcuity Inc. announced that clinical data from its Phase 3 VIKTORIA-1 trial will be presented at the ESMO Congress on October 18, 2025. The presentation will focus on the efficacy and safety of gedatolisib in combination with fulvestrant for patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer. This highlights the company's commitment to developing targeted therapies for oncology.
Read more →CELCCelcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance MINNEAPOLIS, MN
Celcuity Inc. has announced an upsized senior secured term loan facility of $500 million in collaboration with Innovatus Capital Partners and Oxford Finance. The deal increases the company's capital access with $350 million in committed capital and a discretionary $150 million. Celcuity intends to use the funds to support the rolling submission of its New Drug Application for gedatolisib, alongside preparations for commercial launch. This financial enhancement follows positive topline data from its VIKTORIA-1 Phase 3 clinical trial, indicating a strong trajectory for the company moving forward.
Read more →CELC▲ +9.3%on this news
Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program
Celcuity Inc. announced that the FDA has accepted its New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer under the Real-Time Oncology Review program. The NDA submission will be based on positive topline results from the Phase 3 VIKTORIA-1 trial, which showed significant improvements in progression-free survival. The company aims to complete the NDA submission by Q4 2025.
Read more →CELCCelcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update - Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type coh
Celcuity Inc. reported its financial results for the second quarter of 2025, highlighting significant progress in clinical trials and financial restructuring. The company announced a statistically significant improvement in progression-free survival from the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1 trial. They are on track to submit a New Drug Application for gedatolisib in late 2025, supported by a recent financing that bolsters their operational funds. However, rising expenses and an increasing net loss pose notable financial challenges for the company moving forward.
Read more →CELCCelcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call
Celcuity Inc., a clinical-stage biotechnology company, has announced the release of its financial results for the second quarter of 2025, which will occur after market close on August 14, 2025. Management will also host a webcast and teleconference at 4:30 p.m. Eastern Time on the same day to discuss the financial results and provide a corporate update. This event is expected to enhance transparency with stakeholders and offer insights into the company's progress.
Read more →CELCCelcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants MINNEAPOLIS
Celcuity Inc. announced the pricing of its public offerings, which include $175 million in convertible senior notes and additional common stock. The convertible notes will mature in 2031 and carry a 2.750% interest rate, while the common stock is priced at $38 per share. The proceeds are intended for use in working capital and clinical trials. However, the company's decision not to enter into capped call transactions may lead to volatility in stock prices and potential dilution for existing shareholders.
Read more →CELC▲ +167.2%on this newsshared move
Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock MINNEAPOLIS
Celcuity Inc. has announced public offerings totaling $225 million, comprising $150 million in convertible senior notes due 2031 and $75 million in common stock. The company plans to utilize the proceeds for working capital, including clinical trial expenditures and business development. Both offerings are conditional on market conditions, highlighting potential uncertainties regarding their completion. The company is also engaged in multiple clinical trials for its lead candidate, gedatolisib, a treatment for various cancers.
Read more →CELC▲ +167.2%on this newsshared move
Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival ("PFS") Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Hazard Ratios and Improvements in Median PFS are U
Celcuity announced promising topline results from the Phase 3 VIKTORIA-1 trial for its drug gedatolisib, showing significant improvements in progression-free survival among patients with HR-positive, HER2-negative advanced breast cancer. The trials indicated a reduction in the risk of disease progression or death by 76% for the gedatolisib triplet compared to fulvestrant. Both the triplet and doublet regimens demonstrated substantial median PFS improvements over the control. The company plans to submit a New Drug Application to the FDA later this year.
Read more →CELCCelcuity to Announce Topline Results for the PIK3CA Wild-Type Cohort from Phase 3 VIKTORIA-1 Trial in HR+/HER2- Advanced Breast Cancer
Celcuity Inc. has announced a conference call and webcast scheduled for July 28, 2025, to reveal the topline results from its Phase 3 VIKTORIA-1 trial focused on the PIK3CA Wild-Type Cohort in HR+/HER2- advanced breast cancer. This event is expected to provide crucial data on the efficacy of targeted therapies developed by the company. The results may significantly influence treatment approaches for this particular breast cancer subtype.
Read more →CELCCelcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer
Celcuity Inc. has announced that the first patient has been dosed in its Phase 3 VIKTORIA-2 clinical trial, which evaluates gedatolisib combined with standard treatments for HR+/HER2- advanced breast cancer. This trial aims to provide better treatment options for patients who are resistant to endocrine therapy. Preliminary results from earlier studies suggest potential benefits for patients with this challenging condition. However, there are concerns about the untested combination therapies and regulatory timelines.
Read more →CELCCelcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042
Celcuity Inc. announced the issuance of a U.S. patent covering the clinical dosing regimen for its drug candidate gedatolisib, extending patent exclusivity in the U.S. until 2042. This enhances Celcuity's intellectual property portfolio, positioning the company favorably for the future. The company expects to announce topline clinical trial data for the PIK3CA cohorts in late 2025. However, there are risks related to potential challenges to the patent's validity and the timeline of the clinical trial outcomes.
Read more →CELC▲ +6.5%on this news
Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib
Celcuity reported encouraging preliminary clinical data for gedatolisib from two early phase trials. In the Phase 1 trial for metastatic castration-resistant prostate cancer, the six-month radiographic progression-free survival rate was 66%, with no treatment-related discontinuations. In a Phase 2 trial for HER2+ metastatic breast cancer, an objective response rate of 43% was observed. Both trials showed significant promise, leading to further exploration of gedatolisib dosing.
Read more →CELCCelcuity To Present at Upcoming TD Cowen and Jefferies Investor Conferences
Celcuity Inc. (Nasdaq: CELC) has announced that CEO Brian Sullivan will present at the TD Cowen Oncology Innovation Summit on May 28, 2025, and the Jefferies Global Healthcare Conference on June 5, 2025. Investors will have the opportunity for one-on-one meetings, with live webcasts available for both conferences. This event showcases the company’s focus on the development of targeted therapies in oncology.
Read more →CELCCelcuity Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update - The primary completion date of the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is expected in June 2025 and a topline
Celcuity Inc. announced its financial results for Q1 2025, showing significant operational expenses and losses. The company is on track to report topline data for the VIKTORIA-1 trial's PIK3CA wild-type cohort this year, as well as ongoing collaborations with leading hospitals for other cancer treatment evaluations. The financial report also highlighted a solid cash position of $205.7 million, which is expected to fund future clinical trials through 2026. Despite the challenges faced, including increased operating costs and potential delays in trials, the company remains optimistic about its pipeline and upcoming data releases.
Read more →CELCCelcuity Inc. Schedules Release of First Quarter 2025 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release of its financial results for the first quarter of 2025, scheduled after market close on May 14, 2025. The company will also host a webcast and teleconference at 4:30 p.m. Eastern Time on the same day to discuss the results and provide a corporate update. Investors can access the live webcast through a provided link, and a replay will be available on the company's website following the event.
Read more →CELC▼ -8.1%on this news
Celcuity To Present at Upcoming Needham and Stifel Investor Conferences
Celcuity Inc. has announced that its CEO, Brian Sullivan, will be presenting at two upcoming virtual investor conferences: the Stifel 2025 Virtual Targeted Oncology Forum and the 24th Annual Needham Virtual Healthcare Conference. These events are scheduled for April 9 and April 10, 2025, respectively, and will feature opportunities for one-on-one meetings with investors. Live webcasts of the presentations will be available, underscoring the company's ongoing commitment to investor relations and transparency in its oncology-focused initiatives.
Read more →CELCCelcuity Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update - The PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is on track to report topline data in Q2 2025 - VIKTOR
Celcuity Inc. announced its financial results for Q4 and the full year 2024, highlighting significant steps in its clinical development. The PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is expected to report topline data in Q2 2025, with the VIKTORIA-2 trial on track to begin patient enrollment around the same time. The company presented promising preliminary overall survival data for gedatolisib at a recent oncology conference. However, Celcuity also reported a considerable increase in operating expenses and a higher net loss compared to 2023.
Read more →CELCCelcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced plans to release its financial results for the fourth quarter and full year of 2024 on March 31, 2025, after market close. The company will follow the release with a webcast and conference call at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. This release reflects the company's continued efforts in the biotechnology sector, particularly in oncology treatments.
Read more →CELC▼ -9%on this news
Celcuity to Participate at Upcoming Cowen and Leerink Investor Conferences
Celcuity Inc. will be participating in two key investor conferences in March 2025, where CEO Brian Sullivan will present and hold one-on-one meetings with investors. The conferences include the TD Cowen 45th Annual Health Care Conference in Boston and the Leerink Global Healthcare Conference 2025 in Miami. These events provide Celcuity with an opportunity to showcase its developments in targeted therapies for oncology.
Read more →CELCCelcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy at the 2024 San Antonio Breast Cancer Symposium
Celcuity Inc. has announced promising overall survival data from a Phase 1b study evaluating gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, combined with palbociclib and endocrine therapy for patients with HR+, HER2- advanced breast cancer. The median overall survival for treatment-naïve patients was reported at 77.3 months, indicating a strong response compared to existing treatments. Additionally, gedatolisib has received FDA Breakthrough Therapy designation for patients whose disease has progressed after treatment with a CDK4/6 inhibitor. This data was presented at the 2024 San Antonio Breast Cancer Symposium.
Read more →CELCCelcuity Inc. Reports Third Quarter Financial Results and Provides Corporate Update - The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1
Celcuity Inc. reported its third quarter financial results and announced that the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial has reached full enrollment. The company is expected to release topline data for this cohort in late Q1 or Q2 of 2025. A strong cash position of approximately $264 million is forecasted to sustain their clinical development programs through 2026. However, increasing operational costs have led to higher losses in comparison to the previous year’s quarter.
Read more →CELCCelcuity Inc. To Present at Upcoming Stifel and Jefferies Investor Conferences
Celcuity Inc. has announced that its CEO, Brian Sullivan, will speak at upcoming investor conferences, including the Stifel 2024 Healthcare Conference and the Jefferies London Healthcare Conference. The presentations are set to take place on November 19 and November 21, 2024, respectively. Live webcasts of these events will be available for interested investors. This opportunity aims to strengthen investor relations and showcase the company's targeted therapies for oncology.
Read more →CELCCelcuity Inc. Schedules Release of Third Quarter 2024 Financial Results and Webcast/Conference Call
Celcuity Inc. has scheduled its third quarter 2024 financial results release for November 14, 2024, after market close. The company will hold a webcast and teleconference at 4:30 p.m. Eastern Time the same day to discuss the results and provide further updates. This event underscores Celcuity's ongoing efforts to maintain communication with investors and share significant company developments.
Read more →CELCCelcuity Inc. Reports Second Quarter Financial Results and Provides Corporate Update - Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first
Celcuity Inc. has reported its second quarter financial results and announced plans to initiate the Phase 3 VIKTORIA-2 trial for gedatolisib in 2025. The company raised $129 million in financing, ensuring operational continuity through 2026. However, it noted a shift in the proportion of patients with PIK3CA wild-type tumors, affecting enrollment timelines and forecasted data release. Despite increased operating expenses, the company is progressing well with its clinical trials and other cancer-related initiatives.
Read more →CELCCelcuity Inc. Schedules Release of Second Quarter 2024 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced its schedule for the release of financial results for the second quarter of 2024, set to take place after market close on August 14, 2024. The company will also host a webcast and conference call at 4:30 p.m. Eastern Time on the same day to discuss the results and offer a corporate update. This event underscores Celcuity's commitment to communication with its stakeholders and highlights its ongoing developments in targeted therapies for oncology.
Read more →CELC▼ -5.3%on this news
Celcuity To Participate in Jefferies Global Healthcare Conference
Celcuity Inc. announced its participation in the upcoming Jefferies Global Healthcare Conference set to take place in New York from June 4 to June 6, 2024. CEO Brian Sullivan will engage in a fireside chat on June 6 at 10:00 a.m. ET. The event can be followed live via a webcast, further promoting the company’s focus on oncology therapies.
Read more →CELCCelcuity Announces Pricing of Underwritten Common Stock Offering MINNEAPOLIS
Celcuity Inc. has announced the pricing of an underwritten offering of 3,871,000 common stock shares at $15.50 each, anticipated to close on May 31, 2024. The offering aims to raise approximately $60 million which will be utilized for corporate purposes, including funding multiple clinical trials for its lead therapeutic candidate, gedatolisib, specifically targeting HR+/HER2- advanced breast cancer. The offering is facilitated with underwriting by TD Cowen and Stifel, and the company's financial strategy suggests it can sustain operations through at least mid-2026.
Read more →CELCCelcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 million Debt Financing - The Phase 3 clinical t
Celcuity Inc. has announced plans to initiate a Phase 3 clinical trial focusing on gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer. The trial aims to evaluate the efficacy of gedatolisib combined with a CDK4/6 inhibitor and fulvestrant in patients resistant to endocrine therapy. Concurrently, the company secured approximately $62 million in debt financing to support this initiative, reflecting confidence in the drug's potential. The trial is set to begin enrolling patients in the second quarter of 2025.
Read more →CELCCelcuity Inc. Reports First Quarter Financial Results and Provides Corporate Update - The Phase 3 VIKTORIA-1 trial remains on track to report topline data from PIK3CA wild type patient sub-group in the second half of 202
Celcuity Inc. reported its first quarter financial results for 2024, highlighting progress in clinical trials and financial stability. The Phase 3 VIKTORIA-1 trial remains on schedule to deliver topline data from PIK3CA wild type patients in late 2024. The company also commenced a Phase 1b/2 trial for gedatolisib in combination with darolutamide for advanced prostate cancer. Financially, Celcuity holds $177.7 million in cash resources, projected to last into 2026, despite an increase in operating losses compared to the previous year.
Read more →CELCCelcuity Inc. Schedules Release of First Quarter 2024 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release date for its financial results for the first quarter of 2024, set for May 15, 2024. Following the announcement, the company's management will conduct a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. This reflects Celcuity's commitment to maintaining open communication with its stakeholders.
Read more →CELCCelcuity Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update - Dosed the first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the trea
Celcuity Inc. (CELC) has reported its financial results for the fourth quarter and full year of 2023, highlighting the dosing of the first patient in a Phase 1b/2 trial of gedatolisib in combination with darolutamide for metastatic castration resistant prostate cancer. The company raised $65 million to strengthen its financial position and expects to have enough cash to fund operations into the first half of 2026. Notably, it also presented data showing gedatolisib's enhanced effectiveness compared to other PI3K/AKT/mTOR inhibitors at the 2023 SABCS.
Read more →CELCCelcuity Inc. Schedules Release of Fourth Quarter and Full Year 2023 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release of its financial results for the fourth quarter and full year 2023. This event is scheduled to take place on March 27, 2024, after market close. Additionally, the company will host a webcast/teleconference at 4:30 p.m. ET to discuss these results and offer a corporate update. This engagement highlights Celcuity's commitment to maintaining communication with its investors and stakeholders.
Read more →CELCCelcuity to Participate in Leerink Partners Global Biopharma Conference 2024
Celcuity Inc., a biotechnology company focused on oncology therapies, will present at the Leerink Partners Global Biopharma Conference 2024 in Miami from March 11-13, 2024. CEO Brian Sullivan is scheduled to deliver a podium presentation on the final day of the conference. The event will be accessible via a live webcast, which will also be available for replay on the company’s investor relations page.
Read more →CELCCelcuity to Participate in Cowen’s 44th Annual Health Care Conference
Celcuity Inc. announced its participation in Cowen’s 44th Annual Health Care Conference scheduled for March 4-6, 2024, in Boston. The Chief Executive Officer, Brian Sullivan, will conduct a fireside chat on March 6 at 2:10 p.m. ET. Investors can access a live webcast of this event through specific links provided, with a replay available afterward.
Read more →CELCCelcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer
Celcuity Inc. has announced the dosing of the first patient in its Phase 1b/2 clinical trial, CELC-G-201, which evaluates gedatolisib in combination with darolutamide for metastatic castration resistant prostate cancer (mCRPC). The trial aims to assess the safety, tolerability, and recommended Phase 2 dosage of gedatolisib, which targets all Class 1 PI3K isoforms and mTORC1/2. Enrollment is set for up to 54 participants, with the primary objective being to improve radiographic progression-free survival. Collaboration with Bayer AG ensures supply of the androgen receptor inhibitor darolutamide at no cost during the trial.
Read more →CELC▼ -5.5%on this newsshared move
Celcuity Appoints Eldon Mayer as Chief Commercial Officer
Celcuity Inc. has appointed Eldon Mayer as its Chief Commercial Officer, leveraging his extensive biopharmaceutical experience. Mayer's leadership is expected to guide the company in the commercial launch of gedatolisib, a prospective therapy for various tumors. His background includes significant roles in successful product launches across his career, promising a strategic approach to Celcuity's marketing efforts. This transition comes at a critical time as the company prepares for important milestones regarding gedatolisib.
Read more →CELCCelcuity Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Breast Cancer Models at the 2023 San Antonio Breast Cancer Symposium
Celcuity Inc. presented promising preclinical data on gedatolisib, a pan-PI3K/mTOR inhibitor, at the 2023 San Antonio Breast Cancer Symposium. The data indicated that gedatolisib was over 300-fold more potent than single node PAM inhibitors in breast cancer cell lines. In vivo studies demonstrated its effectiveness in reducing tumor growth, suggesting potential advantages over existing therapies. This data emphasizes the importance of gedatolisib's unique mechanism of action in oncology treatment.
Read more →CELCCelcuity to Present Preclinical Data for Gedatolisib at the 2023 San Antonio Breast Cancer Symposium
Celcuity Inc. will present new preclinical data on gedatolisib at the 2023 San Antonio Breast Cancer Symposium. The poster presentation will highlight the drug's enhanced potency and efficacy as a pan-PI3K/mTOR inhibitor compared to other approved PAM inhibitors, particularly in breast cancer cell lines. These promising results may inform ongoing clinical trials, including the Phase 3 VIKTORIA-1 trial assessing gedatolisib in combination therapies for advanced breast cancer. Presentation is scheduled for December 6, 2023.
Read more →CELCCelcuity to Participate in the 6th Annual Evercore ISI HealthCONx Conference
Celcuity Inc. announced its participation in the 6th Annual Evercore ISI HealthCONx Conference scheduled for November 29, 2023, in Miami. Brian Sullivan, the company's Chairman and CEO, will lead a fireside chat during the event. A live webcast of the presentation will be available for those interested in following the discussion on the company's developments in targeted therapies for oncology.
Read more →CELCCelcuity Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Updates - Received FDA clearance of IND to evaluate gedatolisib in combination with darolutamide in patients with metastatic castration re
Celcuity Inc. reported strong financial and corporate updates for Q3 2023, highlighting the FDA's clearance of an IND to evaluate gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer. The company also raised $50 million in equity financing and entered a collaboration with Bayer AG for clinical trials. Despite these positives, Celcuity faced an increased loss compared to the previous year and reported higher operating and research costs. Their ongoing projects aim to impact over 200,000 patients globally.
Read more →CELCCelcuity Inc. Schedules Release of Third Quarter 2023 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release date for its third quarter 2023 financial results, which will be made public before market opening on November 13, 2023. Management plans to host a webcast and teleconference on the same day at 8:00 a.m. Eastern Time to discuss these results and provide a corporate update. This move indicates the company's commitment to transparency and communication with investors and stakeholders.
Read more →CELC▼ -5.4%on this newsshared move
Celcuity To Present at Upcoming Stifel and Jefferies Investor Conferences
Celcuity Inc. announced that its CEO, Brian Sullivan, will present at the Stifel 2023 Healthcare Conference and conduct a fireside chat at the Jefferies London Healthcare Conference. These events will take place on November 14 and 16, 2023, respectively. In addition to presentations, Sullivan will be available for one-on-one investor meetings, furthering the company’s outreach to potential investors.
Read more →CELC▲ +11.4%on this news
Celcuity Inc. Announces $50 Million Private Placement Minneapolis, MN
Celcuity Inc. has announced a private placement expected to yield approximately $50 million in gross proceeds. Institutional investors will purchase pre-funded warrants for shares of common stock at a price of $8.70 per share. The proceeds from this placement will be utilized primarily to further develop gedatolisib, the company's lead therapeutic candidate, while the closing of the placement is anticipated to occur by October 20, 2023, pending customary conditions. Celcuity is also planning to enroll patients in additional clinical trials starting in early 2024.
Read more →CELCCelcuity to Host Virtual Science Day for Investors
Celcuity Inc. will host a Virtual Science Day on September 21, 2023, to discuss its lead compound gedatolisib, a pan-PI3K/mTOR inhibitor, along with its strategy for clinical development in breast and prostate cancer. Key opinion leaders will provide insights into the treatment landscape, emphasizing the importance of targeting the PI3K/mTOR pathway. The company is also preparing to initiate a Phase 1b/2 trial of gedatolisib in combination with Nubeqa in patients with metastatic castration-resistant prostate cancer later this year. This event aims to engage investors and analyze the potential of gedatolisib's differentiated mechanism of action.
Read more →CELCCelcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa (darolutamide) for Planned Phase 1b/2 Clinical Trial
Celcuity Inc. has announced a clinical trial collaboration with Bayer AG to support its Phase 1b/2 clinical trial studying gedatolisib and Nubeqa (darolutamide) for patients with metastatic castration resistant prostate cancer (mCRPC). Bayer will supply Nubeqa at no cost, which will aid Celcuity in minimizing trial costs. The trial is set to begin in early 2024, using gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, an androgen receptor inhibitor. This partnership aims to address the significant therapeutic gap in treatment options for patients with mCRPC who have progressed on previous therapies.
Read more →CELCCelcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer - Received FDA clearance of IND for gedatolisib in combination with darolutamide - Virtual Science Day to be
Celcuity Inc. announced that it has received FDA clearance for its Investigational New Drug application for gedatolisib in combination with darolutamide, paving the way for a Phase 1b/2 clinical trial focused on metastatic castration resistant prostate cancer (mCRPC). The study will enroll up to 54 participants who have experienced disease progression after first-line treatment. The primary goals include assessing safety, tolerability, and progression-free survival. The clinical trial is expected to commence in the first quarter of 2024.
Read more →CELCCelcuity Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Updates - Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countries - Presented updated results fr
Celcuity Inc. reported its second-quarter 2023 financial results, highlighting the recruitment progress of its Phase 3 VIKTORIA-1 clinical trial, which is currently enrolling patients at nearly 200 sites across 20 countries. Updated results from a Phase 1b study of gedatolisib were presented, indicating positive outcomes for patients with HR+/HER2- advanced breast cancer. The company reported a net loss of $14.6 million, though they have significant cash reserves to support ongoing clinical endeavors. Management remains optimistic about the potential of gedatolisib in enhancing patient outcomes.
Read more →CELCCelcuity Inc. Schedules Release of Second Quarter 2023 Financial Results and Webcast/Conference Call
Celcuity Inc. has announced the release date for its second quarter 2023 financial results, which will be disclosed on August 10, 2023, after the market closes. The company will also host a webcast and teleconference at 4:30 p.m. Eastern Time on the same day to discuss these results and provide further corporate updates. This event underscores the company's efforts to communicate effectively with its investors and stakeholders.
Read more →CELCCelcuity to Participate in the BTIG Virtual Biotechnology Conference 2023
Celcuity Inc. has announced its participation in the BTIG Virtual Biotechnology Conference scheduled for August 7-8, 2023. The company's CEO, Brian Sullivan, will engage in one-on-one meetings during the event. This involvement underscores Celcuity's commitment to advancing its pipeline of targeted therapies for oncology. The conference presents an opportunity for increased visibility and potential collaborations in the biotechnology sector.
Read more →CELCCelcuity Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Updates - Presented updated results for treatment-na ve patients from Phase 1b study of gedatolisib at the ESMO Breast Cancer Annual Congr
Celcuity Inc. reported its financial results for the first quarter of 2023 and provided corporate updates. The company is making significant progress with its VIKTORIA-1 Phase 3 clinical trial for gedatolisib in advanced breast cancer, with encouraging median progression-free survival data. However, the company also faced increased operational expenses and reported a larger net loss compared to the previous year. The next data announcements are anticipated in the second half of 2024.
Read more →CELCCelcuity Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update - Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and d
Celcuity Inc. announced its financial results for Q4 and full year 2022, highlighting significant milestones in its clinical trials. The dosing of the first patient in the VIKTORIA-1 trial of gedatolisib in advanced breast cancer triggered a $100 million PIPE financing. Additionally, updated clinical data presented at key conferences showed promising outcomes for their therapies. However, the company also reported increased operating expenses and net losses compared to the previous year, which may raise concerns for future financial health.
Read more →CELCCelcuity Inc. Reports Third Quarter 2022 Financial Results and Provides Corporate Update - Completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 breast cancer study; activated first clinical trial si
Inc. Reports Third Quarter 2022 Financial Results and Provides Corporate Update - Completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 breast cancer study; activated first clinical trial site in the third quarter; expect dosing of first patient by year-end
Read more →CELCCelcuity Appoints Polly Murphy, D.V.M., Ph.D., to Board of Directors Seasoned executive brings over two decades of pharmaceutical business development and commercial strategy experience to Celcuity's Board of Directors M
Appoints Polly Murphy, D.V.M., Ph.D., to Board of Directors executive brings over two decades of pharmaceutical business development and commercial strategy experience to Celcuity's Board September 14, 2022 - Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company f
Read more →CELCCelcuity Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update - Granted Breakthrough Therapy designation by the FDA for gedatolisib in HR+/HER2- advanced breast cancer - Entered into agreement
Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update - Granted Breakthrough Therapy designation by the FDA for gedatolisib in HR+/HER2- advanced breast cancer - Entered into agreements for the private placement sale of $100 million of equity and to
Read more →CELC▲ +5.8%on this news
Celcuity Inc. Announces $100 Million Private Placement Proceeds to Advance Clinical Development of Gedatolisib Including Forthcoming Phase 3 Clinical Study (VIKTORIA-1) Minneapolis, MN
Inc. Announces $100 Million Private Placement to Advance Clinical Development of Gedatolisib Forthcoming Phase 3 Clinical Study (VIKTORIA-1) MN, May 16, 2022 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companio
Read more →CELC▲ +5.8%on this news
Celcuity Inc. Reports First Quarter 2022 Financial Results and Business Updates - Entered into $100 Million Private Placement Agreement - Finalized pivotal Phase 3 trial design for gedatolisib - Received FDA Fast Track d
Inc. Reports First Quarter 2022 Financial Results and Business Updates - Entered into $100 Million Private Placement Agreement - Finalized pivotal Phase 3 trial design for gedatolisib - Received FDA Fast Track designation for gedatolisib in HR+/HER2- advanced breast cancer -
Read more →CELCCelcuity Inc. Reports Fourth Quarter and Full Year 2021 Financial Results, Pivotal Phase 3 Trial Design for Gedatolisib in the Treatment of Advanced Breast Cancer, and Business Updates - Finalized pivotal Phase 3 trial d
Inc. Reports Fourth Quarter and Full Year 2021 Financial Results, Pivotal Phase 3 Trial Design for Gedatolisib in the Treatment of Advanced Breast Cancer, and Business Updates - Finalized pivotal Phase 3 trial design following formal meetings with FDA - Received FDA Fast Track
Read more →CELCto Celcuity's Current Report on Form 8-K filed with the Securities and Exchange Commission on
celc_ex991.htm EXHIBIT 99.1 Celcuity Inc. Reports Third Quarter 2021 Financial Results and Provides Corporate Update - On track to obtain FDA feedback and initiate a Phase 3 study for gedatolisib during the first half of 2022 - Will present updated Phase 1b data during a Spot
Read more →CELCCelcuity Announces Worldwide Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib, a First-in-Class PI3K/mTOR Inhibitor for Breast Cancer -Preliminary data from 103 patients in the expansion portion o
Celcuity Announces Worldwide Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib, a First-in-Class PI3K/mTOR Inhibitor for Breast Cancer data from 103 patients in the expansion portion of a Phase 1b clinical trial demonstrated the drug was well tolerated
Read more →CELCCelcuity Announces Proposed Public Offering of Common
Celcuity Announces Proposed Public Offering of Common MINNEAPOLIS, MN - February 22, 2021 - Celcuity Inc. (Nasdaq:CELC), a clinical stage biotechnology company translating discoveries of new cancer sub-types into 3rd generation diagnostics and expanded therapeutic options for
Read more →CELCCelcuity Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights - Announced a clinical trial collaboration in December with Massachusetts General Hospital, UCLA, and Vanderbilt and Pum
Celcuity Reports Fourth Quarter and Full Year 2020 Financial and Recent Business Highlights - Announced a clinical trial collaboration in December with Massachusetts General Hospital, UCLA, and Vanderbilt and Puma Biotechnology to conduct a Phase II clinical trial. - In Janu
Read more →CELCCelcuity Reports Third Quarter 2020 Financial Results and Recent Business Highlights - New clinical trial collaborations with pharmaceutical companies on track to close - - Cash burn rate steady - - Cash and cash equival
Celcuity Reports Third Quarter 2020 Financial and Recent Business Highlights - New clinical trial collaborations with pharmaceutical companies - Cash burn rate steady - - Cash and cash equivalents of $13.7 million as of September 30, 2020, which is expected to support operat
Read more →CELCCelcuity Reports Second Quarter 2020 Financial Results and Recent Business Highlights - Presented data for first CELsignia Pathway Activity Test for ovarian cancer at AACR Annual Meeting - - Expect to announce new clinic
Celcuity Reports Second Quarter 2020 Financial and Recent Business Highlights Presented data for first CELsignia Pathway Activity Test for ovarian cancer at AACR Annual Meeting - Expect to announce new clinical trial collaborations with pharmaceutical companies and trial sp
Read more →CELCCelcuity Reports First Quarter 2020 Financial Results and Recent Business Highlights - S ignificant progress made in development of new, highly precise diagnostics using proprietary CELsignia platform – - Expect t
Celcuity Reports First Quarter 2020 Financial and Recent Business Highlights Significant progress made in development of new, highly precise diagnostics using proprietary - Expect to announce new clinical trial collaborations with pharmaceutical companies and trial sponsors
Read more →CELCCelcuity Reports Fourth Quarter and Full Year 2019 Financial Results Minneapolis, Minnesota—
Celcuity Reports Fourth Quarter and Full Year 2019 Financial Minnesota March 12, 2020 Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is developing companion diagnostic tests designed to expand the eligible patient populations for targeted therapies,
Read more →CELCCelcuity Presents Results at the 2019 San Antonio Breast Cancer Symposium Evaluating a Sub-Group of PIK3CA WT Breast Cancer Patients Who Have Hyperactive Signaling Tumors Responsive to PI3K Inhibitors Minneapolis, Minnes
Celcuity Presents Results at the 2019 San Antonio Breast Cancer Symposium Evaluating a Sub-Group of PIK3CA WT Breast Cancer Patients Who Have Hyperactive Signaling Tumors Responsive to PI3K Minneapolis, Minnesota December 11, 2019 - Celcuity Inc. (Nasdaq: CELC), a dynamic cel
Read more →CELCCelcuity Announces Appointment of Richard Buller to Board of Directors Minneapolis, Minnesota—
Celcuity Announces Appointment of Richard Buller to Board of Minnesota December 5, 2019 Celcuity Inc. (NASDAQ: CELC) a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical
Read more →CELCCelcuity Reports Third Quarter 2019 Financial Results Minneapolis, Minnesota—
Celcuity Reports Third Quarter 2019 Financial Results Minnesota November 7, 2019 Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcom
Read more →CELCCelcuity Reports Second Quarter 2019 Financial Results Minneapolis, Minnesota
Celcuity Reports Second Quarter 2019 Minneapolis, Minnesota-August 8, 2019-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcomes of c
Read more →CELCCelcuity Announces Appointment of Leo Furcht to Board of Directors Minneapolis, Minnesota
Celcuity Announces Appointment of Leo Furcht to Board of Directors Minneapolis, Minnesota-May 20, 2019 -Celcuity Inc. (NASDAQ: CELC) a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly i
Read more →CELCCelcuity Reports First Quarter 2019 Financial Results Minneapolis, Minnesota
Celcuity Reports First Quarter 2019 Financial Minneapolis, Minnesota-May 7, 2019-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcome
Read more →CELCCelcuity Reports Fourth Quarter and Full Year 2018 Financial Results Minneapolis, Minnesota
Celcuity Reports Fourth Quarter and Full Year 2018 Financial Results Minneapolis, Minnesota-February 26, 2019-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to signific
Read more →CELCCelcuity Reports Third Quarter 2018 Financial Results Minneapolis, Minnesota
Celcuity Reports Third Quarter 2018 Financial Minneapolis, Minnesota-November 13, 2018-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical o
Read more →CELCCelcuity Reports Second Quarter 2018 Financial Results Minneapolis, Minnesota
Celcuity Reports Second Quarter 2018 Minneapolis, Minnesota-August 9, 2018-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcomes of c
Read more →CELCCelcuity Reports First Quarter 2018 Financial Results Minneapolis, Minnesota
Celcuity Reports First Quarter 2018 Financial Minneapolis, Minnesota-May 14, 2018-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcom
Read more →CELCCelcuity Reports Fourth Quarter and Full Year 2017 Financial Results Minneapolis, Minnesota
Celcuity Reports Fourth Quarter and Full Year 2017 Financial Results Minneapolis, Minnesota-March 15, 2018-Celcuity Inc. (Nasdaq: CELC) a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantl
Read more →CELCCelcuity Reports Third Quarter Fiscal 2017 Financial Results Minneapolis, Minnesota
Celcuity Reports Third Quarter Fiscal 2017 Financial Results Minneapolis, Minnesota-November 13, 2017-Celcuity Inc. (NASDAQ: CELC) a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly imp
Read more →CELCCelcuity Announces Pricing of Initial Public Offering
Announces Pricing of Initial Public Offering MINNEAPOLIS--(BUSINESS WIRE)--Celcuity Inc. (NASDAQ: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcomes of c
Read more →Competitive Position
How CELC ranks across every disease it competes inCompetitive Position is a premium feature
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