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Celcuity Inc.

CELC
Richly ValuedBiotech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$67.57
▼ -0.26 · -0.38%

Financials

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R&D Expenses
Operating CF
Total Assets
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52W LOW $45.0352W HIGH $151.02
Volume
33.30 K
Value Traded
71.73 M
Short % Float
28.2%
-5.87%Week
-24.66%1 Month
-36.91%3 Month
-42.06%6 Month
+367.63%5 Year
+1,019.27%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
3.31 B
EPS (TTM)
-4.63
P/E Ratio
-
Ent. Value
2.57 B
Total Shares
48.93 M
Float Shares
40.29 M
Insiders
17.66%
Institutions
103.60%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 1/2 data presentation
gedatolisib in combination with darolutamide
metastatic castration-resistant prostate cancer (mCRPC)
Phase 1/2Small MoleculesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

CELC Catalyst Timeline

Dated clinical, regulatory and corporate events for Celcuity Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Celcuity Inc.

349Total events
19Upcoming
79Tier-1 (high impact)
2017 to 2029Coverage

Upcoming catalysts 2

T2EU MAA Submission
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GedatolisibApproved
T2Oral Presentation
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GedatolisibApproved

Event history 50

●Management ChangeCorporate
David W. Gryska appointed to Celcuity Board of Directors
source ↗
▲Product LaunchREVTORPYKApprovedPost-Market
REVTORPYK now commercially available in the United States
HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutationsource ↗
●sNDA SubmissionREVTORPYKApprovedRegulatory Filing
sNDA submitted to FDA for REVTORPYK in PIK3CA mutant ABC
HR+/HER2-, PIK3CA mutant locally advanced or metastatic breast cancersource ↗
▲Topline ReadoutREVTORPYKApprovedClinical Data
Topline results from PIK3CA mutant cohort of VIKTORIA-1
HR+/HER2-, PIK3CA mutant ABCsource ↗
●Quarterly UpdateCorporate
Q2 2026 financial results reported
source ↗
▲Primary Endpoint MetGedatolisibApprovedClinical Data
Phase 3 PIK3CA mutant cohort of VIKTORIA-1 achieved primary endpoint of PFS
HR+/HER2- PIK3CA mutant advanced breast cancersource ↗
●Dose Finding UpdateGedatolisibApprovedTrial
Phase 1b dose finding: 240 mg dose evaluation completed; 300 mg dose ongoing
Metastatic castration-resistant prostate cancersource ↗
▲Other Regulator MilestoneREVTORPYKApprovedEx-US Regulatory
NCCN Guidelines recommended REVTORPYK as preferred Category 1 option
HR+/HER2- advanced breast cancersource ↗
▲Manufacturing MilestoneREVTORPYKApprovedCMC / Inspection
Commercialization infrastructure build-out complete
source ↗
▲Trial InitiationGedatolisibApprovedTrial
Expanded Access Program opened for gedatolisib
HR+/HER2- advanced breast cancersource ↗
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Past FDA Catalysts and PDUFA Decisions

How CELC actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-09-30gedatolisib Approval Decision NDA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C41 / 100
Pipeline Score
$153M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 35%
Small Cap
(rank 231 of 658)
Percentile Rank
Celcuity Inc. carries a moderate pipeline score (41/100), with $235M risk-adjusted pipeline value, led by Gedatolisib in TNBC - Triple-Negative Breast Cancer (Phase 1).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Gedatolisib Small moleculeMarketedNCT05501886Breast CancerPhase 3 ACTIVE NOT_RECRUITING 2,022Dec 31, 2026
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Clinical Trial Results

Readouts, endpoints and source filings for every CELC program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
gedatolisib
BreakthroughPriorityAccelerated
HR+/HER2- advanced breast cancerPhase 32026-06-02gedatolisib 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 monthsRead MoreCelcuity’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 CancerRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
BAKER BROS. ADVISORS LPFormer 10% ownerSell -261,368 442,940 held$102.50 07/14/2026
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Hedge Fund 13F Activity

Hedge Funds invested in CELC

Fund % of Portfolio Current MV Shares Owned Activity
BAKER BROS. ADVISORS 4.2 % (-19.2 %) 828.15 M 7.92 M
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CELC Institutional Ownership Trends

Options Data

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-12-18
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How CELC ranks across every disease it competes in

Competitive Position is a premium feature
See how CELC ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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CELC News

CELC
Oct 5, 2026
CELCConferences/Events

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Celcuity Inc. announced multiple presentations at the ESMO Congress 2026, including a late-breaking oral presentation and three poster presentations. The presentations will focus on the efficacy of gedatolisib in treating HR+/HER2- advanced breast cancer and mCRPC. The congress will take place in Madrid from October 23-27, 2026.

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CELC
Oct 2, 2026
CELCGeneral

Celcuity Appoints David Gryska To Its Board Of Directors

Celcuity Inc. has appointed David W. Gryska to its Board of Directors, bringing over 35 years of experience in the life sciences sector. This appointment comes as the company transitions into a commercial-stage entity following the FDA approval of its product, REVTORPYK. Gryska's expertise is expected to aid in the launch and growth of the company's therapies.

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CELC
Sep 30, 2026
CELCFDA Updates

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

Celcuity Inc. announced the commercial availability of REVTORPYK (gedatolisib) in the U.S. for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation. The FDA approved REVTORPYK in combination with palbociclib and fulvestrant, showing significant efficacy in clinical trials. The company has also launched a support program to assist patients and healthcare providers.

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CELC
Sep 1, 2026
CELCConferences/Events

Celcuity To Participate in Upcoming Investor Conferences

Celcuity Inc. announced participation in two upcoming investor conferences, where CEO Brian Sullivan will present and hold one-on-one meetings. The events include the Wells Fargo 21st Annual Healthcare Conference and Citi's 2026 Biopharma Back to School Summit. The company is known for its targeted therapies, including the FDA-approved REVTORPYK.

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CELC
Aug 26, 2026
CELCFDA Updates

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity Inc. has submitted a supplemental New Drug Application to the FDA for REVTORPYK (gedatolisib) aimed at treating HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA mutations. This submission is supported by positive results from the VIKTORIA-1 trial, which showed significant improvements in progression-free survival compared to existing treatments. If approved, REVTORPYK would be the first therapy targeting all class I PI3K isoforms for this indication.

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CELC
Aug 13, 2026
CELCFDA Updates
▲ +6.2%on this news

Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update

Celcuity Inc. reported its second quarter 2026 financial results, highlighting the FDA approval of REVTORPYK for HR+/HER2- breast cancer. The company plans to launch the drug in late Q3 2026 and has received a positive recommendation from NCCN guidelines. Additionally, the VIKTORIA-1 trial showed promising survival outcomes, leading to plans for a supplemental NDA submission. Despite these advancements, the company reported a net loss of $78.9 million for the quarter.

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CELC
Aug 6, 2026
CELCConferences/Events

Celcuity Schedules Release of Second Quarter 2026 Financial Results and Webcast/Conference Call

Celcuity Inc. will announce its financial results for Q2 2026 on August 13, 2026, after market close. A webcast and teleconference will follow at 4:30 p.m. EDT for a corporate update. The company continues to focus on targeted therapies for solid tumors, with its first FDA-approved product, REVTORPYK, already in use. Ongoing clinical trials further highlight its commitment to advancing cancer treatment.

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CELC
Jul 30, 2026
CELCFDA Updates
▲ +5.3%on this news

Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer

REVTORPYK (gedatolisib) has been FDA-approved and is now included in the NCCN Clinical Practice Guidelines as a preferred treatment option for HR+/HER2- locally advanced or metastatic breast cancer. It is recommended for use in combination with fulvestrant, with or without palbociclib, for patients without a PIK3CA mutation after prior endocrine therapy. This approval marks a significant advancement in breast cancer treatment.

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CELC
Jul 14, 2026
CELCFDA Updates
▼ -17.6%on this news

Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

Celcuity Inc. has received FDA approval for REVTORPYK™ (gedatolisib), the first therapy to inhibit all class I PI3K isoforms and mTOR complexes for treating HR+/HER2- locally advanced or metastatic breast cancer. The approval is based on positive results from the Phase 3 VIKTORIA-1 trial, which showed significant improvements in progression-free survival. The company plans to launch the drug commercially in late Q3 2026 and will also submit a supplemental NDA for additional indications.

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CELC
Jun 4, 2026
CELCGeneral

Celcuity 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.

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CELC
Jun 3, 2026
CELCGeneral

Celcuity 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.

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CELC
Jun 2, 2026
CELCPhases
▼ -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.

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CELC
Jun 1, 2026
CELCConferences/Events
▼ -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.

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CELC
May 14, 2026
CELCPhases
▲ +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.

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CELC
May 14, 2026
CELCPhases
▲ +8.2%on this news

Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update May 14, 2026 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted

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.

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CELC
May 7, 2026
CELCGeneral
▼ -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.

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CELC
May 4, 2026
CELCPhases
▲ +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.

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CELC
May 1, 2026
CELCPhases

Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant May 1, 2026 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies

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.

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CELC
Mar 26, 2026
CELCGeneral

Celcuity 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.

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About Celcuity Inc.

Minneapolis, MN 155 employees celcuity.com
Headquarters16305 36TH AVENUE N, MINNEAPOLIS, MN, 55446
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