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Celcuity
(NASDAQ:CELC)
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Rating:56Neutral
Price Target:
$95.00
▲(2.96% Upside)
Action:Reiterated
Date:08/26/26
CELC scores in the mid-range: exceptionally strong earnings-call-driven catalysts (FDA/NCCN validation, strong Phase 3 efficacy/safety, and near-term commercialization/filing milestones) are offset by weak current financial performance (no revenue, widening losses, high burn) and a more levered capital structure. Technicals and valuation are neutral-to-challenged, keeping the overall score from moving higher.
Positive Factors
Regulatory and Guideline Validation
FDA approval and Category 1 NCCN recognition establish clinical and regulatory credibility, improve treatment adoption prospects, and strengthen the product’s position with oncologists, payers, and health systems over the commercialization period.
Negative Factors
Pre-Revenue and Loss-Making Model
The absence of recurring product revenue leaves Celcuity dependent on successful commercialization and continued capital access. Accelerating losses reduce financial resilience and make execution setbacks more consequential before a sustainable revenue base develops.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory and Guideline Validation
FDA approval and Category 1 NCCN recognition establish clinical and regulatory credibility, improve treatment adoption prospects, and strengthen the product’s position with oncologists, payers, and health systems over the commercialization period.
Read all positive factors
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$4.51B
Dividend YieldN/A
Average Volume (3M)1.57M
Price to Earnings (P/E)―
Beta (1Y)0.62
Revenue GrowthN/A
EPS Growth-24.72%
CountryUS
Employees155
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.29
Shares Outstanding48,931,908
10 Day Avg. Volume2,363,349
30 Day Avg. Volume1,572,523
Financial Highlights & Ratios
PEG Ratio-0.79
Price to Book (P/B)52.11
Price to Sales (P/S)0.00
P/FCF Ratio-34.13
Enterprise Value/Market Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-0.12
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price Target
$160.89Price Target Upside74.37% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering10
EPS Forecast (FY)-4.85
Revenue Forecast (FY)$38.31M
Celcuity Business Overview & Revenue Model
Company Description
Celcuity, Inc. operates as a cellular analysis company. The company discovers new cancer sub-types and commercializing diagnostic tests designed to improve the clinical outcomes of cancer patients treated with targeted therapies. The firm's propri...
How the Company Makes Money
Celcuity is a clinical-stage biotech and, based on publicly available information, does not have commercialized products generating recurring product sales. As a result, the company’s operations have historically been funded primarily through fina...
Celcuity Earnings Call Summary
Earnings Call Date:Aug 13, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 18, 2026
Earnings Call Sentiment Positive
The call conveyed strong positive momentum: regulatory approval (FDA), rapid NCCN Category 1 endorsement, robust phase 3 efficacy (large PFS gains and lower discontinuation vs comparator), commercial launch readiness, a sizeable addressable market (> $6B annual TAM) and a fortified balance sheet with a cash runway into 2029. Offsetting risks include materially higher operating losses and SG&A tied to launch investments, increased near-term cash burn, conditional reliance on FDA review for a secondary manufacturing site (supply risk), and limited real-time utilization visibility for an IV therapy. Overall, the operational and clinical wins materially outweigh the financial and execution risks described.Positive Updates
FDA Approval and NCCN Category 1 Recommendation
Revtopik (gedatolisib) received FDA approval (July 14, 2026) for HR+ HER2- locally advanced/metastatic breast cancer without a PIK3CA mutation after progression on ≥1 line of endocrine therapy. NCCN updated guidelines to recommend both the gedatolisib triplet and doublet as preferred Category 1 regimens for second-line or subsequent treatment (tumors without PIK3CA mutation).
Negative Updates
Substantial Increase in Net Loss
Q2 2026 net loss was $78.9M ($1.44/share) vs $45.3M ($1.04/share) prior year period — an increase of $33.6M (~74.3%). Non-GAAP adjusted net loss rose to $58.7M from $40.5M, an increase of $18.2M (~44.9%).
Read all updates
Q2-2026 Updates
Positive
Negative
FDA Approval and NCCN Category 1 Recommendation
Revtopik (gedatolisib) received FDA approval (July 14, 2026) for HR+ HER2- locally advanced/metastatic breast cancer without a PIK3CA mutation after progression on ≥1 line of endocrine therapy. NCCN updated guidelines to recommend both the gedatolisib triplet and doublet as preferred Category 1 regimens for second-line or subsequent treatment (tumors without PIK3CA mutation).
Read all positive updates
Company Guidance
Management guided that Revtopik (gedatolisib) shipments are expected to begin late Q3 2026 and an sNDA for the PIK3CA‑mutant VICTORIA‑1 cohort will be submitted in Q3 2026 with global filings to follow; WAC is $10,000 per vial ($30,000 per cycle), Celcuity estimates ~37,000 U.S. second‑line HR+/HER2‑ patients, ~10 cycles/patient and >$6 billion annual TAM at WAC with an expected gross‑to‑net of ~80% (≈20% discounts). Key clinical metrics: in the PIK3CA‑mutant cohort median PFS was 11.1 months (gedatolisib triplet) vs 5.6 months (alpelisib+fulvestrant; HR 0.50) and 11.3 months (gedatolisib doublet) vs 5.6 months (HR 0.51); discontinuation rates due to AEs were ~5.2% (triplet) and 3.8% (doublet) vs 19% for alpelisib; mean gedatolisib cycles were 9.0 (wild‑type triplet; 12% still on), 10.0 (mutant triplet; 22% still on), 9.7 (wild‑type doublet; 12% still on) and 11.3 (mutant doublet; 19% still on). Financials and operational notes: Q2 net loss $78.9M ($1.44/share), non‑GAAP loss $58.7M ($1.07/share), R&D $31.1M, SG&A $35.0M, net cash used in operations $55.4M; cash and short‑term investments $754M at 6/30/2026 (proceeds from $575M convertible offering, net $557.2M; $137M term‑loan repayment) with runway into 2029; expanded access shipments have begun, the secondary manufacturing site requires FDA clearance (review often ~2–4 months; standard 4‑month cadence), and an sNDA review would be 6 months if granted priority or 10 months standard.Celcuity Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
9
Very Negative
Cash Flow
15
Very Negative
| Breakdown | TTM | Dec 2025 | Mar 2025 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -47.00K | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -185.28M | -159.73M | -101.37M | -58.31M | -38.05M | -28.04M |
| Net Income | -226.48M | -177.04M | -111.78M | -63.78M | -40.37M | -29.61M |
Balance Sheet | ||||||
| Total Assets | 828.22M | 466.56M | 245.12M | 191.22M | 175.70M | 85.91M |
| Cash, Cash Equivalents and Short-Term Investments | 754.04M | 441.50M | 235.10M | 180.58M | 168.59M | 84.29M |
| Total Debt | 754.38M | 195.38M | 97.95M | 37.45M | 35.24M | 14.89M |
| Total Liabilities | 841.00M | 366.00M | 129.50M | 51.45M | 41.93M | 17.20M |
| Stockholders Equity | -12.78M | 100.56M | 115.62M | 139.77M | 133.77M | 68.71M |
Cash Flow | ||||||
| Free Cash Flow | -192.16M | -153.53M | -83.72M | -53.91M | -36.17M | -20.39M |
| Operating Cash Flow | -191.71M | -153.28M | -83.47M | -53.81M | -36.01M | -20.31M |
| Investing Cash Flow | -450.27M | -64.08M | -63.07M | -5.01M | -144.03M | -81.40K |
| Financing Cash Flow | 777.67M | 360.55M | 138.39M | 64.91M | 120.33M | 93.04M |
Celcuity Technical Analysis
Neutral
92.27
Price Trends
94.11
Positive
106.91
Negative
105.84
Negative
Market Momentum
-0.20
Negative
53.96
Neutral
74.25
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CELC, the sentiment is Neutral. The current price of 92.27 is above the 20-day moving average (MA) of 91.22, below the 50-day MA of 94.11, and below the 200-day MA of 105.84, indicating a neutral trend. The MACD of -0.20 indicates Negative momentum. The RSI at 53.96 is Neutral, neither overbought nor oversold. The STOCH value of 74.25 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for CELC.
Celcuity Risk Analysis
Celcuity disclosed 47 risk factors in its most recent earnings report. Celcuity reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Celcuity Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
64 Neutral | $10.21B | -31.09 | -29.88% | ― | ― | -6.36% | |
62 Neutral | $6.51B | -56.77 | -20.57% | ― | ― | -76.46% | |
61 Neutral | $3.14B | -64.82 | -13.53% | ― | 105.17% | 53.58% | |
60 Neutral | $4.10B | -21.66 | -16.47% | ― | 3244.67% | 49.14% | |
56 Neutral | $4.51B | -22.16 | -350.78% | ― | ― | -24.72% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
CELC
Celcuity
95.08
45.12
90.31%
IDYA
IDEAYA Biosciences
41.58
16.58
66.32%
TARS
Tarsus Pharmaceuticals
70.65
12.83
22.19%
BLTE
Belite Bio, Inc. ADR
156.69
92.49
144.07%
APGE
Apogee Therapeutics
134.95
97.16
257.11%
Celcuity Corporate Events
Product-Related AnnouncementsRegulatory Filings and Compliance
Celcuity Files sNDA to Expand REVTORPYK Breast Cancer Use
Positive
Aug 26, 2026
On August 26, 2026, Celcuity submitted a supplemental New Drug Application to the U.S. FDA seeking approval of REVTORPYK (gedatolisib) for patients with HR+/HER2-, locally advanced or metastatic breast cancer with a PIK3CA mutation after progressi...
Business Operations and StrategyPrivate Placements and Financing
Celcuity Refinances Debt with New Convertible Notes Offering
Positive
Jun 8, 2026
On June 3, 2026, Celcuity Inc. entered into an underwriting agreement for a public offering of 0.250% Convertible Senior Notes due 2032, initially sized at $500 million but expanded when underwriters exercised a $75 million over-allotment option, ...
Business Operations and StrategyProduct-Related Announcements
Celcuity highlights positive Phase 3 gedatolisib breast cancer data
Positive
Jun 2, 2026
On June 2, 2026, Celcuity reported detailed efficacy and safety data from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in adults with HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer whose diseas...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.