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Celcuity
(NASDAQ:CELC)
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Rating:54Neutral
Price Target:
$61.00
▼(-33.89% Downside)
Action:Reiterated
Date:10/08/26
Overall score reflects a tension between strong earnings-call-driven momentum (FDA approval, compelling trial results, launch progress, and guidance with runway into 2029) versus weak financial performance (no revenue, accelerating losses, high cash burn, and a more leveraged/negative-equity balance sheet). Technicals also detract as the stock is in a clear downtrend with negative momentum despite oversold readings, while valuation metrics are limited by negative earnings and no dividend support.
Positive Factors
Regulatory and Guideline Validation
FDA approval and an NCCN Category 1 recommendation materially validate Revtopik’s clinical utility and positioning in second-line HR+/HER2-negative breast cancer. These endorsements can support physician adoption, payer discussions, and a durable commercial foundation beyond the initial launch period.
Negative Factors
Pre-Revenue and Widening Losses
The absence of revenue leaves Celcuity dependent on financing and successful commercialization to offset a rapidly widening cost base. TTM losses substantially above the 2023 level indicate that earnings quality remains weak, increasing the importance of timely uptake and disciplined spending over the next several quarters.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory and Guideline Validation
FDA approval and an NCCN Category 1 recommendation materially validate Revtopik’s clinical utility and positioning in second-line HR+/HER2-negative breast cancer. These endorsements can support physician adoption, payer discussions, and a durable commercial foundation beyond the initial launch period.
Read all positive factors
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$3.22B
Dividend YieldN/A
Average Volume (3M)1.57M
Price to Earnings (P/E)―
Beta (1Y)0.72
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. Volume2,134,040
30 Day Avg. Volume1,574,243
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 Cap1.78
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-122.03K
Enterprise Value/Ebitda-30.96
Forecast
1Y Price Target
$155.18Price Target Upside68.18% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
EPS Forecast (FY)-5.14
Revenue Forecast (FY)$23.34M
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...
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%).
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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 | -185.22M | -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
Negative
92.27
Price Trends
79.55
Negative
86.57
Negative
101.40
Negative
Market Momentum
-4.90
Negative
42.84
Neutral
85.35
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CELC, the sentiment is Negative. The current price of 92.27 is above the 20-day moving average (MA) of 66.59, above the 50-day MA of 79.55, and below the 200-day MA of 101.40, indicating a bearish trend. The MACD of -4.90 indicates Negative momentum. The RSI at 42.84 is Neutral, neither overbought nor oversold. The STOCH value of 85.35 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 |
|---|---|---|---|---|---|---|---|
61 Neutral | $3.91B | -22.37 | -17.49% | ― | 101.28% | 2.49% | |
56 Neutral | $4.19B | -64.48 | -32.64% | ― | 50.13% | 50.40% | |
55 Neutral | $3.97B | -11.54 | -42.27% | ― | 23.86% | 19.60% | |
55 Neutral | $2.27B | -3.65 | -50.41% | ― | -15.08% | 41.98% | |
54 Neutral | $3.22B | -15.34 | -350.78% | ― | ― | -24.72% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
CELC
Celcuity
65.80
-11.71
-15.11%
ADPT
Adaptive Biotechnologies
26.27
9.15
53.45%
RLAY
Relay Therapeutics
18.12
10.74
145.53%
ABCL
AbCellera Biologics
12.08
6.31
109.36%
RXRX
Recursion Pharmaceuticals
3.80
-2.50
-39.68%
ALMR
Alamar Biosciences, Inc.
30.39
8.39
38.14%
Celcuity Corporate Events
Business Operations and StrategyExecutive/Board Changes
Celcuity adds seasoned director amid oncology commercialization push
Positive
Oct 2, 2026
On October 1, 2026, Celcuity’s board expanded its size from eight to nine members and appointed veteran life sciences executive David W. Gryska as an independent director for a term running through the 2027 annual meeting, also naming him to...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Celcuity launches REVTORPYK for advanced breast cancer
Positive
Sep 30, 2026
On September 30, 2026, Celcuity announced that REVTORPYK is now commercially available in the U.S. for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation, whose disease has progre...
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...
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.