Celcuity (NASDAQ:CELC – Get Free Report) released its quarterly earnings data on Thursday. The company reported ($1.44) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of ($1.16) by ($0.28), Zacks reports.
Here are the key takeaways from Celcuity’s conference call:
- REVTORPYK was FDA-approved for HR-positive, HER2-negative advanced breast cancer without detected PIK3CA mutations, and both its doublet and triplet regimens received preferred Category 1 recommendations in the NCCN guidelines.
- In the PIK3CA-mutant VIKTORIA-1 cohort, gedatolisib-based regimens significantly improved median progression-free survival to approximately 11 months versus 5.6 months for alpelisib plus fulvestrant, while treatment discontinuation due to adverse events was lower for gedatolisib. Celcuity plans to submit an sNDA in the third quarter of 2026.
- Celcuity remains confident that commercial shipments will begin in late Q3 2026. The company has completed its commercial infrastructure, deployed 88 oncology sales specialists, begun an expanded-access program, and estimates a U.S. addressable market exceeding $6 billion annually.
- The VIKTORIA-2 first-line breast cancer program has been expanded to include endocrine-sensitive patients, potentially broadening gedatolisib’s use across most newly diagnosed advanced HR-positive, HER2-negative patients. Celcuity also expects to provide additional prostate cancer data in Q4 2026.
- Second-quarter net loss widened to $78.9 million from $45.3 million year over year, while selling, general and administrative expenses rose sharply due to launch preparation. The company ended June with $754 million in cash and investments and expects funding into 2029, helped by a $575 million convertible-note offering.
Celcuity Stock Performance
Shares of Celcuity stock traded up $5.40 during midday trading on Friday, hitting $92.00. The company had a trading volume of 1,333,561 shares, compared to its average volume of 1,096,723. The company has a fifty day simple moving average of $93.88 and a 200 day simple moving average of $108.45. The stock has a market cap of $4.49 billion, a price-to-earnings ratio of -21.40 and a beta of 0.20. The company has a quick ratio of 12.31, a current ratio of 12.31 and a debt-to-equity ratio of 6.04. Celcuity has a 12-month low of $44.42 and a 12-month high of $151.02.
Wall Street Analyst Weigh In
Check Out Our Latest Stock Analysis on CELC
Institutional Inflows and Outflows
A number of hedge funds and other institutional investors have recently made changes to their positions in the stock. BNP Paribas Financial Markets lifted its stake in shares of Celcuity by 78.9% during the second quarter. BNP Paribas Financial Markets now owns 2,647 shares of the company’s stock worth $35,000 after buying an additional 1,167 shares during the period. US Bancorp DE lifted its position in Celcuity by 25.4% during the 3rd quarter. US Bancorp DE now owns 706 shares of the company’s stock worth $35,000 after acquiring an additional 143 shares during the period. Meeder Asset Management Inc. purchased a new stake in Celcuity during the 4th quarter valued at about $42,000. Tower Research Capital LLC TRC grew its stake in Celcuity by 211.2% during the 2nd quarter. Tower Research Capital LLC TRC now owns 5,549 shares of the company’s stock valued at $74,000 after purchasing an additional 3,766 shares during the last quarter. Finally, Kemnay Advisory Services Inc. acquired a new position in shares of Celcuity in the fourth quarter valued at about $101,000. Hedge funds and other institutional investors own 63.33% of the company’s stock.
Key Stories Impacting Celcuity
Here are the key news stories impacting Celcuity this week:
- Positive Sentiment: HC Wainwright reaffirmed its Buy rating and $155 price target, implying substantial upside from the recent $92 share price. The endorsement reinforces bullish sentiment following Celcuity’s regulatory and commercial progress. Benzinga analyst rating report
- Positive Sentiment: An analyst report maintained a Buy view, citing REVTORPYK/gedatolisib’s FDA approval and rapid NCCN Category 1 inclusion as factors that reduce clinical and adoption risk. Strong VIKTORIA-1 results, including improved efficacy and tolerability, could support rapid physician uptake and a potential blockbuster franchise. Celcuity also reported approximately $754 million in cash, providing funding visibility through 2029 despite elevated launch spending. Celcuity: REVTORPYK Is Now A Commercial Story
- Neutral Sentiment: Stifel Nicolaus maintained a Buy rating but reduced its price target from $175 to $150, while Needham kept a Buy rating and lowered its target from $157 to $140. Both firms remain bullish, but the cuts indicate more cautious near-term assumptions. Benzinga analyst rating reports
- Negative Sentiment: Celcuity’s second-quarter results highlighted commercialization-related financial pressure. The company reported a $1.44 per-share loss, wider than the $1.16 consensus loss, and revenue of only $0.09 million versus the $4.42 million estimate. The results and increased launch-related SG&A prompted analysts to reduce forecasts, although the company’s cash balance provides a substantial operating runway. Celcuity second-quarter 2026 results
Celcuity Company Profile
Celcuity, Inc is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.
Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways.
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