Celcuity (NASDAQ:CELC – Get Free Report) posted its earnings results on Thursday, August 13th. The company reported ($1.44) earnings per share (EPS) for the quarter, missing the consensus estimate 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 Trading Down 2.8%
NASDAQ CELC opened at $77.38 on Wednesday. The company has a quick ratio of 8.93, a current ratio of 8.93 and a debt-to-equity ratio of 6.04. The firm has a 50-day moving average price of $88.21 and a 200 day moving average price of $103.65. The stock has a market capitalization of $3.79 billion, a P/E ratio of -18.00 and a beta of 0.19. Celcuity has a 52-week low of $44.42 and a 52-week high of $151.02.
Analysts Set New Price Targets
Celcuity Company Profile
Celcuity, Inc is a biotechnology company focused on advancing personalized medicine through functional diagnostics. Its technology is designed to analyze living tumor cells obtained from patient tissue and identify abnormal signaling activity that may influence how a cancer responds to specific therapies.
The company’s primary platform, CELsignia, uses proprietary assays to measure the activity of cellular signaling pathways in a patient’s tumor cells. Celcuity develops these tests for use in oncology drug development, patient selection, and potentially as companion diagnostics to help identify patients who are most likely to benefit from targeted treatments.
Celcuity works with biopharmaceutical companies and research organizations to evaluate drug-response biomarkers and support precision oncology programs.
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