Celcuity (NASDAQ:CELC – Get Free Report) issued its earnings results on Thursday, August 13th. The company reported ($1.44) 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 Stock Performance
NASDAQ:CELC opened at $92.27 on Wednesday. The business’s fifty day moving average is $94.38 and its 200 day moving average is $107.44. Celcuity has a 52-week low of $44.42 and a 52-week high of $151.02. The firm has a market cap of $4.51 billion, a price-to-earnings ratio of -21.46 and a beta of 0.20. The company has a debt-to-equity ratio of 6.04, a quick ratio of 8.93 and a current ratio of 8.93.
Institutional Investors Weigh In On Celcuity
Analyst Ratings Changes
CELC has been the subject of a number of recent research reports. Craig Hallum reaffirmed a “buy” rating and issued a $178.00 target price on shares of Celcuity in a report on Wednesday, July 15th. Needham & Company LLC dropped their target price on Celcuity from $157.00 to $140.00 and set a “buy” rating on the stock in a report on Friday, August 14th. Macquarie Infrastructure set a $160.00 price target on shares of Celcuity in a report on Thursday, May 28th. Wall Street Zen downgraded Celcuity from a “sell” rating to a “strong sell” rating in a research note on Saturday, August 15th. Finally, HC Wainwright reaffirmed a “buy” rating and issued a $155.00 price objective on shares of Celcuity in a research report on Friday, August 14th. Ten research analysts have rated the stock with a Buy rating and one has assigned a Sell rating to the stock. Based on data from MarketBeat.com, Celcuity has a consensus rating of “Moderate Buy” and an average price target of $154.55.
Check Out Our Latest Stock Analysis on CELC
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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