Celcuity (NASDAQ:CELC) Releases Quarterly Earnings Results, Beats Estimates By $0.09 EPS

Celcuity (NASDAQ:CELCGet Free Report) released its earnings results on Wednesday. The company reported ($0.97) earnings per share for the quarter, beating analysts’ consensus estimates of ($1.06) by $0.09, Zacks reports.

Here are the key takeaways from Celcuity’s conference call:

  • FDA accepted Celcuity’s NDA for gedatolisib under the Real‑Time Oncology Review program with priority review and a PDUFA goal date of July 17, 2026, positioning a near-term regulatory catalyst.
  • The VIKTORIA‑1 PIK3CA wild‑type cohort showed unprecedented efficacy — median PFS 9.3 vs 2.0 months (HR 0.24) — with generally favorable tolerability; results were presented at major meetings and published in the Journal of Clinical Oncology.
  • Enrollment is complete for the PIK3CA mutant cohort of VIKTORIA‑1 and top‑line results are expected in Q2 2026 with detailed presentation at a medical conference, creating a near‑term data catalyst but with an uncertain outcome.
  • Operating losses widened in 2025 (FY net loss $177M vs $111.8M in 2024) due to R&D and commercial build, but the company ended the year with $441.5M in cash, equivalents and short‑term investments, which management says funds operations through 2027.
  • Commercial build is largely complete with reported strong payer and physician engagement; Celcuity estimates a >$5B second‑line total addressable market and models potential peak revenue up to $2.5B if approved and broadly adopted.

Celcuity Stock Performance

Celcuity stock opened at $114.81 on Friday. The company has a current ratio of 12.26, a quick ratio of 12.26 and a debt-to-equity ratio of 2.74. The firm has a market cap of $5.31 billion, a P/E ratio of -30.29 and a beta of 0.38. Celcuity has a 1-year low of $7.57 and a 1-year high of $120.32. The firm has a 50-day moving average of $109.51 and a 200-day moving average of $90.44.

Wall Street Analyst Weigh In

Several research firms recently issued reports on CELC. Wolfe Research restated an “outperform” rating and set a $110.00 price target on shares of Celcuity in a research report on Thursday, March 12th. Weiss Ratings reiterated a “sell (d-)” rating on shares of Celcuity in a research report on Wednesday, January 21st. Needham & Company LLC reissued a “buy” rating and set a $122.00 price objective on shares of Celcuity in a research note on Thursday. Jefferies Financial Group raised their target price on shares of Celcuity from $108.00 to $134.00 and gave the stock a “buy” rating in a report on Tuesday, December 2nd. Finally, Stifel Nicolaus lifted their target price on shares of Celcuity from $115.00 to $125.00 and gave the stock a “buy” rating in a research note on Thursday. Eight equities research analysts have rated the stock with a Buy rating, one has given a Hold rating and one has given a Sell rating to the company. According to MarketBeat.com, Celcuity has a consensus rating of “Moderate Buy” and an average price target of $109.88.

Read Our Latest Stock Report on CELC

Insider Transactions at Celcuity

In related news, Director David Dalvey sold 20,000 shares of the business’s stock in a transaction dated Tuesday, January 27th. The stock was sold at an average price of $120.03, for a total transaction of $2,400,600.00. Following the transaction, the director owned 90,000 shares in the company, valued at $10,802,700. The trade was a 18.18% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at this link. 15.77% of the stock is currently owned by corporate insiders.

Institutional Inflows and Outflows

A number of hedge funds and other institutional investors have recently made changes to their positions in CELC. Freestone Grove Partners LP bought a new stake in shares of Celcuity during the third quarter valued at approximately $494,000. Polen Capital Management LLC purchased a new stake in Celcuity in the fourth quarter worth $465,000. KVP Capital Advisors LP bought a new position in Celcuity in the fourth quarter worth $399,000. Farallon Capital Management LLC bought a new position in Celcuity in the fourth quarter worth $399,000. Finally, Mercer Global Advisors Inc. ADV purchased a new position in Celcuity during the fourth quarter valued at $376,000. Hedge funds and other institutional investors own 63.33% of the company’s stock.

Celcuity News Roundup

Here are the key news stories impacting Celcuity this week:

  • Positive Sentiment: Stifel Nicolaus raised its price target to $125 and maintained a “buy” rating, signaling increased analyst confidence and providing fresh upside for investors. Article Title
  • Positive Sentiment: Needham & Company reaffirmed its “buy” rating and a $122 price target, reinforcing the broker-dealer support that can sustain upward momentum. Benzinga Street Insider
  • Positive Sentiment: Q4 2025 results beat estimates: EPS of ($0.73) vs. consensus ($1.06) — the miss narrowed and the beat reduces near-term downside from earnings concerns. Market commentary and the company release came with the results. MarketBeat Earnings
  • Positive Sentiment: Management highlighted a potential ~$2.5B annual peak revenue opportunity for gedatolisib and ongoing pivotal milestones/commercial launch preparations — a high commercial upside that supports premium valuations if regulatory and launch execution succeed. MSN Article
  • Neutral Sentiment: Investors can review the full Q4 call transcript and highlights for more color on development timelines, cash runway and next catalysts (transcript and call recording available). Seeking Alpha Transcript Yahoo Highlights
  • Neutral Sentiment: Corporate release summarizing Q4 and full-year 2025 results and the company update (official details on financials and program status). GlobeNewswire
  • Positive Sentiment: Press coverage noting that Celcuity’s breast cancer drug is approaching regulatory milestones/possible approval has likely boosted optimism around near-term value realization. Investing.com
  • Negative Sentiment: Company remains unprofitable (negative EPS) and carries leverage (reported debt-to-equity and negative PE), risks that could limit gains if clinical or regulatory setbacks occur. Press Release PDF

Celcuity Company Profile

(Get Free Report)

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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Earnings History for Celcuity (NASDAQ:CELC)

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