HC Wainwright & Co. Reaffirms Buy Rating for Celcuity, Increases Price Target to $66
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- FDA Priority Review: Celcuity's new drug application for gedatolisib has received FDA priority review, with a PDUFA goal date of July 17, 2026, which could open up a market opportunity exceeding $5 billion, with projected peak annual revenues of $2.5 billion, significantly enhancing the company's market position.
- Clinical Trial Data: In the VIKTORIA-1 clinical trial, the gedatolisib triplet therapy demonstrated a median progression-free survival of 9.3 months, far surpassing fulvestrant's 2 months, indicating its potential as a new standard of care in HR-positive/HER2-negative advanced breast cancer treatment.
- Financial Performance: The net loss for Q4 2025 was $51 million, or $0.97 per share, an increase from $36.7 million in the same quarter of 2024, reflecting high investments in commercialization preparations, with cash reserves expected to sustain operations through 2027.
- Market Readiness: Management has largely completed the establishment of the sales force and internal systems, actively advancing the commercialization of gedatolisib, and aims to enhance engagement with physicians and patients through proactive market strategies and supportive clinical data to increase market share.
- Transaction Overview: On February 17, 2026, Apis Capital disclosed in an SEC filing that it sold 174,000 shares of Celcuity, with an estimated transaction value of approximately $14.3 million based on quarterly average pricing, indicating the firm's active market engagement.
- Position Change: Following the sale, Apis Capital's stake in Celcuity decreased to 602,000 shares, still representing 10.46% of its 13F AUM, highlighting that Celcuity remains its largest holding and reflecting ongoing investor confidence in the company.
- Market Value Increase: At the end of the quarter, the value of the Celcuity position increased by $21.71 million, showcasing significant stock price appreciation and indicating strong performance and market recognition in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged by 741.1% over the past year, significantly outperforming the S&P 500 by 721.31 percentage points, demonstrating its competitive edge and investment appeal in the precision medicine landscape.
- Stake Increase: Perceptive Advisors purchased an additional 203,881 shares of Celcuity in Q4 2026, with an estimated transaction value of $16.76 million, indicating strong confidence in the company's future growth potential.
- Ownership Proportion Rise: Following this purchase, Perceptive Advisors' stake in Celcuity increased to 5.62%, highlighting its significance within the investment portfolio and further drawing market attention to Celcuity.
- Market Performance: As of February 17, 2026, Celcuity shares were priced at $107.32, reflecting a staggering 700% increase over the past year, underscoring strong market anticipation for its drug development.
- FDA Review Progress: Celcuity's new drug application for gedatolisib has received Priority Review from the FDA, with a decision expected by July 17, 2026, a critical timeline that could significantly impact its future market performance.
- Biotech Summit Participation: Celcuity Inc. will participate in the Guggenheim Emerging Outlook: Biotech Summit on February 11-12, 2026, in New York, showcasing its latest advancements in oncology treatments and enhancing its visibility in the biotech industry.
- CEO Interview Schedule: CEO Brian Sullivan is set to engage in a fireside chat at 9:30 a.m. on February 11, where he is expected to discuss the company's strategic direction in targeted therapies, bolstering investor confidence in its growth trajectory.
- Clinical Trial Progress: Celcuity's lead therapeutic candidate, gedatolisib, is involved in multiple clinical trials, including VIKTORIA-1, which has completed enrollment, and VIKTORIA-2, which is currently enrolling, demonstrating the company's ongoing commitment and potential in cancer treatment.
- Unique Drug Mechanism: Gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor, has a mechanism of action that significantly differs from existing therapies, potentially offering new treatment options for various solid tumor patients and further solidifying the company's competitive position in the biopharmaceutical market.

- Significant Efficacy: In the VIKTORIA-1 trial, patients receiving the gedatolisib triplet achieved a median progression-free survival (PFS) of 16.6 months, significantly outperforming the 1.9 months seen with fulvestrant alone, indicating the potential transformative impact of this therapy for HR+, HER2- breast cancer treatment.
- Patient Subgroup Analysis: For patients whose time to progression on prior therapy exceeded 18 months, the triplet regimen demonstrated a median PFS of 12.4 months, while the doublet showed 10.0 months, highlighting the drug's effectiveness in specific patient populations and offering new clinical options.
- Safety Analysis: Most patients experienced effective resolution of stomatitis symptoms within two weeks post-treatment, with a median time to improvement of 12 days for those on the triplet regimen, demonstrating the favorable tolerability of this therapy.
- Clinical Outlook: Celcuity's Chief Medical Officer noted that the safety and efficacy data for gedatolisib provide strong support for future FDA New Drug Application submissions, potentially reshaping the treatment landscape for HR+, HER2- breast cancer.

Earnings Reports Overview: Several companies, including Cisco Systems, Manulife Financial, and Flutter Entertainment, are set to report earnings after hours on November 12, 2025, with varying forecasts indicating potential growth compared to the previous year.
Cisco Systems Performance: Cisco is expected to report earnings per share of $0.80, reflecting a 6.67% increase year-over-year, and has consistently beaten expectations in the past year.
Manulife Financial and Flutter Entertainment: Manulife's forecast is $0.74, a 1.37% increase, while Flutter anticipates $0.17, a significant 30.77% increase, although Manulife has faced recent negative surprises.
Other Companies' Forecasts: Companies like Pan American Silver and Tetra Tech are also reporting, with Pan American expecting a 53.13% increase in earnings, while Cellebrite and Celcuity are projecting declines in earnings per share.








