Celcuity Announces Efficacy Results of Gedatolisib in Advanced Breast Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 18 hours ago
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Should l Buy CELC?
Source: Newsfilter
- Clinical Trial Results: In the VIKTORIA-1 trial, the gedatolisib triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, a significant increase of 7.3 months compared to 2.0 months with fulvestrant, indicating a potential shift in treatment paradigms.
- Efficacy Comparison: The gedatolisib doublet therapy showed a median PFS of 7.4 months versus 2.0 months for fulvestrant, with objective response rates (ORR) of 28.3% and 1%, respectively, highlighting gedatolisib's therapeutic potential in HR+/HER2- breast cancer.
- Safety Assessment: The trial reported that treatment-related adverse events (TRAEs) for both gedatolisib regimens were predominantly low-grade, with the most common grade 3 TRAEs being neutropenia (52.3% and 0%), demonstrating favorable tolerability.
- FDA Review Progress: The U.S. FDA has granted Priority Review for gedatolisib's New Drug Application, with a Prescription Drug User Fee Act goal date set for July 17, 2026, underscoring the drug's significance and potential market impact in breast cancer treatment.
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Analyst Views on CELC
Wall Street analysts forecast CELC stock price to fall
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 113.450
Low
94.00
Averages
106.50
High
126.00
Current: 113.450
Low
94.00
Averages
106.50
High
126.00
About CELC
Celcuity Inc. is a clinical-stage biotechnology company, which develops targeted therapies for the treatment of multiple solid tumor indications. Its lead therapeutic candidate is gedatolisib, a potent, small-molecule reversible inhibitor that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and the two mechanistic targets of rapamycin (mTOR) sub-complexes, mTORC1 and mTORC2. Its development programs for gedatolisib focus on the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), or HR+/HER2-, advanced or metastatic breast cancer and patients with metastatic castration resistant prostate cancer. A Phase III clinical trial of VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast has commenced. Its CELsignia companion diagnostic platform is able to analyze live patient tumor cells.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Celcuity Announces Efficacy Results of Gedatolisib in Advanced Breast Cancer
- Clinical Trial Results: In the VIKTORIA-1 trial, the gedatolisib triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, a significant increase of 7.3 months compared to 2.0 months with fulvestrant, indicating a potential shift in treatment paradigms.
- Efficacy Comparison: The gedatolisib doublet therapy showed a median PFS of 7.4 months versus 2.0 months for fulvestrant, with objective response rates (ORR) of 28.3% and 1%, respectively, highlighting gedatolisib's therapeutic potential in HR+/HER2- breast cancer.
- Safety Assessment: The trial reported that treatment-related adverse events (TRAEs) for both gedatolisib regimens were predominantly low-grade, with the most common grade 3 TRAEs being neutropenia (52.3% and 0%), demonstrating favorable tolerability.
- FDA Review Progress: The U.S. FDA has granted Priority Review for gedatolisib's New Drug Application, with a Prescription Drug User Fee Act goal date set for July 17, 2026, underscoring the drug's significance and potential market impact in breast cancer treatment.
See More
Boxer Capital Increases Stake in Celcuity
- Share Acquisition: Boxer Capital Management disclosed an increase of 135,000 shares in Celcuity during Q4 2025, with an estimated transaction value of $11.10 million, indicating strong confidence in the biotech firm and potentially enhancing its market performance.
- Increased Ownership: Following this acquisition, Boxer Capital now holds a total of 225,000 shares in Celcuity, valued at $22.44 million, representing 4.9% of its 13F reportable assets, highlighting the stock's significance in its investment portfolio.
- Stock Performance: As of February 17, 2026, Celcuity shares were priced at $107.32, reflecting a remarkable 741.1% increase over the past year, significantly outperforming the S&P 500 by 721.3 percentage points, showcasing its strong market appeal and investment potential.
- Industry Risks: While Boxer Capital's acquisition is seen as a bullish signal, the high-risk nature of the biotech sector necessitates caution for investors, particularly given the uncertainties surrounding clinical trial outcomes, suggesting a diversified approach through biotech ETFs may be prudent.
See More
Boxer Capital Increases Stake in Celcuity
- Increased Holdings: Boxer Capital disclosed an acquisition of 135,000 shares of Celcuity in Q4 2025, with an estimated trade value of $11.10 million, reflecting a bullish outlook on the biotech sector.
- Value Appreciation: As of December 31, 2025, Boxer Capital's position in Celcuity was valued at $22.44 million, an increase of $18 million from the previous quarter, demonstrating the dual impact of trading activity and price appreciation.
- Asset Allocation Shift: Celcuity now accounts for 4.9% of Boxer Capital's reportable assets, becoming the firm's fifth-largest position, indicating its growing significance within the biotech investment portfolio.
- Outstanding Market Performance: Celcuity's stock price surged 741.1% over the past year, significantly outperforming the S&P 500 by 721.3 percentage points, showcasing its competitive advantage and market potential in precision oncology.
See More
Surge in Options Trading Volume for ON Holding AG
- Surge in Options Volume: On Holding AG's options trading volume reached 108,317 contracts, equivalent to approximately 10.8 million shares, reflecting a 237.8% increase over its average daily trading volume, indicating strong market interest in the company's future performance.
- High Demand for Call Options: Notably, the $40 strike call option expiring on March 20, 2026, saw a trading volume of 36,567 contracts today, representing about 3.7 million shares, suggesting a significant bullish sentiment among investors regarding the stock's price trajectory.
- Celcuity Inc Options Activity: Celcuity Inc's options volume stood at 8,693 contracts, translating to approximately 869,300 shares, which is 134.5% of its average daily trading volume, highlighting growing investor interest in the company's potential growth.
- Market Enthusiasm for Call Options: For Celcuity Inc, the $130 strike call option expiring on April 17, 2026, recorded a trading volume of 5,005 contracts today, representing around 500,500 shares, further reflecting optimistic investor sentiment about its future performance.
See More
Apis Capital Increases Stake in Garrett Motion by 2.09 Million Shares
- Stake Increase: Apis Capital Advisors, LLC disclosed in a February 17, 2026 SEC filing that it increased its stake in Garrett Motion by 2,090,000 shares, raising its ownership to 6.77%, with the investment now valued at $38.87 million, reflecting a significant $36.96 million increase, indicating strong confidence in the company.
- Performance Metrics: As of February 17, 2026, Garrett Motion's shares were priced at $20.62, representing a remarkable 125.4% increase over the past year, significantly outperforming the S&P 500 by 115.68 percentage points, showcasing the company's robust performance and market recognition in the automotive parts sector.
- Market Demand: Despite the rise of electric vehicles, the automotive industry remains heavily reliant on internal combustion engines, with stringent fuel economy and emissions regulations sustaining demand for turbochargers; Garrett Motion's products enable automakers to meet these requirements while maintaining performance, ensuring revenue stability.
- Investment Outlook: As hybrid vehicles gain traction, Garrett Motion's profitability will depend on steady global vehicle output and ongoing demand for advanced combustion technology, prompting investors to monitor the duration of this transitional phase and its implications for the company's future performance.
See More
Apis Capital Increases Stake in Garrett Motion
- Stake Increase: Apis Capital Advisors, LLC disclosed an increase of 2,090,000 shares in Garrett Motion in a recent SEC filing dated February 17, 2026, with an estimated trade size of approximately $33.28 million, indicating strong confidence in the company.
- Value Appreciation: At quarter-end, the value of Garrett Motion's stake reached $38.87 million, reflecting a $36.96 million increase from the prior period due to both trading activity and price appreciation, further solidifying its position in the portfolio.
- Asset Management Proportion: Following this transaction, Garrett Motion now constitutes 6.77% of Apis Capital's 13F reportable assets under management, highlighting its significance despite not being among the top five holdings in the fund.
- Strong Market Performance: As of February 17, 2026, Garrett Motion shares were priced at $20.62, representing a 125.4% increase over the past year, significantly outperforming the S&P 500 by 115.68 percentage points, underscoring its competitive edge in the automotive parts industry.
See More
Celcuity Announces Efficacy Results of Gedatolisib in Advanced Breast Cancer
- Clinical Trial Results: In the VIKTORIA-1 trial, the gedatolisib triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, a significant increase of 7.3 months compared to 2.0 months with fulvestrant, indicating a potential shift in treatment paradigms.
- Efficacy Comparison: The gedatolisib doublet therapy showed a median PFS of 7.4 months versus 2.0 months for fulvestrant, with objective response rates (ORR) of 28.3% and 1%, respectively, highlighting gedatolisib's therapeutic potential in HR+/HER2- breast cancer.
- Safety Assessment: The trial reported that treatment-related adverse events (TRAEs) for both gedatolisib regimens were predominantly low-grade, with the most common grade 3 TRAEs being neutropenia (52.3% and 0%), demonstrating favorable tolerability.
- FDA Review Progress: The U.S. FDA has granted Priority Review for gedatolisib's New Drug Application, with a Prescription Drug User Fee Act goal date set for July 17, 2026, underscoring the drug's significance and potential market impact in breast cancer treatment.
See More
Boxer Capital Increases Stake in Celcuity
- Share Acquisition: Boxer Capital Management disclosed an increase of 135,000 shares in Celcuity during Q4 2025, with an estimated transaction value of $11.10 million, indicating strong confidence in the biotech firm and potentially enhancing its market performance.
- Increased Ownership: Following this acquisition, Boxer Capital now holds a total of 225,000 shares in Celcuity, valued at $22.44 million, representing 4.9% of its 13F reportable assets, highlighting the stock's significance in its investment portfolio.
- Stock Performance: As of February 17, 2026, Celcuity shares were priced at $107.32, reflecting a remarkable 741.1% increase over the past year, significantly outperforming the S&P 500 by 721.3 percentage points, showcasing its strong market appeal and investment potential.
- Industry Risks: While Boxer Capital's acquisition is seen as a bullish signal, the high-risk nature of the biotech sector necessitates caution for investors, particularly given the uncertainties surrounding clinical trial outcomes, suggesting a diversified approach through biotech ETFs may be prudent.
See More
Boxer Capital Increases Stake in Celcuity
- Increased Holdings: Boxer Capital disclosed an acquisition of 135,000 shares of Celcuity in Q4 2025, with an estimated trade value of $11.10 million, reflecting a bullish outlook on the biotech sector.
- Value Appreciation: As of December 31, 2025, Boxer Capital's position in Celcuity was valued at $22.44 million, an increase of $18 million from the previous quarter, demonstrating the dual impact of trading activity and price appreciation.
- Asset Allocation Shift: Celcuity now accounts for 4.9% of Boxer Capital's reportable assets, becoming the firm's fifth-largest position, indicating its growing significance within the biotech investment portfolio.
- Outstanding Market Performance: Celcuity's stock price surged 741.1% over the past year, significantly outperforming the S&P 500 by 721.3 percentage points, showcasing its competitive advantage and market potential in precision oncology.
See More
Surge in Options Trading Volume for ON Holding AG
- Surge in Options Volume: On Holding AG's options trading volume reached 108,317 contracts, equivalent to approximately 10.8 million shares, reflecting a 237.8% increase over its average daily trading volume, indicating strong market interest in the company's future performance.
- High Demand for Call Options: Notably, the $40 strike call option expiring on March 20, 2026, saw a trading volume of 36,567 contracts today, representing about 3.7 million shares, suggesting a significant bullish sentiment among investors regarding the stock's price trajectory.
- Celcuity Inc Options Activity: Celcuity Inc's options volume stood at 8,693 contracts, translating to approximately 869,300 shares, which is 134.5% of its average daily trading volume, highlighting growing investor interest in the company's potential growth.
- Market Enthusiasm for Call Options: For Celcuity Inc, the $130 strike call option expiring on April 17, 2026, recorded a trading volume of 5,005 contracts today, representing around 500,500 shares, further reflecting optimistic investor sentiment about its future performance.
See More
Apis Capital Increases Stake in Garrett Motion by 2.09 Million Shares
- Stake Increase: Apis Capital Advisors, LLC disclosed in a February 17, 2026 SEC filing that it increased its stake in Garrett Motion by 2,090,000 shares, raising its ownership to 6.77%, with the investment now valued at $38.87 million, reflecting a significant $36.96 million increase, indicating strong confidence in the company.
- Performance Metrics: As of February 17, 2026, Garrett Motion's shares were priced at $20.62, representing a remarkable 125.4% increase over the past year, significantly outperforming the S&P 500 by 115.68 percentage points, showcasing the company's robust performance and market recognition in the automotive parts sector.
- Market Demand: Despite the rise of electric vehicles, the automotive industry remains heavily reliant on internal combustion engines, with stringent fuel economy and emissions regulations sustaining demand for turbochargers; Garrett Motion's products enable automakers to meet these requirements while maintaining performance, ensuring revenue stability.
- Investment Outlook: As hybrid vehicles gain traction, Garrett Motion's profitability will depend on steady global vehicle output and ongoing demand for advanced combustion technology, prompting investors to monitor the duration of this transitional phase and its implications for the company's future performance.
See More
Apis Capital Increases Stake in Garrett Motion
- Stake Increase: Apis Capital Advisors, LLC disclosed an increase of 2,090,000 shares in Garrett Motion in a recent SEC filing dated February 17, 2026, with an estimated trade size of approximately $33.28 million, indicating strong confidence in the company.
- Value Appreciation: At quarter-end, the value of Garrett Motion's stake reached $38.87 million, reflecting a $36.96 million increase from the prior period due to both trading activity and price appreciation, further solidifying its position in the portfolio.
- Asset Management Proportion: Following this transaction, Garrett Motion now constitutes 6.77% of Apis Capital's 13F reportable assets under management, highlighting its significance despite not being among the top five holdings in the fund.
- Strong Market Performance: As of February 17, 2026, Garrett Motion shares were priced at $20.62, representing a 125.4% increase over the past year, significantly outperforming the S&P 500 by 115.68 percentage points, underscoring its competitive edge in the automotive parts industry.
See More
