Celcuity Submits NDA for Gedatolisib, FDA Grants Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
0mins
Should l Buy CELC?
Celcuity announced that the U.S. Food and Drug Administration, FDA, has accepted for filing its New Drug Application, NDA, for gedatolisib in hormone receptor positive, human epidermal growth factor receptor 2 negative, PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act goal date of July 17, 2026. The NDA was submitted under the FDA's Real-Time Oncology Review program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.
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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: 117.100
Low
94.00
Averages
106.50
High
126.00
Current: 117.100
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
Apis Capital Sells Celcuity Shares Worth $14.3 Million
- 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.
See More
Apis Capital Sells Celcuity Shares in $14.3 Million Trade
- Share Reduction Details: Apis Capital Advisors disclosed the sale of 174,000 shares of Celcuity on February 17, 2026, valued at approximately $14.3 million, indicating a strategic response to market fluctuations.
- Position Analysis: Following the sale, Celcuity still represented 10.46% of Apis Capital's 13F AUM, demonstrating the firm's ongoing confidence in Celcuity despite the partial profit-taking.
- Stock Performance Highlights: 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 721.31 percentage points, showcasing its strong market performance.
- Investor Recommendations: Although Apis Capital reduced its stake, Celcuity remains its largest holding, prompting investors to exercise caution regarding the high volatility of biotech stocks and consider biotech ETFs to spread risk and reduce overall volatility.
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
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
Apis Capital Sells Celcuity Shares Worth $14.3 Million
- 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.
See More
Apis Capital Sells Celcuity Shares in $14.3 Million Trade
- Share Reduction Details: Apis Capital Advisors disclosed the sale of 174,000 shares of Celcuity on February 17, 2026, valued at approximately $14.3 million, indicating a strategic response to market fluctuations.
- Position Analysis: Following the sale, Celcuity still represented 10.46% of Apis Capital's 13F AUM, demonstrating the firm's ongoing confidence in Celcuity despite the partial profit-taking.
- Stock Performance Highlights: 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 721.31 percentage points, showcasing its strong market performance.
- Investor Recommendations: Although Apis Capital reduced its stake, Celcuity remains its largest holding, prompting investors to exercise caution regarding the high volatility of biotech stocks and consider biotech ETFs to spread risk and reduce overall volatility.
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
