Celcuity Reports Updated Gedatolisib Data with 16.6 Months PFS in Phase 3 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 11 2025
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Should l Buy CELC?
Source: Newsfilter
- 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.
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Analyst Views on CELC
Wall Street analysts forecast CELC stock price to rise
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 104.870
Low
94.00
Averages
106.50
High
126.00
Current: 104.870
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 Inc. Options Trading Analysis
- Options Selling Risk: Selling put options does not provide investors with the upside potential of owning shares, as the seller only acquires shares if the contract is exercised, meaning they only profit if the stock declines by 58% from the current price.
- Yield Analysis: Under current market conditions, selling the January 2028 put at a $45 strike offers a 9.2% annualized return, indicating that the seller's only profit comes from the premium collected, rather than any potential appreciation of the stock.
- Volatility Consideration: Celcuity Inc's trailing twelve-month volatility stands at 120%, and when combined with fundamental analysis, it can help investors assess whether selling this put option is a worthwhile risk under the current market environment.
- Market Trading Dynamics: On Friday, the put volume among S&P 500 components reached 1.33 million contracts, matching call volume, resulting in a put:call ratio of 0.73, indicating a higher-than-normal demand for puts compared to the long-term median of 0.65, reflecting a shift in market sentiment.
See More
Soleus Capital Increases Stake in Celcuity
- Share Increase: Soleus Capital Management disclosed a purchase of 629,398 shares of Celcuity in an SEC filing, raising its total holdings to over 1.8 million shares valued at $180.36 million, indicating strong confidence in the company.
- Asset Allocation Shift: Celcuity now accounts for 6.7% of Soleus Capital's AUM, becoming its third-largest holding among 95 positions, reflecting investor interest in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged 745% over the past year, significantly outperforming the S&P 500's 14.4% and NASDAQ Composite's 15.7%, highlighting strong market expectations for its future potential.
- Risk Advisory: Despite Celcuity's impressive stock performance, the company currently generates no revenue, necessitating caution from investors regarding inherent risks, as the stock's value is heavily reliant on drug approvals and future profitability prospects.
See More
Celcuity Director Sells $2.4 Million in Shares via Indirect Transaction
- Indirect Share Sale: Director David Dalvey reported an indirect sale of 20,000 shares of Celcuity through Brightstone Venture Capital Fund for approximately $2.4 million, indicating a need for liquidity amid a strong stock performance.
- Holding Proportion Change: This transaction reduced Dalvey's indirect holdings from 110,000 to 90,000 shares, representing 18.18% of his total holdings, reflecting a trend of divestment in the company.
- Market Performance Review: Celcuity's stock has delivered a remarkable 933% total return over the past year, and Dalvey's sale occurs against this backdrop, potentially to lock in profits and manage future uncertainties.
- Trading Plan Context: The sale was executed under a Rule 10b5-1 trading plan adopted by Brightstone, indicating that Dalvey's transaction was prearranged to avoid insider trading implications, reminding investors to focus on the company's fundamentals rather than solely on insider trading activities.
See More
Celcuity to Participate in Biotech Summit 2026
- 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.
See More
Xpeng Inc Reports Disappointing Delivery Numbers, Stock Drops
- Disappointing Delivery Numbers: Xpeng Inc reported delivering 20,011 vehicles in January 2026, a figure that, while substantial, fell short of market expectations, leading to a decline in investor confidence.
- Stock Price Reaction: Following the disappointing delivery results, Xpeng's stock dropped 5.6% in pre-market trading to $16.97, reflecting concerns about the company's future performance among investors.
- Overall Market Trend: U.S. stock futures were lower, with Dow futures falling around 100 points, indicating a cautious market sentiment that could further impact investor attitudes towards Xpeng.
- Industry Impact: The delivery figures from Xpeng may negatively affect overall confidence in the electric vehicle market, especially in an increasingly competitive landscape, prompting investors to reassess their strategies.
See More
Celcuity (CELC) Receives FDA Priority Review for Gedatolisib, Target Action Date July 17, 2026
- FDA Priority Review: Celcuity announced that its lead drug gedatolisib has received FDA priority review, marking a significant advancement in the biotech sector and potentially accelerating market entry.
- Target Approval Date: The FDA has set July 17, 2026, as the target action date for the new drug application for gedatolisib, providing a clear timeline for Celcuity's commercialization strategy.
- Clinical Trial Data Support: According to last month's data update, gedatolisib demonstrated a median progression-free survival of up to 12.4 months in the VIKTORIA-1 clinical trial, indicating its efficacy and favorable safety profile in combination therapy, thereby enhancing the likelihood of FDA approval.
- Revenue Potential Outlook: Celcuity outlines a peak revenue potential of $2.5 billion to $3 billion for gedatolisib, which is expected to attract more investor interest as the company accelerates its launch preparations.
See More
Celcuity Inc. Options Trading Analysis
- Options Selling Risk: Selling put options does not provide investors with the upside potential of owning shares, as the seller only acquires shares if the contract is exercised, meaning they only profit if the stock declines by 58% from the current price.
- Yield Analysis: Under current market conditions, selling the January 2028 put at a $45 strike offers a 9.2% annualized return, indicating that the seller's only profit comes from the premium collected, rather than any potential appreciation of the stock.
- Volatility Consideration: Celcuity Inc's trailing twelve-month volatility stands at 120%, and when combined with fundamental analysis, it can help investors assess whether selling this put option is a worthwhile risk under the current market environment.
- Market Trading Dynamics: On Friday, the put volume among S&P 500 components reached 1.33 million contracts, matching call volume, resulting in a put:call ratio of 0.73, indicating a higher-than-normal demand for puts compared to the long-term median of 0.65, reflecting a shift in market sentiment.
See More
Soleus Capital Increases Stake in Celcuity
- Share Increase: Soleus Capital Management disclosed a purchase of 629,398 shares of Celcuity in an SEC filing, raising its total holdings to over 1.8 million shares valued at $180.36 million, indicating strong confidence in the company.
- Asset Allocation Shift: Celcuity now accounts for 6.7% of Soleus Capital's AUM, becoming its third-largest holding among 95 positions, reflecting investor interest in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged 745% over the past year, significantly outperforming the S&P 500's 14.4% and NASDAQ Composite's 15.7%, highlighting strong market expectations for its future potential.
- Risk Advisory: Despite Celcuity's impressive stock performance, the company currently generates no revenue, necessitating caution from investors regarding inherent risks, as the stock's value is heavily reliant on drug approvals and future profitability prospects.
See More
Celcuity Director Sells $2.4 Million in Shares via Indirect Transaction
- Indirect Share Sale: Director David Dalvey reported an indirect sale of 20,000 shares of Celcuity through Brightstone Venture Capital Fund for approximately $2.4 million, indicating a need for liquidity amid a strong stock performance.
- Holding Proportion Change: This transaction reduced Dalvey's indirect holdings from 110,000 to 90,000 shares, representing 18.18% of his total holdings, reflecting a trend of divestment in the company.
- Market Performance Review: Celcuity's stock has delivered a remarkable 933% total return over the past year, and Dalvey's sale occurs against this backdrop, potentially to lock in profits and manage future uncertainties.
- Trading Plan Context: The sale was executed under a Rule 10b5-1 trading plan adopted by Brightstone, indicating that Dalvey's transaction was prearranged to avoid insider trading implications, reminding investors to focus on the company's fundamentals rather than solely on insider trading activities.
See More
Celcuity to Participate in Biotech Summit 2026
- 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.
See More
Xpeng Inc Reports Disappointing Delivery Numbers, Stock Drops
- Disappointing Delivery Numbers: Xpeng Inc reported delivering 20,011 vehicles in January 2026, a figure that, while substantial, fell short of market expectations, leading to a decline in investor confidence.
- Stock Price Reaction: Following the disappointing delivery results, Xpeng's stock dropped 5.6% in pre-market trading to $16.97, reflecting concerns about the company's future performance among investors.
- Overall Market Trend: U.S. stock futures were lower, with Dow futures falling around 100 points, indicating a cautious market sentiment that could further impact investor attitudes towards Xpeng.
- Industry Impact: The delivery figures from Xpeng may negatively affect overall confidence in the electric vehicle market, especially in an increasingly competitive landscape, prompting investors to reassess their strategies.
See More
Celcuity (CELC) Receives FDA Priority Review for Gedatolisib, Target Action Date July 17, 2026
- FDA Priority Review: Celcuity announced that its lead drug gedatolisib has received FDA priority review, marking a significant advancement in the biotech sector and potentially accelerating market entry.
- Target Approval Date: The FDA has set July 17, 2026, as the target action date for the new drug application for gedatolisib, providing a clear timeline for Celcuity's commercialization strategy.
- Clinical Trial Data Support: According to last month's data update, gedatolisib demonstrated a median progression-free survival of up to 12.4 months in the VIKTORIA-1 clinical trial, indicating its efficacy and favorable safety profile in combination therapy, thereby enhancing the likelihood of FDA approval.
- Revenue Potential Outlook: Celcuity outlines a peak revenue potential of $2.5 billion to $3 billion for gedatolisib, which is expected to attract more investor interest as the company accelerates its launch preparations.
See More
