Celcuity Reports Positive Results from VIKTORIA-1 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 01 2026
0mins
Should l Buy CELC?
Source: Newsfilter
- Clinical Trial Results: Celcuity's VIKTORIA-1 trial shows that the combination of gedatolisib and fulvestrant significantly improves progression-free survival (PFS) in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer, indicating its potential in treatment.
- FDA Application Plans: Celcuity intends to submit a supplemental New Drug Application (sNDA) to the FDA for gedatolisib, which could change the standard of care, particularly in the second-line treatment setting.
- Safety Analysis: Both gedatolisib regimens demonstrated good tolerability with no new safety signals, providing confidence for future clinical applications and potentially attracting more investor interest.
- Market Outlook: With HR+/HER2- breast cancer accounting for 70% of all cases and approximately 40% having PIK3CA mutations, the success of gedatolisib could open new market opportunities for Celcuity, enhancing its competitiveness in the biopharmaceutical sector.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CELC?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 130.710
Low
94.00
Averages
106.50
High
126.00
Current: 130.710
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.
ACT Capital Management Acquires New Position in Alumis Worth $4.36 Million
- New Position: On May 8, 2026, ACT Capital Management disclosed a new position in Alumis by acquiring 174,250 shares valued at approximately $4.36 million, indicating strong confidence in the company's future prospects.
- Quarterly Valuation: The position's valuation stood at $3.84 million at quarter-end, reflecting the impact of market price changes and share count, highlighting Alumis's significance in the investment portfolio.
- Stock Performance: Alumis shares surged 350% over the past year, significantly outperforming the S&P 500's 30% gain, showcasing its robust growth potential in the biopharmaceutical sector.
- Clinical Progress: Alumis reported positive Phase 3 data for moderate-to-severe plaque psoriasis in March, with plans to submit a New Drug Application in the second half of 2026, further boosting investor confidence in its drug development pipeline.
See More
Middle East Tensions Weigh on Stock Market Performance
- Market Decline: The S&P 500 index fell by 0.41%, the Dow Jones Industrial Average dropped by 1.13%, and the Nasdaq 100 index decreased by 0.21%, reflecting investor concerns over escalating tensions in the Middle East, which dampened market sentiment.
- Oil Price Surge: WTI crude oil prices surged over 4% following exchanges of fire between the US and Iran in the Strait of Hormuz, raising inflation expectations and pushing bond yields higher, with the 10-year T-note yield reaching a five-week high of 4.46%.
- Strong Economic Data: US March factory orders rose by 1.5% month-over-month, exceeding expectations of 0.6%, marking the largest increase in four months, indicating economic resilience that could provide support to the stock market.
- Earnings Optimism: As of Monday, 82% of the 322 S&P 500 companies that reported Q1 earnings exceeded estimates, with projected earnings growth of 12% year-over-year for Q1, although excluding the technology sector, the growth is only 3%, highlighting performance disparities across sectors.
See More
Celcuity (CELC.US) Director Plans to Sell $3.52 Million in Common Stock via Form 144
- Stock Sale Announcement: Celcuity's Director, Dalvey David, plans to sell 25,000 shares of its common stock on May 4.
- Market Value: The total market value of the shares being sold is approximately $3.52 million.
See More
Amazon Launches Supply Chain Services, Pressuring Logistics Stocks
- Logistics Stocks Decline: Amazon's announcement of its own supply chain services has pressured logistics stocks, with GXO Logistics down 11%, UPS falling about 10%, and both FedEx and C.H. Robinson sinking 9%, indicating market concerns over Amazon's competitive threat.
- Berkshire Hathaway's Steady Performance: CEO Greg Abel reassured investors at the annual shareholders meeting, leading to nearly a 1% increase in stock price, which reflects growing investor confidence in the company's future opportunities and alleviates concerns about breaking up the conglomerate.
- Global Business Travel Group Acquisition: Long Lake's $6.3 billion acquisition of Global Business Travel Group signals confidence in AI's potential to reshape the travel sector, resulting in a 57% surge in the company's stock price, showcasing optimistic market expectations for future growth.
- Norwegian Cruise Line Lowers Forecast: Norwegian Cruise Line's stock dropped 8% after it sharply cut its second-quarter and full-year estimates due to skyrocketing fuel prices from the U.S.-Iran conflict, reflecting market concerns about its profitability amid rising operational costs.
See More
US Stock Market Volatility Amid Oil Price Recovery
- Market Volatility: The S&P 500 index fell by 0.04%, the Dow Jones Industrial Average decreased by 0.42%, while the Nasdaq 100 index rose by 0.19%, indicating market fluctuations amid heightened tensions in the Strait of Hormuz, leading to cautious investor sentiment.
- Oil Price Recovery: WTI crude oil prices slightly increased following an unverified report of two missiles hitting a US patrol boat, despite US Central Command stating no US ships were struck, highlighting the market's sensitivity to geopolitical risks.
- Corporate Earnings Optimism: So far, 82% of the 317 S&P 500 companies that reported earnings exceeded expectations, with Q1 earnings projected to rise by 12% year-over-year, demonstrating corporate resilience driven by AI investments, which may support the stock market.
- Interest Rate Expectations Shift: The market discounts only a 3% chance of a 25 basis point rate cut at the upcoming FOMC meeting in June, while the ECB's rate hike expectations stand at 93%, reflecting differing investor outlooks on future monetary policy.
See More
Celcuity Upgraded to Buy with Price Target Raised to $165
- Upgrade Announcement: H.C. Wainwright upgraded Celcuity from ‘Neutral’ to ‘Buy’ and raised its price target from $94 to $165, citing positive Phase 3 trial results that indicate significant potential in breast cancer treatment.
- Price Target Increase: Citizens also raised its price target for Celcuity from $150 to $160 while maintaining an ‘Outperform’ rating, highlighting the drug's promising application in second-line ER+/HER2- breast cancer with an expected progression-free survival of 11-12 months.
- Positive Market Reaction: Celcuity's shares surged over 15% in pre-market trading on Monday, and if these gains hold through the regular session, it would mark the stock's best single-day performance in over six months, reflecting strong market confidence in its new therapy.
- Acquisition Potential: Analysts suggest that Celcuity could become an acquisition target in the oncology sector, as its breast cancer therapy gedatolisib achieved its primary endpoint in the Phase 3 trial, demonstrating significant clinical relevance that could reshape market dynamics.
See More
ACT Capital Management Acquires New Position in Alumis Worth $4.36 Million
- New Position: On May 8, 2026, ACT Capital Management disclosed a new position in Alumis by acquiring 174,250 shares valued at approximately $4.36 million, indicating strong confidence in the company's future prospects.
- Quarterly Valuation: The position's valuation stood at $3.84 million at quarter-end, reflecting the impact of market price changes and share count, highlighting Alumis's significance in the investment portfolio.
- Stock Performance: Alumis shares surged 350% over the past year, significantly outperforming the S&P 500's 30% gain, showcasing its robust growth potential in the biopharmaceutical sector.
- Clinical Progress: Alumis reported positive Phase 3 data for moderate-to-severe plaque psoriasis in March, with plans to submit a New Drug Application in the second half of 2026, further boosting investor confidence in its drug development pipeline.
See More
Middle East Tensions Weigh on Stock Market Performance
- Market Decline: The S&P 500 index fell by 0.41%, the Dow Jones Industrial Average dropped by 1.13%, and the Nasdaq 100 index decreased by 0.21%, reflecting investor concerns over escalating tensions in the Middle East, which dampened market sentiment.
- Oil Price Surge: WTI crude oil prices surged over 4% following exchanges of fire between the US and Iran in the Strait of Hormuz, raising inflation expectations and pushing bond yields higher, with the 10-year T-note yield reaching a five-week high of 4.46%.
- Strong Economic Data: US March factory orders rose by 1.5% month-over-month, exceeding expectations of 0.6%, marking the largest increase in four months, indicating economic resilience that could provide support to the stock market.
- Earnings Optimism: As of Monday, 82% of the 322 S&P 500 companies that reported Q1 earnings exceeded estimates, with projected earnings growth of 12% year-over-year for Q1, although excluding the technology sector, the growth is only 3%, highlighting performance disparities across sectors.
See More
Celcuity (CELC.US) Director Plans to Sell $3.52 Million in Common Stock via Form 144
- Stock Sale Announcement: Celcuity's Director, Dalvey David, plans to sell 25,000 shares of its common stock on May 4.
- Market Value: The total market value of the shares being sold is approximately $3.52 million.
See More
Amazon Launches Supply Chain Services, Pressuring Logistics Stocks
- Logistics Stocks Decline: Amazon's announcement of its own supply chain services has pressured logistics stocks, with GXO Logistics down 11%, UPS falling about 10%, and both FedEx and C.H. Robinson sinking 9%, indicating market concerns over Amazon's competitive threat.
- Berkshire Hathaway's Steady Performance: CEO Greg Abel reassured investors at the annual shareholders meeting, leading to nearly a 1% increase in stock price, which reflects growing investor confidence in the company's future opportunities and alleviates concerns about breaking up the conglomerate.
- Global Business Travel Group Acquisition: Long Lake's $6.3 billion acquisition of Global Business Travel Group signals confidence in AI's potential to reshape the travel sector, resulting in a 57% surge in the company's stock price, showcasing optimistic market expectations for future growth.
- Norwegian Cruise Line Lowers Forecast: Norwegian Cruise Line's stock dropped 8% after it sharply cut its second-quarter and full-year estimates due to skyrocketing fuel prices from the U.S.-Iran conflict, reflecting market concerns about its profitability amid rising operational costs.
See More
US Stock Market Volatility Amid Oil Price Recovery
- Market Volatility: The S&P 500 index fell by 0.04%, the Dow Jones Industrial Average decreased by 0.42%, while the Nasdaq 100 index rose by 0.19%, indicating market fluctuations amid heightened tensions in the Strait of Hormuz, leading to cautious investor sentiment.
- Oil Price Recovery: WTI crude oil prices slightly increased following an unverified report of two missiles hitting a US patrol boat, despite US Central Command stating no US ships were struck, highlighting the market's sensitivity to geopolitical risks.
- Corporate Earnings Optimism: So far, 82% of the 317 S&P 500 companies that reported earnings exceeded expectations, with Q1 earnings projected to rise by 12% year-over-year, demonstrating corporate resilience driven by AI investments, which may support the stock market.
- Interest Rate Expectations Shift: The market discounts only a 3% chance of a 25 basis point rate cut at the upcoming FOMC meeting in June, while the ECB's rate hike expectations stand at 93%, reflecting differing investor outlooks on future monetary policy.
See More
Celcuity Upgraded to Buy with Price Target Raised to $165
- Upgrade Announcement: H.C. Wainwright upgraded Celcuity from ‘Neutral’ to ‘Buy’ and raised its price target from $94 to $165, citing positive Phase 3 trial results that indicate significant potential in breast cancer treatment.
- Price Target Increase: Citizens also raised its price target for Celcuity from $150 to $160 while maintaining an ‘Outperform’ rating, highlighting the drug's promising application in second-line ER+/HER2- breast cancer with an expected progression-free survival of 11-12 months.
- Positive Market Reaction: Celcuity's shares surged over 15% in pre-market trading on Monday, and if these gains hold through the regular session, it would mark the stock's best single-day performance in over six months, reflecting strong market confidence in its new therapy.
- Acquisition Potential: Analysts suggest that Celcuity could become an acquisition target in the oncology sector, as its breast cancer therapy gedatolisib achieved its primary endpoint in the Phase 3 trial, demonstrating significant clinical relevance that could reshape market dynamics.
See More
