Celcuity Updates on VIKTORIA-2 Clinical Trial Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Source: Newsfilter
- Trial Expansion: Celcuity announced the addition of a study for endocrine-sensitive HR+/HER2- advanced breast cancer patients in the VIKTORIA-2 clinical trial, which is expected to significantly enhance treatment options and meet the needs of more patients.
- Survival Data: In the Phase 1b trial, patients receiving gedatolisib, palbociclib, and letrozole had a median progression-free survival of 48.6 months and overall survival of 77.3 months, indicating the potential advantages of this combination therapy.
- FDA Feedback: Prior to finalizing the VIKTORIA-2 trial design, Celcuity conducted a Type B meeting with the FDA to obtain feedback and alignment on the new design, ensuring compliance and scientific integrity of the clinical trial.
- Patent Application: Celcuity has submitted a patent application for a subcutaneous formulation of gedatolisib to the USPTO, aiming to provide patients with an injection alternative to infusion, supporting the potential for long-term treatment options.
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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: 130.910
Low
94.00
Averages
106.50
High
126.00
Current: 130.910
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 kinase inhibitor of phosphatidylinositol 3-kinase (PI3K), serine/threonine-protein kinase protein kinase B (AKT), mechanistic target of rapamycin (mTOR) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. A Phase III clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (HR+/HER2-) advanced breast cancer (ABC) has completed enrollment and reported detailed results for cohort 1, patients with PIK3CA wild-type (WT) tumors, and has completed enrollment of cohort 2, patients with PIK3CA mutant-type (MT) tumors.
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.
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- Survival Data: In the Phase 1b trial, patients receiving gedatolisib, palbociclib, and letrozole had a median progression-free survival of 48.6 months and overall survival of 77.3 months, indicating the potential advantages of this combination therapy.
- FDA Feedback: Prior to finalizing the VIKTORIA-2 trial design, Celcuity conducted a Type B meeting with the FDA to obtain feedback and alignment on the new design, ensuring compliance and scientific integrity of the clinical trial.
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- Quarter-End Position Value: As of March 31, 2026, Boxer Capital's position in Corvus was valued at $16.09 million, reflecting an active investment strategy amidst stock price fluctuations, further solidifying its standing in the biotech sector.
- Financial Overview: Corvus Pharmaceuticals ended Q1 2026 with $236.7 million in cash and marketable securities, with management stating that this funding will support operations into Q2 2028, despite posting a quarterly net loss of $13.7 million as R&D spending continues to rise.
- Clinical Trial Progress: Corvus is conducting a Phase 2 trial expected to enroll approximately 200 patients, with preliminary data showing that 75% of patients maintained effective responses after treatment cessation, indicating potential in immune modulation that may attract further investor interest.
See More
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- FDA Review Optimism: CEO Brian Sullivan expressed optimism about the FDA's decision by July 17, although management's cautious stance on FDA interactions and refusal to answer related questions during the call may impact investor confidence.
- R&D and Financial Status: CFO Vicky Hahne reported a net loss of $52.8 million for Q1 2026, translating to a loss of $0.97 per share, with cash and short-term investments totaling $387.1 million, indicating financial pressure as the company prepares for R&D and market activities through 2027.
- Clinical Trial Expansion: Sullivan announced the expansion of the VIKTORIA-2 trial to include a study for endocrine-sensitive disease, with top-line data expected by the end of 2028, strategically enhancing the company's competitive position in breast cancer treatment.
- New Formulation Development: The company is advancing the development of a subcutaneous formulation of gedatolisib and has submitted its first patent application, indicating Celcuity's proactive approach to product diversification and market responsiveness, despite potential challenges from required FDA equivalence studies.
See More
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- Earnings Surprise: Celcuity reported a Q1 GAAP EPS of -$0.97, beating expectations by $0.09, indicating an improvement in financial performance despite ongoing losses.
- Cash Flow Pressure: The net cash used in operating activities for Q1 2026 was $55.1 million, significantly up from $35.9 million in the prior year, reflecting increased operational expenditure pressures.
- Strong Cash Reserves: At the end of Q1 2026, Celcuity had $387.1 million in cash, cash equivalents, and short-term investments, ensuring sufficient liquidity to meet operational funding needs in the coming years.
- Positive Future Outlook: The company expects to finance operations through 2027 using cash, cash equivalents, investments, and drawdowns on its debt facility, demonstrating confidence in future growth prospects.
See More
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- Trial Expansion: Celcuity announced the addition of a study for endocrine-sensitive HR+/HER2- advanced breast cancer patients in the VIKTORIA-2 clinical trial, which is expected to significantly enhance treatment options and meet the needs of more patients.
- Survival Data: In the Phase 1b trial, patients receiving gedatolisib, palbociclib, and letrozole had a median progression-free survival of 48.6 months and overall survival of 77.3 months, indicating the potential advantages of this combination therapy.
- FDA Feedback: Prior to finalizing the VIKTORIA-2 trial design, Celcuity conducted a Type B meeting with the FDA to obtain feedback and alignment on the new design, ensuring compliance and scientific integrity of the clinical trial.
- Patent Application: Celcuity has submitted a patent application for a subcutaneous formulation of gedatolisib to the USPTO, aiming to provide patients with an injection alternative to infusion, supporting the potential for long-term treatment options.
See More
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- 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
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- 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
