Celcuity Submits NDA for Gedatolisib, FDA Grants Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
0mins
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 over the next 12 months. According to Wall Street analysts, the average 1-year price target for CELC is 106.50 USD with a low forecast of 94.00 USD and a high forecast of 126.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 114.530
Low
94.00
Averages
106.50
High
126.00
Current: 114.530
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 (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.
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Celcuity (CELC) Receives FDA Priority Review for Gedatolisib with Goal Date of July 17, 2026
- NDA Acceptance: Celcuity's New Drug Application for gedatolisib has been accepted by the FDA, targeting hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, showcasing the company's potential in oncology treatment.
- Priority Review Granted: The FDA has granted Priority Review status to the application, setting a goal date of July 17, 2026, indicating the agency's recognition of the drug's significance and potential market value.
- Clinical Trial Basis: The submission is based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial, demonstrating the drug's efficacy in clinical research and laying the groundwork for future market introduction.
- Market Reaction: Despite the positive FDA news, Celcuity shares fell over 2% in pre-market trading, reflecting cautious investor sentiment regarding the drug's market prospects, which may impact investor confidence.
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