Celcuity's Drug Nears FDA Review Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 27 2026
0mins
Should l Buy CELC?
Source: NASDAQ.COM
- Analyst Coverage Initiated: Analyst Silvan Turkcan initiated coverage on Celcuity with a 'buy' rating and a price target of $150 per share, nearly 20% above the latest closing price, reflecting strong market confidence in the company.
- Clinical Candidate Outlook: Celcuity's leading drug candidate, gedatolisib, targets advanced breast cancer, with the FDA set to complete its review of the New Drug Application in less than two months, which could significantly boost the company's market value and attract more investor interest.
- Potential Market Impact: Gedatolisib is not only expected to treat breast cancer; the analyst noted its potential for approval in other indications, which would further enhance its market value and strengthen Celcuity's strategic position.
- Increased Investor Attention: With gedatolisib's high potential, Celcuity has become a focal point for biotech investors, and despite the high stock price, the potential of its leading drug candidate could further elevate its market value.
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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: 131.060
Low
94.00
Averages
106.50
High
126.00
Current: 131.060
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.
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- 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.
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