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Investing.com - H.C. Wainwright raised its price target on Celcuity Inc (NASDAQ:CELC) to $66.00 from $50.00 on Monday, while maintaining a Buy rating on the stock. With a market capitalization of $2.2 billion and trading near its 52-week high of $53.85, Celcuity has caught analysts’ attention, maintaining a strong Buy consensus rating of 1.25. According to InvestingPro analysis, the stock appears to be trading above its Fair Value.
The price target increase follows Celcuity’s second-quarter 2025 financial results reported on August 14. The company confirmed plans to submit a new drug application (NDA) by year-end for gedatolisib in combination with fulvestrant with or without palbociclib for treating HR+/HER2- advanced breast cancer in CDK4/6-pretreated patients. The stock has demonstrated remarkable momentum, posting a 306% return over the past six months.
H.C. Wainwright believes the recently disclosed topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 study strongly supports FDA approval. If successful, the drug could receive marketing approval by mid-2026.
The gedatolisib triplet and doublet regimens demonstrated median progression-free survival improvements of 7.3 and 5.4 months respectively, compared to fulvestrant monotherapy. Celcuity plans to publish complete analysis of this cohort at a medical conference later this year.
The company continues to expect topline data from the PIK3CA mutant cohort of the VIKTORIA-1 study during the fourth quarter of 2025.
In other recent news, Celcuity reported a second-quarter loss of $1.04 per share, which was below analysts’ expectations of a $0.88 loss. This earnings miss resulted in an 18.18% negative surprise, raising concerns among investors despite the company’s positive trial data and extended patent exclusivity. In the analyst community, Stifel raised its price target for Celcuity to $68, citing the company’s plans to present primary analysis and full safety data at a medical congress by year-end. Needham, however, lowered its price target to $70 due to concerns over dilution following the second-quarter financial results. Jefferies took a more optimistic stance, increasing its price target to $79, driven by what it termed "unprecedented" progression-free survival data from a Phase III study. These developments reflect varying perspectives on Celcuity’s potential and underline the importance of recent trial data and strategic plans.
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