Key insights
- Leerink lowered its price target for Celcuity (CELC) to $155 from $160 following disappointing Phase 3 trial results, causing the stock to drop significantly. While the data may still support approval, the median progression-free survival was numerically lower than in earlier trials. This news introduces a bearish sentiment for CELC, potentially impacting investor confidence in the biotech sector due to trial outcome uncertainties.
Investing.com - Leerink lowered its price target on Celcuity Inc (NASDAQ:CELC) shares to $155 from $160 while maintaining an Outperform rating. The adjustment follows the company’s VIKTORIA-1 trial results in the PIK3CA-mutant cohort released today. The stock tumbled to $93.96, down from its previous close of $132.88, reflecting investor concerns about the trial data. According to InvestingPro analysis, the stock appears overvalued at current levels based on Fair Value metrics.
The trial showed the gedatolisib plus fulvestrant plus palbociclib arm achieved a median progression-free survival of 11.1 months versus 5.6 months for the alpelisib plus fulvestrant control arm. The gedatolisib plus fulvestrant doublet arm recorded a median progression-free survival of 11.3 months versus 5.6 months for the control arm.
The absolute median progression-free survival of approximately 11 months in both arms was numerically lower than the 11.6 months seen in the Phase 1b trial. The control arm performance was consistent with other standard-of-care options in this setting, including capivasertib plus fulvestrant in a post-CDK4/6 population at 5.5 months median progression-free survival.
Leerink lowered its duration estimates to reflect the Phase 3 results, with 11 months in second-line treatment and 9 months in third-line and beyond. The firm did not change its penetration assumptions pending clarity from clinicians on how they weigh the magnitude of benefit over oral agents.
The firm noted the data appears supportive of approval despite the lower absolute progression-free survival compared to earlier trial results. For deeper insights into Celcuity’s valuation and growth prospects, investors can access the comprehensive Pro Research Report, available for this and 1,400+ other US equities on InvestingPro.
In other recent news, Celcuity Inc. presented promising results from its Phase 3 VIKTORIA-1 clinical trial at the American Society of Clinical Oncology Annual Meeting. The trial focused on gedatolisib, an investigational treatment for certain types of breast cancer, showing a 50% reduction in the risk of disease progression or death compared to existing treatments. Median progression-free survival was significantly longer at 11.1 months for patients receiving the gedatolisib-triplet therapy versus 5.6 months for those on alpelisib plus fulvestrant. Despite these positive outcomes, Celcuity’s stock experienced a notable decline. In terms of analyst perspectives, Stifel reiterated a Buy rating with a $175.00 price target, citing the trial’s results as aligning with their expectations. Similarly, Citizens maintained a Market Outperform rating, emphasizing the importance of the upcoming ASCO event for highlighting gedatolisib’s potential. These developments come as the company prepares for a potential approval of gedatolisib in July. Celcuity plans to discuss the trial results further in an upcoming conference call.
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