Market snapshot
Wolfe Research has advised investors to purchase shares of Celcuity (NASDAQ:CELC) if the stock weakens in response to an external catalyst. Celcuity is currently priced at $105.84 and has delivered a 787.29% return over the past year, with the share price approaching its 52-week high of $120.31.
Analyst view and cautions
While endorsing a buying approach on weakness, Wolfe Research emphasized caution around extrapolating earlier clinical success to the company's ongoing studies. The research house warned that the persevERA trial presents a tougher benchmark than prior work with giredestrant. Wolfe qualified its stance by acknowledging giredestrant as "a good drug," but reiterated that "we think investors should be careful when extrapolating giredestrant’s prior success to persevERA as it is a more difficult trial to beat, even after acknowledging that giredestrant is a good drug."
Wolfe closed its commentary with a clear tactical recommendation for investors: "We’d be buyers of CELC on any weakness related to the external catalyst."
Analyst consensus and valuation note
According to InvestingPro data reported alongside Wolfe’s view, Celcuity retains a strong analyst consensus, with 2 analysts having recently revised earnings estimates upward for the upcoming period. That said, the company is described as overvalued relative to Fair Value estimates, signaling a valuation premium despite the favorable analyst activity.
Regulatory and clinical developments
On the regulatory front, Celcuity announced that the U.S. Food and Drug Administration has accepted its New Drug Application for gedatolisib and granted the submission Priority Review. The agency has set a decision date of July 17, 2026. The NDA seeks approval for gedatolisib in the treatment of hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations from the FDA.
Clinical data supporting the regulatory push include results from the Phase 3 VIKTORIA-1 trial. That study reported a median progression-free survival of 12.4 months for a subset of patients treated with gedatolisib in combination with palbociclib and fulvestrant.
Market reactions and analyst moves
The VIKTORIA-1 readout and the FDA filing have prompted near-term analyst adjustments. Leerink Partners raised its price target for Celcuity to $118 and maintained an Outperform rating, citing the positive Phase 3 data. Jefferies also increased its target to $134 and continues to carry a Buy rating, noting forthcoming presentations that will provide further detail on gedatolisib’s efficacy and safety datasets.
Outlook
Combined, Wolfe Research’s tactical buying recommendation on weakness, the FDA’s acceptance of the NDA with Priority Review, and supportive Phase 3 data have contributed to heightened market attention on Celcuity. At the same time, the firm’s caution about the relative difficulty of the persevERA trial and the company’s valuation above Fair Value point to material clinical and market risks that investors will need to weigh.
Key takeaways
- Wolfe Research recommends buying Celcuity on any weakness tied to an external catalyst, while cautioning about the persevERA trial’s difficulty.
- Celcuity shares are trading at $105.84, up 787.29% over the past year and approaching a 52-week high of $120.31.
- The FDA has accepted the gedatolisib NDA and granted Priority Review with a July 17, 2026 decision date; Phase 3 data showed a median PFS of 12.4 months in a specified patient group.
Sector impact
- Healthcare - oncology drug development and regulatory outcomes are central to near-term valuation moves.
- Equities - biotech stock volatility tied to catalysts and trial readouts may influence broader small-cap healthcare performance.