NEW YORK, May 29, 2026, 18:04 EDT
- Celcuity traded at $132.88 late Friday, up $2.14 from the last close. Volume was close to 1.42 million shares.
- Celcuity said CEO Brian Sullivan is set to speak at Jefferies on June 4 and at Goldman Sachs on June 10.
- Celcuity will release full VIKTORIA-1 breast-cancer results June 2 at ASCO. The FDA is set to decide on gedatolisib by July 17.
Celcuity Inc. shares gained late Friday, topping the biotech sector as the company heads toward several cancer-drug updates, investor meetings, and an upcoming FDA decision date.
Shares of the Minneapolis-based biotech traded at $132.88, adding $2.14, or around 1.6% on the day. The SPDR S&P Biotech ETF edged up roughly 0.5%. The iShares Nasdaq Biotechnology ETF was little changed.
Celcuity is in focus on timing with investor events around the corner. The company said Thursday that CEO and co-founder Sullivan will speak at Jefferies Global Healthcare Conference in a fireside chat and hold one-on-one meetings June 4, then head to the Goldman Sachs 47th Annual Global Healthcare Conference on June 10.
Coming up, Wall Street will see more clinical data. Celcuity plans to share full results from the PIK3CA-mutant group in its Phase 3 VIKTORIA-1 trial on June 2 at the American Society of Clinical Oncology meeting in Chicago. A Phase 3 trial checks if a therapy is effective and safe enough for regulators.
Nasdaq’s main session was over when this was published. Official trading is 9:30 a.m. to 4 p.m. Eastern, then after-hours runs until 8 p.m. Celcuity’s last quoted trade in the dataset hit at 5:35 p.m. EDT.
Gedatolisib is still the main question for Celcuity shares. The drug, aimed at blocking the PI3K/AKT/mTOR (PAM) pathway, has an FDA new drug application in hand for HR+/HER2-/PIK3CA wild-type advanced breast cancer. The FDA has accepted the filing, given it a priority review and a July 17 Prescription Drug User Fee Act goal date, which is when a decision is expected.
Celcuity CEO Sullivan said this month the company is “on track to launch gedatolisib commercially” if it gets approval in the third quarter. Celcuity reported a net loss of $52.8 million, or 97 cents per share, in the first quarter. Cash, investments and available debt drawdowns should fund operations through 2027, the company said. Celcuity
Celcuity said patients in the PIK3CA-mutant group had better progression-free survival on gedatolisib plus fulvestrant and palbociclib, and on gedatolisib plus fulvestrant. Both regimens hit statistical significance and showed clinical benefit. Progression-free survival is the length of time patients do not see their disease worsen. Sara Hurvitz, a co-principal investigator from Fred Hutch Cancer Center, said comprehensive PAM blockade could “significantly improve outcomes” over drugs that only hit one part of the pathway. Celcuity
Celcuity is moving gedatolisib into earlier-line use. The company said its VIKTORIA-2 trial now has two first-line studies for HR+/HER2- advanced breast cancer, bringing in endocrine-sensitive cases. Chief Medical Officer Igor Gorbatchevsky said earlier first-line Phase 1b data were “very encouraging.” Celcuity
The bar for competition is high. Celcuity ran its mutant-cohort comparison against alpelisib plus fulvestrant; Novartis sells alpelisib as Piqray for patients with PIK3CA-mutated HR+/HER2- advanced breast cancer. In VIKTORIA-2, the control arms include ribociclib-based combos. The FDA calls ribociclib Novartis’s Kisqali.
But the risk is also clear. Celcuity still loses money, has negative earnings, and a lot is baked into the price ahead of a key FDA decision. Any delay, bad safety news, slow sales or stronger results from other players could hit the shares quickly. After-hours moves can also be sharper with less liquidity than during regular trading.
