CELC News & Events

Celcuity announced publication of efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology. The cohort consists of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative PIK3CA WT advanced breast cancer, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The objective response rate of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia; stomatitis rash; and hyperglycemia. The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia, leukopenia, and pneumonitis. TRAEs led to the discontinuation of study treatment in 2.3% of patienThe U.S. FDA has granted Priority Review of Celcuity's New Drug Application for gedatolisib and assigned a Prescription Drug User Fee Act goal date of July 17, 2026.

Welcome to this week's installment of "The Short Interest Report" - The Fly's weekly recap of short interest trends among some of the most widely followed high-short-float stocks. Using the data from our partnerwhich utilizes the latest information from stock lenders to estimate short interest changes for thousands of publicly traded companies, this report will screen for some of biggest changes in short interest as a percentage of free float and days-to-cover ratios while also considering the short interest data on some of the more volatile and heavier-traded names of the week. Based on the availability of data from Ortex, the report tracks the trading period that covers prior Friday through Thursday of this week, excluding holidays. As a basis of comparison for stocks discussed below, the S&P 500 index was down 0.5%, the Nasdaq Composite was down 0.4%, the Russell 2000 index was up 1.7%, the Russell 2000 Growth ETFwas up 1.6%, and the Russell 2000 Value ETFwas up 1.8% in the four-day trading session range through January 22.SHORT INTEREST GAINERSAs profiled last week, Ortex-reported short interest on Celcuityhad troughed at a three-month low below 20% in the final week of November, followed by a gradual ascend that picked up speed in the first half of January. The bears demonstrated greater resolve as the percentage of short interest to free float had jumped from 23.7% to 28.8% last week, and this week, the trend continued, with short interest gaining another three percentage points to 31.8% - now less than two points away from 2025 highs just north of 33%. With trading volume holding steady, days-to-cover on the name also continued to climb, rising from 5.0 to 6.0. The stock, meanwhile, was up 5.2% in the four-day period covered through Thursday and has now gained 10.3% year-to-date.Ortex-reported short interest on Intuitive Machineshad tracked in the 20%-23% range from the first week of December just beyond the half-way point of January, though this week has seen a spike in short positioning from 23.0% all the way above 28% - the highest level since September of 2024. Days-to-cover on the name is down notably however, slipping from 5.0 to 4.6 amid a more pronounced period of trading volume activity since mid-December. The stock has nearly tripled since its mid-November lows, rising from $8 per share to over $22, though while the bears were initially prone to reduce exposure, shorts are increasingly re-establishing positions in the new year. This week, Intuitive Machines shares were up another 5.7% in the four-day period covered, with year-to-date gain now seen at 23%.SHORT INTEREST DECLINERSOrtex-reported short interest on Redwirepeaked around 31% in the first week of January as bears looked to fade the 40% advance in the first few days of the new year, but as shares continued to climb, exuberance on the short side gave way to caution. This week, short positioning as a percentage of free float for Redwire fell from 26.4% to 21.8% - the lowest level since mid-November. Days to cover also scaled back to 3.2 from 3.8, even with trading volumes on the stock remaining well above normal ranges. The stock, meanwhile, picked up another 10% in the four-day period through Thursday and now stands having gained 18% from short interest peak on January 6th, 65% year-to-date, and 158% from mid-November lows.Ortex-reported short interest on Rezolve AIskyrocketed from 8% in the first week of December to an all-time high above 32% by mid-January as the stock also more than doubled in that timespan. With shares rolling over this week in conjunction with the company's announced $250M registered direct offering however, bears are also booking profits - short interest as a percentage of free float has declined from 32.3% all the way down to 21.3%, while days-to-cover on the name is down from 4.2 to 1.8. Rezolve AI has lost 25% in the four-day period covered and more than half of its value since the stock's peak in mid-September, though year-to-date in 2026, shares are still up 22%.

Celcuity announced that the U.S. Food and Drug Administration, FDA, has accepted for filing its New Drug Application, NDA, for gedatolisib in hormone receptor positive, human epidermal growth factor receptor 2 negative, PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act goal date of July 17, 2026. The NDA was submitted under the FDA's Real-Time Oncology Review program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.