Celcuity (CELC) used Citi's Biopharma Back to School Summit on September 9, 2026 to brief investors on the commercial launch of REVTORPYK (gedatolisib), a pan‑PI3K/mTORC1/2 inhibitor. The company said the product will enter the market this quarter, with a 90‑person oncology sales force already in place following a second‑quarter hire.
The drug will be offered in two regimens: a doublet with fulvestrant and a triplet adding palbocicline. Physician feedback suggests an 80/20 split favoring the triplet. Celcuity estimates the time to peak sales at 36 to 42 months, with 36 months viewed as the most realistic scenario.
Celcuity highlighted recent clinical milestones. Wild‑type PIK3CA data were released on July 24‑25, while mutant PIK3CA results were presented at ASCO. An NDA for the PIK3CA‑mutant indication has been filed, with a priority review expected and potential FDA approval projected for the second quarter. Manufacturing validation is on track, aiming for four validated sites by the end of 2027.
The company outlined its target breast‑cancer population. Approximately 40% of patients are double wild‑type (no PIK3CA or ESR1 mutations), another 40% carry a PIK3CA mutation (with or without ESR1), and 20% are PIK3CA wild‑type but ESR1 mutant. Of the roughly 90,000 women diagnosed annually with first‑line metastatic breast cancer, about 60,000 have endocrine‑sensitive disease, historically receiving about 25 months of benefit; a Phase I‑B study of gedatolisib plus palbocicline and letrozole showed a median progression‑free survival of 48 months. The remaining 30,000 patients have endocrine‑resistant disease, historically limited to 7‑8 months of benefit.
Celcuity also referenced prostate‑cancer data, noting PTEN loss in roughly 25% of patients. Preclinical work suggests REVTORPYK activity is less dependent on PTEN status than single‑target AKT inhibitors such as TRUQAP.
Financial metrics were reiterated. Celcuity’s market capitalization stands at $4.55 billion, with the stock trading around $93.02, a 52‑week high of $151.02 and a 1‑year return of 53%. Wall Street analysts have price targets ranging from $140 to $177. No new revenue guidance was provided during the call.
Future data readouts include the VIKTORIA‑2 endocrine‑resistant study expected in late 2028‑2029 and a prostate‑cancer Phase I‑B/II update slated for ESMO by the end of 2024.
