Celcuity wins FDA approval for breast cancer drug, shares fall on delay
Celcuity’s FDA win came with a delayed launch and safety questions, sending shares down about 8% as investors focused on commercialization, not approval.
Celcuity shares fell about 8% in premarket trading after the company delayed Revtorpyk sales, its first marketed product, even after winning U.S. Food and Drug Administration approval for the drug. The Minneapolis-based biotech needs more time to ensure supply is adequate before commercialization begins.
The FDA approved gedatolisib, sold as Revtorpyk, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on or after at least one line of endocrine therapy. The agency granted Priority Review and assigned a July 17, 2026 PDUFA goal date, with the application handled through the FDA’s Real-Time Oncology Review program. The drug had already picked up Breakthrough Therapy and Fast Track designations.
Revtorpyk’s label sets a dosing schedule, 180 mg intravenously once weekly on Days 1, 8 and 15 of a 28-day cycle, and recommends a steroid-containing alcohol-free mouthwash to reduce stomatitis. It also carries warnings for severe stomatitis, severe rash and severe hyperglycemia.
In a late-stage trial, Revtorpyk combined with Pfizer’s Ibrance and fulvestrant cut the risk of disease progression or death by 76%. Patients on the three-drug regimen went a median 9.3 months without their cancer worsening, compared with two months for patients taking fulvestrant alone. 12% of patients on the combination stopped treatment because of side effects, mouth inflammation affected 72% of patients, and 22% had severe cases.
HR-positive, HER2-negative breast cancer accounts for about 70% of all breast cancers, and roughly 60% of those tumors are PIK3CA wild-type. Brian Sullivan said the approval was the answer to a “20-year challenge” in the PI3K/AKT/mTOR pathway, and Celcuity says the drug is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms and mTORC1 and mTORC2.
Celcuity is also preparing a supplemental application for patients with a PIK3CA mutation around the launch window, while Revtorpyk continues to be studied in a phase 3 first-line breast cancer trial.
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