Celcuity Submits sNDA to FDA for REVTORPYK in PIK3CA-Mutant Breast Cancer
CELC has more than doubled off its 52-week low of $44.42.
Summary
An sNDA has been filed for REVTORPYK in PIK3CA-mutant advanced breast cancer, supported by Phase 3 data showing a 50% reduction in progression risk. Approval would make it the first pan-PI3K/mTOR inhibitor for this population.
Key Events · Product Development and Regulatory · CELC
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sNDA Submitted for PIK3CA-Mutant Indication
A supplemental New Drug Application has been submitted to the FDA for REVTORPYK in HR+/HER2- advanced breast cancer with PIK3CA mutation, following progression on endocrine therapy.
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Phase 3 Efficacy Data
The REVTORPYK-triplet reduced risk of progression or death by 50% (HR=0.50, p<0.0001) with median PFS of 11.1 months vs 5.6 months for alpelisib; the doublet showed HR=0.51 and median PFS of 11.3 months.
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Market Expansion Potential
PIK3CA mutations occur in approximately 40% of HR+/HER2- breast cancers, significantly expanding the addressable population beyond the wild-type approval granted July 14, 2026.
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Regulatory Timeline
The FDA review timeline has not yet been disclosed; the company states it will work collaboratively with the FDA on the application.
Analysis · CELC · Industrial Applications And Services
A supplemental New Drug Application has been submitted to expand REVTORPYK's label to PIK3CA-mutant HR+/HER2- advanced breast cancer. The filing is supported by strong Phase 3 data showing a 50% reduction in disease progression risk versus standard of care. If approved, REVTORPYK would be the first pan-PI3K/mTOR inhibitor for this mutation-positive population, which represents roughly 40% of HR+/HER2- breast cancers. This expands the addressable market beyond the wild-type approval granted in July 2026.
How filings like this one have moved
In the 30 days to Sep 14, 2026, 35.8% of the 1045 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was -0.43%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, CELC was trading at $91.00 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $4.5B. The 52-week trading range was $44.42 to $151.02. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.