Celcuity Inc. announced the FDA has accepted its supplemental New Drug Application for REVTORPYK (gedatolisib) to treat hormone receptor positive, HER2-negative, locally advanced or metastatic breast cancer with PIK3CA mutation after progression on endocrine therapy. The FDA set a PDUFA goal date of June 25, 2027. This acceptance follows positive Phase 3 clinical trial data and builds on REVTORPYK's prior FDA approval for patients without the PIK3CA mutation. If approved, the drug could expand treatment options for a broader patient group with this common breast cancer subtype.
Celcuity's FDA acceptance of the sNDA for REVTORPYK provides context for health sector investors. For readers following health stocks, here is Pluang's market snapshot as of Nov 09, 2026 19:41 WIB: out of 150 priced US health-sector stocks tradable on Pluang, 121 rose and 18 fell today. Notable movers include INO (Inovio Pharmaceuticals Inc) at USD 1.32 with a 1-day change of +8.64% and a typical hold time of 41 days, FLNA (Cassava Sciences Inc) at USD 0.48 with +5.94% change and a 39-day hold time, and LFST (LifeStance Health Group Inc.) at USD 12.99 with -5.66% change and a 12-day hold time.
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