Celcuity Regulatory Wednesday, August 26, 2026 +0.50 Positive

Celcuity submits sNDA for REVTORPYK in breast cancer

Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK targeting breast cancer patients with a PIK3CA mutation. Market relevance: If approved, it could become the first therapy to inhibit all class I PI3K isoforms in advanced breast cancer.

View original filing at SEC.gov →
AI-generated summary for informational purposes only. Always verify against the original filing. Not investment advice. BriefTape is not a registered investment adviser.

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