Celcuity
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Celcuity’s first approved drug, Revtorpyk, is indicated for the second-line treatment of advanced HER2- breast cancer patients without PIK3CA mutations—a key use distinction that sets it apart from other PIK3/AKT blockers in the space, according to Jefferies.
Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Clinical-stage biotech company Celcuity announced Thursday that it had entered into a global licensing agreement with Pfizer to develop and commercialize gedatolisib, the latter company’s first-in-class PI3K/mTOR inhibitor for the treatment of breast cancer.
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