Celcuity wins first FDA approval with Revtorpyk in advanced breast cancer

USA-based biotech Celcuity (Nasdaq: CELC) has won its first US Food and Drug Administration (FDA) approval, with the regulator clearing Revtorpyk (gedatolisib) for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one line of endocrine therapy in the metastatic setting.

The approval, announced on July 14, covers Revtorpyk in combination with fulvestrant, with or without Pfizer’s (NYSE: PFE) Ibrance (palbociclib). Celcuity’s shares closed up 7% at $111.05 on Tuesday as investors welcomed the long-awaited regulatory milestone.