Celcuity's sNDA for REVTORPYK accepted for FDA review in HR+/HER2- PIK3CA-mutant breast cancer

Celcuity announced the FDA has accepted its supplemental New Drug Application for REVTORPYK (gedatolisib) to treat patients with HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer. The FDA set a PDUFA goal date of June 25, 2027 for completion of its review.

Detected & updated continuously · Source: Nebula