Foresee Pharmaceuticals (TPEx:6576) has completed the Casppian Phase 3 clinical trial for FP-001 42 mg, an investigational treatment for Central Precocious Puberty.
The company plans to submit a New Drug Application to the U.S. FDA by late 2026.
FP-001 42 mg is a sustained-release GnRH agonist administered every six months via subcutaneous injection.
The trial achieved 94% suppression of serum luteinizing hormone below 4 mIU/mL at Week 24, exceeding the 80% success criterion.
In other news, the European Medicines Agency recommended approval of Foresee's CAMCEVI 21mg for advanced prostate cancer.
