Foresee Pharmaceuticals Advances Towards FDA Filing for Precocious Puberty Treatment
Foresee plans FDA filing for precocious puberty treatment

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Foresee Pharmaceuticals has completed Phase 3 trials for FP-001, a treatment for Central Precocious Puberty, and plans to file a New Drug Application with the FDA by late 2026. The drug, a sustained-release GnRH agonist, showed promising results with 94% of patients meeting the primary endpoint.
- 01FP-001 achieved a primary endpoint of serum luteinizing hormone suppression in 94% of patients at Week 24.
- 02The treatment demonstrated statistical significance with a P-value of 0.0005.
- 03Foresee Pharmaceuticals plans to submit a New Drug Application to the FDA by late 2026.
- 04The company is also finalizing a Clinical Study Report and will present results at the ENDO 2026 conference.
- 05Foresee's CAMCEVI 21mg for advanced prostate cancer received a positive opinion from the European Medicines Agency.
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Foresee Pharmaceuticals (TPEx:6576) has completed the Casppian Phase 3 clinical trial for its investigational treatment FP-001 42 mg, aimed at Central Precocious Puberty. The trial concluded with the last patient visit, and results indicated that 94% of participants met the primary endpoint of serum luteinizing hormone suppression below 4 mIU/mL at Week 24, surpassing the success criterion of 80% with a statistically significant P-value of 0.0005. The company plans to file a New Drug Application with the U.S. Food and Drug Administration by late 2026 and subsequently with other global health authorities. FP-001 is a sustained-release GnRH agonist designed for biannual subcutaneous administration. Additionally, Foresee is preparing to present the trial results at the Endocrine Society ENDO 2026 conference in Chicago. The company, which focuses on long-acting injectable technologies for rare diseases, also received a positive opinion from the European Medicines Agency for its CAMCEVI 21mg treatment for advanced prostate cancer, indicating a growing presence in the European market.
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The approval of FP-001 could provide a new treatment option for children with Central Precocious Puberty, addressing a significant medical need.
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