• Foresee outlines plan for NDA submission to FDA and other global health authorities by late 2026
• Plan for NDA Submission and Global Regulatory Filings
• The Casppian Phase 3 Study was accepted for Presentation at the Endocrine Society, ENDO 2026: A Potential New Six-Month Treatment Option for Central Precocious Puberty

TAIPEI, May 27, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the successful completion of the Casppian Phase 3 clinical trial, with the Last Patient Last Visit (LPLV) now concluded. This milestone follows the previously reported positive topline results demonstrating that FP-001 42 mg (leuprolide mesylate), an investigational, sustained-release GnRH agonist administered every six months, met its primary efficacy endpoint in children with Central Precocious Puberty (CPP).

As previously announced, the study's primary endpoint was defined as the percentage of patients with serum luteinizing hormone (LH) concentrations < 4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Week 24. The results were statistically significant (P-value = 0.0005), with 94% of patients achieving LH suppression below the threshold, far exceeding the pre-specified success criterion of 80%. FP-001 42 mg was well tolerated, with a safety profile consistent with the established class of GnRH agonists. With LPLV now complete, Foresee is accelerating regulatory preparations. Foresee plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by late 2026, with subsequent submissions planned for other health agencies.

"The completion of the Last Patient Last Visit marks the end of active trial conduct and the beginning of our final regulatory push. The robust 94% LH suppression rate sustained over a full six months with a single injection is a testament to the power of our Stabilized Injectable Formulation (SIF) technology. We are now fully focused on data lock, clinical study report finalization, and preparing a comprehensive NDA package that tells the complete clinical story of FP-001's potential for these young patients," stated Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development

"With the trial now complete, we have confirmed that FP-001 42 mg not only met its primary endpoint but did so with an efficacy profile that we believe sets a new benchmark for six-month dosing in CPP. Importantly, the safety profile remained consistent and well-managed throughout the study period, with no new or unexpected adverse events. We are confident that this six-month option, if approved, could significantly reduce the burden of frequent injections for children and their families." stated Yisheng Lee, M.D., Chief Medical Officer

"Reaching Last Patient Last Visit in the Casppian study is a pivotal achievement that transforms our positive topline results into a tangible regulatory asset. Our team is now executing a clear, expedited plan to submit an NDA to the FDA by late 2026, followed by submissions to other global health authorities. We believe FP-001 has the potential to become the first RTU every six-month injection in treating CPP patients, and we are committed to bringing this six-month dosing option to patients worldwide as swiftly as possible." stated Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals

Plan for NDA Submission and Global Regulatory Filings

Following the completion of LPLV, Foresee has initiated the following regulatory pathway:

• Q2-Q3 2026: Finalize Clinical Study Report (CSR) and complete all statistical analyses.
• Q3-Q4 2026: Submit NDA to U.S. FDA.
• H2 2026 – H1 2027: Submit marketing authorization applications to other health agencies in strategic markets.
• Ongoing: Engage in pre-NDA meetings and regulatory discussions to ensure a streamlined review process.

Full results from the completed Casppian Phase 3 trial will be submitted for presentation at an upcoming major scientific conference in pediatric endocrinology. In addition, the Phase III Casppian Study for FP-001 was accepted for Presentation at the Endocrine Society, ENDO 2026.

• The abstract, titled: An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin Dependent) Precocious Puberty (Casppian Study)
• The abstract Content: The Phase III study successfully met its primary efficacy endpoint with high statistical significance (P = 0.0005). Results demonstrated that 94% of patients achieved the primary outcome of serum luteinizing hormone (LH) suppression to prepubertal levels (< 4 mIU/mL) following a GnRHa stimulation test at Week 24, far exceeding the pre-specified success criterion of 80%
• Location & Date: ENDO 2026 conference from June 13-16, 2026, in Chicago, IL. USA.

About Central Precocious Puberty (CPP)

Central Precocious Puberty is a condition characterized by premature activation of the pituitary-gonadal axis, leading to early puberty. If left untreated, CPP can result in accelerated bone maturation and reduced final adult height, as well as significant psychosocial challenges for affected children. The current standard of care involves treatment with GnRH agonists to halt pubertal progression.

About FP-001 42 mg

FP-001 42 mg is an investigational, sustained-release formulation of a GnRH agonist being developed for the treatment of CPP. It is designed to provide continuous suppression of gonadotropin secretion for 6 months following a single subcutaneous injection, offering a less-frequent dosing alternative to existing therapies.

About Foresee Pharmaceuticals Co., Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.

Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August 25, 2025. Foresee was notified by its licensing partners in April and May 2026 regarding the successful drug approvals in Canada and the granting of EMA marketing authorization in the EU. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical trial successfully reached its primary endpoint in December 2025 (p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the second half of 2026. Concurrently, CAMCEVI 6-month LAI formulation has completed its Phase 3 clinical trial for another indication in premenopausal breast cancer in China, and the partner is preparing to submit a marketing authorization application to China's NMPA as the next step. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. In January 2026, the global rights for the MMP-12 Inhibitor series were exclusively licensed to Primevera Therapeutics LLC for all subsequent R&D. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. www.foreseepharma.com

SOURCE Foresee Pharmaceuticals