{"success":true,"data":{"pressRelease":{"id":"45907","rtpr_id":"nPn79lBl3a","ticker":"6576","exchange":"TPEx","all_tickers":["6576"],"title":"Foresee Pharmaceuticals Announces Completion of Casppian Phase 3 Study with Last Patient Last Visit and Confirms Topline Results: 94% of Patients Achieve LH Suppression with 6-Month Dosing Interval of Leuprolide Mesylate, also the acceptance of Casppian Study for Presentation at Endocrine Society, ENDO 2026 Medical Conference, as a Potential New Six-Month Treatment Option for Central Precocious Puberty","author":"PR Newswire","published_at":"2026-05-27T08:43:48.646Z","article_body":"Foresee Pharmaceuticals Announces Completion of Casppian Phase 3 Study with Last Patient Last Visit and Confirms Topline Results: 94% of Patients Achieve LH Suppression with 6-Month Dosing Interval of Leuprolide Mesylate, also the acceptance of Casppian Study for Presentation at Endocrine Society, ENDO 2026 Medical Conference, as a Potential New Six-Month Treatment Option for Central Precocious Puberty\n\nPR Newswire\n\nTAIPEI, May 27, 2026\n\n * Foresee outlines plan for NDA submission to FDA and other global health\nauthorities by late 2026\n * Plan for NDA Submission and Global Regulatory Filings\n * The Casppian Phase 3 Study was accepted for Presentation at the Endocrine\nSociety, ENDO 2026: A Potential New Six-Month Treatment Option for Central\nPrecocious Puberty\nTAIPEI, May 27, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576),\n(\"Foresee\") today announced the successful completion of the Casppian Phase 3\nclinical trial, with the Last Patient Last Visit (LPLV) now concluded. This\nmilestone follows the previously reported positive topline results\ndemonstrating that FP-001 42 mg (leuprolide mesylate), an investigational,\nsustained-release GnRH agonist administered every six months, met its primary\nefficacy endpoint in children with Central Precocious Puberty (CPP).\n\nAs previously announced, the study's primary endpoint was defined as the\npercentage of patients with serum luteinizing hormone (LH) concentrations <\n4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Week\n24. The results were statistically significant (P-value = 0.0005), with 94% of\npatients achieving LH suppression below the threshold, far exceeding the\npre-specified success criterion of 80%. FP-001 42 mg was well tolerated, with\na safety profile consistent with the established class of GnRH agonists. With\nLPLV now complete, Foresee is accelerating regulatory preparations. Foresee\nplans to submit a New Drug Application (NDA) to the U.S. Food and Drug\nAdministration (FDA) by late 2026, with subsequent submissions planned for\nother health agencies.\n\n\"The completion of the Last Patient Last Visit marks the end of active trial\nconduct and the beginning of our final regulatory push. The robust 94% LH\nsuppression rate sustained over a full six months with a single injection is a\ntestament to the power of our Stabilized Injectable Formulation (SIF)\ntechnology. We are now fully focused on data lock, clinical study report\nfinalization, and preparing a comprehensive NDA package that tells the\ncomplete clinical story of FP-001's potential for these young patients,\"\nstated Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development\n\n\"With the trial now complete, we have confirmed that FP-001 42 mg not only met\nits primary endpoint but did so with an efficacy profile that we believe sets\na new benchmark for six-month dosing in CPP. Importantly, the safety profile\nremained consistent and well-managed throughout the study period, with no new\nor unexpected adverse events. We are confident that this six-month option, if\napproved, could significantly reduce the burden of frequent injections for\nchildren and their families.\" stated Yisheng Lee, M.D., Chief Medical Officer\n\n\"Reaching Last Patient Last Visit in the Casppian study is a pivotal\nachievement that transforms our positive topline results into a tangible\nregulatory asset. Our team is now executing a clear, expedited plan to submit\nan NDA to the FDA by late 2026, followed by submissions to other global\nhealth authorities. We believe FP-001 has the potential to become the first\nRTU every six-month injection in treating CPP patients, and we are committed\nto bringing this six-month dosing option to patients worldwide as swiftly as\npossible.\" stated Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer\nof Foresee Pharmaceuticals\n\nPlan for NDA Submission and Global Regulatory Filings\n\nFollowing the completion of LPLV, Foresee has initiated the following\nregulatory pathway:\n\n * Q2-Q3 2026: Finalize Clinical Study Report (CSR) and complete all statistical\nanalyses.\n * Q3-Q4 2026: Submit NDA to U.S. FDA.\n * H2 2026 – H1 2027: Submit marketing authorization applications to other\nhealth agencies in strategic markets.\n * Ongoing: Engage in pre-NDA meetings and regulatory discussions to ensure a\nstreamlined review process.\nFull results from the completed Casppian Phase 3 trial will be submitted for\npresentation at an upcoming major scientific conference in pediatric\nendocrinology. In addition, the Phase III Casppian Study for FP-001 was\naccepted for Presentation at the Endocrine Society, ENDO 2026.\n\n * The abstract, titled: An Open-label, Single Arm, Multicenter, Phase III Study\non the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled\nRelease in Patients with Central (Gonadotropin Dependent) Precocious Puberty\n(Casppian Study)\n * The abstract Content: The Phase III study successfully met its primary\nefficacy endpoint with high statistical significance (P = 0.0005). Results\ndemonstrated that 94% of patients achieved the primary outcome of serum\nluteinizing hormone (LH) suppression to prepubertal levels (< 4 mIU/mL)\nfollowing a GnRHa stimulation test at Week 24, far exceeding the pre-specified\nsuccess criterion of 80%\n * Location & Date: ENDO 2026 conference from June 13-16, 2026, in Chicago,\nIL. USA.\nAbout Central Precocious Puberty (CPP)\n\nCentral Precocious Puberty is a condition characterized by premature\nactivation of the pituitary-gonadal axis, leading to early puberty. If left\nuntreated, CPP can result in accelerated bone maturation and reduced final\nadult height, as well as significant psychosocial challenges for affected\nchildren. The current standard of care involves treatment with GnRH agonists\nto halt pubertal progression.\n\nAbout FP-001 42 mg\n\nFP-001 42 mg is an investigational, sustained-release formulation of a GnRH\nagonist being developed for the treatment of CPP. It is designed to provide\ncontinuous suppression of gonadotropin secretion for 6 months following a\nsingle subcutaneous injection, offering a less-frequent dosing alternative to\nexisting therapies.\n\nAbout Foresee Pharmaceuticals Co., Ltd.\n\nForesee is a Taiwan and US-based biopharmaceutical company listed on the\nTaipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key\nareas, namely its unique Stabilized Injectable Formulation (SIF) long-acting\ninjectable (LAI) technology with derived drug products targeting specialty\nmarkets and secondly, its transformative preclinical and clinical\nfirst-in-class NCE programs targeting rare and severe disease areas with high\nunmet needs.\n\nForesee's product portfolio includes late and early-stage programs. CAMCEVI 42\nmg, for the treatment of advanced prostate cancer, is now approved in the\nU.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in\nApril 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August\n25, 2025. Foresee was notified by its licensing partners in April and May 2026\nregarding the successful drug approvals in Canada and the granting of EMA\nmarketing authorization in the EU. For the second indication of CAMCEVI\n6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase\n3 clinical trial successfully reached its primary endpoint in December 2025\n(p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the\nsecond half of 2026. Concurrently, CAMCEVI 6-month LAI formulation has\ncompleted its Phase 3 clinical trial for another indication in premenopausal\nbreast cancer in China, and the partner is preparing to submit a marketing\nauthorization application to China's NMPA as the next step. Aderamastat\n(FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and\nfibrotic diseases, successfully completed a Phase 2 proof-of-concept study in\nallergic asthmatic patients. Future development of aderamastat will be in rare\nimmune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020),\na follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy\nvolunteers, with development targeted in severe asthma and COPD. In January\n2026, the global rights for the MMP-12 Inhibitor series were exclusively\nlicensed to Primevera Therapeutics LLC for all subsequent R&D.\nMirivadelgat (FP-045) is a highly selective oral small molecule allosteric\nactivator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD\nstudy in pulmonary hypertension-interstitial lung disease (PH-ILD) patients\nwas initiated in the second quarter of 2025. www.foreseepharma.com\n(http://www.foreseepharma.com/)\n\nSOURCE Foresee Pharmaceuticals\n\n\n\nFor more information: Foresee Pharmaceuticals, Business Development Inquiries: Mathieu Boudreau, Ph.D., CBO/COO, mathieu.boudreau@foreseepharma.com; Media/Investor Inquiries: Stephanie Tsai, Investor Relations/Public Relations, stephanie.tsai@foreseepharma.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn79lBl3a","title":"Foresee Pharmaceuticals Announces Completion of Casppian Phase 3 Study with Last Patient Last Visit and Confirms Topline Results: 94% of Patients Achieve LH Suppression with 6-Month Dosing Interval of Leuprolide Mesylate, also the acceptance of Casppian Study for Presentation at Endocrine Society, ENDO 2026 Medical Conference, as a Potential New Six-Month Treatment Option for Central Precocious Puberty","author":"PR Newswire","ticker":"6576","created":"2026-05-27T08:43:48.646Z","tickers":["6576"],"exchange":"TPEx","article_body":"Foresee Pharmaceuticals Announces Completion of Casppian Phase 3 Study with Last Patient Last Visit and Confirms Topline Results: 94% of Patients Achieve LH Suppression with 6-Month Dosing Interval of Leuprolide Mesylate, also the acceptance of Casppian Study for Presentation at Endocrine Society, ENDO 2026 Medical Conference, as a Potential New Six-Month Treatment Option for Central Precocious Puberty\n\nPR Newswire\n\nTAIPEI, May 27, 2026\n\n * Foresee outlines plan for NDA submission to FDA and other global health\nauthorities by late 2026\n * Plan for NDA Submission and Global Regulatory Filings\n * The Casppian Phase 3 Study was accepted for Presentation at the Endocrine\nSociety, ENDO 2026: A Potential New Six-Month Treatment Option for Central\nPrecocious Puberty\nTAIPEI, May 27, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576),\n(\"Foresee\") today announced the successful completion of the Casppian Phase 3\nclinical trial, with the Last Patient Last Visit (LPLV) now concluded. This\nmilestone follows the previously reported positive topline results\ndemonstrating that FP-001 42 mg (leuprolide mesylate), an investigational,\nsustained-release GnRH agonist administered every six months, met its primary\nefficacy endpoint in children with Central Precocious Puberty (CPP).\n\nAs previously announced, the study's primary endpoint was defined as the\npercentage of patients with serum luteinizing hormone (LH) concentrations <\n4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Week\n24. The results were statistically significant (P-value = 0.0005), with 94% of\npatients achieving LH suppression below the threshold, far exceeding the\npre-specified success criterion of 80%. FP-001 42 mg was well tolerated, with\na safety profile consistent with the established class of GnRH agonists. With\nLPLV now complete, Foresee is accelerating regulatory preparations. Foresee\nplans to submit a New Drug Application (NDA) to the U.S. Food and Drug\nAdministration (FDA) by late 2026, with subsequent submissions planned for\nother health agencies.\n\n\"The completion of the Last Patient Last Visit marks the end of active trial\nconduct and the beginning of our final regulatory push. The robust 94% LH\nsuppression rate sustained over a full six months with a single injection is a\ntestament to the power of our Stabilized Injectable Formulation (SIF)\ntechnology. We are now fully focused on data lock, clinical study report\nfinalization, and preparing a comprehensive NDA package that tells the\ncomplete clinical story of FP-001's potential for these young patients,\"\nstated Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development\n\n\"With the trial now complete, we have confirmed that FP-001 42 mg not only met\nits primary endpoint but did so with an efficacy profile that we believe sets\na new benchmark for six-month dosing in CPP. Importantly, the safety profile\nremained consistent and well-managed throughout the study period, with no new\nor unexpected adverse events. We are confident that this six-month option, if\napproved, could significantly reduce the burden of frequent injections for\nchildren and their families.\" stated Yisheng Lee, M.D., Chief Medical Officer\n\n\"Reaching Last Patient Last Visit in the Casppian study is a pivotal\nachievement that transforms our positive topline results into a tangible\nregulatory asset. Our team is now executing a clear, expedited plan to submit\nan NDA to the FDA by late 2026, followed by submissions to other global\nhealth authorities. We believe FP-001 has the potential to become the first\nRTU every six-month injection in treating CPP patients, and we are committed\nto bringing this six-month dosing option to patients worldwide as swiftly as\npossible.\" stated Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer\nof Foresee Pharmaceuticals\n\nPlan for NDA Submission and Global Regulatory Filings\n\nFollowing the completion of LPLV, Foresee has initiated the following\nregulatory pathway:\n\n * Q2-Q3 2026: Finalize Clinical Study Report (CSR) and complete all statistical\nanalyses.\n * Q3-Q4 2026: Submit NDA to U.S. FDA.\n * H2 2026 – H1 2027: Submit marketing authorization applications to other\nhealth agencies in strategic markets.\n * Ongoing: Engage in pre-NDA meetings and regulatory discussions to ensure a\nstreamlined review process.\nFull results from the completed Casppian Phase 3 trial will be submitted for\npresentation at an upcoming major scientific conference in pediatric\nendocrinology. In addition, the Phase III Casppian Study for FP-001 was\naccepted for Presentation at the Endocrine Society, ENDO 2026.\n\n * The abstract, titled: An Open-label, Single Arm, Multicenter, Phase III Study\non the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled\nRelease in Patients with Central (Gonadotropin Dependent) Precocious Puberty\n(Casppian Study)\n * The abstract Content: The Phase III study successfully met its primary\nefficacy endpoint with high statistical significance (P = 0.0005). Results\ndemonstrated that 94% of patients achieved the primary outcome of serum\nluteinizing hormone (LH) suppression to prepubertal levels (< 4 mIU/mL)\nfollowing a GnRHa stimulation test at Week 24, far exceeding the pre-specified\nsuccess criterion of 80%\n * Location & Date: ENDO 2026 conference from June 13-16, 2026, in Chicago,\nIL. USA.\nAbout Central Precocious Puberty (CPP)\n\nCentral Precocious Puberty is a condition characterized by premature\nactivation of the pituitary-gonadal axis, leading to early puberty. If left\nuntreated, CPP can result in accelerated bone maturation and reduced final\nadult height, as well as significant psychosocial challenges for affected\nchildren. The current standard of care involves treatment with GnRH agonists\nto halt pubertal progression.\n\nAbout FP-001 42 mg\n\nFP-001 42 mg is an investigational, sustained-release formulation of a GnRH\nagonist being developed for the treatment of CPP. It is designed to provide\ncontinuous suppression of gonadotropin secretion for 6 months following a\nsingle subcutaneous injection, offering a less-frequent dosing alternative to\nexisting therapies.\n\nAbout Foresee Pharmaceuticals Co., Ltd.\n\nForesee is a Taiwan and US-based biopharmaceutical company listed on the\nTaipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key\nareas, namely its unique Stabilized Injectable Formulation (SIF) long-acting\ninjectable (LAI) technology with derived drug products targeting specialty\nmarkets and secondly, its transformative preclinical and clinical\nfirst-in-class NCE programs targeting rare and severe disease areas with high\nunmet needs.\n\nForesee's product portfolio includes late and early-stage programs. CAMCEVI 42\nmg, for the treatment of advanced prostate cancer, is now approved in the\nU.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in\nApril 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August\n25, 2025. Foresee was notified by its licensing partners in April and May 2026\nregarding the successful drug approvals in Canada and the granting of EMA\nmarketing authorization in the EU. For the second indication of CAMCEVI\n6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase\n3 clinical trial successfully reached its primary endpoint in December 2025\n(p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the\nsecond half of 2026. Concurrently, CAMCEVI 6-month LAI formulation has\ncompleted its Phase 3 clinical trial for another indication in premenopausal\nbreast cancer in China, and the partner is preparing to submit a marketing\nauthorization application to China's NMPA as the next step. Aderamastat\n(FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and\nfibrotic diseases, successfully completed a Phase 2 proof-of-concept study in\nallergic asthmatic patients. Future development of aderamastat will be in rare\nimmune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020),\na follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy\nvolunteers, with development targeted in severe asthma and COPD. In January\n2026, the global rights for the MMP-12 Inhibitor series were exclusively\nlicensed to Primevera Therapeutics LLC for all subsequent R&D.\nMirivadelgat (FP-045) is a highly selective oral small molecule allosteric\nactivator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD\nstudy in pulmonary hypertension-interstitial lung disease (PH-ILD) patients\nwas initiated in the second quarter of 2025. www.foreseepharma.com\n(http://www.foreseepharma.com/)\n\nSOURCE Foresee Pharmaceuticals\n\n\n\nFor more information: Foresee Pharmaceuticals, Business Development Inquiries: Mathieu Boudreau, Ph.D., CBO/COO, mathieu.boudreau@foreseepharma.com; Media/Investor Inquiries: Stephanie Tsai, Investor Relations/Public Relations, stephanie.tsai@foreseepharma.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-05-27T08:43:48.685078722Z","server_sent_at_ms":1779871428685},"received_at":"2026-05-27T08:43:48.769Z","source_url":null},"analysis":{"id":"35339","press_release_id":"45907","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Foresee Pharmaceuticals completed its pivotal Casppian Phase 3 trial for FP-001 in Central Precocious Puberty, achieving Last Patient Last Visit.\n\nThe study met its primary endpoint with 94% of patients achieving LH suppression, significantly exceeding the 80% success threshold with a p-value of 0.0005.\n\nThe company plans to submit a New Drug Application to the FDA by late 2026 and will present the data at the ENDO 2026 conference in June.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Pivotal Phase 3 complete for Foresee's CPP asset; 94% efficacy rate supports late-2026 NDA filing."},"keyFigures":{"drugName":"FP-001 42 mg (leuprolide mesylate)","phaseOfTrial":"Phase 3","customDimensions":{"p_value":"0.0005","dosing_interval":"6 months","success_threshold":"80%","lh_suppression_rate":"94%"}},"quotedText":"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.","namedEntities":{"people":[{"name":"Bassem Elmankabadi","role":"Senior Vice President of Clinical Development"},{"name":"Yisheng Lee","role":"Chief Medical Officer"},{"name":"Ben Chien","role":"Chairman and Chief Executive Officer"},{"name":"Mathieu Boudreau","role":"CBO/COO"},{"name":"Stephanie Tsai","role":"Investor Relations/Public Relations"}],"products":["FP-001","leuprolide mesylate","CAMCEVI","CAMCEVI ETM","Aderamastat","Linvemastat","Mirivadelgat"],"companies":[{"name":"Foresee Pharmaceuticals","ticker":"6576","relationship":"filer"},{"name":"FDA","relationship":"regulatory authority"},{"name":"Endocrine Society","relationship":"conference organizer"},{"name":"Primevera Therapeutics LLC","relationship":"licensing partner"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Completion of a pivotal Phase 3 trial with strong efficacy (94% vs 80% threshold) and a clear path to NDA submission by late 2026. This is a major de-risking event for the CPP indication, though it is not yet an FDA approval."},"tickerRelevance":{"others":[],"primary":"6576"},"globalImportance":45,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"pivotal_trial_completion","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"neutral","retailFavoriteBoost":0}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Foresee Pharmaceuticals completed its pivotal Casppian Phase 3 trial for FP-001 in Central Precocious Puberty, achieving Last Patient Last Visit.\n\nThe study met its primary endpoint with 94% of patients achieving LH suppression, significantly exceeding the 80% success threshold with a p-value of 0.0005.\n\nThe company plans to submit a New Drug Application to the FDA by late 2026 and will present the data at the ENDO 2026 conference in June.","key_figures":{"drugName":"FP-001 42 mg (leuprolide mesylate)","phaseOfTrial":"Phase 3","customDimensions":{"p_value":"0.0005","dosing_interval":"6 months","success_threshold":"80%","lh_suppression_rate":"94%"}},"named_entities":{"people":[{"name":"Bassem Elmankabadi","role":"Senior Vice President of Clinical Development"},{"name":"Yisheng Lee","role":"Chief Medical Officer"},{"name":"Ben Chien","role":"Chairman and Chief Executive Officer"},{"name":"Mathieu Boudreau","role":"CBO/COO"},{"name":"Stephanie Tsai","role":"Investor Relations/Public Relations"}],"products":["FP-001","leuprolide mesylate","CAMCEVI","CAMCEVI ETM","Aderamastat","Linvemastat","Mirivadelgat"],"companies":[{"name":"Foresee Pharmaceuticals","ticker":"6576","relationship":"filer"},{"name":"FDA","relationship":"regulatory authority"},{"name":"Endocrine Society","relationship":"conference organizer"},{"name":"Primevera Therapeutics LLC","relationship":"licensing partner"}],"dollarAmounts":[]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-05-27T08:44:04.395Z","global_importance":45,"audience_relevance":30,"importance_components":{"tickerTier":"small-cap","eventGravity":"pivotal_trial_completion","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"neutral","retailFavoriteBoost":0}},"durationMs":15685,"modelName":"george-droid-qwen-72b"}}