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Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News
Investorideas.com· 2025-10-08 13:41
Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News October 8, 2025 - (Investorideas.com Newswire), a go-to investing platform covering biotech and medtech stocks releases an industry snapshot looking at recent clinical trial updates, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. Recent clinical trial update news from Aethlon Medical, Inc. (Nasdaq: AE ...
MBX Biosciences, Inc. - Special Call
Seeking Alpha· 2025-09-25 01:27
Core Insights - MBX Biosciences announced positive top-line results from its Phase II clinical trial of once-weekly canvuparatide for patients with hypoparathyroidism [2] Group 1: Clinical Trial Results - The Phase II trial demonstrated promising outcomes for canvuparatide in treating hypoparathyroidism [2] - Six-month results from the ongoing open-label extension study were also reported [2] Group 2: Company Leadership - The conference call featured key executives from MBX, including CEO Kent Hawryluk, CMO Dr. Sam Azoulay, and CFO Rick Bartram [4]
MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% Responder Rate at 6 Months in Open-Label Extension
Globenewswire· 2025-09-22 11:00
Core Insights - MBX Biosciences announced that once-weekly canvuparatide achieved statistical significance in the primary endpoint at Week 12 of the Phase 2 Avail trial for chronic hypoparathyroidism, with 63% of treated patients meeting the endpoint compared to 31% in the placebo group [2][3][7] - The company is preparing to initiate a Phase 3 clinical trial in 2026 based on the positive results from the Avail trial [4][5] - Canvuparatide was well tolerated, with no serious adverse events reported during the 12-week trial [1][13] Phase 2 Avail Trial Results - In the 12-week trial, 63% of canvuparatide-treated patients achieved the primary composite endpoint, while 79% maintained responder status at 6 months in the open-label extension [3][7] - The primary endpoint involved maintaining serum calcium levels in the normal range (8.2–10.6 mg/dL) and independence from conventional therapy [3][7] - All 64 patients completed the 12-week study, and 94% chose to enter the open-label extension [2][11] Safety and Tolerability - Canvuparatide was generally well tolerated, with most treatment-emergent adverse events classified as mild or moderate [13] - Injection site reactions occurred in 19% of the treatment group compared to 13% in the placebo group, with no treatment-related serious adverse events reported [13] Future Development - The company plans to present additional data from the Phase 2 trial and open-label extension at an upcoming major medical meeting [9] - The results support the potential of canvuparatide as a best-in-class treatment for hypoparathyroidism, addressing significant unmet medical needs [5][15] About Hypoparathyroidism - Hypoparathyroidism is a rare endocrine disease affecting over 250,000 individuals in the U.S. and Europe, characterized by low calcium levels due to parathyroid hormone deficiency [12] - Current treatments primarily involve high doses of oral calcium and active vitamin D supplements, which do not address the underlying cause of the disease [12]
MBX Biosciences to Provide Topline Results from its Phase 2 Trial of Potential Once-Weekly Canvuparatide for Hypoparathyroidism (HP) on Monday, September 22
Globenewswire· 2025-09-19 20:18
Core Insights - MBX Biosciences, Inc. is set to announce topline results from its Phase 2 clinical trial of canvuparatide for chronic hypoparathyroidism on September 22, 2025 [1] - The company will host a conference call and webcast to discuss the trial results, accessible via a live link or by phone [2] - MBX Biosciences focuses on developing precision peptide therapies for endocrine and metabolic disorders using its proprietary PEP™ platform [3] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies for endocrine and metabolic disorders [3] - The company is advancing a pipeline of candidates targeting significant unmet medical needs with large market opportunities [3]
MBX Biosciences Appoints Andreas Moraitis, M.D., as Senior Vice President of Clinical Development
Globenewswire· 2025-06-23 12:00
Core Insights - MBX Biosciences has appointed Dr. Andreas Moraitis as Senior Vice President of Clinical Development, bringing extensive experience in endocrinology to lead the clinical development of its lead product candidate, canvuparatide [1][2] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders, utilizing its proprietary PEP™ platform [3] - The company is advancing a pipeline that includes canvuparatide (MBX 2109) in Phase 2 for chronic hypoparathyroidism, imapextide (MBX 1416) in Phase 1 for post-bariatric hypoglycemia, and an obesity portfolio with multiple candidates in development [3] Leadership and Expertise - Dr. Moraitis has over a decade of experience in leading clinical development programs at Corcept Therapeutics, where he oversaw programs for rare endocrine diseases and supported NDA filings [2] - His background includes serving as Clinical Assistant Professor in the Endocrine Oncology Program at the University of Michigan and completing a fellowship in Adult and Reproductive Endocrinology at the National Institutes of Health [2] Product Potential - Canvuparatide is positioned as a meaningful new treatment option for patients with hypoparathyroidism, addressing significant unmet medical needs in this area [2] - The company aims to deliver differentiated endocrine and metabolic compounds to underserved patients, leveraging Dr. Moraitis's expertise to advance its pipeline [2][3]