Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly
Shots:
- Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025)
- Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These trials met their 1 & 2EPs, demonstrating sustained or decreased IGF-1 levels & decreased symptom burden
- Additionally, Paltusotine (PO, QD), a SST2 nonpeptide agonist, is advancing into P-III trial for carcinoid syndrome in neuroendocrine tumors following positive P-II data that showed rapid & sustained reductions in flushing episodes as well as bowel movement frequency
Ref: Globenewswire | Image: Crinetics Pharmaceuticals
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
