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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