Crinetics (CRNX) announced that the European Medicines Agency has validated the marketing authorization application for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth hormone. The MAA will now be reviewed by the Committee for Medicinal Products for Human Use. Additionally, the EMA on February 27 granted paltusotine Orphan Drug Designation for the treatment of acromegaly.
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