PharmaTher Announces FDA Extends Review Period for Ketamine; New Approval Goal Date August 9, 2025

Core Points - The U.S. FDA has extended the approval goal date for PharmaTher's new drug application for ketamine to August 9, 2025, from the previous date of June 4, 2025, allowing more time for review of additional information classified as a minor amendment [1] - PharmaTher has confirmed that it has addressed all issues raised in the FDA's Complete Response Letter dated October 22, 2024, and does not anticipate the extension will materially impact its operational and business development initiatives for 2025 [2] Company Overview - PharmaTher Holdings Ltd. is a specialty pharmaceutical company focused on ketamine to address unmet medical needs in various areas including surgery, pain, mental health, and neurological indications [2]