Akili Announces Results From Shionogi's Phase 3 Clinical Trial Of Localized Version Of Akili's EndeavorRx For Pediatric ADHD Patients In Japan, Now Under Review For Nationwide Marketing Approval
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Akili, Inc. (NASDAQ:AKLI) and its Japanese partner Shionogi & Co. Ltd announced the submission of the digital therapeutic SDT-001, a localized version of Akili's EndeavorRx for pediatric ADHD, for marketing approval in Japan. The submission follows favorable results from a Phase 3 clinical trial demonstrating significant improvements in ADHD symptoms among pediatric patients. No safety concerns were observed. Approval in Japan could expand access to an effective ADHD treatment option in a market with limited pharmaceutical options for pediatric patients.
February 26, 2024 | 1:49 pm
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Akili, Inc.'s submission of SDT-001 for marketing approval in Japan, following positive Phase 3 trial results, could significantly impact its market position and growth prospects in the digital therapeutics space, especially for pediatric ADHD treatment.
The successful Phase 3 trial results and the submission for marketing approval in Japan represent a critical step for Akili, Inc. in expanding its product's global reach. Given the lack of widely available pharmaceutical options for pediatric ADHD in Japan, approval of SDT-001 could significantly boost Akili's market presence and validate its technology further. The positive trial outcomes and safety profile enhance the likelihood of approval, potentially leading to increased investor confidence and stock price appreciation in the short term.
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