Akili (NASDAQ: AKLI) stock surged after the digital medicine company announced that its Japanese partner, Shionogi & Co. Ltd, initiated the marketing approval process in Japan for SDT-001, a digital therapeutic aimed at improving attention in children with ADHD.
Akili (AKLI) has revealed a significant development in its collaboration with Japanese partner Shionogi & Co. Ltd. The latter has officially submitted a request for marketing approval in Japan for SDT-001.
SDT-001 is a localized adaptation of Akili’s EndeavorRx, hailed as the foremost prescription digital therapeutic for pediatric ADHD, which gained authorization from the FDA in the United States.
Marketing Approval Request for SDT-001 in Japan
The submission is based on promising outcomes from a Phase 3 clinical trial conducted in Japan. This trial involved 164 pediatric patients diagnosed with ADHD, aged between 6 and 17, who were concurrently undergoing conventional treatments. Results showcased that individuals treated with SDT-001 exhibited statistically noteworthy improvements in attention metrics compared to a control cohort after six weeks. No severe adverse reactions linked to the treatment were recorded during the trial.
Dr. Scott Kollins, Chief Medical Officer at Akili, underscored the significance of this milestone, noting the potential for SDT-001 to offer a new treatment avenue in Japan, particularly for ADHD patients who may face limited access to traditional pharmaceutical therapies.
Akili’s portfolio includes a range of cognitive treatment solutions, with EndeavorRx catering to children and EndeavorOTC tailored for adults. These products leverage proprietary technology to target cognitive impairment. EndeavorRx requires a prescription and is intended to complement a comprehensive therapeutic regimen. The primary adverse reaction observed was frustration due to the game’s challenging nature.
This submission to Japan’s Ministry of Health, Labor, and Welfare marks a pivotal stride towards broadening the reach of Akili’s digital therapeutics across global markets. The company remains steadfast in its mission to develop clinically validated yet engaging treatments, effectively reshaping the landscape of medicine through technological innovation.
Akili (NASDAQ: AKLI) Stock Reaction
AKLI stock soared 104.11% to close at $0.45 on Monday. The traders had exchanged hands with 127,689,358 (127.68 million) shares compared to the average daily trading volume of 159.57K.
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