Akali swings FDA approval for first ADHD treatment game [Yahoo! Finance]
Akili, Inc. (AKLI)
Company Research
Source: Yahoo! Finance
Food and Drug Administration (FDA), marking the first-ever over-the-counter (OTC) video game to be cleared by the authority. Dubbed EndeavorOTC, the game comes in the form of a smartphone app and was cleared through the FDA's 510(k) pathway after 83% of patients demonstrated a clinical response to the treatment in a clinical trial. The STARS-ADHD-Adult trial (NCT05183919), also found that nearly three-quarters (72.5%) of patients reported at least some improvement in their quality of life (QoL) by way of the Adult ADHD Quality of Life Scale. A further 45.8% of patients met a prespecified threshold for clinically meaningful improvement. The game, in the infinite runner genre, is available as part of a subscription model and is available on iOS and Android devices. CEO of Akili, Matt Franklin said: “This FDA authorisation of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we're incredibly proud of pioneering a ne
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News
- Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video Game [Yahoo! Finance]Yahoo! Finance
- Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video GameBusiness Wire
- AKILI INVESTOR ALERT BY THE FORMER ATTORNEY GENERAL OF LOUISIANA: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Akili, Inc. - AKLIPR Newswire
- SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates AKLI, CALT, SGE on Behalf of ShareholdersGlobeNewswire
- SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates MRO, ATRI, SRDX, AKLI on Behalf of ShareholdersPR Newswire
AKLI
Sec Filings
- 6/18/24 - Form 8-K
- 6/11/24 - Form 4
- 6/10/24 - Form SC
- AKLI's page on the SEC website