Share Prices & Company Research

Market News

23 Jun 2020 | 07:29

PureTech's Akili gets CE-mark for 'EndeavourRx'

(Sharecast News) - Clinical-stage biotherapeutics company PureTech Health announced on Tuesday that its 'founded entity' subsidiary Akili has received a CE-mark for 'EndeavorRx', or AKL-T01, as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with attention deficit hyperactivity disorder (ADHD). The FTSE 250 company said that, while EndeavorRx was not yet available in Europe, the CE-mark would enable Akili to market EndeavorRx in European Economic Area (EEA) member countries.

It said ADHD is one of the most common psychiatric disorders in childhood, with almost 5% of children in Europe diagnosed with the disorder.

The CE-mark followed last week's US Food and Drug Administration (FDA) decision, which made EndeavorRx the first FDA-cleared prescription treatment delivered through a video game, and the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition.

With a near-term focus on launching the EndeavorRx prescription treatment in the US, PureTech said Akili was exploring expansion opportunities in Europe as part of its global strategy.

In March 2019, Akili announced a strategic partnership with Shionogi to develop and commercialise EndeavorRx in Japan and Taiwan.

"Akili's European marketing authorisation today is an important milestone for families in Europe looking to help their children with ADHD," said PureTech founder and chief executive officer Daphne Zohar.

"This is on the heels of the exciting news of Akili's FDA clearance last week and Gelesis' receipt of a European CE-mark for 'Plenity' earlier this month.

"We are so proud that two products developed from our unique research and development engine have now received marketing authorisation in both the US and Europe."

At 0840 BST, shares in PureTech Health were down 0.19% at 269.5p.
Get in touch today
Join Redmayne Bentley
Talk to us now about opening a new account or transferring your account from another provider
0113 243 6941
Get in touch today
Contact your local office
Contact your local office to find out more
The value of your investments and the income from them may go down as well as up, and you could get back less than you invested.
Continuing our Personal Service: View our Latest COVID-19 Update: 15th January 2021
We use cookies on this site to improve your experience and help us provide you with a better website. An explanation of the cookies we use and their purpose can be found within our Cookie Policy. Your continued use of this site means you consent to the use of cookies.