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PureTech firm Gelesis gets Europe approval for 'Plenity'

Tue, 02nd Jun 2020 07:37

(Sharecast News) - Clinical stage biotherapeutics company PureTech Health announced on Tuesday that its founded company Gelesis has received approval to market 'Plenity', a novel weight-loss treatment, in Europe.

The FTSE 250 company said Gelesis received a CE-mark for Plenity as a class 3 medical device, indicated for weight loss in overweight and obese adults with a body mass index of between 25 and 40, when used in conjunction with diet and exercise.

It said Gelesis would now be able to market Plenity throughout the European Economic Area and in other countries that recognise the CE mark.

Gelesis previously received clearance for Plenity from the US Food and Drug Administration (FDA), and planned to bring Plenity to the United States first, where it is now available to a limited extent while it ramps up its commercial operations and inventory for a broad launch in 2021.

"This is an important milestone for Gelesis and for the millions of adults across Europe who are seeking to manage their weight," said PureTech's chief innovation officer Eric Elenko.

"We look forward to continued progress from Gelesis' novel hydrogel platform and to the broad launch of Plenity across of the world."

At 0950 BST, shares in PureTech Health were up 2.2% at 255.5p.
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IN BRIEF: PureTech Health begins pulmonary fibrosis study

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IN BRIEF: PureTech Health's founded firm Vedanta launches new facility

PureTech Health PLC - Boston, Massachusetts-based clinical-stage biotherapeutics firm - Announces that its founded firm Entity Vedanta Biosciences Inc launches a new manufacturing facility. The facility will "provide clinical and commercial supply of oral therapies" for people infected with a diarrhoea-causing bacteria, firm says.

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IN BRIEF: PureTech Health's Gelesis wins USD15 million Plenity order

PureTech Health PLC - Boston, Massachusetts-based clinical-stage biotherapeutics - Investee Gelesis Holdings Inc receives another USD15 million pre-order for its weight management aid product Plenity from its distribution partner, New-York based telehealth firm Ro. It brings the total orders from Ro to USD55 million, out of which USD45 million was ordered in the last 12 months, PureTech Health adds.

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IN BRIEF: PureTech shares rise as unveils USD50 million share buyback

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PureTech to buy back up to $50m of shares

(Sharecast News) - PureTech Health has announced a $50m share buyback programme, sending shares in the FTSE 250 biotech sharply higher.

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PureTech entity Gelesis reports positive data for weight loss drug

(Alliance News) - Boston-based biotechnology company PureTech Health PLC's founded entity Gelesis Holdings Inc said on Wednesday that its weight loss drug showed positive responses in adults in clinical trials.

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