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PuriCore To Submit New Drug Application For PR022 To FDA In 2017

9th Jun 2016 07:53

LONDON (Alliance News) - PuriCore PLC on Thursday said it has successfully completed a pre-investigational new drug application meeting with the US Food & Drug Administration for PuriCore's PR022 drug.

PR022 is a topical hydrogel being developed for the treatment of atopic dermatitis, which is a chronic inflammatory skin disease. The meeting paves the way for the biopharmaceutical company to submit its first IND application to the FDA for atopic dermatitis, which it has earmarked for the first quarter of 2017.

"We are extremely pleased with the progress we have made in advancing our new strategic focus as an emerging specialty pharmaceutical company and the development plans for our platform technology remain on track. The successful completion of our pre-IND meeting for PR022 builds on a continuing, constructive dialogue with the FDA. We are confident that our IND will be filed on schedule by quarter-one 2017, and that our clinical trial plan will be straightforward," Chief Executive Alex Martin said in a statement.

Shares in PuriCore were trading up 4.9% at 23.60 pence on Thursday morning.

By Karolina Kaminska; [email protected] @KarolinaAllNews

Copyright 2016 Alliance News Limited. All Rights Reserved.


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