No recommendation
No news or research item is a personal recommendation to deal. Hargreaves Lansdown may not share ShareCast's (powered by Digital Look) views.
(Sharecast News) - Pharmaceutical giant GSK said on Tuesday that the US Food and Drug Administration had accepted its new drug application for bepirovirsen for priority review, with the drug being assessed as a potential treatment for adults with chronic hepatitis B.
GSK said the therapy had also been granted breakthrough therapy designation, which follows its receipt of fasttrack status in February 2024, intended to speed reviews for treatments addressing serious unmet need.
The FTSE 100-listed firm stated the submission and breakthrough designation were backed by positive Phase III BWell 1 and BWell 2 results, where bepirovirsen delivered "statistically significant and clinically meaningful" functionalcure rates and showed an "acceptable safety profile".
GSK noted that chronic hepatitis B affects more than 250m people worldwide and around 1.7m in the US, with current standard therapies often requiring lifelong treatment and delivering functionalcure rates of roughly 1%.
As of 1020 BST, GSK shares were down 0.74% at 2,001p.
Reporting by Iain Gilbert at Sharecast.com
See latest RNS at Investegate
The value of investments can go down in value as well as up, so you could get back less than you invest. It is therefore important that you understand the risks and commitments. This website is not personal advice based on your circumstances. So you can make informed decisions for yourself we aim to provide you with the best information, best service and best prices. If you are unsure about the suitability of an investment please contact us for advice.