LONDON: GSK shares plunged more than 6% on Friday, hitting the lowest point in Britain’s blue-chip FTSE 100 index after a US FDA advisory panel voted against approving its blood cancer drug Blenrep. The panel raised concerns over side effects, dealing a blow to the British drugmaker’s efforts to revive the treatment, which was withdrawn from US markets in 2022.
At 0807 GMT, GSK shares dropped as much as 7% to 1,315 pence, while the broader FTSE 100 index rose 0.2%. The company had submitted a renewed application based on two late-stage trials showing that Blenrep combination therapies reduced the risk of death and delayed cancer progression.
The setback comes as GSK seeks to offset declining sales from its top drugs and vaccines with newer approvals. The company is also preparing for patent expirations in its HIV portfolio starting in 2028. Analysts from Berenberg, JPMorgan, and Barclays predict the FDA is unlikely to approve Blenrep, with a final decision expected next week.
While the FDA usually follows advisory panel recommendations, it is not obligated to do so. GSK had previously projected peak annual sales of over 3 billion pounds for Blenrep, with the US expected to be its largest market. However, JPMorgan analysts now suggest the company may need to revise its sales targets and long-term revenue goals.
“GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review,“ the company said in a statement. The FDA panel highlighted side effects such as blurred vision, photophobia, and dry eyes, along with concerns over dosing and lack of US patient representation in trials.
GSK is set to release its second-quarter earnings report on July 30. - Reuters
