- Delaware court agrees to review
- Hepatitis B drug gets fast track approval
- Nucala approval in Japan
Biopharma giant GSK (GSK) was one of the top gainers in the FTSE today, rising 2% to £16.47 after releasing positive drug updates and news that the Delaware Supreme court has agreed to review its prior decision to allow expert witnesses in the ongoing Zantac litigation cases.
The shares have advanced around 11% for the year so far compared with 8% for the blue-chip FTSE 100 index.
Investment director Russ Mould at AJ Bell commented: ‘The market has reacted positively to news that Delaware’s highest court will hear an appeal by GSK and other drugmakers who sold the product.
‘It’s a positive step forward for the pharmaceutical giant but by no means the end of the story.’
GSK said: ‘Interlocutory reviews (intermediate decisions) are granted in exceptional circumstances, and GSK is pleased that the Supreme Court is of the view that such circumstances are present here’.
The company has highlighted 16 human studies which support the scientific consensus which states there is no consistent or reliable evidence that Zantac increases the risk of any cancer.
APPROVALS IN JAPAN
In other news, GSK said the MHLW (Japanese Ministry of Health, Labour and Welfare) has granted SENKU designation for its investigational treatment of chronic Hepatitis B, called bepirovirsen.
This means patients are given early access through an expedited review process applicable for serious conditions with an unmet need.
This is the second designation received for the drug following the US FDA’s (Food and Drug Administration) fast track designation granted earlier in 2024.
GSK said Bepirovirsen is the only single-agent drug in late-stage trials which has shown potential to achieve clinically meaningful functional care response when combined with oral treatments.
The MHLW has also approved GSK’s monoclonal antibody Nucala for the treatment of adults with chronic rhinosinusitis with nasal polyps.
Kaivan Khavandi, global head of respiratory and immunology commented: ‘The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids.’
The approval was based on a late-stage trial which studied the effectiveness and safety of the compound over a 52-week period on a population of Japanese, Chinese and Russian patients.
Disclaimer: Financial services company AJ Bell referenced in the article owns Shares magazine. The author (Martin Gamble) and the editor (Steven Frazer) of the article own shares in AJ Bell.
