FDA Approval for BENLYSTA issued to GLAXOSMITHKLINE LLC

GSK's Hibsago (bepirovirsen) approved in Canada for chronic hepatitis B, offering a finite treatment option. Approval based on Phase III trials showing 19-26% functional cure rates. Targets 262,000 Canadians with chronic hepatitis B, a leading cause of liver cancer. Supply expected in early 2027.

GSK reported Q3 revenue and core profit gains, with GAAP EPS of 39p and £1.54bn net income. The company launched a £1.9bn cost-cutting plan, completed a $10.6bn acquisition of Nuvalent, and received FDA approval for Hibsago. Vaccine sales were mixed, while specialty medicines, including HIV, oncology, and respiratory/immunology, saw increases. GSK plans 18 Phase III trials in 2026 and aims to double its clinical-stage oncology assets.

October FDA approvals include Novartis' remibrutinib for dermographism, Teva's once-monthly olanzapine for schizophrenia, Genentech's satralizumab for thyroid eye disease, GSK's bepirovirsen for chronic HBV, and AbbVie's risankizumab for Crohn disease. Each approval offers new treatment options and was based on clinical trial data.

FTSE 100 was flat but outperformed European markets. AstraZeneca (AZN) rose 7% on strong earnings and reaffirmed guidance. BP (BP) gained 0.5% with $8.46B profit. Banks and miners fell, with NatWest (NWG) down 9%. The index rose 0.4% weekly and 12% in October.

GSK's Hibsago received FDA approval for chronic hepatitis B treatment. Jefferies downgraded GSK to Hold, reducing its price target by 17.1%. India capped trade margins on cancer drugs, but GSK's Jemperli price remained unchanged.

Jefferies downgraded GSK to Hold, cutting its price target to $55.90. The drugmaker's shares fell 1% after a 4.8% drop following Q3 results. Analyst Michael Leuchten cited limited earnings momentum and launch execution risk, though long-term revenue goals remain. GSK trades at a discount to peers due to concerns about future earnings.