Can Specialty Meds Offset GSK’s $2.2B Legal Charges and Sizzling R&D Setbacks on Oct. 28?

GSK received FDA approvals for Jemperli (rectal cancer) and Hibsago (hepatitis B) in one week, with different risk profiles. Roche agreed to a $15B deal with Hansoh Pharmaceutical for cancer treatments. Point-of-care marketing spending reached $1.2B in 2025, up 15% from 2024, according to industry data.

The FDA approved GSK's Hibsago for chronic hepatitis B, showing 19% of patients achieved a functional cure in trials. The approval positions GSK ahead of competitors like Brii Biosciences. According to the FDA, this marks an important advance for patients. GSK is also approved for Jemperli, an immunotherapy for rectal cancer, showing 68% clinical complete response in trials.

The FDA approved GSK's Hibsago (bepirovirsen), a new chronic hepatitis B treatment that may allow some patients to stop therapy. It's used with existing antivirals in adults without cirrhosis. Clinical trials showed 19% of patients maintained viral control after stopping treatment. GSK expects peak sales over £2 billion. The drug was licensed from Ionis Pharmaceuticals.

The FDA approved Hibsago, a new hepatitis B treatment developed by GSK and Ionis. In trials, 19% of patients maintained virus control for 24 weeks post-treatment. It's for adults without cirrhosis, with specific viral load and antigen levels. The FDA warned of potential severe side effects, including hepatic reactions and low platelet counts.

The FDA approved dolutegravir, an HIV treatment, for newborns based on an international study. The study, involving UC San Diego and Boston Medical Center, found a safe dosing regimen for infants. The approval expands treatment options for HIV-infected newborns, according to the researchers.

GSK and Ionis' Hibsago (bepirovirsen) received FDA approval for chronic hepatitis B, offering a functional cure. Analysts at H.C. Wainwright see this as a significant milestone, opening the market for competitors like Gilead, Arrowhead, and Aligos. The drug is approved for a specific patient population, leaving opportunities for other therapies. Several companies will present data at the AASLD meeting in November.