FDA approves GSK's functional cure for hepatitis B

Moderna (MRNA) shares fell 4% to $193.62, extending an 18% drop, after full late-stage results for its melanoma vaccine with Merck (MRK) were released. The data met expectations but fell short of high hopes, triggering a correction. Moderna's stock is more exposed due to its focus on oncology, while Merck's stock declined 0.8% to $146. Pfizer (PFE) also saw a minor decline of 0.7% to $30.22.

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.

Abrocitinib, a drug by Pfizer, showed sustained improvement in skin clearance and itch reduction for 112 weeks in patients with moderate or severe atopic dermatitis (AD), according to a post hoc analysis of two phase 3 trials. The study found that both 100 mg and 200 mg doses maintained efficacy, with no unexpected safety signals. Pfizer sponsored the research, and some authors have ties to the company.