FDA Approves First-in-Class Hepatitis B Functional Cure Drug
GSK sits 18% above its 52-week low of $42.845.
Summary
The FDA approved Hibsago (bepirovirsen) for chronic hepatitis B in adults without cirrhosis, making it the first antisense oligonucleotide cleared in the US for the disease. The drug posted a 19% functional cure rate in the B-Well phase III trials versus under 1% for standard of care after a year, and 26% in patients with HBsAg at or below 1000 IU/ml. This follows the August 24 6-K disclosing the first global approval in Japan, so the US label is the second major market and the larger commercial opportunity. GSK licensed the asset from Ionis and is running regulatory submissions in multiple other geographies with decisions expected in the coming months. The label carries boxed warnings for on-treatment hepatic flares and thrombocytopenia, which will shape prescribing and monitoring but do not undercut the efficacy story.
At the time of this announcement, GSK was trading at $50.70 on NYSE in the Life Sciences sector, with a market capitalization of approximately $98.9B. The 52-week trading range was $42.85 to $61.70. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.