GSK's Chronic Hepatitis B Drug Meets Goals in Two Late-Stage Studies

GSK plc GSK announced positive results from two phase III studies, B-Well 1 and B-Well 2, which evaluated its investigational chronic hepatitis B (CHB) therapy called bepirovirsen.

Both studies met their primary endpoints. Treatment with bepirovirsen plus the current standard of care (SoC) — nucleos(t)ide analogues — demonstrated a statistically significant and clinically meaningful functional cure rate, compared to SoC alone, in participants with baseline surface antigen (HBsAg) of 3000 IU/ml or lower. HBsAg is a viral protein that signals ongoing infection.

In connection with CHB, functional cure is achieved when the virus can no longer be detected in the blood. This was measured by the sustained loss of HBsAg and undetectable hepatitis B virus DNA for at least 24 weeks after treatment.

Per GSK, treatment with bepirovirsen achieved statistically significant results across all ranked endpoints. The company claimed that the drug was more effective in patients with baseline HBsAg of 1000 IU/ml or lower.

However, GSK did not share any numbers supporting these results. It intends to present the full results at a future medical meeting and also publish them in a peer-reviewed journal.

GSK to Seek Marketing Nod for Bepirovirsen Soon

Based on the above results, GSK intends to submit regulatory filings across the world for bepirovirsen in the first quarter of 2026. If approved, the drug has the potential to become the first finite six-month therapeutic option for CHB.

GSK estimates that CHB affects more than 250 million people across the globe. Per the company, bepirovirsen has the potential to be the first CHB therapy that can achieve a meaningful functional cure.

The drug was originally developed by Ionis Pharmaceuticals IONS and licensed to GSK in 2019. In return for granting these rights, IONS is eligible to receive milestone payments, as well as tiered royalties of 10-12% on the drug’s net sales.

GSK Stock’s Performance

Year to date, shares of GSK have gained 50% compared to the industry’s 21% growth.

Secures EU Nod for Shingles Shot in Prefilled Syringe Format

In a separate press release, GSK announced that the European Commission has approved the administration of its shingles vaccine, Shingrix, in a prefilled syringe. This makes it easier for healthcare professionals to administer the vaccine, as the previous process required them to combine a lyophilised powder antigen with a liquid adjuvant.

The approval was based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation. Per GSK, there is no change in indication or dosing requirement between the two options.

GSK’s Zacks Rank

GSK currently carries a Zacks Rank #3 (Hold).

GSK PLC Sponsored ADR Price

 

GSK PLC Sponsored ADR price | GSK PLC Sponsored ADR Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are CorMedix CRMD and Keros Therapeutics KROS, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87 over the past 60 days, while the same for 2026 has increased from $2.49 to $2.88. CRMD shares have risen 53% in the past year.

CorMedix’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 27.04%.

In the past 60 days, estimates for Keros Therapeutics’ 2025 earnings per share (EPS) have risen from $2.02 to $2.25. Loss estimates for 2026 have improved from $3.65 to $3.47 during the same period. In the past year, shares of KROS have risen 24%.

KROS’s earnings beat estimates in three of the trailing four quarters, while missing the mark on one occasion. On average, the company delivered a surprise of 9,098.63%.

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This article originally published on Zacks Investment Research (zacks.com).

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