FDA Accepts Priority Review for Bepirovirsen by GSK and Ionis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 28 2026
0mins
Should l Buy GSK?
Source: NASDAQ.COM
- FDA Priority Review: The FDA has accepted GSK's New Drug Application for Bepirovirsen, developed in partnership with Ionis, for priority review, marking a significant advancement in chronic hepatitis B treatment, with a decision expected by October 26, 2026.
- Breakthrough Therapy Designation: Bepirovirsen has received Breakthrough Therapy designation from the FDA, indicating its potential in treating chronic hepatitis B, which may provide new treatment options for patients and enhance market competitiveness.
- Clinical Trial Support: The regulatory submission is supported by positive results from the global B-Well 1 and B-Well 2 trials, which demonstrated statistically significant functional cure rates, thereby bolstering its credibility for clinical use.
- International Regulatory Review: Bepirovirsen is also under review by the European Medicines Agency, the China National Medical Products Administration, and Japan's Ministry of Health, Labour and Welfare, highlighting its global market potential and broad impact on chronic hepatitis B patients.
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Analyst Views on GSK
Wall Street analysts forecast GSK stock price to fall
6 Analyst Rating
1 Buy
2 Hold
3 Sell
Moderate Sell
Current: 50.500
Low
20.15
Averages
38.72
High
55.60
Current: 50.500
Low
20.15
Averages
38.72
High
55.60
About GSK
GSK plc is a United Kingdom-based biopharma company. The Company’s segments include Commercial Operations and Research and Development. The Company is focused on the science of the immune system and advanced technologies, investing in four core therapeutic areas-respiratory, immunology and inflammation; oncology; human immunodeficiency virus (HIV), and infectious diseases. Its specialty medicines prevent and treat diseases, from asthma, cancer and HIV to autoimmune diseases like lupus. General medicines include inhalers for asthma and chronic obstructive pulmonary disease (COPD) with antibiotics. Its portfolio also includes Efimosfermin, a fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development. The Company also engaged in ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody. The Company also owns HS235, a potential molecule for the treatment of pulmonary hypertension (PH).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Market Reaction Analysis: Alector's stock price increase following the trial discontinuation reflects investor trust in the company's other research projects, indicating that despite setbacks, the market remains optimistic about its potential in the neuroscience field.
See More
