GSK's Antiviral Drug Application Accepted for EMA Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy GSK?
GSK announced that the European Medicines Agency, EMA, has accepted for review the marketing authorisation application, MAA, for the use of bepirovirsen, an investigational antisense oligonucleotide, ASO, in the treatment of adults with chronic hepatitis B. The regulatory submission to EMA is based on positive results from the B-Well 1 and B-Well 2 Phase III trials. Both trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.
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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: 54.230
Low
20.15
Averages
38.72
High
55.60
Current: 54.230
Low
20.15
Averages
38.72
High
55.60
About GSK
GSK plc is a biopharma company. The Company’s segments include Commercial Operations and Research and Development. Its portfolio and pipeline are focused on developing medicines and vaccines in four core therapeutic areas, which are the areas of human health it focuses on to prevent and treat disease: respiratory, immunology and inflammation; oncology; human immunodeficiency virus (HIV), and infectious diseases. Its specialty medicines prevent and treat diseases, from HIV to respiratory diseases, immune-mediated conditions like lupus, and cancer. General medicines include inhaled medicines for asthma and 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. It is in phase IIb clinical development for prophylactic protection against food allergens.
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 Strategy: GSK's SVP, Global Head of Respiratory, Immunology & Inflammation R&D, Kaivan Khavandi, stated that with Exdensur approved in several major markets, the company aims to transform the treatment paradigm for severe asthma, further solidifying its market leadership.
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See More
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- Recent Transaction Activity: Prior to the Excellergy deal, Novartis announced the acquisition of Pikavation Therapeutics for up to $3 billion to secure rights to an experimental breast cancer drug, highlighting its strategic focus on oncology.
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See More
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- Clinical Trial Results: The application is based on positive outcomes from the B-Well 1 and B-Well 2 Phase III trials, indicating the drug's potential efficacy and safety in treating chronic hepatitis B, which could address a significant unmet medical need.
- Collaborative Development: GSK licensed bepirovirsen from Ionis Pharmaceuticals and collaborated on its development, showcasing the company's strategic partnerships in advancing innovative therapeutics.
- Market Potential Assessment: Although the drug is not yet approved anywhere globally, successful market entry could open new opportunities for GSK in the chronic hepatitis B treatment space, enhancing its competitive position in the biopharmaceutical industry.
See More
