GSK Reports Positive Phase III Results for Hepatitis B Treatment Bepirovirsen
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: NASDAQ.COM
- Successful Clinical Trials: GSK's hepatitis B treatment bepirovirsen demonstrated positive results in Phase III B-Well 1 and B-Well 2 trials, with 19% of patients achieving a functional cure compared to 0% in the placebo group, indicating a potential breakthrough in hepatitis B treatment.
- Outstanding Performance in Low Viral Load Patients: Among patients with lower baseline viral activity, the functional cure rate increased to 26%, showcasing the drug's significant efficacy in specific patient populations and potentially changing the landscape of hepatitis B therapy.
- Sustained Viral Suppression Rate: After stopping therapy for 72 weeks, 23% of bepirovirsen-treated patients achieved sustained viral suppression, while none in the placebo group did, highlighting the drug's potential for long-term efficacy.
- Regulatory Review Progress: Bepirovirsen is currently under priority review by the U.S. FDA and undergoing regulatory assessments in Europe, Japan, and China, with GSK expecting the first regulatory decisions in Q3 2026, indicating a promising market outlook.
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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: 51.240
Low
20.15
Averages
38.72
High
55.60
Current: 51.240
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.
GSK Reports Positive Phase III Results for Hepatitis B Treatment Bepirovirsen
- Successful Clinical Trials: GSK's hepatitis B treatment bepirovirsen demonstrated positive results in Phase III B-Well 1 and B-Well 2 trials, with 19% of patients achieving a functional cure compared to 0% in the placebo group, indicating a potential breakthrough in hepatitis B treatment.
- Outstanding Performance in Low Viral Load Patients: Among patients with lower baseline viral activity, the functional cure rate increased to 26%, showcasing the drug's significant efficacy in specific patient populations and potentially changing the landscape of hepatitis B therapy.
- Sustained Viral Suppression Rate: After stopping therapy for 72 weeks, 23% of bepirovirsen-treated patients achieved sustained viral suppression, while none in the placebo group did, highlighting the drug's potential for long-term efficacy.
- Regulatory Review Progress: Bepirovirsen is currently under priority review by the U.S. FDA and undergoing regulatory assessments in Europe, Japan, and China, with GSK expecting the first regulatory decisions in Q3 2026, indicating a promising market outlook.
See More
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- JNJ TREMFYA Label Expansion: Johnson & Johnson (JNJ) received FDA approval to add structural joint-damage inhibition data to the TREMFYA label for active psoriatic arthritis, confirming its unique position in first-line treatment with no new safety signals, reinforcing its market leadership.
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- AbbVie's DECNUPAZ Approval: AbbVie (ABBV) received FDA approval for DECNUPAZ to treat ultra-rare blood cancer BPDCN, supported by Phase 1 data showing a 69.7% composite complete response rate and a median duration of 9.7 months, marking a significant innovation in hematologic oncology.
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GSK's Antisense Drug Shows Promise in Hepatitis B Trials
- Clinical Trial Success: GSK's antisense drug bepirovirsen, developed with Ionis Pharma, achieved a 19% functional cure rate in two late-stage trials, significantly surpassing the current standard treatment's less than 1% cure rate, marking a new hope for chronic hepatitis B treatment.
- Significant Treatment Effects: In the B-Well 1 and B-Well 2 Phase 3 trials, six months of bepirovirsen therapy resulted in undetectable hepatitis B virus DNA and surface antigens for at least six months post-therapy, demonstrating clinically meaningful efficacy.
- Good Safety Profile: Conducted across 29 countries with chronic hepatitis patients, the studies indicated that bepirovirsen has an acceptable safety and tolerability profile consistent with previous trials, laying a solid foundation for its future market application.
- Long-term Impact Potential: GSK's science chief Tony Wood emphasized that bepirovirsen not only offers the potential for significantly improved functional cure rates but also may reduce the risk of long-term liver complications, including cancer, indicating a major advancement in chronic hepatitis B treatment.
See More
Eli Lilly Returns to Vaccine Market with $4 Billion Acquisition of Three Companies
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- Vaccine Development Potential: Curevo's shingles vaccine demonstrated a lower incidence of side effects in phase 2 trials (7.3% compared to GSK's 33%), which could enhance patient uptake and completion rates, thereby strengthening Lilly's competitive position in the vaccine market.
- Strategic Acquisitions: By acquiring Vaccine Company, Lilly aims to potentially launch the first-ever vaccine for the common virus EBV, which is linked to various serious diseases, presenting significant market potential given that around 95% of adults are infected with the virus.
- Market Opportunity Analysis: Although Lilly did not provide revenue estimates for the new vaccines, considering GSK's Shingrix vaccine generated $4.8 billion in sales in 2025, Lilly's new vaccine products could capture a share of the market, particularly with the shingles vaccine's competitive potential.
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- Political Turmoil Impacting Markets: The recent volatility in UK assets, particularly the 10-year gilt yield nearing post-2008 highs, reflects market uncertainty stemming from Prime Minister Keir Starmer's questioned leadership and potential challenges from rival Andy Burnham.
- Investor Optimism on Large Caps: Despite the political upheaval, Citi analysts maintain a bullish outlook on the FTSE 100, citing its significant commodity and defensive exposure as a geopolitical hedge, indicating strong investor confidence in large-cap stocks.
- Opportunities in Small Caps: Jupiter Asset Management's Adrian Gosden highlights that while small and mid-cap stocks (SMIDs) face severe challenges, identifying financially sound companies could yield substantial returns, especially given the current pessimistic market sentiment.
- Attraction of SALO Businesses: Ben Needham from Ninety One notes that the market's harsh treatment of soft asset, low obsolescence SALO businesses has created attractive investment opportunities, particularly as many companies accelerate buybacks and cash returns, signaling strong value amidst the turmoil.
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- Severity of Outbreak: The WHO reports that the ongoing Ebola outbreak in East Africa has resulted in over 130 deaths, with suspected cases rising to 600 in the Democratic Republic of the Congo and Uganda, indicating the severity and potential spread of the epidemic.
- Public Health Emergency: WHO Director-General Tedros declared the Ebola outbreak a Public Health Emergency of International Concern, marking the highest level of global health alert, reflecting the urgency and potential threat to global health posed by the epidemic.
- Vaccine Development Progress: Although no vaccines are currently available for the Bundibugyo strain, WHO advisors stated that two candidate vaccines are under study, demonstrating scientific efforts to combat the outbreak and future hope for prevention.
- International Travel Restrictions: The U.S. CDC has imposed travel restrictions from three African countries to prevent the spread of the Ebola virus, indicating the international community's heightened awareness and response measures to the outbreak.
See More
GSK Reports Positive Phase III Results for Hepatitis B Treatment Bepirovirsen
- Successful Clinical Trials: GSK's hepatitis B treatment bepirovirsen demonstrated positive results in Phase III B-Well 1 and B-Well 2 trials, with 19% of patients achieving a functional cure compared to 0% in the placebo group, indicating a potential breakthrough in hepatitis B treatment.
- Outstanding Performance in Low Viral Load Patients: Among patients with lower baseline viral activity, the functional cure rate increased to 26%, showcasing the drug's significant efficacy in specific patient populations and potentially changing the landscape of hepatitis B therapy.
- Sustained Viral Suppression Rate: After stopping therapy for 72 weeks, 23% of bepirovirsen-treated patients achieved sustained viral suppression, while none in the placebo group did, highlighting the drug's potential for long-term efficacy.
- Regulatory Review Progress: Bepirovirsen is currently under priority review by the U.S. FDA and undergoing regulatory assessments in Europe, Japan, and China, with GSK expecting the first regulatory decisions in Q3 2026, indicating a promising market outlook.
See More
Regulatory Approvals and Collaborations in Biotech Sector
- FDA Approval for AZN: AstraZeneca (AZN) secured FDA approval for the IMFINZI + BCG combination in high-risk non-muscle-invasive bladder cancer, supported by Phase 3 POTOMAC data showing a 32% reduction in recurrence or death, enhancing its competitive edge in oncology.
- JNJ TREMFYA Label Expansion: Johnson & Johnson (JNJ) received FDA approval to add structural joint-damage inhibition data to the TREMFYA label for active psoriatic arthritis, confirming its unique position in first-line treatment with no new safety signals, reinforcing its market leadership.
- LINZESS Approved for Children: Ironwood Pharmaceuticals (IRWD) gained FDA approval for LINZESS to treat functional constipation in children aged 2-5, based on a 12-week Phase 3 trial showing significant improvement in spontaneous bowel movements, expanding its pediatric market influence.
- AbbVie's DECNUPAZ Approval: AbbVie (ABBV) received FDA approval for DECNUPAZ to treat ultra-rare blood cancer BPDCN, supported by Phase 1 data showing a 69.7% composite complete response rate and a median duration of 9.7 months, marking a significant innovation in hematologic oncology.
See More
GSK's Antisense Drug Shows Promise in Hepatitis B Trials
- Clinical Trial Success: GSK's antisense drug bepirovirsen, developed with Ionis Pharma, achieved a 19% functional cure rate in two late-stage trials, significantly surpassing the current standard treatment's less than 1% cure rate, marking a new hope for chronic hepatitis B treatment.
- Significant Treatment Effects: In the B-Well 1 and B-Well 2 Phase 3 trials, six months of bepirovirsen therapy resulted in undetectable hepatitis B virus DNA and surface antigens for at least six months post-therapy, demonstrating clinically meaningful efficacy.
- Good Safety Profile: Conducted across 29 countries with chronic hepatitis patients, the studies indicated that bepirovirsen has an acceptable safety and tolerability profile consistent with previous trials, laying a solid foundation for its future market application.
- Long-term Impact Potential: GSK's science chief Tony Wood emphasized that bepirovirsen not only offers the potential for significantly improved functional cure rates but also may reduce the risk of long-term liver complications, including cancer, indicating a major advancement in chronic hepatitis B treatment.
See More
Eli Lilly Returns to Vaccine Market with $4 Billion Acquisition of Three Companies
- Return to Vaccine Market: Eli Lilly announced the acquisition of three vaccine manufacturers for nearly $4 billion, including $1.5 billion for Curevo, which is developing a shingles vaccine, marking its return to the vaccine and infectious disease sector despite regulatory uncertainties.
- Vaccine Development Potential: Curevo's shingles vaccine demonstrated a lower incidence of side effects in phase 2 trials (7.3% compared to GSK's 33%), which could enhance patient uptake and completion rates, thereby strengthening Lilly's competitive position in the vaccine market.
- Strategic Acquisitions: By acquiring Vaccine Company, Lilly aims to potentially launch the first-ever vaccine for the common virus EBV, which is linked to various serious diseases, presenting significant market potential given that around 95% of adults are infected with the virus.
- Market Opportunity Analysis: Although Lilly did not provide revenue estimates for the new vaccines, considering GSK's Shingrix vaccine generated $4.8 billion in sales in 2025, Lilly's new vaccine products could capture a share of the market, particularly with the shingles vaccine's competitive potential.
See More
Volatility in UK Assets Amid Political Turmoil and Investment Opportunities
- Political Turmoil Impacting Markets: The recent volatility in UK assets, particularly the 10-year gilt yield nearing post-2008 highs, reflects market uncertainty stemming from Prime Minister Keir Starmer's questioned leadership and potential challenges from rival Andy Burnham.
- Investor Optimism on Large Caps: Despite the political upheaval, Citi analysts maintain a bullish outlook on the FTSE 100, citing its significant commodity and defensive exposure as a geopolitical hedge, indicating strong investor confidence in large-cap stocks.
- Opportunities in Small Caps: Jupiter Asset Management's Adrian Gosden highlights that while small and mid-cap stocks (SMIDs) face severe challenges, identifying financially sound companies could yield substantial returns, especially given the current pessimistic market sentiment.
- Attraction of SALO Businesses: Ben Needham from Ninety One notes that the market's harsh treatment of soft asset, low obsolescence SALO businesses has created attractive investment opportunities, particularly as many companies accelerate buybacks and cash returns, signaling strong value amidst the turmoil.
See More
WHO Warns of Potential Worsening of Ebola Outbreak
- Severity of Outbreak: The WHO reports that the ongoing Ebola outbreak in East Africa has resulted in over 130 deaths, with suspected cases rising to 600 in the Democratic Republic of the Congo and Uganda, indicating the severity and potential spread of the epidemic.
- Public Health Emergency: WHO Director-General Tedros declared the Ebola outbreak a Public Health Emergency of International Concern, marking the highest level of global health alert, reflecting the urgency and potential threat to global health posed by the epidemic.
- Vaccine Development Progress: Although no vaccines are currently available for the Bundibugyo strain, WHO advisors stated that two candidate vaccines are under study, demonstrating scientific efforts to combat the outbreak and future hope for prevention.
- International Travel Restrictions: The U.S. CDC has imposed travel restrictions from three African countries to prevent the spread of the Ebola virus, indicating the international community's heightened awareness and response measures to the outbreak.
See More
