GSK News & Events

Ionis Pharmaceuticals (IONS) partner GSK (GSK) announced data for bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis B. Results from the two Phase 3 trials, B-Well 1 and B-Well 2, were simultaneously published in the New England Journal of Medicine and presented at the European Association for the Study of the Liver congress. GSK licensed bepirovirsen from Ionis and the two companies have collaborated on its development. Pooled data from both trials showed that six-month treatment with bepirovirsen achieved a statistically significant and clinically meaningful 19% functional cure response rate in the overall study population, meeting the primary endpoints. In a key secondary endpoint, a functional cure rate of 26% was achieved in participants with 1000 IU/ml HBsAg level, a group that represents approximately 45% of diagnosed CHB cases globally. The current standard of care typically requires lifelong therapy, with functional cure rates achieved in less than 1% of patients. Functional cure occurs when the hepatitis B virus DNA and HBsAg are undetectable in the blood for at least six months after stopping all treatment. This indicates the disease is being controlled by the immune system without medication. Notably, in an exploratory analysis, 49% of bepirovirsen recipients achieved a quantitative hepatitis B surface antigen of 100 IU/mL one year after the end of treatment. Medical literature has linked this level of low surface antigen with increased immune control and improved patient outcomes. Moreover, 23% of all bepirovirsen recipients and 31% of bepirovirsen recipients with baseline HBsAg of 1000 IU/mL % achieved a sustained DNA lower limit of quantification at week 72 after stopping all treatment at week 48. The trials showed an acceptable safety and tolerability profile consistent with other studies of bepirovirsen. The three most frequently observed adverse events were injection site erythema, local pain and temporary rise in the blood level of a liver enzyme. Bepirovirsen is currently under priority review by the FDA with both Breakthrough and Fast Track Designation. It is also under review by regulatory authorities in Europe, Japan with SENKU designation and China with Breakthrough Therapy and Priority Review designation. GSK anticipates the first regulatory decisions in Q3 2026 and launch preparations are underway. GSK licensed bepirovirsen from Ionis in 2019 under a collaborative development and licensing agreement. Under the terms of the agreement, Ionis has received an upfront payment, license fee and development and regulatory milestone payments and is eligible to receive additional regulatory and sales milestone payments as well as tiered royalties of 10%-12% on net sales of bepirovirsen.

Stocks finished mixed to start the week as investors continue to watch climbing oil prices while awaiting more developments out of the Middle East. Investors are increasingly worried that inflation is becoming entrenched due to energy prices, persistent fiscal deficits and resilient economic demand. Markets are now pricing in a meaningful possibility that the Federal Reserve could raise rates again later this year instead of cutting them.Of note, President Trump stated in athat he was asked by the leaders of several Middle Eastern nations to hold off a planned military attack on Iran, which was scheduled for tomorrow, but added that he has instructed the U.S. military leadership "to be prepared to go forward with a full, large scale assault of Iran, on a moment's notice, in the event that an acceptable Deal is not reached."Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Dominionand NextEra Energyin an all-stock transactionPublicisLiveRampfor $2.2BFordand EDF Group announced the signing of aTrump plans to announce a "dramatic expansion" of discounted prescription medication offerings available on TrumpRx,A U.S. jury on Monday ruled against Elon Musk in his lawsuit against OpenAI, finding the AI company not liable to the Teslafounder for having allegedly strayed from its original mission to benefit humanity,2. WALL STREET CALLS:F5to Outperform from In Line at Evercore ISIZscalerto Buy at B. RileyCoreWeaveand Nebiuswith lowered Neutral ratings as a new analyst took over coverage at DA DavidsonApplied Materialsto Equal Weight at Morgan StanleySalesforcewith an Underperform at BofA amid structural reset3. AROUND THE WEB:NvidiaCEO Jensen Huang told Bloomberg that it is up to China to decide on AI chips and that he looks forward to China being a more open marketTakedahas been ordered to pay hundreds of millions for violating antitrust law by delaying the generic version of its branded Amitiza drug, Bloomberg saysApple'srevamped Siri may launch in beta, and will have an option to auto-delete chats, Bloomberg reportsPresident Trump said he "should have asked for more" of a stake in Intelon behalf of the U.S. government, Fortune saysVinFast'splanned sale of two Vietnamese factories will allow the company to shed $6.9B in debt and obligations to help assist its path to profitability, Bloomberg says4. MOVERS:Hive Digitalwas higher afteris planning to build a new AI infrastructure facility in the Greater Toronto Area with approximately 320 megawatts of utility capacityCourseraincreased after announcing aServiceNowgained after BofAcoverage of the stock with a Buy ratingDesign Therapeuticswas lower afterRegeneronfell after its Phase 3 trial of fianlimab5. EARNINGS/GUIDANCE:Bradyand raised its guidance for FY26iQiyi, with EPS and revenue lower year-over-yearGossamer Bio, with CEO Faheem Hasnain commenting, "We are executing across multiple fronts at Gossamer"RedCloudreportedand reaffirmed guidance for FY26Baidu, with EPS and revenue lower year-over-yearINDEXES:The Dow rose 159.95, or 0.32%, to 49,686.12, the Nasdaq lost 134.41, or 0.51%, to 26,090.73, and the S&P 500 declined 5.45, or 0.074%, to 7,403.05.