GSK PLC Stock Price, News & Analysis

GSK plc (LSE/NYSE: GSK) has announced its agreement to acquire BELLUS Health Inc. (TSX/NASDAQ: BLU) for US$14.75 per share, totaling an approximate equity value of US$2.0 billion. This acquisition aims to strengthen GSK's specialty medicines and respiratory pipeline, particularly through camlipixant, a selective P2X3 antagonist for refractory chronic cough (RCC), currently in phase III clinical trials with a launch anticipated in 2026. The deal is projected to be accretive to adjusted EPS starting from 2027 and has significant sales potential through 2031.

With an estimated 28 million patients suffering from chronic cough globally, this acquisition addresses a substantial unmet medical need, as no approved medicines currently exist for RCC in the US and EU.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has achieved a $30 million milestone from GSK (LSE/NYSE: GSK) following the initiation of GSK4532990's Phase 2b trial for treating non-alcoholic steatohepatitis (NASH). This investigational RNA interference therapeutic was licensed to GSK in November 2021, with Arrowhead retaining rights for Greater China. The trial, known as HORIZON (NCT05583344), will assess the drug's efficacy and safety in up to 246 participants with pre-cirrhotic NASH. GSK4532990 targets HSD17B13, a gene linked to metabolic protection against NASH.

PathAI has partnered with GSK to conduct the HORIZON Phase 2b clinical trial targeting non-alcoholic steatohepatitis (NASH). This randomized trial will assess the efficacy of GSK4532990 on improving liver histology compared to placebo in patients with advanced fibrosis. PathAI will utilize its AIM-NASH tool for AI-driven histologic evaluation and provide comprehensive pathology services from biopsy analysis to lab services at its Memphis facility. The trial aims to last up to 76 weeks, with treatment lasting up to 52 weeks. This partnership builds on their existing collaboration focusing on drug development in NASH and oncology.

GSK announced promising interim results from the RUBY phase III trial, which evaluates dostarlimab-gxly combined with standard chemotherapy for advanced endometrial cancer. Notably, a 72% reduction in disease progression risk was observed in the dMMR/MSI-H subgroup, while an overall reduction of 36% was reported across all participants. The trial showcased clinically meaningful trends in overall survival and was presented at prestigious medical forums, with regulatory submissions anticipated by mid-2023. These advancements underscore GSK’s commitment to improving treatment options for endometrial cancer.

GSK has launched a national health education campaign called Sideline RSV in partnership with Earvin “Magic” Johnson to raise awareness about the risks of Respiratory Syncytial Virus (RSV) among older adults. The campaign aims to educate this demographic, particularly those with chronic health issues, about RSV's severity, given that approximately 177,000 adults aged 65+ are hospitalized annually in the US due to RSV, leading to an estimated 14,000 deaths. The campaign will include a dedicated website, social media initiatives, and community events to enhance understanding and encourage discussions about RSV and its risks.

GSK plc (LSE/NYSE: GSK) announced that the US FDA granted full approval for Jemperli (dostarlimab-gxly) as a treatment for adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. This decision is based on long-term data from the GARNET phase I trial, showing an overall response rate of 45.4%. Additionally, 85.9% of patients experienced a response duration of at least 12 months. GSK aims for Jemperli to serve as a core element in its immuno-oncology development programs.

WuXi Biologics has signed a license agreement with GSK granting exclusive rights to one preclinical bi-specific T cell engaging antibody and options for three more. WuXi Biologics will receive an upfront payment of $40 million and could earn up to $1.46 billion from milestone payments. The agreement highlights GSK’s expansion into novel cancer therapies and validates WuXi's proprietary technology platforms. The CEO of WuXi emphasized the significance of this partnership in facilitating GSK's ability to develop potentially life-saving treatments for patients worldwide.