Core Insights - GSK's new drug application for linerixibat has been accepted by the FDA for review, with a decision expected on March 24, 2026 [1][7] - If approved, linerixibat could fulfill a significant unmet medical need for patients suffering from cholestatic pruritus associated with primary biliary cholangitis (PBC) [2][5] GSK's Drug Development - The NDA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in cholestatic pruritus and related sleep interference compared to placebo [4][7] - Cholestatic pruritus is a common symptom of PBC, a rare autoimmune disease that can lead to liver failure [5] Competitive Landscape - Other companies are also pursuing treatments for PBC, including Gilead Sciences, which received accelerated approval for seladelpar in August 2024 [8] - Seladelpar was acquired by Gilead for $4.3 billion and is now part of their liver disease portfolio [9] - Mirum Pharmaceuticals is developing volixibat, another oral IBAT inhibitor, currently in phase IIb trials [9]

Core Viewpoint - Theravance Biopharma has entered into a definitive agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK for $225 million in cash, translating confidence in Trelegy's sustained success into immediate value for shareholders [1][2] Financial Summary - The sale of Outer Year Royalties will provide Theravance Biopharma with $225 million in cash, in addition to the $1.1 billion received from the initial sale of Trelegy royalty interests in 2022, bringing the total potential lifetime value from Trelegy monetization efforts to $1.525 billion [3][6] - The company retains rights to receive up to $150 million in remaining Trelegy sales-related milestones in 2025 and 2026 from Royalty Pharma, with minimal growth required over 2024 actuals to achieve these milestones [3][6] Strategic Review Committee - This transaction is the first outcome of the ongoing efforts of the Strategic Review Committee formed by the Board of Directors to assess strategic alternatives and enhance shareholder value [4] - The Committee will continue to evaluate various alternatives to maximize shareholder value, although there is no assurance that additional transactions will occur [4] Product Development - Theravance Biopharma is focused on growing YUPELRI and advancing ampreloxetine towards potential regulatory approval and launch, indicating a commitment to developing its product pipeline [2][8]

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has GSK (GSK) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.GSK is a member of the Medical sector. This group includes 997 individual stocks and currently holds a Zacks Sector Rank of #4. The Zacks Sector Rank includes 16 different groups and is ...

GSK plc GSK and Spero Therapeutics Inc SPRO on Wednesday announced that the pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop early for efficacy. Spero’s stock price was up 245.89% at last check Wednesday following the news. The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC) based on a planned interim analysis of data from 1,690 patients enrolled in the study. Also Read: GSK To Buy Phase-3 Ready Liver Di ...

CAMBRIDGE, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK), today announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary endpoint and will stop early for efficacy (NCT06059846).3 The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC) that completed a pre-specified inte ...

GSK plc (GSK) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma.The CHMP recommended the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone for treating relapsed/refractory multiple myeloma in adult patients who have received at least one prior therapy. The ...

Core Viewpoint - GSK's Nucala has received FDA approval for a fifth indication, allowing it to treat certain patients with chronic obstructive pulmonary disease (COPD), marking a significant expansion of its therapeutic applications [1][3]. Group 1: Product Approval and Indications - Nucala is now approved as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype [1]. - The drug is already approved for severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome in various regions, including the U.S. and Europe [2]. - The approval was supported by data from the late-stage MATINEE study, which demonstrated a significant reduction in the annualized rate of moderate to severe exacerbations when Nucala was added to inhaled maintenance therapy [3]. Group 2: Market Context and Competition - The FDA's decision makes Nucala the second biologic treatment approved for COPD and the third new COPD drug approved in the U.S. in the past year [9]. - Nucala will compete directly with Sanofi and Regeneron's Dupixent, which was the first biologic treatment for COPD approved in September of the previous year [10]. - Verona Pharma's Ohtuvayre was also approved last year as the first inhaled product with a novel mechanism of action for COPD maintenance treatment in over 20 years, highlighting the competitive landscape [11]. Group 3: Company Strategy and Financial Outlook - GSK aims to generate over £40 billion in annual sales by 2031, focusing on therapeutic areas such as HIV, immunology/respiratory, and oncology [5]. - The company expects to launch five new products or line extensions this year, with three already approved in the first half of 2025 [6]. - Year-to-date, GSK shares have gained 15%, outperforming the industry, which has seen a 6% decline [7].

Gilead Sciences, Inc. (GILD) and GSK (GSK) are pioneers in the human immunodeficiency virus (HIV) treatment space.Gilead Sciences is a dominant player in the HIV market with market-leading treatments. HIV drug sales accounted for 69% of total product sales in the first quarter of 2025. GILD’s diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases.GSK, too, has a strong HIV portfolio in the industry. HIV drug sales accounted for 23% of total sales in the fi ...

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of GSK (GSK) and Acadia Pharmaceuticals (ACAD) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank puts an emphasis on earnings estimates and estim ...

GSK plc (GSK) announced that it has signed an agreement with Massachusetts-based biopharmaceutical company Boston Pharmaceuticals to acquire the latter’s lead pipeline drug, efimosfermin alfa.Efimosfermin is an investigational long-acting variant of FGF21 protein designed to treat and prevent the progression of steatotic liver disease (SLD), commonly known as fatty liver disease. Boston Pharma is currently evaluating the drug in mid-stage studies for metabolic dysfunction-associated steatohepatitis (MASH), ...