Camlipixant

With no FDA-approved treatments for refractory chronic cough (RCC), patients have long faced limited options – but Trevi Therapeutics is hoping to change that. On Monday, the company announced that its investigational oral therapy Haduvio (nalbuphine extended-release) met its primary endpoint in the Phase IIa RIVER trial, showing a statistically significant 57% placebo-adjusted reduction in 24-hour cough frequency.The crossover study, which enrolled 66 patients with RCC, demonstrated that Haduvio reduced cough frequency by 67% from baseline, compared to 10% with placebo. The therapy also showed similar efficacy in both moderate (10-19 coughs/hour) and severe (20+ coughs/hour) patient subgroups, with reductions of 68% and 66%, respectively.Trevi plans to discuss next steps with the FDA while continuing its parallel Phase IIb CORAL trial in chronic cough associated with idiopathic pulmonary fibrosis (IPF), which recently completed enrollment. Topline results there are due this half."The RIVER trial demonstrated that Haduvio was highly effective, and worked quickly at the lowest dose tested across a broad range of cough counts," said CEO Jennifer Good. "These results, coupled with our existing IPF chronic cough results, are further evidence of the effectiveness of Haduvio's central and peripheral KAMA mechanism in treating these difficult neurological cough conditions." Company shares were up over 41% on the news Monday.While Trevi's success may be capturing investor attention, other players have struggled to gain traction in the space. In 2023, Merck & Co. received a second complete response letter from the FDA for its oral P2X3 receptor antagonist gefapixant, despite the drug being approved in Europe and Japan. The US regulator had concluded that Merck's application "did not meet substantial evidence of effectiveness" for treating refractory or unexplained chronic cough.Meanwhile, GSK is hoping camlipixant, another P2X3 antagonist, can help turn the company's fortunes around (see – Vital Signs: Pharma's worst performers of 2024, and how they can turn the tide in 2025). Phase III results for the drug, which GSK acquired through its $2-billion deal for Bellus Health, are expected at the end of this year.In Phase IIb SOOTHE trial results published earlier this month in the American Journal of Respiratory and Critical Care Medicine, camlipixant demonstrated a 34% placebo-adjusted reduction in 24-hour cough frequency.Before the RIVER readout, Oppenheimer analysts said they "lean optimistic that Haduvio's performance in RIVER will open the door to a sizable second opportunity in RCC patients inadequately addressed by other therapies." Specifically, they highlighted that efficacy in the severe cough segment would "best inform its prospects for those in whom alternatives, including GSK's Phase III-stage camlipixant, are insufficient."

Sales, profit and earnings growth driven by strong Specialty Medicines performance Total 2025 sales £32.7 billion +4% AER; +7% CER Specialty Medicines sales £13.5 billion (+17%); Respiratory, Immunology & Inflammation £3.8 billion (+18%); Oncology £2.0 billion (+43%); HIV sales £7.7 billion (+11%) Vaccines sales £9.2 billion (+2%); Shingrix £3.6 billion (+8%); Meningitis vaccines £1.6 billion (+12%); and Arexvy £0.6 billion (+2%) General Medicines sales £10.0 billion (-1%); Trelegy £3.0 billion (+13%) Total operating profit >100% and Total EPS >100% driven by lower Significant legal expenses, lower CCL charges and higher other operating income, partly offset by intangible asset impairments Core operating profit +11% and Core EPS +12% reflecting Specialty Medicines and Vaccines growth, SG&A productivity, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines Cash generated from operations of £8.9 billion with free cash flow of £4.0 billion R&D momentum further strengthens growth prospects: 5 major FDA approvals: Blenrep, Exdensur, Nucala COPD, Penmenvy, Blujepa 7 pivotal trial starts including: risvutatug rezetecan (ris-rez) for 2L/3L ES-SCLC; efimosfermin in MASH; Exdensur for COPD; and velzatinib for 2L GIST New assets acquired: efimosfermin (liver disease); velzatinib/IDRX-42 (gastrointestinal cancer); and agreement to acquire ozureprubart (food allergies) Agreements/collaborations with Hengrui (RI&I and oncology); Empirico (COPD); and LTZ Therapeutics (oncology) 29 projects currently in clinical development for RI&I and Oncology diseases 2 new major product approvals expected: bepirovirsen, potential first-in-class treatment for chronic hepatitis B; and tebipenem, first oral treatment for complicated UTIs 5 pivotal readouts: bepirovirsen for chronic hepatitis B (positive); camlipixant (chronic cough); Jemperli (rectal cancer); Q4M HIV PrEP; and Exdensur for EGPA 10 pivotal trial starts, including for ADCs B7-H3 (ris-rez) & B7-H4 (mocertatug rezetecan, mo-rez) to treat multiple cancer types Continued commitment to shareholder returns Q4 2025 dividend of 18p declared; 66p FY 2025; 70p expected for full year 2026 £1.4 billion executed to date as part of the £2 billion share buyback programme announced at FY 2024 2026 guidance and 2031 sales outlook reaffirmed Expect 2026 turnover growth of between 3% to 5%; Core operating profit growth of between 7% to 9%; Core EPS growth of between 7% to 9% 2031 sales outlook of more than £40 billion Luke Miels, Chief Executive Officer, GSK: “GSK delivered another strong performance in 2025, driven mainly by Specialty Medicines, with double-digit sales growth in Respiratory, Immunology & Inflammation (RI&I), Oncology and HIV. Good R&D progress also continued, with 5 major product approvals achieved and several acquisitions and new partnerships completed to strengthen the pipeline further in oncology and RI&I. We expect this positive momentum to continue in 2026, which will be a key year of execution and operational delivery with strong focus on commercial launches and accelerating R&D. We are well placed to move forward in this next phase for GSK - to deliver our outlooks - and to create new value for patients and shareholders.” Assumptions and cautionary statement regarding forward-looking statements The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in legislation, regulation, government actions and policies, including the impact of any potential tariffs or other restrictive trade policies on the Group's products, or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate. This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. 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Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and readers are cautioned not to place undue reliance on the forward-looking statements. All guidance, outlooks and expectations should be read together with the guidance and outlooks, assumptions and cautionary statements in this full year and Q4 2025 earnings release and in the Group's 2024 Annual Report on Form 20-F. Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to factors that are beyond the Group’s control or precise estimate. The Group cautions investors that a number of important factors, including those in this document, could cause actual results to differ materially from those expressed or implied in any forward-looking statement. Such factors include, but are not limited to, those discussed under ‘Risk Factors’ in the Group’s Annual Report on Form 20-F for 2024. Any forward-looking statements made by or on behalf of the Group speak only as of the date they are made and are based upon the knowledge and information available to the Directors on the date of this report. You might also like