The setback sent GSK’s shares down by about 4 per cent on Friday, as investors assessed the potential impact of the failed programme on the company’s long-term growth strategy.
Data from the trials showed that the higher 50 milligram dose of camlipixant reduced daily coughing over a 12-week period in one study. However, the result was not replicated in a second trial that evaluated the treatment over 24 weeks, preventing the drug from meeting the required success benchmarks.
The development has raised concerns among some investors who are closely watching whether GSK can deliver on its target of achieving £40 billion ($53.76 billion) in annual revenue by 2031.
Although GSK has maintained confidence in its long-term financial outlook, the company had previously projected that camlipixant could generate peak annual sales of about £2.5 billion. Analysts, however, had offered more conservative estimates closer to £1 billion.
Markus Manns, portfolio manager at GSK shareholder Union Investment, said the drug had always carried significant development risks because chronic cough remains a difficult condition to treat.
"The camlipixant development program was seen as having an above average risk of failing, as chronic cough is a difficult-to-treat disease," Manns said, adding that the setback could increase pressure on GSK to pursue more acquisitions.
The outcome also adds to the challenges facing GSK’s Chief Executive Officer Luke Miels, who took over from Emma Walmsley in January. Miels is under pressure to reassure investors that the company can meet its growth targets while preparing for potential revenue pressures from upcoming patent expiries, including its major HIV medicine dolutegravir.
Impact on Long-Term Revenue Goals
Analysts at JPMorgan had previously identified camlipixant as one of the potential growth drivers that could help narrow the gap between market expectations and GSK’s 2031 revenue ambition.
While GSK has projected annual sales of £40 billion by 2031, some analysts estimate the company may generate closer to £35 billion, making future product launches and acquisitions important parts of its growth strategy.
Despite the trial failure, some analysts described the impact as limited.
"Getting this through would have been a nice to have but not a must-have for the top-line trajectory," Jefferies analyst Michael Leuchten said.
Leuchten added that recent acquisitions could support GSK’s future growth and may not yet be fully reflected in investor expectations.
Last month, GSK completed its largest-ever acquisition, spending $10.6 billion to buy US-based cancer-focused biotechnology company Nuvalent, strengthening its oncology pipeline.
Drug Showed Limited Patient Benefit
GSK said the trial results indicated that camlipixant was unlikely to deliver a meaningful transformation in the treatment of refractory chronic cough.
The lower 25 milligram dose failed to demonstrate a clear benefit in either study, while neither dosage met key secondary objectives, including improvements reported by patients through the Chronic Cough Diary assessment.
The company said it would stop further development of camlipixant for chronic cough but would continue evaluating the drug as a potential treatment for irritable bowel syndrome.
GSK also said it plans to share the trial findings with the scientific community to support further research into refractory chronic cough, a condition with limited available treatment options.
An estimated 10 million people worldwide suffer from the condition each year, with severe cases causing patients to cough hundreds of times daily.
GSK acquired camlipixant through its $2 billion purchase of Bellus Health in 2023, as part of efforts to expand its respiratory medicines portfolio and develop new sources of future revenue.