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GSK Discontinues Development of Camlipixant for Refractory Chronic Cough
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Key Takeaways
GSK ended camlipixant development for refractory chronic cough after mixed phase III study data.
GSK's CALM-1 met its primary endpoint, while CALM-2 and key secondary endpoints fell short.
GSK will continue evaluating camlipixant in a phase IIb study for IBS-D and IBS-M after the RCC decision.
GSK plc (GSK - Free Report) has announced that it is discontinuing development of camlipixant, an investigational P2X3 receptor antagonist, for the treatment of adults with refractory chronic cough (RCC).
GSK was evaluating camlipixant at 50 mg and 25 mg twice-daily doses in phase III CALM-1 and CALM-2 studies versus placebo.
The CALM-1 study achieved its primary endpoint, with camlipixant 50 mg twice daily demonstrating a statistically significant reduction in 24-hour cough frequency after 12 weeks of treatment. However, the CALM-2 study failed to achieve statistical significance for the same endpoint after 24 weeks of treatment. The lower 25 mg twice-daily dose did not demonstrate statistically significant improvements in either study. Key secondary endpoints, including patient-reported outcomes, did not meet predefined efficacy thresholds in either study.
However, camlipixant demonstrated a favorable safety profile and was generally well tolerated.
Refractory chronic cough is a condition in which chronic cough persists despite appropriate evaluation and optimal treatment of identifiable underlying conditions, representing a significant unmet medical need due to its limited effective treatment options.
Year to date, GSK’s shares have risen 9.4% compared with the industry’s 3% growth.
Image Source: Zacks Investment Research
GSK Discontinues RCC Development, Continues IBS Program
Following a comprehensive review of the CALM program data, GSK concluded that the level of efficacy observed is unlikely to provide a meaningful improvement in patient care. Consequently, the company has decided not to advance the development of camlipixant for RCC.
Although development in RCC has been discontinued, GSK will continue evaluating camlipixant in the ongoing phase IIb BALANCE study, which is investigating the candidate's efficacy and safety in adults with irritable bowel syndrome with diarrhea (IBS-D) and irritable bowel syndrome with mixed bowel habits (IBS-M).
Camlipixant was added to GSK’s portfolio with the acquisition of BELLUS Health in June 2023 for approximately $2 billion, strengthening its specialty medicines and respiratory pipeline.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 21% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, loss-per-share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have risen 1.6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have gained 118.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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GSK Discontinues Development of Camlipixant for Refractory Chronic Cough
Key Takeaways
GSK plc (GSK - Free Report) has announced that it is discontinuing development of camlipixant, an investigational P2X3 receptor antagonist, for the treatment of adults with refractory chronic cough (RCC).
GSK was evaluating camlipixant at 50 mg and 25 mg twice-daily doses in phase III CALM-1 and CALM-2 studies versus placebo.
The CALM-1 study achieved its primary endpoint, with camlipixant 50 mg twice daily demonstrating a statistically significant reduction in 24-hour cough frequency after 12 weeks of treatment. However, the CALM-2 study failed to achieve statistical significance for the same endpoint after 24 weeks of treatment. The lower 25 mg twice-daily dose did not demonstrate statistically significant improvements in either study. Key secondary endpoints, including patient-reported outcomes, did not meet predefined efficacy thresholds in either study.
However, camlipixant demonstrated a favorable safety profile and was generally well tolerated.
Refractory chronic cough is a condition in which chronic cough persists despite appropriate evaluation and optimal treatment of identifiable underlying conditions, representing a significant unmet medical need due to its limited effective treatment options.
Year to date, GSK’s shares have risen 9.4% compared with the industry’s 3% growth.
Image Source: Zacks Investment Research
GSK Discontinues RCC Development, Continues IBS Program
Following a comprehensive review of the CALM program data, GSK concluded that the level of efficacy observed is unlikely to provide a meaningful improvement in patient care. Consequently, the company has decided not to advance the development of camlipixant for RCC.
Although development in RCC has been discontinued, GSK will continue evaluating camlipixant in the ongoing phase IIb BALANCE study, which is investigating the candidate's efficacy and safety in adults with irritable bowel syndrome with diarrhea (IBS-D) and irritable bowel syndrome with mixed bowel habits (IBS-M).
Camlipixant was added to GSK’s portfolio with the acquisition of BELLUS Health in June 2023 for approximately $2 billion, strengthening its specialty medicines and respiratory pipeline.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 21% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, loss-per-share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have risen 1.6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have gained 118.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.