Merck's Chronic Cough Treatment Candidate Receives Second Time FDA Rejection
Portfolio Pulse from Vandana Singh
The FDA has issued a second Complete Response Letter (CRL) to Merck & Co Inc (NYSE:MRK) for gefapixant, a drug candidate for treating refractory chronic cough (RCC) and unexplained chronic cough (UCC) in adults, citing insufficient evidence of effectiveness. The CRL did not question the safety of gefapixant. Merck is currently reviewing the FDA's feedback. This development may benefit GSK Plc (NYSE:GSK), which has a competing chronic cough drug, camlipixant, in Phase 3 trials with expected approval in 2026. MRK's stock price saw a slight increase in premarket trading.
December 21, 2023 | 1:51 pm
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NEGATIVE IMPACT
Merck's gefapixant faces a second FDA rejection due to insufficient efficacy evidence, potentially delaying or halting its market entry for chronic cough treatment.
The FDA's rejection of gefapixant is a significant setback for Merck, likely delaying the drug's potential market entry and impacting revenue expectations from this treatment. The negative regulatory news could lead to short-term bearish sentiment among investors, despite the slight premarket stock price increase.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
GSK's camlipixant may benefit from the FDA's rejection of Merck's gefapixant, as it is a competing chronic cough treatment currently in Phase 3 trials.
The FDA's ruling against Merck's gefapixant could indirectly benefit GSK by reducing competition in the chronic cough treatment market. GSK's camlipixant, if successful in Phase 3 trials and approved, could capture market share that might have gone to gefapixant. This potential competitive advantage could positively influence GSK's stock in the short term.
CONFIDENCE 75
IMPORTANCE 60
RELEVANCE 70