Merck's Latest Drug For Chronic Cough Faces FDA Pushback
Portfolio Pulse from Nabaparna Bhattacharya
Merck & Company, Inc.'s (NYSE:MRK) new drug gefapixant faces skepticism from an FDA advisory panel due to questionable efficacy and side effects. The panel voted 12 to 1, highlighting minor reductions in cough frequency and a high dropout rate in trials. Despite Merck's defense of gefapixant, the FDA's final decision is pending for December 27. If approved, gefapixant will compete with GSK Plc's (NYSE:GSK) camlipixant. Merck's cancer drug was recently approved for a type of gastric cancer. MRK shares dropped slightly by 0.24%.
November 18, 2023 | 6:21 pm
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NEGATIVE IMPACT
Merck's gefapixant faces FDA panel skepticism over efficacy and side effects, potentially delaying approval. Recent approval of a cancer drug shows Merck's R&D strength.
The negative feedback from the FDA panel on gefapixant could lead to a delay or denial of approval, which may negatively impact Merck's stock price in the short term. However, the recent approval of a cancer drug may mitigate some investor concerns about Merck's R&D capabilities.
CONFIDENCE 80
IMPORTANCE 80
RELEVANCE 90
NEUTRAL IMPACT
GSK's camlipixant, a competitor to Merck's gefapixant, is in late-stage development for chronic cough treatment, with a significant market potential.
GSK's camlipixant is mentioned as a competitor to Merck's gefapixant. The potential delay or denial of gefapixant's approval could be beneficial for GSK, but the impact is uncertain as camlipixant is still in development and not yet approved.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 50