Merck (MRK) Receives CRL for Gefapixant
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 8/20/2026
- Wall St slips on rising bond yields; Walmart results weigh
- Walmart shares fall despite earnings beat
- Alibaba stock dips as Q2 profit misses estimates despite strong AI cloud growth
- Wolfe remains "broadly bullish on AI semis stocks", names Top Pick
- Moderna stock pulls back after massive one-day rally: analysts weigh in
- Marvell issues Google warrant tied to custom chip deal
- FOMC minutes from July 28-29th meeting
- US stock futures steady after tech slump; investors focus on Middle East tensions
- Lowe's Cos. (LOW) Tops Q2 EPS by 17c, Misses on Revenue; Offers Fy27 Guidance
- Deutsche Bank calls Treasury buyback doubling similar to ’operation twist’
Merck Provides U.S. Regulatory Update on Gefapixant
December 20, 2023 4:30 PM ESTRAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Mercks New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In the CRL, the FDA concluded that Mercks application did not meet substantial evidence of effectiveness for treating... More
