BUZZ-Traws Pharma falls after FDA puts flu drug application on clinical hold
Reuters
Yesterday
BUZZ-Traws Pharma falls after FDA puts flu drug application on clinical hold
** Shares of Traws Pharma TRAW.O down 20.81% at $1.58 premarket
** Co says the U.S. FDA placed on clinical hold its investigational new drug application for tivoxavir marboxil, a single oral tablet for prevention of seasonal influenza
** Adds that FDA flagged concerns "with the mutagenicity data package" for drug in application
** Also says it filed the application to allow the government's biomedical research unit to fully review its bid for inclusion in the strategic stockpile for avian‑flu treatment
** Clinical hold does not directly impact ongoing and planned studies outside of the United States; working to mitigate issue in clinical development plan - TRAW
** TRAW shares up 74.3% YTD
(Reporting by Gnaneshwar Rajan in Bengaluru)
((Gnaneshwar.Rajan@thomsonreuters.com;))
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