Agile Therapeutics (NASDAQ:AGRX) slumps 39% after hours on the news that the FDA has extended its action date for its decision on the company’s marketing application for contraceptive patch Twirla (levonorgestrel/ethinyl estradiol) transdermal system.
The new PDUFA date is February 16, 2020 (from this Saturday, November 16).
On October 30, an FDA advisory panel voted 14-1 in favor of approval. It’s been a long slog for the company considering it has been pursuing the FDA nod since 2012.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.