Dec 14 European health regulators recommended approval of Alexza Pharmaceuticals Inc's experimental drug Adasuve for controlling agitation in adults with schizophrenia and bipolar disorders, sending its shares up 24 percent before the bell.
The recommendation from the European Medicines Agency (EMA) will now be forwarded to the European Commission, which normally endorses recommendations within two or three months.
Adasuve is under review by the U.S. Food and Drug Administration, which is due to make a decision by Dec. 21.
The study enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder. Two late-stage studies were conducted, and both demonstrated statistically significant reductions in agitation compared to a placebo.
The EMA recommendation was that Adasuve should be administered only in a hospital and under the supervision of a healthcare professional.
Shares of the company were up 19 percent at $6.25 in premarket trading. They closed at $5.24 on Thursday on the Nasdaq. (Reporting by Ben Hirschler in London and Adithya Venkatesan in Bangalore; Editing by Sriraj Kalluvila)