Obseva jumps after FDA accepts menstrual bleeding drug for review

Obseva SA

22/11/2021 11:06

** U.S.-listed shares of Swiss drug developer  OBSV.O  jump
19% to $2.76 premarket - set to open at their highest in over a
month
    ** Stock, among biggest pct gainers, second most actively
traded across U.S exchanges before the bell 
    ** Obseva says U.S. FDA accepted the marketing application
for its drug candidate, linzagolix, to manage heavy menstrual
bleeding associated with uterine fibroids in premenopausal women
 urn:newsml:reuters.com:*:nGNEbZgKK1
    ** The regulator has set a target action date of September
13 next year, by when it will decide on the approval of the
drug- co
    ** Says the drug is also under the review of the European
Medicine Agency (EMA) with an approval recommendation from the
regulator's panel expected in Q4 this year
    ** Separately, company also says pharma industry veteran
Stephanie Brown has been selected to join its board and will be
proposed for election at its annual general meeting next year
 urn:newsml:reuters.com:*:nGNX7JbGFS
    ** Stock had risen 11.5% YTD, up to last close 

 (Reporting by Amruta Khandekar)
 ((Amruta.Khandekar@thomsonreuters.com;))