FDA declines approval for Ascendis Pharma's hormone disorder treatment

Ascendis Pharma A/S

01/05/2023 13:02

** U.S.-listed shares of Denmark-based Ascendis Pharma
 A71.F   ASND.O  rise ~18% premarket to $82.5
    ** Co says U.S. Food & Drug Administration (FDA) has
declined to approve its experimental therapy to treat adult
patients with a hormone disorder called hypoparathyroidism
    ** The FDA cited concerns related to manufacturing control
of the drug and device combination
    ** However, the FDA did not express concerns about the
clinical data submitted and did not seek fresh pre-clinical or
late-stage trials
    ** TD Cowen analyst Yaron Werber wrote in a note on Friday a
"complete response letter declining approval is likely, which
will lead to a more than one year delay"
    ** "We see the stock going up 20-25% if the pushout is by
year end 2023 only and the company can refile quickly with a
Class I review cycle" - TD Cowen 
   ** Up to last close, stock down ~42% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))