Ascendis Pharma jumps as FDA does not seek new trial for hormone disorder therapy

Ascendis Pharma A/S

01/05/2023 15:11

(Updates)
    ** U.S.-listed shares of Denmark-based Ascendis Pharma
 A71.F   ASND.O  rise 18.3% to ~$83
    ** Stock set for its biggest one-day pct rise in more than
one and half years, if gains hold
    ** 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 for the therapy TransCon PTH
    ** Co said it would request a meeting with the FDA as soon
as possible on the best path forward
    ** TD Cowen analyst Yaron Werber wrote in a note on Friday a
complete response letter declining approval is likely, and
expected the stock to advance if the delay was to the end of
this year
   ** Stock down ~32% YTD

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