Ascelia Pharma AB (publ) (ticker: ACE), a biotechnology company focused on improving the lives of people living with rare cancer conditions, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Orviglance®. Ascelia will engage with the FDA to find an expedited path forward.
The FDA has informed the Company that it is currently unable to approve the NDA for Orviglance in its present form and has requested additional clinical data and product documentation.
We seek to understand the issues in detail and plan to request a Type A meeting with the FDA as soon as possible.
“We remain confident in Orviglance and are committed to making it available to patients.” said Magnus Corfitzen, CEO of Ascelia Pharma. “Our focus now is to work with the FDA to identify an expedited path forward. We will provide further updates when appropriate.”
The Company has a cash runway into 2027 and will assess potential cost saving initiatives.