- Headline data from the re-evaluation of SPARKLE is expected by
May 2024 - Headline data can be reached with current funding, with a runway into Q3 2024
- The commercialization strategy for Orviglance is expanded to also consider partnership opportunities for launch in the US
The headline results milestone can be reached with the company’s currently available funding. In order to focus all resources and activities on the SPARKLE image re-evaluation, cost cutting initiatives have been taken, including a significant reduction of the organization, which was announced at the end of August. These initiatives extend the company’s cash runway into Q3 2024.
“While the need to complete a re-evaluation of images from our SPARKLE study was unexpected, we are pleased that we now have clarity on what is required and how long it will take to reach headline results. Our entire team is focused on executing this plan and dedicated to ensuring the delivery of robust and conclusive results by May next year. We look forward to bringing Orviglance to patients in need and continue to have confidence in the commercial opportunity.” said Magnus Corfitzen, CEO of
Orviglance has been granted an Orphan Drug Designation by the
“Until now the commercial strategy has been focused on building our own launch organization in the US with selected outsourced operations. In light of the new timeline for Orviglance development, we now expand the commercialization strategy to also consider partnership opportunities for launch in the US,” said Julie Waras Brogren, Deputy CEO & Chief Commercial Officer.
Our confidence in the commercial potential of Orviglance is unchanged, but having a partner would significantly reduce our investments in the launch”, she continues.
© Modular Finance, source