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Press release

Flerie’s portfolio company Xspray Pharma appoints Blake Leitch as CEO and resubmits application for market approval of Dasynoc® to the FDA

Flerie

Flerie AB’s (publ) portfolio company Xspray Pharma has announced the appointment of Blake Leitch as CEO, with Per Andersson transitioning to a key role as Chief Scientific Officer (CSO). The changes are scheduled to be completed by June 1, 2026, at the latest. In addition, Xspray Pharma has reported that the application for market approval of Dasynoc® has been resubmitted to the U.S. Food and Drug Administration (FDA), with a PDUFA date expected no later than August 2026.

Blake Leitch brings over 20 years of experience in building and scaling pharmaceutical businesses worldwide. He has a strong track record in launching new products, executing commercial strategies and driving the expansion of international pharmaceutical businesses in the US, Europe and Asia. Blake Leitch is currently Vice President, Head of Europe, Commercial, and a Member of the Executive Leadership Team at Biocon Biologics.

The leadership changes will aid Xspray Pharma as it continues its transition into a commercial pharmaceutical company, with two drug candidates currently under regulatory review – Dasynoc® and XS003 nilotinib. Xspray Pharma has now submitted its response to the CRL (Complete Response Letter) received from the FDA in October 2025 related to the NDA (New Drug Application) for market approval of Dasynoc®, an amorphous dasatinib for the treatment of CML (chronic myeloid leukemia) and ALL (acute lymphoblastic leukemia). The company plans to launch both Dasynoc® and XC003 nilotinib in the second half of 2026.

“The appointment of Blake Leitch reflects Xspray’s ambition to accelerate its commercial transformation. His track record of launching and commercialising pharmaceutical products across global markets complements Per Andersson's scientific leadership, strengthening the company ahead of the upcoming regulatory approvals. It is also very encouraging that Xspray has now resubmitted its application for market approval of Dasynoc and is planning for a market launch in H2 2026, along with another of its drug candidates – XS003 nilotinib,” says Ted Fjällman, CEO of Flerie.


Read Xspray Pharma’s full press releases here: 
https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-appoints-blake-leitch-as-ceo-per-andersson-continues-as-chief-scientific-officer-cso/

https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-re-submits-its-fda-application-for-dasynoc/

Flerie’s holding in Xspray Pharma amounts to 18%.

For more information:
Ted Fjällman, CEO
Email: ir@flerie.com

Flerie in brief
Flerie is an active long-term life science investor, with a broad and diversified portfolio of innovative companies based on pioneering science. We invest in product development and commercial growth opportunities globally alongside other leading investors, focusing predominantly on private companies that are otherwise difficult to access. Flerie’s active ownership model, broad network and resources support and accelerate the development of the portfolio projects, creating value for shareholders. Flerie AB’s ordinary share is listed on Nasdaq Stockholm with the ticker FLERIE. For further information please visit www.flerie.com

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Flerie’s portfolio company Xspray Pharma appoints Blake Leitch as CEO and resubmits application for market approval of Dasynoc® to the FDA

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