Mendus: Vididencel secures Fast Track designation in AML - Edison

Mendus has announced that the FDA has granted Fast Track designation to its lead cancer vaccine, vididencel, as a potential maintenance therapy in acute myeloid leukaemia (AML). This regulatory decision was based on interim results from the ADVANCE II trial (reported in December 2022), which showed encouraging survival data to support vididencel as a monotherapy in AML maintenance, as well as a desirable safety profile. Benefits of Fast Track designation include more frequent interactions with the FDA for an expedited approval process and a ‘rolling review’ for its market application. We believe that Fast Track designation represents a key milestone, enabling a potentially accelerated route to market, provided clinical results continue to be positive. Updated data (relapse free survival and overall survival) from the ADVANCE II trial are expected in Q424. Mendus is also preparing for an additional Phase II combination trial with Onureg, which is on track to commence by end-2023.

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Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/report/mendus967150/preview