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FDA sets Feb target review date for IBT-backed Stemline Therapeutics

FDA sets Feb target review date for IBT-backed Stemline Therapeutics

FDA sets Feb target review date for IBT-backed Stemline Therapeutics

The US FDA has accepted  Stemline Therapeutics (Nasdaq:STML)’s filing for Elzonris (tagraxofusp) for review for blastic plasmacytoid dendritic cell neoplasm (BPDCN), an extremely rare haematological cancer, and with priority review, the agency has set itself a PDUFA target action date of 21 February 2019 – although it may render a decision earlier. Stemline is an investee for UK-listed International Biotechnology Trust (IBT,  2.4% of NAV)  and Polar Capital Global Healthcare Trust (PCGH).

Stemline estimates there are potentially just 1,600-3,200 patients with BPDCN in the US and EU. With the filing accepted in BPDCN, investor interest is moving to potential secondary indications with Elzonris being evaluated in trials for chronic myelomonocytic leukemia (CMML), myelofibrosis, acute myeloid leukaemia and myeloma.  CMML may be the first of these. It is a condition defined by high counts of monoblasts with enlargement of the spleen seen in around half of patients. Frontline treatment is with hypomethylating agents, but there is no standard of care for relapsed/refractory patients, which may present the development opportunity. Stem-cell transplant is the potentially only curative intervention, although this is often not possible due to age at diagnosis and/or co-morbidities.

Stemline shares were up 2% this morning at $15.32/share in response to the news. The company now has a market capitalisation of $481m and with reported cash of $106m at end March, its enterprise value is $375m.

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