Friday, 21 December 2012

Spectrum also confirms Belinostat reaches primary endpoint

As had already been made known by Topotarget (CPH: TOPO) a while ago, Spectrum Pharmaceuticals (NASDAQ: SPPI) confirmed that pivotal Phase 2 BELIEF trial of HDAC-inhibitor belinostat in peripheral t-cell lymphoma reaches its SPA determined primary endpoint of at least 20% ORR. Investors had been hoping for more disclosure before year-end but that will now come out in T-Cell Lymphoma Forum in San Francisco from January 24-26 next year. Spectrum expects NDA filing by mid-year 2013, which is also once again pushing the date further. Topotarget needs milestone payments with the next one from acceptance for review of the drug that would happen within 60 days from filing. PDUFA action date would then be in 2014.

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