Topotarget falls on belinostat delay, lowered 2013 outlook

Topotarget A/S (CSE:TOPO) fell DKK0.37 (13%) to DKK2.57 on Thursday after the company said it now expects to report a loss in 2013 instead of a profit on the year due to the delay in an NDA submission to FDA by partner Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) for belinostat. Spectrum disclosed in its 2Q13 earnings on Wednesday that it now plans to submit an NDA for belinostat to treat peripheral T cell lymphoma (PTCL) in 4Q13. Previously, the company said it planned to submit the NDA mid-year.

Topotarget is eligible to receive a $10 million milestone payment and 1 million Spectrum shares on FDA acceptance of the NDA as well as a $24 million payment on FDA approval of belinostat. As a result of the submission delay, Topotarget said it now expects the first milestone payment in 1Q14 and expects a 2013 loss of DKK46-DKK51 million ($8.2-$9.1 million) instead of revenues of DKK49-DKK54 million ($8.7-$9.6 million) on the year. The 1 million Spectrum shares are valued at $8.2 million based on Spectrum's close of $8.22 on Wednesday, before the company released its 2Q13 earnings. ...