Update: Rigosertib (IV) on the way back
After meetings with the FDA and several European national regulatory agencies, Onconova has informed the investment community that it will pursue an indication of rigosertib IV in patients who are primary hypomethylating agents (HMA) failures, with the detailed pivotal trial design to be unveiled in Q414. We consider this a positive first step of rigosertib IV’s comeback from the failure of meeting the primary endpoint in the Phase III ONTIME trial. We have adjusted our valuation based on new timelines of rigosertib IV and rigosertib oral (its pivotal trial is delayed until H115 from previously before year the end of 2014). Our current valuation is $262m, or $12.1 per basic share.Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule product candidates primarily to treat cancer. Substantially all of the company's existing effort is focused on its primary product candidate, rigosertib. Rigosertib is being tested in an intravenous formulation as a single agent, and an oral formulation in combination with azacitidine, in clinical trials for patients with higher-risk myelodysplastic syndromes. Briciclib, another of the company's product candidates, is a small molecule targeting an intracellular regulatory protein, Cyclin D1, which is often found at elevated levels in cancer cells.
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