Four Directors at Onconova Therapeutics Inc bought 119,104 shares at between 0.256USD and 0.265USD. The significance rating of the trade was 67/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directo...
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After receiving feedback from US and EU regulatory authorities, Onconova submitted a trial protocol in April with overall survival as the primary endpoint for its pivotal trial in myelodysplastic syndrome (MDS) patients. We remain confident of the ultimate success of rigosertib (IV), although we have taken a more conservative view of the launch timelines. As such, we have lowered our valuation to $171m or $7.91 per basic share, from $254m or $11.70 per share.
Onconova recently updated the scientific and investment communities on its development plans for rigosertib (IV) in myelodysplastic syndrome (MDS). While another Phase III trial will be necessary to gain FDA approval, European Medicines Agency (EMA) draft guidelines regarding subgroup analyses of clinical studies suggest a filing in Europe with the existing data may be possible. We expect clarity on the Phase III protocol necessary for US approval and the EU regulatory path in Q115. We have adju...
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 ...
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