Update: The path forward for rigosertib (IV)
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 adjusted our valuation slightly to $254m or $11.70 per 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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