Edison re-evaluates Onconova based on extended rigosertib timeline after trial failure
After failing to meet the primary endpoint of its trial of rigosertib (IV), oncology specialist Onconova (Nasdaq: ONTX) has informed the investment community that it will be pursuing an indication of the drug in patients where primary hypomethylating agents (HMA) fail.
The detailed pivotal trial design will be unveiled in the fourth quarter, following meetings with the US Food and Drug Administration and European regulators.
Edison Equity Research has updated its valuation of the company to a lower $262 million, or $12.1 per basic share, from $311 million, or $14.5 million per basic share, to reflect the longer timeframe for bringing the product to market. Despite the drug’s failure to meet the overall survival primary endpoint, it did demonstrate a statistically-significant overall survival benefit in a pre-defined subgroup of patients who progressed on or failed to respond to treatment with HMAs.
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