Onconova could file NDA for cancer drug rigosertib next year
Analysts at Edison Equity Research have indicated that US biopharma company Onconova Therapeutics (Nasdaq: ONTX) could be in a position to file a New Drug Application for rare cancer drug rigosertib next year.
In a research note, Edison analysts say that the application could be made if the drug meets its primary endpoint in the ONTIME Phase III trial in higher-risk, second-line myelodysplastic syndromes (MDS) in the first quarter of 2014.
It adds that oral rigosertib, which is in Phase II trials for lower-risk MDS, could open a much larger market if positive Phase II data are confirmed in a pivotal trial. “With three drug candidates in clinical trials, six active preclinical programs and cash beyond 2014, Onconova appears to be an attractive investment,” noted the analysts, valuing the company at $476 million, or $22.3 per share.
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