Maxim Group raised its price target for Onconova Therapeutics (NASDAQ:ONTX) to $3 from $1.25 after the company announced that the required number of survival events for the pivotal Phase 3 INSPIRE study of IV rigosertib in higher-risk myelodysplastic syndrome (HR-MDS) patients has been reached. The stock closed at $1.28 on July 29.
The Phase 3 study, which completed enrollment of 360 patients in March, is treating HR-MDS patients with either rigosertib plus best supportive care or physician’s choice plus best supportive care.
Having reached the next milestone of 288 survival events, topline data is now expected by the end of the third quarter of 2020, in line with prior guidance, writes analyst Naureen Quibria.
Given the study design, she said Onconova has two opportunities for approval: either in intent-to-treat patients and/or the very high risk subset. While the INSPIRE readout is a “binary” event for Onconova shares, there are “several areas to focus on that suggest the probability of success favors Onconova, in our view.”
Ms. Quibria said that prior data in the ONTIME trial, VHR patients, the majority of patients now in INSPIRE, experienced the most significant benefit. A data monitoring committee review of the trial leading to trial size expansion suggested there was enough of a therapeutic signal to then expand the trial to maintain power. Onconova also has two shots on goal: VHR MDS patients and intent-to-treat patients, she added.