In an April 25 research note, ROTH Capital Partners analyst Jotin Marango reported that the last required major adverse cardiac event, the 250th, occurred in Resverlogix Corp.'s (RVX:TSX) BETonMACE Phase 3 trial of apabetalone. The company expects to release corresponding topline data between mid-June and mid-August 2019.
"We remain bullish on the risk/reward of apabetalone into the Phase 3 readout, based on Phase 2 data and the Phase 3 design, the commercial opportunity and the lateral indication optionality of the drug," Marengo commented.
The next step, before the data readout, is conducting last study visits for all of the participating patients, noted Marango. Subsequently the database will be locked, and about two weeks after that, Resverlogix will announce the study results.
Should those data be positive, regulatory review and potential approval would follow, which would take place throughout this year and next, Marango explained. Commercialization of apabetalone then would begin in 2021, with a label for patients with type 2 diabetes and at high cardiovascular disease risk following hospitalization, a population consistent with that in the Phase 3 study.
The analyst noted that apabetalone would likely reach peak global sales of more than $1 billion by 2025, based on the market performance of the type 2 diabetes medication Jardiance (empagliflozin).
Also, Marango added, with its strong safety profile, Resverlogix could expand the use of apabetalone beyond the BETonMACE population.
ROTH has a Buy rating and a CA$10 per share target price on Resverlogix, whose stock is currently trading at around CA$3.97 per share.[NLINSERT]
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Disclosures from ROTH Capital Partners, Resverlogix Corp., Company Note, April 25, 2019
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