Analysts for H.C. Wainwright and SVB Leerink raised their price targets for ImmunoGen (NASDAQ:IMGN) after the FDA advised that a new single-arm study in platinum-resistant ovarian cancer (prOC) could support accelerated approval for the company’s mirvetuximab soravtansine. At midday on Dec. 17, the stock was changing hands at $4.34, up 45 cents, or 12%.
HCW analyst Debjit Chattopadhyay writes that based on the FDA guidance, the company will initiate SORAYA, a trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin.
Top-line data are now anticipated during the first half of 2021, which if positive, implies a commercial launch during mid-2022, “about a year ahead of launch estimates, which were predicated on the success of the now re-designated confirmatory trial MIRASOL,” he added.
The MIRASOL confirmatory trial on track to begin enrollment during the fourth quarter of 2019. MIRASOL is a randomized Phase 3 trial in which 430 patients are to be randomized on a one-to-one basis to receive either mirvetuximab or investigator’s choice of single-agent chemotherapy. Topline data are anticipated during mid-2022.
Mr. Chattopadhyay raised his price target for ImmunoGen to $9 from $5.
Jonathan Chang of SVB Leerink said, “We believe the SORAYA study could succeed given the overall response rate endpoint and relatively low bar in prOC, although we still think there is risk associated with mirvetuximab soravtansine, given failure of the FORWARD-I study and exploratory biomarker analysis.”
He raised his price target to $4 from $2.
