- Tuesday, the FDA granted accelerated approval for ImmunoGen Inc's IMGN Elahere (mirvetuximab soravtansine-gynx) for folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- HC Wainwright says the approved label does not require a prior treatment with bevacizumab, which according to management, could nearly double the eligible patient population.
- The analyst increased the price target from $12 to $20, with a Buy rating.
- Elahere's broader-than-expected label might result from the FDA's access to preliminary objective response rate (ORR) and duration of response (DOR) data from both arms of the MIRASOL study.
- Elahere's label includes a boxed warning for ocular toxicities, but HC Wainwright believes it would have a limited impact on Elahere's adoption.
- Each 21-day cycle treatment would cost $18,000-$25,000, with an annual cost of $182,400 per patient.
- BMO Capital Markets says ImmunoGen shares were under pressure (-13% vs. -0.26% XBI) following the Elahere approval conference call, which was a surprise.
- BMO analyst raised the price target from $17 to $19 on incrementally more positive on MIRASOL data in early 2023.
- The analyst expects mirvetuximab can only achieve ~$300 million peak sales, undervaluing the ovarian cancer opportunity.
- Price Action: IMGN shares are up 5.09% at $5.27 on the last check Wednesday.
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