- On Friday, FDA's Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 that Y-mAbs Therapeutics Inc YMAB did not provide sufficient evidence to conclude that omburtamab improves overall survival.
- Guggenheim says the news is disappointing, slashing the price target from $26 to $18, given the unlikelihood of a priority review voucher worth around $70 million in net proceeds and the current cash runway into mid-2024. The analyst maintained the Buy rating on the stock.
- The analyst notes omburtamab was a relatively minor value driver, with around $20 million in the U.S. peak sales for the lead indication.
- Pipeline focus will likely shift to GD2-SADA, where YMAB aims to initiate dosing by YE 2022 and provide initial imaging data from ~5-10 patients by 2H 2023.
- HC Wainwright lowered the price target for YMAB from $63 to $19 and maintained a Buy rating.
- The analyst says that Y-mAbs demonstrated the validity of the approach embodied by omburtamab, but this candidate faces an uncertain future, and it cannot be assured of Y-mAbs' commitment or ability to address the concerns raised by the FDA's advisory committee.
- HC Wainwright expects the FDA to issue a Complete Response Letter within the coming weeks.
- Price Action: YMAB shares are down 56.56% at $3.90 on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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