On Friday, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 that Y-mAbs Therapeutics Inc (NASDAQ: 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.
Latest Ratings for YMAB
Date | Firm | Action | From | To |
|---|---|---|---|---|
Feb 2022  | HC Wainwright & Co. | Maintains | Buy | |
Jan 2022 | JP Morgan | Maintains | Neutral | |
Nov 2021 | JP Morgan | Downgrades | Overweight | Neutral |
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Source: https://finance.yahoo.com/news/analysts-slash-y-mabs-therapeutics-190154097.html