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On Friday, FDA’s Oncologic Medicine Advisory Committee (ODAC) voted 16 to 0 that Y-mAbs Therapeutics Inc (NASDAQ: YMAB) didn’t present enough proof to conclude that omburtamab improves general survival.
Guggenheim says the information is disappointing, slashing the worth goal from $26 to $18, given the unlikelihood of a precedence evaluate voucher price round $70 million in web proceeds and the present money runway into mid-2024. The analyst maintained the Purchase score on the inventory.
The analyst notes omburtamab was a comparatively minor worth driver, with round $20 million within the U.S. peak gross sales for the lead indication.
Pipeline focus will possible shift to GD2-SADA, the place YMAB goals to provoke dosing by YE 2022 and supply preliminary imaging information from ~5-10 sufferers by 2H 2023.
HC Wainwright lowered the value goal for YMAB from $63 to $19 and maintained a Purchase score.
The analyst says that Y-mAbs demonstrated the validity of the method embodied by omburtamab, however this candidate faces an unsure future, and it can’t be assured of Y-mAbs’ dedication or skill to handle the considerations raised by the FDA’s advisory committee.
HC Wainwright expects the FDA to challenge a Full Response Letter inside the coming weeks.
Worth Motion: YMAB shares are down 56.56% at $3.90 on the final examine Monday.
Date | Agency | Motion | From | To |
---|---|---|---|---|
Feb 2022 | HC Wainwright & Co. | Maintains | Purchase | |
Jan 2022 | JP Morgan | Maintains | Impartial | |
Nov 2021 | JP Morgan | Downgrades | Chubby | Impartial |
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