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YMAB

Y-mAbs Therapeutics

$22.17

-0.36 (-1.60%)

17:42
12/10/18
12/10
17:42
12/10/18
17:42

Y-mAbs Therapeutics humanized bispecific GD2 antibody IND receives FDA clearance

Y-mAbs Therapeutics announced that the FDA has cleared the investigational new drug, or IND, application for a humanized bispecific GD2 antibody. It is anticipated that a Phase 1/2 clinical trial will soon be initiated to begin screening patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2 solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy. This bispecific product candidate is a fully humanized IgG-scFv format antibody, licensed by Memorial Sloan Kettering to Y-mAbs, in which the anti-CD3 scFv is linked to naxitamab IgG1 and the Fc region is mutated to help prevent cytokine release as well as complement-mediated pain side effects. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.

YMAB Y-mAbs Therapeutics
$22.17

-0.36 (-1.60%)

10/16/18
COWN
10/16/18
INITIATION
COWN
Outperform
Y-mAbs Therapeutics initiated with an Outperform at Cowen
Cowen analyst Boris Peaker initiated Y-mAbs Therapeutics with an Outperform rating. He noted the company has two pivotal stage drugs for rare pediatric cancers. He believes the assets are highly de-risked and offer high barriers for potential competitors. Peaker has not established a price target yet.
10/16/18
ADAM
10/16/18
INITIATION
Target $30
ADAM
Buy
Y-mAbs Therapeutics initiated with a Buy at Canaccord
Canaccord analyst Arlinda Lee initiated Y-mAbs Therapeutics with a Buy rating citing its staggered and deep pipeline including two late stage clinical drug candidates. The analyst sees top-line data from the company's pivotal Study 201 of naxitamab and an initiation of Study 17-251 of naxitamab + chemo in refractory NB in 2018 as near-term catalysts. Lee has a $30 price target on Y-mAbs Therapeutics shares.
10/16/18
BOFA
10/16/18
INITIATION
Target $26
BOFA
Buy
Y-mAbs Therapeutics initiated with a Buy at BofA/Merrill
BofA/Merrill analyst Ying Huang initiated Y-mAbs Therapeutics with a Buy and $26 price target saying lead assets and near-term catalysts provide an attractive opportunity for investors. Huang said Y-mAbs' story is de-risked with its two drugs for rare pediatric indications, both having impressive safety and efficacy.
10/16/18
BTIG
10/16/18
INITIATION
Target $35
BTIG
Buy
Y-mAbs Therapeutics initiated with a Buy at BTIG
BTIG analyst Thomas Shrader initiated Y-mAbs with a Buy rating and a price target of $35, citing the company's pivotal trial development of treatment of neuroblastoma tumors and their central nervous system metastases. The analyst notes that Y-mAbs' two biologics license applications expected to be submitted in mid-2019 look "more attractive" than the current standard of care.

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