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TBIO

Translate Bio

$5.53

-0.12 (-2.12%)

07:38
01/22/19
01/22
07:38
01/22/19
07:38

Translate Bio announces clinical hold on MRT5201 IND application from FDA

Translate Bio announced that the company has received verbal notification from the FDA that the agency has completed its review of the company's investigational new drug application, or IND, submission for MRT5201 for the treatment of ornithine transcarbamylase, or OTC, deficiency and has additional clinical and nonclinical questions. The company submitted the IND in December 2018 to support the initiation of a Phase 1/2 clinical trial in patients with OTC deficiency. The FDA is placing the IND on clinical hold until these questions are resolved. The company expects to receive formal written communication with additional information from the FDA in the near future and plans to work with the FDA in an effort to resolve its questions as promptly as possible.

TBIO Translate Bio
$5.53

-0.12 (-2.12%)

12/24/18
HCWC
12/24/18
INITIATION
Target $21
HCWC
Buy
Translate Bio initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Andrew Fein started Translate Bio with a Buy rating and $21 price target. The analyst believes MRT platform validation by either clinical program "can have significant read-through to other disease states." By using a proprietary mRNA therapeutic platform, or MRT, the company can deliver mRNA that encodes functional proteins and therapeutically bypass the defect, says the analyst.
07/23/18
SBSH
07/23/18
INITIATION
Target $20
SBSH
Buy
Translate Bio initiated with a Buy at Citi
Citi analyst Yigal Nochomovitz started Translate Bio with a Buy rating and $20 price target. The analyst views the company as a lower risk way to play the gene correction theme.
07/23/18
EVER
07/23/18
INITIATION
Target $25
EVER
Outperform
Translate Bio initiated with an Outperform at Evercore ISI
Evercore ISI initiated Translate Bio with an Outperform and $25 price target.
07/23/18
LEER
07/23/18
INITIATION
Target $24
LEER
Outperform
Translate Bio initiated with an Outperform at Leerink
Leerink analyst Geoffrey Porges initiated Translate Bio with an Outperform and $24 price target.

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