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FOLD

Amicus

$10.04

0.47 (4.91%)

07:12
01/03/19
01/03
07:12
01/03/19
07:12

Amicus initiates gene therapy study for CLN3 Batten disease

Amicus announced the initiation of a Phase 1/2 clinical study to evaluate the safety and efficacy of a single intrathecal administration of adeno-associated virus serotype 9 AAV9-CLN3 gene therapy in children with CLN3 Batten disease. Batten disease is the common name for a broad class of rare, fatal, inherited disorders of the nervous system also known as neuronal ceroid lipofuscinoses, or NCLs. The initial patient completed a one-month observation period following dosing with no serious adverse events reported to date. This first in human study of an investigational gene therapy in CLN3 Batten disease, a life-threatening genetic neurologic disorder that typically begins in early childhood and results in premature death, is currently being conducted at Nationwide Children's Hospital. CLN3 is the most prevalent of the Batten's disorders affecting an estimated 5,000+ patients. The Phase 1/2 study is enrolling children aged 3 to 10 years with a confirmed diagnosis of CLN3 Batten disease in two sequential intrathecal dose groups: a one-time low-dose of AAV9-CLN3 and a one-time high-dose of AAV9-CLN3 after evaluation of Group 1 participants. Both groups will participate in the current study for a period of three years. Amicus plans to present clinical data from this study, including interim data, at future scientific congresses and other relevant venues. The primary outcome measures are safety and efficacy as determined using the physical disability subscale of the Unified Batten Disease Rating Scale in CLN3 Batten disease.

FOLD Amicus
$10.04

0.47 (4.91%)

12/17/18
GUGG
12/17/18
INITIATION
Target $18
GUGG
Buy
Amicus initiated with a Buy at Guggenheim
Guggenheim analyst Whitney Ijem started Amicus Therapeutics with a Buy rating and $18 price target. The analyst thinks Amicus shares are well positioned headed into 2019 given the ongoing Galafold launch and the company's "robust pipeline of new gene therapy assets that will produce several updates throughout the year."
10/29/18
SBSH
10/29/18
INITIATION
Target $12
SBSH
Neutral
Amicus initiated with a Neutral at Citi
Citi analyst Mohit Bansal started Amicus Therapeutics with a Hold rating and $12 price target. The analyst is less optimistic over the longer term about uptake of Galafold among untreated patients and believes the company's investment case may take time to play out.
08/17/18
CHDN
08/17/18
DOWNGRADE
CHDN
Neutral
Amicus downgraded to Neutral from Buy at Chardan
05/08/18
JPMS
05/08/18
NO CHANGE
JPMS
Amicus lower on Pompe program commentary, says JPMorgan
JPMorgan analyst Anupam Rama attributes today's post-earnings weakness in shares of Amicus Therapeutics to "conservative commentary" on the call related to the Pompe program. The analyst, however, does not believe that the regulatory scenarios he outlined last month for the program have fundamentally changed. Nonetheless, Rama thinks commentary on the call, particularly on timing, was perceived as cautious. Amicus shares are down 7.5% to $13.49 in midday trading.

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