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FOLD

Amicus

$14.91

-0.53 (-3.43%)

07:38
01/08/18
01/08
07:38
01/08/18
07:38

Amicus sees FDA acceptance of U.S. NDA for filing in Q1

John F. Crowley, Chairman and CEO of Amicus Therapeutics, stated, "During 2017 we continued to build a leading global rare disease biotech company while advancing our vision to maximize the impact of our medicines for people living with rare diseases. We exceeded our EU launch and regulatory objectives for our Fabry precision medicine Galafold, and we reported clinical data from our Pompe clinical study that lays the foundation for a potential new treatment paradigm for this muscle disease. Throughout 2018 we are poised to create significant additional value for patients and shareholders across our key programs in Fabry and Pompe, and through our focused commitment to advancing and expanding a pipeline of novel medicines for rare metabolic diseases." The company's anticipated milestones include FDA acceptance of U.S. NDA for filing in 1Q18; Regulatory decision on Japanese J-NDA in 1H18; and ATB101 co-formulated with migalastat advancing toward the clinic in 2019.

FOLD Amicus
$14.91

-0.53 (-3.43%)

08/17/17
JPMS
08/17/17
NO CHANGE
JPMS
JPMorgan lists top SMID Biotechnology picks following Q2 results
Analysts at JPMorgan continue think selectively remains important in the small-to-mid cap Biotechnology space. The analysts listed their favorite ideas in "five key buckets." Amicus (FOLD) is the top long-term pick, Ironwood (IRWD) is the top pick among relative underperformers, Otonomy (OTIC) is the top play for a clinical/binary event, Sarepta (SRPT) is the name to take advantage of the recent share weakness, and Ignyta (RXDX) is the "underfollowed/undervalued" favorite, according to JPMorgan's Biotech team.
09/14/17
BARD
09/14/17
NO CHANGE
Target $16
BARD
Outperform
Amicus SD-101 failure disappointing, but removes key overhang, says Baird
Baird analyst Michael Ulz noted Amicus reported its SD-101 Phase 3 study missed all of its endpoints. Although disappointing, the trial was given a low probability of success. This news removes a key overhang for the company, setting up additional upside with its Pompe program, Ulz tells investors. He remains encouraged by the early data from the Pompe program, which should be releasing full six-month data later this month. Ulz reiterated his Outperform rating and raised his price target to $16 from $15 on Amicus shares.
09/15/17
JPMS
09/15/17
NO CHANGE
Target $15
JPMS
Overweight
JPMorgan continues to see upside in Amicus shares
JPMorgan analyst Anupam Rama says Amicus Therapeutics remains one of his top picks, and that he continues to see upside from current share levels, ahead of the upcoming Pompe data readout. The analyst sees a high probability that the Q3 data update will meet or exceed the efficacy benchmarks, leading to increased probability of success/revenue estimates across Street models. His base case, with a 75% probability of success assumption, still provides for 10%-15% upside from current share levels. His "homerun scenario," which is maintaining the 6MWD benefit shown in Q2 or better, has the stock rallying 35%-40%.
10/04/17
BOFA
10/04/17
NO CHANGE
Target $20
BOFA
Buy
Amicus price target raised to $20 from $15 at BofA/Merrill
BofA/Merrill analyst Tazeen Ahmad raised Amicus' price target to $20 from $15 saying the Phase 1/2 trial results of ATB200/AT2221 in Pompe disease were impressive. The analyst thinks the strong data justifies progression into pivotal trials and may result in an accelerated approval path. Ahmad rates Amicus a Buy.

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