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FOLD

Amicus

$7.74

0.17 (2.25%)

07:33
05/19/17
05/19
07:33
05/19/17
07:33

Amicus announces planned analysis of ESSENCE trial primary endpoints

Amicus Therapeutics announced it has completed the analysis plan for the primary endpoints in the blinded ongoing Phase 3 clinical study, ESSENCE, of the novel topical medicine SD-101 for epidermolysis bullosa. ESSENCE is a double-blind, placebo-controlled registration study that completed enrollment of more than 160 patients who have a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB. Based on discussions and written communication from the Dermatology Division of the U.S. FDA, Amicus will analyze the primary endpoints for the Phase 3 ESSENCE study as follows: The endpoint of "time to wound closure within 3 months" will be analyzed first. If the difference between SD-101 6% and placebo is statistically significant, then the study will be considered a success; If the first endpoint is statistically significant, then "proportion of patients with target wound closure at month 3" will be analyzed and considered statistically significant at p less than or equal to 0.05. Amicus said it is on track to report top-line data from the ESSENCE study during the third quarter of 2017. To date, more than 95% of patients completing the 3-month primary treatment period have elected to continue in the open-label extension study. Jay Barth, Chief Medical Officer of Amicus, said, "We believe that the planned analysis of the primary endpoints increases our overall likelihood for success in the Phase 3 ESSENCE study of SD-101 for epidermolysis bullosa."

  • 13

    Jun

FOLD Amicus
$7.74

0.17 (2.25%)

11/29/16
COWN
11/29/16
NO CHANGE
Target $12
COWN
Outperform
Amicus price target lowered to $12 from $15 at Cowen
Cowen analyst Ritu Baral lowered her price target on Amicus to $12 from $15 after the FDA told the company it could not file the Galafold NDA with current data and that data from a new trial is expected in 2019. Baral maintained her Outperform rating on Amicus, stating that the planned GI trial has a good chance of success.
01/24/17
BARD
01/24/17
UPGRADE
BARD
Outperform
Amicus upgraded to Outperform from Neutral at Baird
01/24/17
BARD
01/24/17
UPGRADE
Target $10
BARD
Outperform
Amicus upgraded to Outperform at Baird
As reported previously, Baird analyst Michael Ulz upgraded Amicus to Outperform from Neutral saying the company removed two overhangs by providing regulatory clarity for Galafold in the U.S. as well as a strengthening its balance sheet. The analyst believes the launch of Galafold by itself supports the company's current valuation and he sees multiple opportunities for upside from its pipeline. Ulz raised his price target to $10 from $7 on Amicus shares.
01/24/17
01/24/17
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Tableau (DATA) upgraded to Buy from Neutral at Citi with analyst Walter Pritchard saying consensus estimates for fiscal 2017 look low. Revenue transition impacted numbers more than the Street realized in 2016, Pritchard tells investors in a research note. The analyst raised his price target for the shares to $64 from $50. 2. Agrium (AGU) upgraded to Outperform from Market Perform at Cowen, while CF Industries (CF), Mosaic (MOS), and Potash (POT) were upgraded to Market Perform from Underperform. 3. Calithera Biosciences (CALA) upgraded to Neutral from Sell at Citi with analyst Robyn Karnauskas citing her conversation with management. Management now appears more open to partnering, Karnauskas tells investors in a research note. 4. Home Bancshares (HOMB) upgraded to Buy from Hold at Sandler O'Neill. 5. Amicus (FOLD) upgraded to Outperform from Neutral at Baird with analyst Michael Ulz saying the company removed two overhangs by providing regulatory clarity for Galafold in the U.S. as well as a strengthening its balance sheet. Ulz raised his price target to $10 from $7 on Amicus shares. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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