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FOLD

Amicus

$8.32

-0.58 (-6.52%)

17:17
11/28/16
11/28
17:17
11/28/16
17:17

Amicus to pursue more migalastat data as FDA rules out quick path

Amicus Therapeutics (FOLD) plunged in after-hours trading after ruling out accelerated approval for its migalastat product and confirming the need for additional data. AMICUS SAYS MORE DATA NEEDED: In a press release shortly after market close, Amicus detailed its "planned regulatory pathway to collect additional data to support full approval" of migalastat: "Following several collaborative discussions with the FDA, including the receipt of final written minutes from an in-person Type B meeting, the company plans to collect additional data on gastrointestinal symptoms in Fabry patients who have an amenable mutation. Key elements of the additional data generation... may include: Randomized, 12-month, placebo-controlled pivotal 'cross-over' study in treatment naive Fabry patients who have an amenable mutation and GI symptoms. Crossover study design provides sufficient powering with a small number of patients, ~35 patients planned. Primary endpoint to assess diarrhea based upon established FDA irritable bowel syndrome guidance." Amicus noted it is working with the FDA to finalize the clinical protocol and plans to initiate enrollment in 2017, with data expected in 2019. The company also disclosed that "during its review of the briefing document submitted and in discussions with Amicus, the FDA acknowledged that significant unmet medical need exists in Fabry disease. The agency also indicated that kidney globotriaosylceramide is currently not considered a basis for an accelerated approval under Subpart H." Weighing in on the news, CEO John Crowley stated, "While we believe that the totality of the data from our studies with migalastat support the submission of a new drug application today, we acknowledge the FDA's position that accelerated approval based on kidney GL-3 reduction is not currently an option... FDA has been flexible in allowing a crossover design and in our use of established GI endpoints to measure clinical benefit in Fabry patients. We are fully committed to the additional work necessary to move migalastat toward approval." PRICE ACTION: Shares of Amicus are down 27.76% to $6.01 in post-market trading.

FOLD Amicus
$8.32

-0.58 (-6.52%)

06/14/16
LEER
06/14/16
NO CHANGE
Target $19
LEER
Outperform
Protalix development encouraging for Amicus Galafold, says Leerink
Leerink analyst Joseph Schwartz is "incrementally encouraged" by the news that Protalix (PLX) reached an agreement with the FDA to advance its Fabry ERT into a pivotal trial, just before Amicus' (FOLD) meeting with the agency to discuss a regulatory path for its Galafold. Amicus was poised to emphasize non-renal data in the upcoming FDA meeting, but now the company has "another way to win" by using renal data, the analyst tells investors in a research note. Schwartz now assigns a 33% probability for Galafold. The analyst reiterates an Outperform rating on Amicus' stock and raised his price target on the shares to $19 from $17.
07/20/16
JPMS
07/20/16
NO CHANGE
Target $13
JPMS
Overweight
Amicus risk/reward 'compelling' at current levels, says JPMorgan
JPMorgan analyst Anupam Rama views the risk/reward for shares of Amicus Therapeutics at current levels as "compelling." After declining 39% year-to-date, Amicus is essentially only pricing in outside the U.S. Galafold sales in Fabry disease plus cash, Rama tells investors in a research note. Very little credit is being given to the company's U.S. migalastat, Zorblisa or the Pompe program, which all have events in the second half of 2016, the analyst contends. Rama thinks only one of the three need to hit for the stock to trade "materially higher," with upside ranging from 20%-100%-plus on a single success, and "meaningfully more upside" potential on multiple positive updates. Rama reiterates an Overweight rating on Amicus with a $13 price target.
08/22/16
GSCO
08/22/16
NO CHANGE
GSCO
Goldman lists companies to be in focus after Medivation deal
After Pfizer (PFE) announced it has agreed to acquire Medivation (MDVN) for $81.50 per share in cash, Goldman Sachs analyst Salveen Richter said he expects a focus on other commercial small-to-mid-cap cancer companies, including Incyte (INCY), Seattle Genetics (SGEN), ARIAD (ARIA) and Exelixis (EXEL). Also noting that Sanofi (SNY), which was pursuing Medivation, has recently suggested an interest in a rare disease transaction up to potentially as large as $20B, he would expect rare disease companies of that size - such as BioMarin (BMRN), Amicus (FOLD) and Ultragenyx (RARE) - to be in focus as well.
10/07/16
GSCO
10/07/16
NO CHANGE
GSCO
Smid-cap Biotech sector upgraded to Attractive from Neutral at Goldman
Goldman analyst Salveen Richter upgraded the Smid-cap biotechnology to Attractive and said he favors and companies with near-term pipeline data or regulatory events where he has conviction.Names he recommends are Buy rated BioMarin (BMRN), bluebird bio (BLUE), GW Pharma (GWPH), Incyte (INCY), Kite (KITE), and Sage (SAGE).

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AET

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APRN

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DPS

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HBI

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ABM

ABM

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IVTY

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