Amicus (FOLD) Boasts Strong Pipeline Amid Stiff Competition

We issued an updated report on Amicus Therapeutics, Inc. (NASDAQ:FOLD) on Jan 23.

Amicus is a global patient-centric biotechnology company engaged in the discovery, development and commercialization of a diverse set of novel treatments for patients living with rare metabolic diseases.

Shares of the company have declined 28.5% in the past year compared with the industry’s decline of 22.9%.

The company has one marketed medicine in its portfolio, Galafold (migalastat), which is the first and the only approved oral precision medicine for the treatment of patients with Fabry disease, a rare disease having amenable genetic variants. Galafold was given an accelerated nod by the FDA in August 2018. The initial uptake of the drug was ahead of internal expectations, with 149 new patient prescriptions written as of Dec 31, 2018. The drug has blockbuster potential and Amicus aims to almost double its revenues, expecting the metric to be in the range of $160-$180 million on a worldwide basis in 2019. It anticipates more than 1000 Fabry patients to be on Galafold treatment by 2019-end. Amicus projects peak sales opportunity for Galafold to be more than $500 million.

The company boasts a strong pipeline, including lead candidate AT-GAA (also known as ATB200/AT2221), which is a differentiated biologic for Pompe disease. Amicus plans to enhance the body of clinical data for AT-GAA in ongoing studies, including the pivotal phase III PROPEL study. The PROPEL (ATB200-03) study was initiated by the company last December on adult patients with late onset Pompe disease. Based on regulatory feedback from both the FDA and the European Medicines Agency (EMA), the study is expected to support approval for a broad indication, including ERT-switch and treatment-naïve patients. In the second half of 2018, the company expanded its pipeline to include 14 new gene therapy programs and drive future growth platform for rare metabolic diseases.

However, Amicus still depends heavily on the sales of its first product, Galafold. Though launched in the United States and across some other countries, Galafold will take some time to see its sales pick up.

Zacks Rank & Stocks to Consider

Amicus currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks worth considering are Celgene Corporation (NASDAQ:CELG) , Aduro Biotech, Inc. (NASDAQ:ADRO) and Axovant Sciences Ltd. (NASDAQ:AXON) . All the companies sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings per share estimates have increased from $8.79 to $8.80 for 2018 in the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.54%.

Aduro’sloss per share estimates have narrowed from $1.11 to $1.06 for 2018 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 5.49%.

Axovant’s loss per share estimates have narrowed from $1.60 to $1.25 for 2019 and from $1.35 to $1.03 for 2020 in the past 90 days.

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