Ultragenyx's Shares Surge More Than 80% in the Year So Far
The share price of Ultragenyx Pharmaceutical Inc. RARE has surged 85.2% year to date against the industry’s decline of 4.7%.
Let’s take a look at the factors that led to the increase.
The company’s antibody targeting fibroblast growth factor 23 (FGF23), Crysvita was approved and launched in April 2018 in the United States for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients. Crysvita received European conditional marketing authorization, in February 2018, for the treatment of XLH with radiographic evidence of bone disease in children aged one year or older, and adolescents with growing skeletons.
In Europe, a filing to expand the label of the drug to include adults with XLH is also planned. It is the only treatment that targets the underlying cause of this rare, hereditary, lifelong disease and can generate significant revenues for the company. The approval of the drug is a boost for the company.
Mepsevii, an enzyme replacement therapy, is the first and the only medicine approved for the treatment of children and adults with non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII) in the United States. Last month, the European Commission (EC) also approved the Marketing Authorization Application (MAA) for Mepsevii, for the treatment of MPS VII.
Ultragenyxis is also developing UX007, a synthetic triglyceride, for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD). In August, the FDA accepted Ultragenyx’s most recent proposal to submit a new drug application (NDA) for UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) based on existing data.
The company also has some gene-therapy candidates in its pipeline. These include DTX301, which is an adeno-associated virus 8 (AAV8) being evaluated for the treatment of patients with Ornithine transcarbamylase (OTC) deficiency. DTX401 is another AAV8 gene-therapy candidate being evaluated for the treatment of patients with glycogen storage disease type Ia (GSDIa). The FDA granted Fast Track designation to DTX401 for the treatment of GSDIa in July 2018.
The company is developing DTX201, its FVIII gene-therapy program for the treatment of hemophilia A in collaboration with Bayer BAYRY. The investigational new drug (IND) application was accepted by the FDA and made active in the second quarter of 2018. A potential approval of these candidates will drive the company’s revenues.
Ultragenyx Pharmaceutical Inc. Price
Ultragenyx Pharmaceutical Inc. Price | Ultragenyx Pharmaceutical Inc. Quote
Zacks Rank & Stocks to Consider
Ultragenyx is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. GILD and Ligand Pharmaceuticals Inc. LGND, both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.15 to $6.58 for 2018 and from $6.33 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 3.1% so far this year.
Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 92.9% year to date.
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