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BioMarin's (BMRN) Pegvaliase Review Period Extended by FDA

Zacks Equity Research

BioMarin Pharmaceutical Inc. BMRN announced that the FDA has extended the review period of its biologics license application (BLA) for its investigational therapy, pegvaliase, by three months to May 25, 2018. Currently, the company is looking to get pegvaliase approved for lowering blood phenylalanine (Phe) levels in adults with phenylketonuria (PKU), a rare genetic enzyme deficiency disorder, having uncontrolled blood Phe levels with existing treatment options.

In August, the FDA accepted BioMarin's BLA and granted priority review status. However, the regulatory body requested additional information on chemistry, manufacturing and controls related to pegvaliase. The submission of the information to the FDA was classified as a major amendment that will extend the review process by three months.

BioMarin’s shares are up 9.2% so far this year, which compares favorably with an increase of 3.2% registered by the industry during this period.

 

BioMarin is hoping that pegvaliase, if approved, will supplement BioMarin’s phenylketonuria portfolio, which also includes Kuvan. A potential approval will strengthen BioMarin’s commercial leadership in the treatment of PKU and boost the top line.

Kuvan generated revenues of $300.1 million in the first nine months of 2017, up 16% year over year.

However, Kuvan is set to face generic competition from 2020. The approval of pegvaliase will help BioMarin to offset any loss of revenues from Kuvan.

According to information provided by the company, approximately 50,000 individuals in the developed countries are diagnosed with PKU, thus reflecting a significant need for such therapies.

BioMarin Pharmaceutical Inc. Price

BioMarin Pharmaceutical Inc. Price | BioMarin Pharmaceutical Inc. Quote

Zacks Rank & Stocks to Consider

BioMarin has a Zacks Rank #3 (Hold). Some better-ranked health care stocks include Sucampo Pharmaceuticals (SCMP), Achillion Pharmaceuticals, Inc. (ACHN) and Corcept Therapeutics Incorporated (CORT). While Sucampo sports a Zacks Rank #1 (Strong Buy), Achillion and Corcept carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 25.4%, year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 to 67 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 4.51%.

Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 146.5% year to date.

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