Eagle Pharmaceuticals, Inc.
), which went public last month, has as many as six candidates in
its pipeline in addition to two approved products. The company,
which raised more than $50 million from its initial public
offering, intends to use the funds primarily to develop its
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In keeping with its efforts to expand its product portfolio,
Eagle Pharma announced last week that the new drug application
for the company's candidate dantrolene will be reviewed on a
priority basis by the U.S. Food and Drug Administration (FDA). A
decision from the U.S. regulatory body is expected by Jul 22,
2014 (target date). Eagle Pharma is seeking approval of the
candidate for treating patients suffering from malignant
hyperthermia. Eagle Pharma stated in its press release that the
FDA has conditionally accepted the company's proposed trade name
of Ryanodex to market the drug on approval.
The hyper-metabolic rare disorder is often triggered when
genetically susceptible individuals come in contact with certain
inhaled anesthetics or succinylcholine (a muscle relaxant)
causing symptoms such as high blood pressure, elevated carbon
dioxide levels and high fever. The disease should be treated
immediately to avoid fatality.
The candidate enjoys an orphan drug designation from the FDA. The
designation is granted by the FDA to indications being developed
to treat/prevent rare diseases (affecting less than 200,000
people in the U.S.) having significant unmet medical needs.
Moreover, the status makes the drug eligible for seven years of
marketing exclusivity in the U.S. following approval for the
orphan indication. Additionally, this status also provides
several other benefits to Eagle Pharma on the candidate's
We expect investor focus to remain on the regulatory status of
Ryanodex going forward.
Eagle Pharma carries a Zacks Rank #3 (Hold). Better ranked stocks
in the medical sector include
Questcor Pharmaceuticals, Inc.
Lannett Company, Inc.