Update on Eagle Pharma's Ryanodex - Analyst Blog
27 3월 2014 - 1:00AM
Zacks
Eagle Pharmaceuticals,
Inc. (EGRX), 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 pipeline.
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 development costs.
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 Shire (SHPG),
Questcor Pharmaceuticals, Inc. (QCOR) and
Lannett Company, Inc. (LCI).
EAGLE PHARMACT (EGRX): Free Stock Analysis Report
LANNETT INC (LCI): Free Stock Analysis Report
QUESTCOR PHARMA (QCOR): Free Stock Analysis Report
SHIRE PLC-ADR (SHPG): Free Stock Analysis Report
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