Arena Pharmaceuticals, Inc.
) recently initiated a phase I multiple dose study with APD811,
which is being developed for the treatment of pulmonary arterial
Arena Pharma is expecting to enroll 30 healthy adult volunteers
for this randomized, double-blind and placebo-controlled dose
titration trial. The trial will study the safety, tolerability and
pharmacokinetics of the candidate.
We note that the PAH market already has players like
Gilead Sciences Inc.
United Therapeutics Corporation
Meanwhile, Arena Pharma achieved a major milestone in June this
year when the US Food and Drug Administration (FDA) approved Belviq
as an adjunct to a healthy diet (low on calories) and increased
physical activity for chronic weight management in obese (Body Mass
Index, or BMI, ≥30) or overweight (BMI ≥27) adults suffering from
at least one weight-related co-morbid condition. The move marks the
first FDA approval for a weight-loss drug in 13 years.
The safety and efficacy of Belviq when co-administered with
other weight loss products and the effect on cardiovascular
morbidity and mortality are yet to be established. Hence, the FDA
recommended Belviq to be classified by the US Drug Enforcement
Administration (DEA) as a scheduled drug.
Belviq is currently under review in the EU and the company has
filed a marketing application in Switzerland. Arena Pharma and
Eisai have a partnership agreement for Belviq.
We currently have a Neutral recommendation on Arena Pharma. The
stock carries a Zacks #3 Rank (short-term Hold rating).
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