Arena Pharmaceuticals, Inc. (ARNA - Snapshot Report) recently initiated a phase I multiple dose study with APD811, which is being developed for the treatment of pulmonary arterial hypertension (PAH).
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. (GILD - Analyst Report), GlaxoSmithKline plc (GSK - Analyst Report), Actelion Ltd. (ALIOF) and United Therapeutics Corporation (UTHR - Analyst Report).
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).