What Awaits Arena Pharma This Month?

(RTTNews) - Shares of Arena Pharmaceuticals Inc. (ARNA) have returned 18% year-to-date, nearly double the gain of the Nasdaq Biotechnology index.

Arena, the originator of weight-loss drug Belviq, now has a pipeline comprised of multiple development stage products, targeting a broad range of disease applications.

Belviq, Arena's internally discovered drug, secured FDA approval in June 2012. Wall Street was bullish about the prospects of the drug, and investors were hoping it could be a blockbuster. But Belviq didn't live up to expectations and its sales failed to take off, leaving Arena frustrated. Last January, Arena sold the global rights to Belviq to its marketing partner Eisai Co Ltd., and decided to focus on its clinical programs.

Pipeline

The drug candidates in Arena's pipeline include Etrasimod, an oral, selective sphingosine-1-phosphate (S1P) receptor modulator intended for the potential treatment of multiple immune and inflammatory diseases, Ralinepag, a next generation, oral, once-daily, selective prostacyclin receptor agonist intended for the potential treatment of pulmonary arterial hypertension, and Olorinab, an oral, full agonist of the cannabinoid 2 (CB2) receptor intended for the potential treatment of visceral pain, specifically pain associated with Crohn's disease.

Etrasimod

-- Results from a phase II trial of Etrasimod in patients with Ulcerative Colitis, dubbed OASIS, were reported in March of this year. In the trial, patients who received the 2 mg dose of Etrasimod achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints.

-- A phase III program with Etrasimod in ulcerative colitis is being planned.

Etrasimod is also being explored in other indications say, Crohn's disease and Primary biliary cholangitis.

-- A phase II/III trial of Etrasimod in Crohn's disease is being planned, and a phase II trial of Etrasimod in Primary biliary cholangitis is underway.

Ralinepag

Ralinepag for the potential treatment of pulmonary arterial hypertension is under phase III development.

The phase III program of Ralinepag is designed to include 3 studies namely,

-- ADVANCE OUTCOMES (301): Time to clinical events outcomes study, which is underway.

-- ADVANCE CAPACITY (302): Exercise capacity study to evaluate a peak oxygen uptake (VO2) via cardiopulmonary exercise testing (CPET), which is expected to be initiated next quarter.

-- ADVANCE ENDURANCE (304): Exercise capacity study measuring 6-minute walk distance (6MWD), which is expected to be initiated in the first quarter of next year.

Olorinab

-- A phase II study of Olorinab for pain associated with Crohn's disease is underway, with results expected this month (September).

*Key Numbers:

Accumulated deficit: $1.53 billion Cash on hand: $592.4 million Shares outstanding: 49.3 million

(*As of June 30, 2018).

Shares of Arena underwent a 1 for 10 reverse split on June 19, 2017. The stock has traded in a range of $23.79 to $50.05 in the last 1 year.