Arena (ARNA) Tumbles as Mid-Stage Gastrointestinal Study Fails

Arena Pharmaceuticals ARNA announced that its phase IIb CULTIVATE study evaluating cannabinoid receptor 2 agonist candidate, olorinab, in patients with abdominal pain due to irritable bowel syndrome (IBS) failed to meet the primary endpoint. The candidate did not achieve statistically significant improvement in the overall average abdominal pain score (AAPS) from baseline to week 12, the study’s primary endpoint.

Shares of Arena declined 8.9% in after-hours trading on Mar 2, following the news. However, the company’s shares have gained 53.7% in the past year compared with the industry’s 7.8% increase.

The CULTIVATE study evaluated three thrice-a-day doses of olorinab — 10 mg, 25 mg, and 50 mg — for safety and change in abdominal pain from baseline, as measured by AAPS. Data showed that the candidate was safe and well tolerated in the study.

Although the candidate failed to achieve statistically significant improvement in the AAPS for the overall study population, the 50mg dose demonstrated a clinically meaningful and statistically significant reduction in AAPS in patients with moderate to severe pain who had baseline AAPS of 6.5 points or more. Data showed that the thrice-a-day 50mg dose of olorinab reduced AAPS by 1.64 points compared with placebo and 3.93 points from baseline.

The company believes that the data from patients with moderate to severe pain receiving the 50mg dose were promising and hold potential for further development. It plans to present detailed data at an upcoming medical meeting. The company will and evaluate possible strategic options for olorinab and anticipates that a phase III registration program can be feasible with the 50mg dose in the specified population. However, the initiation of the late-stage is subject to regulatory approval.

Meanwhile, Arena is evaluating its lead pipeline candidate, etrasimod, in several gastrointestinal disorders. The candidate is presently in late-stage development for ulcerative colitis. The company is evaluating the candidate in the pivotal phase III ELEVATE UC 52 study and another phase III ELEVATE UC 12 study as a treatment for moderately-to-severely active ulcerative colitis. Top-line data from both studies are expected in the first quarter of 2022.

Earlier this month, the company initiated a phase IIb study — VOYAGE — to evaluate etrasimod in patients with eosinophilic esophagitis (EoE). The company is also evaluating the candidate in the phase IIb/III CULTIVATE study in patients with Crohn's disease.

Arena is also developing etrasimod in alopecia areata (AA) patients in a phase II study. The company is progressing the candidate in a phase III registrational program to evaluate it as a potential treatment for atopic dermatitis. It also has two early-stage candidates, ADP418 and temanogrel in its pipeline.

Arena Pharmaceuticals, Inc. Price

Arena Pharmaceuticals, Inc. price | Arena Pharmaceuticals, Inc. Quote

Zacks Rank and Stocks to Consider

Currently, Arena is a Zacks Rank #4 (Sell) stock.

Some better-ranked stocks from the biotech sector include Moderna (NASDAQ:MRNA), Inc. MRNA, Lexicon Pharmaceuticals (NASDAQ:LXRX), Inc. LXRX and Repligen (NASDAQ:RGEN) Corporation RGEN. While Moderna sports a Zacks Rank #1 (Strong Buy), Lexicon and Dynavax (NASDAQ:DVAX) carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Moderna’s earnings per share estimates have moved up from $9.50 to $15.65 for 2021 in the past 30 days. The stock has soared 434.1% in the past year.

Lexicon’s loss per share estimates have narrowed from 17 cents to 1 cent for 2021 in the past 30 days. The company delivered an earnings surprise of 21.72%, on average, in the last four quarters. The stock has risen 184.4% in the past year.

Repligen’s earnings per share estimates have moved north from $2.03 to $2.23 for 2021 in the past 30 days. The company delivered an earnings surprise of 51.51%, on average, in the last four quarters. The stock has risen 125.4% in the past year.

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