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Arena’s Ralinepag Positive in Phase II PAH Study, Shares Up


Arena Pharmaceuticals, Inc.’s ARNA shares surged 41.3% in after-market trading on Monday after the company announced that a phase II study evaluating its key pipeline candidate, ralinepag, in pulmonary arterial hypertension (PAH), met its primary endpoint. Also, the company plans to present detailed results from the study in future medical congresses.

Arena’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Its stock was up 29.5%, while the industry registered an addition of 6.6%.

The randomized, double-blind phase II study evaluated oral administration of ralinepag in patients with PAH, WHO/NYHA functional class II-IV, over 21 weeks for absolute change in PVR from baseline. Most patients were also receiving multiple background therapies.

Top-line data from the study demonstrated a statistical significance for ralinepag in improving pulmonary vascular resistance (PVR) compared to placebo. It is to be noted that PVR worsened from baseline in patients who were given a placebo. On the contrary, treatment with ralinepag resulted in an improvement of 29.8% in PVR compared to placebo and 20.1% compared to baseline. It also demonstrated numerical improvement in patient’s ability to exercise as measured by six-minute walk distance test.

Moreover, the company said the positive data from the study paves way for an expedited initiation of a phase III program.

We remind investors that the company had announced results from a phase I bioavailability study evaluating the safety, tolerability and pharmacokinetic (PK) profile of ralinepag XR tablets last month. The data showed that the once-daily XR tablet helped in reducing the maximum plasma concentration of ralinepag compared with the IR capsule, while maintaining similar total plasma concentrations. Moreover, ralinepag had an orphan drug status for PAH.

Notably, PAH is a disease that causes high blood pressure in the lungs. But the therapies presently available only have positive effects in PAH but are unable to cure the disease. Also, the disease progresses despite treatment in most patients. However, the improvement in PVR after treating with ralinepag is expected to bring long-term therapeutic effect in patients.

We note that the PAH market is highly attractive given the low diagnosis rate, the low penetration of existing therapies and the significant unmet medical need.

Recently, pharmaceutical giant Johnson & Johnson, Inc. JNJ acquired Swiss biotech Actelion which helped it gain a foothold in the PAH market. Actelion's PAH franchise includes differentiated, innovative medicines like Opsumit, Uptravi and Tracleer.

Also, United Therapeutics Corporation UTHR holds a strong position in the PAH market with four approved products targeting this indication. The four products include Remoduli, Adcirca, Tyvaso and Orenitram. Pfizer’s PFE Revatio is used for the same indication as well.

Moreover, with lackluster sales of Arena’s only marketed drug, Belviq, for chronic weight management, any positive news on its pipeline candidates will boost the company’s shares.

Zacks Rank

Arena currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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