Reata Successfully Completes Neuromuscular Disorder Study

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) announced successful completion of a phase II study — MOXIe — evaluating its neuromuscular disorder candidate, omaveloxolone, for treating Friedreich’s ataxia (“FA”). Data from the study demonstrated that patients treated with omaveloxolone achieved a statistically significant, placebo-corrected 2.4 point improvement in modified Friedreich’s Ataxia Rating Scale (mFARS) after 48 weeks of treatment.

Shares of Reata rallied more than 30% on Oct 14 in after-hours trading, following the positive study data readout. In fact, the company’s shares have increased 79.3% so far this year against the industry’s decrease of 7%.

Data from the MOXIe study also demonstrated that omaveloxolone improved the mFARS scores of patients with pes cavus, a musculoskeletal foot deformity. The candidate achieved improvement of placebo-corrected 1.93 in mFARS. Moreover, it was observed in the study that the improvement in mFARS increased over the course of treatment. The candidate was also well tolerated in patients.

Friedreich’s ataxia is a progressive neuromuscular disorder, which can lead to loss of coordination, muscle weakness, fatigue and premature death. Patients can suffer from motor incapacitation and require a wheelchair for movements. The severity of FA disorder is measured by the FDA-accepted mFARS, which tests the ability of a patient’s activities based on speaking and swallowing, upper limb coordination, lower limb coordination and standing and walking.

Based on the data from the MOXIe study, Reata is planning to file regulatory applications seeking approval for omaveloxolone for treating FA, following discussions with regulatory authorities.

Currently, there are no approved therapies for treating FA. Per the press release, 5,000 children and adults suffer from FA in the United States and 22,000 globally. A successful commercialization following a potential approval to omaveloxolone will likely provide a significant boost to the company.

Apart from omaveloxolone, Reata is developing another candidate, bardoxolone methyl (bardoxolone), in pivotal studies. The company is developing bardoxolone in phase III studies targeting several kidney diseases – autosomal dominant polycystic kidney disease, Alport syndrome and connective tissue disease-pulmonary arterial hypertension. The company is developing bardoxolone in several mid-stage studies as a potential treatment for chronic kidney diseases.

Please note that Reata re-acquired development, manufacturing and commercialization rights related to omaveloxolone and bardoxolone from AbbVie (NYSE:ABBV) earlier this month. The company believes that reacquisition of rights to these candidates will help it to achieve strategic flexibility and control regarding development and commercialization.

Zacks Rank

Reata currently carries a Zacks Rank #4 (Sell).

A couple of better-ranked stocks in the healthcare sector include BeiGene, Ltd. (NASDAQ:BGNE) and Fibrocell Science Inc (NASDAQ:FCSC) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BeiGene’s loss per share estimates have narrowed from $11.46 to $11.23 for 2019 and from $13.55 to $13.17 for 2020 over the past 60 days.

Fibrocell’s loss per share estimates have changed from $1.31 to earnings of 10 cents for 2019 and narrowed from $1.13 to 97 cents for 2020 over the past 60 days.

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