AXON On Watch, Catalysts Ahead For CPRX, BABY Marches On, XOMA Crashes

(RTTNews) - Axovant Sciences Ltd. (AXON) has announced encouraging results from a phase 2b clinical trial evaluating its lead product candidate, RVT-101, as an adjunctive therapy to Donepezil in patients with mild-to-moderate Alzheimer's disease.

According to the trial results, patients receiving 35 mg RVT-101 in combination with Donepezil demonstrated statistically significant improvements in cognition and function at 12, 24, 36, and 48 weeks compared to patients receiving Donepezil alone.

Axovant intends to commence a confirmatory phase 3 program in the fourth quarter of 2015. The company also plans to evaluate RVT-101 as a potential treatment for other types of dementia later this year.

AXON closed Wednesday's trading at $18.16, down 6.44%.

Capnia Inc. (CAPN) has enrolled the first patient in an investigator-sponsored clinical trial evaluating its proprietary nasal, non-inhaled carbon dioxide technology for the treatment of cluster headaches.

The trial is designed to enroll 25 patients with episodic cluster headaches, and top-line data are expected in 2016.

Last week, the company received a written notice of deficiency from the Nasdaq Stock Market for not maintaining a $35 million minimum Market Value of Listed Securities ("MVLS") for its common stock. Capnia has time until January 13, 2016 to regain compliance.

CAPN closed Wednesday's trading at $2.81, down 1.40%.

Catalyst Pharmaceuticals Inc. (CPRX) has initiated a rolling submission of a New Drug Application to the FDA for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. The company intends to complete the submission of the NDA in the fourth quarter of 2015, at which time it will be requesting a Priority Review of the application.

Lambert-Eaton Myasthenic Syndrome, or LEMS, is an autoimmune neuromuscular disease in which the release of acetylcholine is decreased at the neuromuscular junction, resulting in muscle weakness.

Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes (CMS).

CPRX closed Wednesday's trading 8.10% higher at $5.74.

Intra-Cellular Therapies Inc. (ITCI) intends to commence a phase III program of ITI-007 for the treatment of depressive episodes associated with bipolar disorder later this year.

The phase III program consists of two multicenter, randomized, double-blind, placebo-controlled clinical trials. The first phase III study will evaluate ITI-007 as a monotherapy and the second phase III study will evaluate ITI-007 as an adjunctive therapy with lithium or Valproate.

ITCI closed Wednesday's trading 6.08% higher at $30.71.

Natus Medical Inc. (BABY) touched a new high of $46.82 on Wednesday following record second quarter results.

The companycompany reported a non-GAAP net income of $11.2 million or $0.34 per share on revenue of $91.9 million for the second quarter ended June 30, 2015. This compared with a non-GAAP net income of $8.9 million or $0.28 per share and revenue of $86.32 million in the year-ago quarter.

For the third quarter of 2015, the company expects revenue of $93.0 million to $94.0 million and non-GAAP earnings per share of $0.37 to $0.38.

Natus also increased its non-GAAP earnings guidance for the full year 2015 and now expects to report non-GAAP earnings per share of $1.50 to $1.52, an increase from previous guidance of $1.47 to $1.51. Full year 2015 revenue guidance was unchanged at $376 million to $378 million.

BABY closed Wednesday's trading at $46.33, up 6.60%.

Shares of XOMA Corp. (XOMA) plunged more than 77% on Wednesday following the failure of a phase III study of Gevokizumab in patients with Behçet's disease uveitis, run by its partner Servier, failed to meet the primary endpoint.

In the trial, dubbed EYEGUARD-B, which enrolled 83 patients, the primary endpoint of the time to first acute ocular exacerbation was not met.

XOMA closed Wednesday's trading at $1.00, down 77.25%.