AXSM Looks To Busy Year Ahead, SUPN Makes Peace Again, ESPR Hits New High

(RTTNews) - Axsome Therapeutics Inc. (AXSM) has a couple of clinical trial catalysts coming its way in the months ahead.

The company's key drug candidate is AXS-02, a first in class, oral, targeted, non opioid therapeutic for chronic pain, under phase III trials in knee OA associated with bone marrow lesions, dubbed COAST-1, and in Complex Regional Pain Syndrome, dubbed CREATE-1.

Interim analysis results from COAST-1 are expected in 3Q, 2017 and interim efficacy analysis results from CREATE-1 are anticipated in 4Q, 2017.

Another drug candidate in the pipeline is AXS-05 for treatment resistant depression, which is also under phase III trial, dubbed STRIDE-1. Top line data from STRIDE-1 are anticipated in 1Q, 2018.

AXSM closed Tuesday's trading at $4.45, down 9.18%.

Esperion Therapeutics Inc. (ESPR) has initiated a phase II clinical study to assess the efficacy and safety of triplet oral therapy with bempedoic acid, ezetimibe and atorvastatin in patients with hypercholesterolemia.

The study is expected to enroll approximately 60 patients with hypercholesterolemia at approximately 20 sites across the U.S. The primary objective of the study is to assess the LDL-C lowering efficacy of the triplet oral therapy versus placebo.

Top-line results are expected by the fourth quarter of 2017.

ESPR touched a new high of $32.71 on Tuesday, before closing the day's trading at $31.33, up 0.16%.

REGENXBIO Inc. (RGNX) has initiated a phase I/II clinical trial of RGX-501 for the treatment of homozygous familial hypercholesterolemia.

The trial will enroll up to 12 patients with HoFH in the U.S. and Canada. The primary objective is to assess the safety of a single intravenous administration of RGX-501. The company expects to report interim trial results by the end of 2017.

RGNX closed Tuesday's trading at $20.85, up 6.11%.

Revance Therapeutics Inc. (RVNC) has completed patient enrollment in two pivotal phase III trials of its investigational drug candidate RT002 (DaxibotulinumtoxinA for Injection) for the treatment of moderate to severe glabellar lines in adults.

The pivotal trials have enrolled a total of approximately 600 subjects at multiple sites in the United States and Canada. In both trials, subjects have been randomized in a 2:1 ratio to either the RT002 or placebo treatment groups, respectively.

The company expects to report topline results from both pivotal Phase 3 trials in the fourth quarter of 2017.

RVNC closed Tuesday's trading at $18.50, up 0.82%.

A day after entering into a settlement agreement with Zydus Pharmaceutical Inc. and Cadila Healthcare Limited on Trokendi XR patent litigation, Supernus Pharmaceuticals Inc. (SUPN) has now made peace with another litigant - this time, it is with Actavis.

Supernus' Trokendi XR is an antiepileptic drug indicated for the treatment of epilepsy, and it was approved by the FDA in 2013. The patent protection for Trokendi XR expires no earlier than 2027.

In October 2014, Supernus sued Actavis, now a subsidiary of Teva Pharmaceuticals Industries (TEVA), alleging that Actavis infringed Trokendi XR patents by submitting to the FDA an Abbreviated New Drug Application seeking to market a generic version of Trokendi XR prior to the expiration of Supernus' patents.

Now that a settlement has been reached, Actavis is permitted to begin selling a generic version of Trokendi XR on January 1, 2023, or earlier under certain circumstances.

Trokendi XR recorded sales of $158.4 million in 2016, up $110.3 million in 2015.

SUPN closed Tuesday's trading at $26.40, down 11.26%.

Vital Therapies Inc.'s (VTL) phase III trial designed to evaluate ELAD System in subjects with severe acute alcoholic hepatitis is underway.

ELAD is an investigational extracorporeal, human cell-based LIVER SUPPORT SYSTEM designed with the proposed intent to supplement hepatic function in order to improve survival rates among subjects with liver failure.

The top line data from the trial are anticipated around mid-2018.

VTL closed Tuesday's trading at $4.35, up 1.16%.