AKBA Jumps On Otsuka Deal, MNOV Abuzz, CAPR Counting On HOPE...

(RTTNews) - Shares of Akebia Therapeutics Inc. (AKBA) jumped over 28% in after-hours trading on Tuesday, following an expanded collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. to develop and commercialize Vadadustat in Europe, China and other territories.

Vadadustat is an oral hypoxia-inducible factor (HIF) stabiliser currently in phase III development for the treatment of anemia associated with chronic kidney disease.

Previously, the two companies had a collaboration to develop and commercialize Vadadustat only in the U.S.

Under the terms of the expanded collaboration agreement, Akebia will receive $208 million or more in committed capital from Otsuka, including $73 million upon signing and $135 million or more of development funding. In addition, Akebia is eligible to receive up to $657 million in milestone payments, representing a total transaction value of approximately $865 million, as well as tiered, double-digit royalties from Otsuka.

AKBA closed Tuesday's trading at $9.37, up 0.64%. In after hours, the stock was up 28.07% to $12.0.

Aratana Therapeutics Inc. (PETX) intends to make ENTYCE, which was approved last May for appetite stimulation in dogs, commercially available by the fall of 2017, if all goes well as planned.

The Company noted that it recently met with the U.S. Food and Drug Administration Center for Veterinary Medicine (CVM) regarding the proposed manufacturing transfer of ENTYCE. Aratana intends to resubmit the required prior approval submission in the coming weeks.

PETX closed Tuesday's trading at $6.04, down 1.15%. In after-hours, the stock was up 7.62% to $6.50.

Asterias Biotherapeutics Inc.'s (AST) phase 1/2a clinical trial of AST-OPC1 for acute spinal cord injury, dubbed SCiStar, will continue without modification, following the recommendation by the study's Data Monitoring Committee.

The SCiStar study is designed to enroll as many as 35 patients with subacute cervical spinal cord injury.

AST closed Tuesday's trading at $3.75, up 10.29%.

Capricor Therapeutics Inc. (CAPR) has announced positive 6-month results from its phase I/II trial of CAP-1002 for the treatment of patients with Duchenne muscular dystrophy.

The phase I/II trial of CAP-1002 is known by the name HOPE, and it is a 12-month study.

The six-month data of the study reveals that patients treated with CAP-1002 had a statistically-significant improvement compared to usual care controls in certain measures of cardiac and upper limb function.

Capricor expects to report top-line 12-month results from the HOPE-Duchenne Trial in the fourth quarter of 2017.

CAPR closed Tuesday's trading at $3.23, up 4.53%.

Shares of Epizyme Inc. (EPZM) touched a new 52-week high on Tuesday, following FDA's Fast Track designation to Tazemetostat, the Company's drug candidate for the treatment of patients with relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations.

A phase II study of Tazemetostat in non-Hodgkin lymphoma and another phase II study of Tazemetostat in genetically defined solid tumors are underway, and data from the trials are expected to be reported in the first half of 2017.

EPZM touched a new 52-week high of $17.95 on Tuesday, before closing the day's trading at $17.45, up 17.11%.

Shares of MediciNova Inc. (MNOV) were up more than 20% in extended trading on Tuesday, following encouraging exploratory interim data from an ongoing phase II clinical trial of MN-166 in amyotrophic lateral sclerosis.

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.

This study is being conducted by MediciNova, in collaboration with Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System's Neuromuscular/ALS-MDA Center.

MNOV closed Tuesday's trading at $5.57, up 2.58%. In after-hours, the stock was up 21.18% to $6.75.

The FDA has approved a new once-monthly 300 mg dose of Praluent injection for the treatment of adults with high low-density lipoprotein cholesterol.

Praluent, developed jointly by Sanofi (SNY) and Regeneron (REGN), was first approved in July 2015.

The drug is already available in two dosages with two levels of efficacy - namely 75 mg and 150 mg - and is administered subcutaneously once every 2 weeks. It is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol.

The newly approved 300 mg dose of Praluent is administered via two 150 mg injections at two different injection sites. Each 1 mL pre-filled pen delivers 150 mg of Praluent in 20 seconds or less. The European Commission also approved the monthly 300 mg dose of Praluent in November 2016.

Commenting on the approval of the monthly 300 mg dose of Praluent, Robert Pordy, ?Vice President of Cardiovascular & Metabolism Therapeutics, Regeneron, said that it is an encouraging news because it enables physicians to further tailor their treatment to lower LDL cholesterol.

REGN closed Tuesday's trading at $372.32, up 0.10%.