AKBA On Track, CNAT On Watchlist, KITE Flies On AMGN Deal, PFE Opens Wallet

(RTTNews) - Akebia Therapeutics Inc. (AKBA) has completed enrollment in two planned cohorts of its phase II study of AKB-6548 in patients with anemia related to chronic kidney disease undergoing dialysis.

Each cohort consists of 30 patients with anemia undergoing dialysis who were switched from injectable recombinant erythropoiesis-stimulating agent therapy to once-daily, oral doses of AKB-6548.

The company plans to expand the study by including an additional cohort of 30 patients who will receive AKB-6548 three times per week.

Akebia remains on track to report top-line data from its phase II study of AKB-6548 in the third quarter of 2015.

AKBA closed Monday's trading at $11.09, down 3.57%.

Aratana Therapeutics Inc.'s (PETX) canine-specific monoclonal antibody AT-004 - targeting CD20 as an aid in the treatment of B-cell lymphoma in dogs - which was granted a conditional license from the U.S. Department of Agriculture in January 2014, has now received a full license.

AT-004 is exclusively partnered with a third party for commercialization in the United States and Canada. Aratana retains development and commercial rights for AT-004 in other geographies.

PETX closed Monday's trading at $17.76, down 2.47%.

BrainStorm Cell Therapeutics Inc.'s (BCLI) phase IIa clinical trial of NurOwn in amyotrophic lateral sclerosis patients has achieved its primary endpoint in demonstrating that NurOwn is safe and well-tolerated at doses up to 2 million cells per kilogram administered intrathecally and 48 million cells administered intramuscularly.

The NurOwn technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types.

The study had enrolled 14 subjects with amyotrophic lateral sclerosis at Hadassah Medical Center in Jerusalem. Of the 12 subjects with three or more months of follow-up, 92% experienced an improvement in the rate disease progression for the three month period after administration of NurOwn, according to the company.

The company now plans to proceed to a multi-dose study to see if the positive results can be amplified and extended by administering repeated doses.

BCLI, which touched an all-time high of $8.47 on Friday, has given back most of its gains, and closed Monday's trading at $5.75, down 23.33%.

Conatus Pharmaceuticals Inc. (CNAT) will be reporting top-line results from three clinical trials of its lead investigational compound Emricasan in subjects with varying degrees of organ impairment - a phase II trial in patients with acute-on-chronic liver failure, phase I trial in patients with mild, moderate and severe hepatic impairment, and phase I trial in patients with severe renal impairment - after the market close on Thursday, January 8, 2015.

Emricasan is a first-in-class, orally active caspase protease inhibitor that interrupts the progression of liver disease by reducing the activity of enzymes that mediate inflammation and cell death.

CNAT closed Monday's trading 24.35% higher at $10.06.

Cutera Inc.'s (CUTR) fourth quarter revenue of 2014 is roughly $25.5 million, according to preliminary estimates, an increase of 15% compared to the same period in 2013. The company is scheduled to discuss its Q4 results and 2015 outlook in detail on its earnings call in February.

CUTR closed Monday's trading 5.06% higher at $11.41.

Mast Therapeutics Inc. (MSTX) remains on track to complete enrolment in a pivotal phase III study of its drug candidate Vepoloxamer in sickle cell disease by the end of 2015.

In the phase III study, dubbed EPIC, 130 patients have been randomized so far, which is more than the one-third enrolment milestone, ahead of internal projections. The company anticipates reporting top line results in the first quarter of 2016.

The other milestones anticipated by the company in 2015 include, reporting data from a repeat-dose nonclinical study of Vepoloxamer in heart failure; initiating a phase 2 clinical study of Vepoloxamer in acute decompensated heart failure; initiating enrolment in an open-label EPIC extension study, referred to as EPIC-E, to expand the company's existing safety database regarding repeat exposure to Vepoloxamer; reporting data from a nonclinical study of Vepoloxamer in embolic stroke; and reporting data from one or more of the Phase 2a studies of AIR001 in patients suffering heart failure with preserved ejection fraction.

MSTX closed Monday's trading at $0.59, up 2.61%. In after-hours, the stock lost 5.08% and was at $0.56.

Shares of Kite Pharma Inc. (KITE) touched an all-time high of $70.21 on Monday before closing the day's trading at $69.75 after the company announced a strategic cancer immunotherapy collaboration with Amgen (AMGN).

Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary novel Chimeric Antigen Receptor (CAR) platform, research and development and manufacturing capabilities, and expertise.

Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND) filing. Each company will then be responsible for clinical development and commercialization of their respective CAR therapeutic candidates, including all related expenses.

Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing. Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite's intellectual property for CAR T cell products.

Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties. Further terms of the agreement are not being disclosed.

Pfizer Inc. (PFE) has made its first acquisition of the year with the purchase of a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren.

The acquisition provides Pfizer with a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program.

The company acquired Baxter International Inc.'s portfolio of marketed vaccines consisting of NeisVac-C and FSME-IMMUN/TicoVac last year.

NeisVac-C is a vaccine that helps protect against meningitis caused by group C meningococci while FSME-IMMUN/TicoVac is a vaccine that helps protect against tick-borne encephalitis.

PFE closed Monday's trading at $31.16, down 0.54%.

Protalix BioTherapeutics Inc. (PLX) will be presenting interim efficacy and safety data from its ongoing phase I/II trial of PRX-102 for Fabry disease at the JP Morgan Healthcare Conference on January 15, 2015.

The company expects to initiate a phase III trial for PRX 102 in early 2016.

PLX closed Monday's trading at $2.17, up 16.04%.