NVCR Up On FDA Nod, PeriCoach Now Available OTC, FDA Panel Backs GP2015

(RTTNews) - Akari Therapeutics (AKTX) has been given the go-ahead by the UK Medicines & Healthcare Products Regulatory Agency to conduct a phase II trial of Coversin in patients with paroxysmal nocturnal hemoglobinuria.

The phase 2 trial will study Coversin for 90 days in up to 10 patients with PNH who are not receiving any other complement therapy. The primary endpoint of the trial is the reduction in Lactate Dehydrogenase (LDH), an important blood marker of hemolysis, at day 28.

AKTX closed Wednesday's trading 3.57% higher at $11.60.

IntelGenx Corp. (IGX.V)(IGXT.OB) has initiated a phase 1 clinical trial of Montelukast, a unique drug repurposing opportunity for the treatment of degenerative diseases of the brain, such as: mild cognitive impairment and Alzheimer's disease.

The results from this trial are expected to be available in September 2016.

IGXT.OB closed Wednesday's trading at $0.49, up 0.26%.

MediciNova Inc. (MNOV) said that an external Data Safety Monitoring Board will review the results of an interim efficacy analysis of the company's Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis in the fourth quarter of 2016.

The company noted that 50% of patients in the trial have completed the 96-week treatment period.

MNOV closed Wednesday's trading at $7.03, down 2.50%.

Shares of NovoCure Ltd. (NVCR) were up over 5% in extended trading on Wednesday, following FDA approval of the company's premarket approval supplement application for its second generation Optune system.

Optune is a wearable and portable, FDA-approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of the brain where the glioblastoma multiforme tumor is located.

The second generation Optune system is less than half the weight and size of first generation Optune system.

The company said that it will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.

In the first quarter of 2016, there number of prescriptions received for Optune was 755, an increase of 73 percent from the first quarter 2015 and 36 percent from the fourth quarter 2015.

The company is slated to report Q2 financial results on July 28, 2016.

NVCR closed Wednesday's trading at $11.96, down 1.97%. In after hours, the stock was up 5.69% to $12.64.

An FDA panel, which reviewed the Biologics License Application for GP2015, submitted by Sandoz, the generic pharmaceuticals division of Novartis (NVS), has voted unanimously in support of the drug.

GP2015 is a proposed biosimilar to Amgen Inc.'s (AMGN) Enbrel.

Enbrel, which generated sales of $5.36 billion in 2015, is approved for rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

The BLA for GP2015 is Sandoz's second biosimilar application to the FDA - the first one being Zarxio, which is biosimilar to Amgen's Neupogen, a drug used to treat neutropenia, a lack of certain white blood cells caused by cancer or a bone marrow transplant. Zarxio was approved by the FDA last March.

NVS closed Wednesday's trading at $82.03, up 0.43%.

PeriCoach pelvic floor trainer, an at-home pelvic floor trainer device, has been approved by the FDA as an over-the-counter treatment for mild, moderate and stress urinary incontinence and urge incontinence.

PeriCoach, the first pelvic floor muscle training system that includes a device, web portal and smartphone app, received 510(k) clearance from the FDA in March 2015.

It is estimated that 50 percent of women will experience urinary incontinence, or UI, at some point in their lives. Pelvic floor muscle exercise (PFME) is recommended as first line non-pharmacologic treatment for the millions of women-estimated at one in three - who suffer from urinary incontinence.

ZELTIQ Aesthetics Inc.'s (ZLTQ) CoolSculpting procedure has now received approval in China for fat layer reduction of the abdomen and flanks.

CoolSculpting is a non-invasive fat reduction procedure, and it received its initial FDA clearance for fat reduction in abdomen as well as flanks (love handles) in September 2010. It received expanded FDA clearance to treat thighs in April 2014 and to treat double chin in September 2015.

Recently, the use of CoolSculpting was further expanded to reduce fat around bra straps, on the back and underneath the buttocks, following FDA clearance in April of this year.

ZLTQ closed Wednesday's trading at $31.46, up 3.66%.