ADHD Doesn't MEASURE Up, AMGN ARISEs To The Occasion, ITCI Misses Study Goal

(RTTNews) - Alcobra Ltd.'s (ADHD) Investigational New Drug Applications for drug candidate MDX in Attention Deficit Hyperactivity Disorder and Fragile X Syndrome have been put on full clinical hold, following adverse neurological findings in a pre-clinical study.

The clinical hold also affects an ongoing phase III trial of MDX in adult patients with Attention Deficit Hyperactivity Disorder, known as the "MEASURE" study.

ADHD closed Wednesday's trading at $4.62, up 0.22%.

Amgen's (AMGN) first phase III study of investigational drug Erenumab in episodic migraine prevention has met the primary endpoint.

In patients with episodic migraine, the study, dubbed ARISE, demonstrated a statistically significant 2.9-day reduction from baseline in monthly migraine days in the Erenumab arm (70 mg) compared to a 1.8-day reduction in the placebo arm at 12 weeks.

A second phase III episodic migraine study evaluating both 70 mg and 140 mg doses of Erenumab for 24 weeks is underway, and is expected to be completed by the end of this year.

Erenumab is being co-developed by Amgen and Novartis. While Amgen has commercialization rights to Erenumab in the U.S., Canada and Japan, Novartis has rights in Europe and the rest of the world.

AMGN closed Wednesday's trading at $169.71, down 1.12%.

Chembio Diagnostics Inc. (CEMI) has been awarded a 12-month contract, valued at $330 thousand, by the U.S. Centers for Disease Control and Prevention for the purchase of point-of-care surveillance diagnostic assays for Zika, Dengue and Chikungunya.

The company will provide its DPP Zika IgM/IgG Assay, DPP Zika/Chikungunya/Dengue IgM/IgG Combination Assay, and DPP Micro Reader to the CDC for a surveillance testing pilot program in India, Peru, Guatemala and Haiti.

CEMI closed Wednesday's trading at $7.14, up 0.56%.

Shares of Intra-Cellular Therapies Inc. (ITCI) plunged more than 67% in extended trading on Wednesday, as its second phase III trial of investigational schizophrenia med ITI-007 failed to meet the trial goals.

The trial, known as Study '302, which was conducted at 13 sites in the United States consisted of 696 patients randomized (1:1:1:1) to receive ITI-007 60 or 20 mg, approved schizophrenia drug Risperidone 4 mg as the active control, or placebo once daily in the morning for six weeks.

The first phase III trial of ITI-007, dubbed Study '301 was positive and was completed in September 2015 with 450 patients.

ITCI closed Wednesday's trading at $42.35, up 2.00%. In after-hours, the stock was down 67.89% to $13.60.

Sarepta Therapeutics Inc. (SRPT), which won FDA approval for its Duchenne muscular dystrophy med Exondys 51 last week, has now initiated a phase III clinical trial of SRP-4045 and SRP-4053 in patients with Duchenne muscular dystrophy amenable to exon 45 or 53 skipping.

The trial, dubbed ESSENCE, will enroll approximately 99 patients aged 7 to 13 years, inclusive, with at least 45 patients amenable to exon 45 skipping and 45 patients amenable to exon 53 skipping. Approximately 66 patients will be randomized to receive either SRP-4045 or SRP-4053, depending on deletion mutation, and 33 patients will be randomized to receive placebo.

As you may know Exondys 51, which is said to cost $300,000 per year, is meant for Duchenne muscular dystrophy patients amenable to skipping Exon 51.

SRPT, which touched an all-time high of $63.73 on Wednesday, closed the day's trading at $62.24, up 5.31%.

The FDA has approved Vertex Pharmaceuticals Inc.'s (VRTX) ORKAMBI for use in children with cystic fibrosis ages 6 through 11 who have two copies of F508del mutation. Having two copies of F508del mutation (one inherited from each parent) is the leading cause of cystic fibrosis.

Orkambi was approved by the FDA last July to treat cystic fibrosis in patients 12 years and older, who have the F508del mutation. The company expects total 2016 product revenues for ORKAMBI to range between $1.0 billion and $1.1 billion.

VRTX closed Wednesday's trading at $88.84, down 0.31%.