ADHD Doesn't MEASURE Up, JAZZ Abuzz, NBIX Slips On Failed Study

(RTTNews) - Alcobra Ltd.'s (ADHD) second phase III clinical trial of its investigational product Metadoxine Extended Release for the treatment of attention deficit hyperactivity disorder in adult patients has failed to meet the primary endpoint.

The trial, dubbed MEASURE, did not demonstrate a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales (CAARS).

ADHD touched a new low of $0.83 on Tuesday before closing the day's trading at $0.93, down 50.66%.

Chembio Diagnostics Inc. (CEMI) has received a CE mark for its DPP HIV-Syphilis combination assay, which means that it can be sold within the member states of the European Union and the Caribbean region, except for Puerto Rico.

The Chembio DPP HIV-Syphilis Assay is a single-use, rapid screening test for the detection of antibodies to HIV types 1 and 2 and syphilis Treponema pallidum using fingerstick whole blood, venous whole blood, serum, or plasma. The test requires a small 10 µl blood sample and provides results in as little as 15 minutes.

CEMI closed Tuesday's trading at $6.30, unchanged from the previous day's close.

Jazz Pharmaceuticals plc (JAZZ) has enrolled the first patient in its phase III clinical trial comparing the efficacy and safety of Defibrotide versus best supportive care for the potential prevention of hepatic veno-occlusive disease in high risk patients.

The Defibrotide clinical trial will be conducted across approximately 100 medical centers in the United States, Canada, Asia Pacific and countries in the European Union, and will enroll approximately 400 adult and pediatric patients.

In other news, Jazz Pharma's lead marketed product Xyrem will now have to face competition as the FDA has approved the first generic version of that drug.

Xyrem is indicated for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy.

JAZZ closed Tuesday's trading at $115.57, down 1.47%.

Neurocrine Biosciences Inc.'s (NBIX) phase II study of INGREZZA in adults with Tourette syndrome has failed to meet the key goal.

In the trial, dubbed T-Forward, the pre-specified primary endpoint, the change-from-baseline in the Yale Global Tic Severity Scale (YGTSS) at Week 8 was not met.

Commenting on the development, Kevin Gorman, CEO of Neurocrine said, "At present, we are not disclosing specific details of this study in order to avoid the potential introduction of assessment bias in the ongoing Phase II T-Force GREEN study of pediatric Tourette patients. We look forward to the pediatric study readout next quarter and our subsequent discussion with the FDA on our plans for Phase III development of INGREZZA in Tourette syndrome."

NBIX closed Tuesday's trading at $40.17, down 4.92%. In after-hours, the stock lost another 5.40% to $38.00.

Shares of Pulmatrix Inc. (PULM) soared over 127% on Tuesday following the receipt of FDA's "Qualified Infectious Disease Product designation for its drug candidate for treating fungal infections in the lungs of cystic fibrosis patients, PUR1900.

The new designation confers an expedited regulatory review for PUR1900. Added to the existing FDA Orphan drug designation for PUR1900, the QIDP status bestows a full 12 years of market exclusivity, the company noted.

PULM closed Tuesday's trading at $1.55, up 127.97%. In after-hours, the stock was down 8.39% to $1.42.

Tetraphase Pharmaceuticals Inc. (TTPH) has dosed the first patient in its phase III clinical trial of Eravacycline in complicated urinary tract infections.

The trial, dubbed IGNITE3 is evaluating the efficacy and safety of once-daily intravenous (IV) Eravacycline compared to Ertapenem.

Meanwhile, the company is on track to report top-line results from the ongoing IGNITE4 study in complicated intra-abdominal infections during the fourth quarter of 2017.

IGNITE4 is a phase III trial evaluating the efficacy and safety of intravenous (IV) Eravacycline compared to Meropenem in complicated intra-abdominal infections.

TTPH closed Tuesday's trading at $4.25, down 4.92%.