ADHD Abuzz, All Clear For GALE's NeuVax, FDA Lifts Clinical Hold On DCVax-L

(RTTNews) - Shares of Alcobra Ltd. (ADHD) rose more than 11% in extended trading on Monday after the company reported it had a productive pre-IND meeting with the FDA for ADAIR, a novel product candidate for the treatment of attention deficit hyperactivity disorder.

The company plans to develop ADAIR under 505(b)(2) regulatory pathway. The FDA provided guidance on the necessary steps towards an NDA, which is expected to be submitted before the end of 2018, noted the company.

ADHD closed Monday's trading at $1.30, down 4.41%. In after-hours, the stock was up 11.54% to $1.45.

Cellectis S.A. (CLLS) has received the FDA nod to move its most advanced, wholly owned TALEN gene-edited product candidate UCART123 into clinical testing.

UCART123 is being developed for patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). It becomes the first allogeneic, "off-the-shelf" gene-edited CAR T-cell product candidate to be approved for clinical trials.

Cellectis intends to initiate phase I trials with UCART123 in the first half of 2017.

CLLS closed Monday's trading at $20.01, up 0.05%. In after-hours, the stock was up 1.20% to $20.25.

Cytori Therapeutics Inc. (CYTX) has been granted Small Business status by the FDA's Division of Industry and Consumer Education, entitling it to receive significant financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings.

A phase III trial of HABEO Cell Therapy, evaluating the company's lead development candidate currently under investigation for use in scleroderma, is underway.

Enrollment in the trial, dubbed STAR, was completed in mid-2016. Data unblinding and analysis will commence once the last enrolled subject has completed their 48-week follow-up visit, anticipated to be in mid-2017.

The filing of premarket approval application for HABEO Cell Therapy is anticipated later in 2017.

CYTX closed Monday's trading at $1.68, up 5.66%.

Shares of Galena Biopharma Inc. (GALE) jumped more than 17% on Monday, following the Data Safety Monitoring Board recommendation that two NeuVax clinical trials in combination with Roche's blockbuster breast cancer drug, Herceptin be continued, following a futility assessment.

Last June, an Independent Data Monitoring Committee stopped a phase III trial of breast cancer vaccine NeuVax, dubbed PRESENT, for futility, which meant that the possibility of getting a positive result was remote.

In light of the early termination of the PRESENT trial, the independent Data Safety Monitoring Board performed separate futility assessments on a phase IIb trial of NeuVax in combination with Herceptin in node positive and triple negative HER2 IHC 1+/2+, and a phase II trial of NeuVax in combination with Herceptin in high risk, node positive or negative HER2 IHC 3+ patients.

This time around, the recommendations from the Data Safety Monitoring Board for NeuVax in combination with Herceptin are positive as there were no safety concerns and the studies were not deemed futile, according to the company.

GALE closed Monday's trading at $1.41, up 17.50%. In after-hours, the stock was up 2.13% to $1.44.

The partial clinical hold imposed by the FDA on Northwest Biotherapeutics' (NWBO.OB) phase III trial of DCVax-L for newly diagnosed Glioblastome multiforme brain cancer, in August 2015, in regard to new screening of patients has been lifted.

According to the company, the trial has enrolled 331 patients. The trial endpoints involve thresholds of 248 "events" for progression-free survival and 233 "events" for overall survival.

While the PFS events have surpassed the 248-event threshold, the OS events have not yet reached the 233-event threshold. It is anticipated that it will be several months until the trial reaches 233 OS events.

NWBO.OB closed Monday's trading at $0.44, up 8.80%.

Shares of Psychemedics Corp. (PMD), a provider of hair testing for the detection of drugs of abuse, were up over 7% in extended trading on Monday, following record revenue and earnings for the fourth quarter ended December 31, 2016.

The net income for the fourth quarter of 2016 was $2.4 million or $0.43 per share on revenue of $10.8 million. This compared with a net income of $185 thousand or $0.03 per share and revenue of $6.1 million in the year-ago quarter.

The company also announced a quarterly dividend of $0.15 per share payable to shareholders of record as of February 16, 2017 to be paid on February 27, 2017.

PMD closed Monday's trading at $21.45, unchanged from the previous day's close. In after-hours, the stock was up 7.23% to $23.00.