KOOL Tweaks Workforce, VNDA To Face FDA, XNPT Crashed For A Reason, TRIV Zooms

(RTTNews) - Following a positive pre-NDA meeting with the FDA, Amicus Therapeutics (FOLD) plans to submit an NDA for its investigational product Migalastat for the treatment of Fabry disease in the fourth quarter of 2015 under Accelerated Approval.

The company's marketing submission for Migalastat in Europe is already being reviewed under Accelerated Assessment and an Opinion is expected by year-end.

FOLD closed Tuesday's trading at $18.23, unchanged from the previous day's close.

ARIAD Pharmaceuticals Inc. (ARIA) has completed enrollment in its pivotal phase II trial of its investigational product Brigatinib, achieving the enrollment target of 220 patients at approximately 75 sites in North America, Europe and Asia.

The trial, dubbed ALTA, is evaluating Brigatinib in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy.

The company expects to present the first data from the trial at the American Society of Clinical Oncology (ASCO) annual meeting in 2016.

ARIA closed Tuesday's trading at $8.03, up 0.12%.

In order to reduce costs and further align available resources behind important clinical programs, Cesca Therapeutics Inc. (KOOL) has decided to reduce about 15 job positions in various functions and eliminate a number of open positions that will not be back-filled.

The restructuring is expected to reduce annual operating costs primarily in the cord blood banking business by approximately $3.3 million, and the company will incur a restructuring charge of about $245,000 in the current quarter of fiscal 2016, which includes one-time termination benefits principally comprised of severance payments.

KOOL closed Tuesday's trading at $0.64, up 1.19%.

DENTSPLY International Inc. (XRAY) and Sirona Dental Systems Inc. (SIRO) are set to combine in an all-stock merger of equals, creating the world's largest manufacturer of professional dental products and technologies.

The combined company with an implied pro forma equity value of roughly $13.3 billion, based on the closing prices of DENTSPLY and Sirona on September 14, 2015, will be known by the name DENTSPLY SIRONA and trade on the NASDAQ under the symbol "XRAY" The transaction is expected to be completed in the first quarter of calendar 2016.

SIRO closed Tuesday's trading at $99.31, up 1.24%.

GW Pharmaceuticals plc's (GWPH) exploratory phase 2a placebo-controlled clinical trial of Cannabidiol in patients with schizophrenia who had previously failed to respond adequately to first line anti-psychotic medications has yielded positive results.

As part of the trial, patients remaining on their anti-psychotic medication were randomized to receive Cannabidiol or placebo as adjunct therapy. The addition of Cannabidiol to the medication of patients who were only partially responsive to standard anti-psychotic treatment produced significant improvements in outcome measures compared with placebo. Moreover, the improvements were not associated with adverse effects, noted Philip McGuire, the Principal Investigator of the study.

GWPH closed Tuesday's trading 7.58% higher at $115.

RepliCel Life Sciences Inc. (REPCF.OB)(RP.V) has initiated its European phase I study of intradermal injections of RCS-01 to treat aged and sun damaged at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

This RCS-01 trial initiation represents the second clinical trial of RepliCel's non-bulbar dermal sheath fibroblast (NBDS) platform to be initiated this year, the first being RCT-01 in Canada for chronic tendinosis.

The study is projected to include 30 participants, male and female, with 6-month data anticipated in autumn 2016.

REPCF.OB closed Tuesday's trading at $0.27, down 0.37%.

Shares of TriVascular Technologies Inc. (TRIV) were up more than 60% in extended trading on Tuesday after the company announced that the first European patients have been treated successfully with its Ovation iX Abdominal Stent Graft System in Germany and England.

The Ovation iX System, which received CE Mark and approval from the FDA earlier this year, has a new, built-in procedural option available to replace retrograde cannulation of the main body device, facilitating placement of the contralateral iliac stent graft.

TRIV closed Tuesday's trading at $4.82, up 2.77%. In after hours, the stock was up 60.17% to $7.72.

Vanda Pharmaceuticals Inc.'s (VNDA) supplemental New Drug Application for Fanapt seeking approval as a maintenance treatment of schizophrenia in adults has been accepted for review by the FDA.

The FDA'S decision is set for May 27, 2016.

Fanapt was approved by the FDA in 2009 to treat adults with schizophrenia. The net product sales of Fanapt in Q1, 2015 were $14.7 million. For full year 2015, it is expected to range between $55 million to $65 million.

VNDA closed Tuesday's trading 3.77% higher at $13.76.

Shares of XenoPort Inc. (XNPT) plunged 28% on Tuesday despite the company announcing positive results from a phase II study of XP23829 in psoriasis as investors were not happy about the gastrointestinal events and treatment emergent adverse events in the trial, which were related to XP23829.

According to the trial results, XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score.

The diarrhea adverse event rates ranged from 22% to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache.

The company believes it will be ready to potentially initiate phase III studies with XP23829 in psoriasis in 2016.

XNPT closed Tuesday's trading at $4.84, down 28.08%.