GALE's Present & Future, HNSN, CSII Products Get CE Mark, EBIO On Track

(RTTNews) - Alder BioPharmaceuticals Inc. (ALDR) is planning to initiate a second phase IIb trial for ALD403 in migraine prevention in the first half of 2015.

A phase IIb dose-ranging trial of ALD403 for the preventative treatment of chronic migraine sufferers is already underway, and primary endpoint data from this trial are expected in the second half of 2015.

Alder is also actively seeking a new partner to continue the development plans for its investigational rheumatoid arthritis drug Clazakizumab, which is under phase II testing. The full global rights to Clazakizumab were returned by Bristol-Myers Squibb to Alder last month.

ALDR closed Monday's trading at $18.02, up 0.61%.

Cardiovascular Systems Inc. (CSII) has received CE Mark for its Stealth 360º Orbital Atherectomy System to treat patients who suffer from peripheral arterial disease.

In the fiscal first quarter ended September 30, 2014, the results of which were announced last week, the company reported a net loss of $8.22 million or $0.26 per share on revenue of $41.4 million. This compared with a net loss of $7.29 million or $0.29 per share and revenue of $29.8 million in the first quarter of fiscal 2014.

For the fiscal second quarter ending December 31, 2014, the company anticipates net loss in the range of $11.0 million to $12.0 million, or loss per common share ranging from $0.35 to $0.38 on revenue range of $43.1 million to $44.8 million.

CSII closed Monday's trading at $29.95, down 3.39%.

Eleven Biotherapeutics Inc. (EBIO) has completed patient enrollment in its first pivotal, phase III clinical study of EBI-005 in patients with dry eye disease. The company expects reporting top-line results from the study in the second quarter of 2015.

EBIO closed Monday's trading at $10.65, up 0.85%.

Galena Biopharma Inc. (GALE) has a couple of events to look forward to over the next 6 months. The company will be reporting results from a phase IIa clinical trial of GALE-301 in ovarian and endometrial cancers and a phase II trial of GALE-401 in patients with myeloproliferative neoplasms (MPN)-related thrombocytosis.

The company is evaluating its investigational vaccine NeuVax (nelipepimut-S) to prevent or delay breast cancer recurrence after standard of care treatment (chemotherapy, hormone therapy, radiation therapy) in a phase III study, dubbed PRESENT trial.

As of September 22, 2014, 533 of the 700 patients required by the clinical trial protocol had been treated in the PRESENT trial. The company expects to treat 700 patients by the end of January 2015 with the intention to over-enroll the study, targeting the end of Q1, 2015 to close enrollment.

In July of this year, Galena licensed the U.S. rights for the commercial product Zuplenz oral soluble film from MonoSol Rx, LLC.

Zuplenz was approved in 2010 by the FDA in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV.

Galena expects to launch Zuplenz in the first quarter 2015.

GALE closed Monday's trading at $1.91, down 6.83%. In after-hours, the stock was up 1.57% to $1.94.

Hansen Medical Inc.'s (HNSN) Magellan 6Fr Robotic Catheter has received CE Marking for use in the peripheral vasculature. The Magellan 6Fr Robotic Catheter received FDA clearance earlier this year and is commercially available in the U.S.

The company is scheduled to announce Q3, 2014 results on Nov.4, 2014, after the market close.

HNSN closed Monday's trading at $0.88, down 3.30%.

Prothena Corp. plc (PRTA) expects to report additional data from an ongoing phase I trial for NEOD001 in patients with AL amyloidosis this quarter.

The phase 1 study is evaluating the safety, tolerability, pharmacokinetics and immunogenicity of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction. It is also designed to define a maximally tolerated dose and/or recommended dose(s) for a phase 2/3 study and to evaluate exploratory biomarkers of cardiac, renal and hepatic function.

The company presented encouraging interim data from the phase I trial in April of this year. A phase 2/3 study of NEOD001 in patients with AL amyloidosis is also expected to be initiated this quarter.

Another catalyst coming its way is data from a phase 1 single ascending dose clinical study of Parkinson's disease drug candidate PRX002 in healthy subjects in the first half of 2015. Data from a phase 1 multiple ascending dose clinical study of PRX002 in patients with Parkinson's disease are expected in 2016.

PRTA closed Monday's trading 1.19% higher at $22.19.

Syneron Medical Ltd. (ELOS) has received FDA clearance for its new PicoWay picosecond device, a state-of-the-art dual wavelength device, for the removal of tattoos.

The company noted that the regulatory clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. PicoWay will be launched in the U.S., following the launch of the product in the international market in October.

The company is scheduled to release third quarter 2014 financial results before the market opens on Wednesday, November 12, 2014.

ELOS closed Monday's trading 4.27% higher at $9.76.