CPIX Returns To Black, ADMP Breathes Easy, TNXP For Long Haul, CERU Hits A High

(RTTNews) - Adamis Pharmaceuticals Corp. (ADMP) has announced positive pharmacokinetic study results for its dry powder inhaler product, APC-5000, which is being developed for the treatment of asthma and chronic obstructive pulmonary disease.

In the phase I pharmacokinetic study, the bio-availability of APC-5000 Dry Powder Inhaler was compared to GlaxoSmithKline's FDA-approved Advair Diskus DPI.

Based on the study results, the company believes that APC-5000, while using less drug, will still be as efficacious as Advair. This hypothesis will be tested in a phase III study comparing the efficacy of APC-5000 and Advair for non-inferiority.

ADMP closed Tuesday's trading 5.08% higher at $6.82.

Amicus Therapeutics (FOLD) expects to file marketing authorization application for Migalastat monotherapy for Fabry disease by mid-2015.

The company has a meeting with the FDA scheduled this quarter to discuss the U.S. regulatory approval pathway for Migalastat monotherapy.

FOLD closed Tuesday's trading at $8.48, up 0.36%.

CEL-SCI Corp.(CVM) achieved record enrollment of 25 patients in a global pivotal phase III head and neck cancer trial for its investigational immunotherapy Multikine in February. Twenty four patients were enrolled in the trial in January.

A total of 377 patients have been enrolled in the world's largest phase III study in head and neck cancer as of February 28, 2015. The goal is to enroll a total of 880 patients through approximately 100 clinical centers in about 25 countries by the end of 2015, according to the company.

CVM closed Tuesday's trading at $1.14, up 5.56%.

Cerulean Pharma Inc. (CERU) has signed a clinical research agreement with the GOG Foundation Inc. to conduct an open-label phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer.

The first patient in the trial is expected to be enrolled in the second quarter of 2015. The study is designed to enroll 18 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer, and is meant to identify the maximum tolerated dose (MTD) as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel.

CERU touched a new high of $8.46 on Tuesday before closing the day's trading at $7.58, down 8.01%.

Cumberland Pharmaceuticals Inc. (CPIX) touched a 52-week high on Tuesday after turning around to profit in Q4 and full year 2014 on higher revenues.

For the three months ended December 31, 2014, adjusted earnings were $1.8 million or $0.10 per share on net revenues of $9.3 million. This compared with a loss of $1.9 million or $0.10 per share and revenues of $8.2 million in the prior year period.

For the year ended December 31, 2014, adjusted earnings were $6.3 million or $0.35 per share on net revenues of $36.9 million. The company incurred a loss of $1.8 million $0.10 per share on revenues of $32.0 million in 2013.

CPIX touched a 52-week high high of $6.52 on Tuesday before closing the day's trading at $6.40.

Receptos Inc.'s (RCPT) 24-week maintenance portion of its phase II trial of Ozanimod in patients with moderately-to-severely active ulcerative colitis is expected to be completed in the second half of this year.

The company plans to initiate a phase 3 program of Ozanimodin in ulcerative colitis and phase 2 program in Crohn's disease in 2015.

A phase II trial evaluating RPC4046 in Eosinophilic Esophagitis, which is underway, is expected to be completed in the first half of 2016.

RCPT closed Tuesday's trading at $124.99, down 1.65%.

Tonix Pharmaceuticals Holding Corp. (TNXP) expects to begin a prospective 500-patient phase 3 study of TNX-102 SL in fibromyalgia, dubbed AFFIRM trial, in the second quarter of 2015. Top line results from the trial are expected in the second half of 2016.

If approved, TNX-102 SL would be the first medicine for fibromyalgia to target non-restorative sleep and would be highly differentiated from currently marketed drug products, noted the company.

A phase 2 study of TNX-102 SL in post-traumatic stress disorder, known as AtEase trial is underway, and top line results from this trial are anticipated in the first half of 2016.

TNXP closed Tuesday's trading at $6.05, up 2.20%.