OGXI Disappoints, CHMA Hands Out Pink Slips Again, No Issues For ANTH's Solution

(RTTNews) - Anthera Pharmaceuticals Inc.'s (ANTH) phase III clinical study of Sollpura in cystic fibrosis patients with exocrine pancreatic insufficiency has been allowed to continue - with the Data and Safety Monitoring Board having "no concerns regarding safety of the data to date.

The study, dubbed SOLUTION, is evaluating the efficacy and safety of Sollpura, a conventional biotechnological pancreatic enzyme replacement therapy compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency. The company expects top-line efficacy data to be presented in the fourth quarter of 2016.

ANTH closed Tuesday's trading at $3.42, up 7.89%.

Bovie Medical Corp. (BVX) has received 510(k) clearance from the FDA for its new bipolar ablator, branded 'PlazXact', an innovative tool that offers surgeons precision and safety when performing arthroscopic procedures.

The PlazXact is the company's first entry into the arthroscopic surgery market, and additional growth products are expected to be launched in 2017 and beyond.

BVX closed Tuesday's trading at $3.06, up 3.90%.

CASI Pharmaceuticals Inc.'s (CASI) phase 2 trial of ENMD-2076 in fibrolamellar carcinoma has met its Stage 1 endpoint of objective response for non-futility, and is advancing to Stage 2 development.

In Stage 1, 16 patients were evaluated and an additional 13 patients will be recruited in Stage 2. A full interim analysis will be conducted and reported after all 16 patients have reached study endpoint of responses.

CASI closed Tuesday's trading 8.74% higher at $1.12.

Chiasma Inc. (CHMA), which announced a workforce reduction of about 33% in June of this year, is further reducing its workforce by approximately 44%, primarily in its research and general and administrative functions.

The company is seeking to rein in operating expenses and extend its cash runway.

An aggregate charge related to the headcount reduction of approximately $0.8 million to $1.0 million for one-time severance and related costs will be incurred by the company in the third quarter of 2016. As of June 30, 2016, Chiasma had $115.6 million of cash, cash equivalents and marketable securities.

CHMA closed Tuesday's trading at $2.71, down 7.82%.

Indivior PLC's (INDV.L) phase III pivotal study of RBP-6000 buprenorphine monthly depot for the treatment of opioid use disorder has met the primary endpoint.

In the study, RBP-6000 achieved the primary endpoint of the cumulative distribution function of the percentage of urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24.

The company noted that it remains on track to complete the data analysis of the phase III trial as well as the open-label long-term assessment of the safety and tolerability of RBP-6000 by Q1 2017.

INDV.L closed Tuesday's trading at 301.00 GBp, up 0.64%.

Shares of OncoGenex Pharmaceuticals Inc. (OGXI) slumped over 41% on Tuesday as the company's phase III trial of Custirsen in men with metastatic castrate-resistant prostate cancer failed to meet the primary endpoint.

In the study, dubbed AFFINITY, there was no statistically significant improvement in overall survival for patients treated with Custirsen in combination with Cabazitaxel/Prednisone compared to Cabazitaxel/Prednisone alone.

OGXI closed Tuesday's trading at $0.52, down 41.08%.

vTv Therapeutics Inc. (VTVT) has completed enrollment in its phase II trial evaluating TTP273 for the treatment of Type 2 diabetes. Topline results from this study, dubbed LOGRA, are expected by the end of this year.

A pivotal phase III trial evaluating Azeliragon for the treatment of patients with mild Alzheimer's disease, known as STEADFAST, is underway, which is on track to complete enrollment in the third quarter.

VTVT closed Tuesday's trading at $5.87, down 1.51%.