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ETRM Gets Recharged, NBY Awaits Dec Data, Will TXMD Rejoice This Qtr?


EnteroMedics Inc.'s (ETRM) two year follow up results from a pivotal study of vBloc Neurometabolic Therapy for the treatment of obesity, dubbed ReCharge, has demonstrated clinically significant weight loss and sustained improvements in obesity related risk factors.

At 2 years, the average weight loss was 21% ± 25% excess weight loss or 8% ±10% total body weight loss (TBL). Fifty-eight percent of subjects had at least 5% TBL and 45% had at least 7.5% TBL. Only one serious complication has occurred in the 2 years, noted the company.

ETRM closed Wednesday's trading at $0.29, down 2.85%. In after hours, the stock was up 8.62% at $0.31.

NovaBay Pharmaceuticals Inc. (NBY) is expected to report results from a phase 2b trial evaluating its proprietary anti-microbial compound Auriclosene (NVC-422) to reduce urinary catheter blockage and encrustation in patients with long-term indwelling urinary catheters in early December.

NBY closed Wednesday's trading at $0.20, up 0.93%.

Paratek Pharmaceuticals Inc.'s (PRTK) investigational drug Omadacycline has been granted Fast Track Designation by the FDA for Acute Bacterial Skin and Skin Structure Infections, Community Acquired Bacterial Pneumonia and Complicated Urinary Tract Infections.

A phase III trial evaluating Omadacycline against Linezolid in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is underway, and top-line data from this study are projected to be available in the second half of 2016.

A second pivotal phase III study to assess the safety and efficacy of Omadacycline in the treatment of Community Acquired Bacterial Pneumonia (CABP) is planned for initiation before the end of this year, with top-line data from the study projected to be available in the second half of 2017.

TherapeuticsMD Inc. (TXMD) is scheduled to report topline data from a phase III trial of TX-004HR, dubbed Rejoice, for the treatment of moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause, this quarter.

TX-004HR is an investigational 17ß-estradiol vaginal drug product candidate, and it utilizes a unique VagiCap softgel capsule technology that may provide easy delivery.

Will investors rejoice at the trial results? Stay tuned…

Another phase III trial of the company, known as REPLENISH, evaluating TX-001HR, an investigational once-daily oral softgel capsule, to treat vasomotor symptoms of menopause completed enrollment last month.

TXMD closed Wednesday's trading at $6.41, down 0.93%. In after-hours, the stock was up 7.02% to $6.85.

TetraLogic Pharmaceuticals Corp. (TLOG) expects interim data from the phase 2b portion of a phase II trial of its drug candidate Birinapant in higher risk myelodysplastic syndromes in early January 2016.

The company has achieved enrollment target in its phase II trial of SHAPE, a topical HDAC inhibitor, in early stage Cutaneous T-cell Lymphoma, with data expected in early January 2016.

TLOG closed Wednesday's trading at $1.83, down 0.54%.

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