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Be All Ears For DVAX, QURE, TLOG Disappoints, CCXI Clears Trial

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ChemoCentryx Inc.'s (CCXI) European phase II trial of CCX168 in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis, or AAV, has met the primary endpoint.

In the study, dubbed CLEAR, all treatment groups receiving CCX168 demonstrated a statistically significant non-inferior clinical efficacy outcome when compared to standard of care.

The North American phase II trial of CCX168 in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis is underway. Top-line data from this study, dubbed CLASSIC, are expected in mid-2016.

CCXI closed Wednesday's trading at $5.75, down 15.57%.

Dynavax Technologies Corp. (DVAX) is scheduled to host a conference call tomorrow morning, January 7, 2016, at 8:30 a.m. EST to review top-line clinical data from its phase 3 study of HEPLISAV-B in adult patients with hepatitis B.

DVAX closed Wednesday's trading at $21.18, down 8.55%.

FibroGen Inc. (FGEN) has enrolled the first two patients in a phase II trial of its investigational compound FG-3019 in patients with Duchenne muscular dystrophy.

This phase II study is designed to enrol up to 22 non-ambulatory DMD patients who are at least 12 years of age. An interim analysis of safety and efficacy will be performed after all evaluable subjects complete one year of dosing. If the interim analysis indicates a potential benefit from FG-3019, the study will be extended to two years, according to the company.

FGEN closed Wednesday's trading at $27.07, down 9.98%.

OXiGENE Inc. (OXGN) has been granted orphan drug designation for its drug candidate CA4P for the treatment of neuroendocrine tumors. The designation provides for seven years of marketing exclusivity following product approval.
CA4P has previously received orphan drug designation from the FDA for the treatment of ovarian cancer.

The company recently completed enrolment in its phase 2a clinical trial of CA4P in both gastrointestinal and pancreatic neuroendocrine tumors. Final data from the trials are expected to be available later in 2016.

OXGN closed Wednesday's trading at $0.75, down 2.81%.

Recro Pharma Inc.'s (REPH) intravenous Meloxicam for the treatment of acute pain following bunionectomy surgery has shown to be well tolerated with statistically significant analgesic effect in a phase II trial.

The company expects to initiate the pivotal phase III trials of IV Meloxicam during the first quarter of 2016.

REPH closed Wednesday's trading at $9.10, up 3.88%.

Shares of TetraLogic Pharmaceuticals Corp. (TLOG) slumped over 68% in extended trading on Wednesday, following the company's decision to terminate its phase 2 study of Birinapant in patients suffering from myelodysplastic syndromes.

In the phase II trial, Birinapant co-administered with azacitidine in first line higher risk patients suffering from myelodysplastic syndromes, Birinapant did not demonstrate any clinical benefit over placebo on the primary endpoint of response rate after four months of therapy, according to the company.

In another phase II study, which evaluated the company's topical HDAC inhibitor candidate SHAPE in patients suffering from earlier stage cutaneous T-cell lymphoma, or CTCL, clinical benefit was observed in 8 of 34 patients after six months of treatment.

According to the company, SHAPE also showed improvement in pruritus (itch), a significant symptom associated with CTCL. Thirty-eight percent of patients demonstrated a clinically meaningful decrease in pruritus during the study.
The 60 patient study is now fully enrolled, and the company expects that final results will be available in mid-2016.

TLOG closed Wednesday's trading at $1.70, down 7.61%. In after hours, the stock was down 68.24% at $0.54.

uniQure N.V. (QURE) will be releasing topline results from its Hemophilia B phase I/II gene therapy low-dose cohort clinical trial at 06:00 EST/12:00 CET on January 7, 2016.

A conference call is scheduled at 08:30 EST/14:30 CET after the press release has been issued to discuss the update.

QURE closed Wednesday's trading at $14.91, down 7.79%.

Zynerba Pharmaceuticals Inc.'s (ZYNE) ZYN002 cannabidiol gel, in development for the treatment of epilepsy, osteoarthritis and Fragile X Syndrome, has proven to be safe and well tolerated at all four dose levels in healthy volunteers in a phase I study.

The phase I study had enrolled 32 healthy volunteers and 12 patients with epilepsy. Final results, including results from patients with epilepsy, are expected in the first half of 2016.

Another phase I trial of ZYN002, which will enrol 16 healthy volunteers, followed by 12 patients with epilepsy, has been initiated. Results from this trial are also expected in the first half of 2016.

ZYNE closed Wednesday's trading at $9.10, down 1.62%.

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