30.09.2016 06:42:55

AUPH Regains Aura, THLD Slumps On Quitting Tarloxotinib Program, CEMP Abuzz

(RTTNews) - Shares of Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) were up more than 17% in after-hours trading on Thursday, following positive data from its phase IIb trial of Voclosporin in lupus nephritis.

The trial, dubbed AURA-LV, has achieved the primary endpoint of Complete Remission as well as pre-specified secondary endpoints at 24 weeks.

The study will continue till its 48-week endpoint, upon which similar and additional secondary analysis will be analysed and presented early next year, says the company.

AUPH closed Thursday's trading at $2.64, up 9.10%. In after-hours, the stock was up another 17.42% to $3.10.

Arbutus Biopharma Corp. (ABUS) has reported encouraging interim results from the first two cohorts of the ongoing phase II multi-dose clinical trial of ARB-1467 in chronically infected HBV patients.

According to the trial results, single dose ARB-1467 for Cohorts 1 and 2 demonstrate significant reductions in serum HBsAg levels. Importantly, multiple dose results from Cohort 1 show a step-wise, additive reduction in serum HBsAg, the company added. Additional multi-dose data from the trial are expected to be released later this year.

ABUS closed Thursday's trading at $3.89, up 2.37%. In after-hours, the stock was down 10.80% to $3.47.

Cempra Inc. (CEMP) has reported encouraging interim results from the first six nonalcoholic steatohepatitis patients treated with Solithromycin in a phase II study.

According to the trial results, all six nonalcoholic steatohepatitis (NASH) patients who had completed 90 days of Solithromycin treatment had a reduction in their nonalcoholic fatty liver disease activity score. The levels of liver enzyme alanine aminotransferase were also reduced in all the 6 patients.

Cempra plans to continue the phase II study to obtain data from up to 15 NASH patients. Enrollment is expected to complete in the first quarter of 2017.

CEMP closed Thursday's trading at $23.88, down 8.92%. In after-hours, the stock was up 4.10% to $24.86.

Genocea Biosciences Inc.'s (GNCA) phase 2b trial of GEN-003 for the treatment of genital herpes has demonstrated significant reduction of viral shedding.

According to the trial results, the 60 µg per protein/50 µg of Matrix-M2 dose of GEN-003 demonstrated a statistically significant 40 percent reduction from baseline in the viral shedding rate versus a marginal increase of 6 percent for placebo.

The company expects to report six-month placebo-controlled clinical data from the phase 2b trial of GEN-003 in January 2017.

GNCA closed Thursday's trading at $5.06, down 11.54%.

Shares of Marinus Pharmaceuticals Inc. (MRNS) were down more than 26% on Thursday, despite positive results from its phase II exploratory trial of Ganaxolone PCDH19 in pediatric epilepsy.

According to the trial results, 64% (7 of 11) of patients showed a seizure reduction compared to baseline, and 57% (4 of the 7 patients) showed a reduction of greater than 50% compared to baseline.

However, there were three serious adverse events in the trial - one patient reporting with rash and two patients experiencing seizures.

The enrollment in the trial has been expanded to include patients with CDKL5, Lennox-Gastaut Syndrome and other pediatric genetic epilepsies. Data from these additional patient populations will be available next year, noted the company.

MRNS closed Thursday's trading at $2.00, down 26.74%.

Shares of Threshold Pharmaceuticals Inc. (THLD) were down 64% in extended trading on Thursday as the overall results from two phase II proof-of-concept clinical trials of its drug candidate Tarloxotinib didn't warrant further development of the compound.

In a phase II proof-of-concept trial of Tarloxotinib in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN arm) or skin (SCCS arm), the primary interim response rate endpoint was achieved in the SCCS arm of the trial but wasn't achieved in the SCCHN arm.

Another second phase II proof-of-concept trial of Tarloxotinib, conducted in patients with EGFR-mutant, T790M-negative, advanced non-small cell lung cancer too has not achieved the primary goal.

In light of the poor data, the company has decided to discontinue investment in its Tarloxotinib program.

Threshold licensed exclusive worldwide rights to Tarloxotinib from the University of Auckland, New Zealand, in September 2014.

THLD closed Thursday's trading at $1.18, unchanged from the previous day's close. In after hours, the stock was down 62.88% to $0.43.

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