ANTH Dims On BRIGHT-SC Data, CYAD Fails To Chart, LLY Gets FDA Panel Nod

(RTTNews) - An interim analysis of proteinuria data from Anthera Pharmaceuticals Inc.'s (ANTH) phase II proof-of-concept study of Blisibimod in IgA nephropathy, dubbed BRIGHT-SC, has revealed that the trial did not meet the predefined statistical primary endpoint of complete or partial response.

Proteinuria, which refers to a condition in which urine contains an abnormal amount of protein, is one of the common symptoms of IgA nephropathy.

The company noted that the positive trends in the longer-term proteinuria and immunological data from the study are encouraging and provide a strong rationale to continue the study.

The company expects to present data from patients reaching 48-week time point of the study later this year.

ANTH closed Tuesday's trading at $3.07, up 2.68%. In after hours, the stock was down 10.42% to $2.75.

Aurinia Pharmaceuticals Inc. (AUPH)(AUP.TO) has completed an analysis of the first 7 patients who have finished 24 weeks therapy in its open label, exploratory study evaluating Voclosporin in active lupus nephritis.

There is a reduction in disease activity as can be seen from the data. According to the study results, at 24 weeks 57% (4/7) of patients continued to be in complete remission as measured by a urinary protein creatinine ratio. Among these seven AURION patients there was a 54% mean reduction in proteinuria at 24 weeks compared to pre-treatment levels along with consistent improvements in C3, C4 and anti-DS DNA. Renal function as measured by eGFR remained stable and no new safety signals were observed, added the company.

A phase 2b trial of Voclosporin in active lupus nephritis, dubbed AURA, is underway, and results are expected to be released later this summer.

AUPH closed Tuesday's trading at $2.70, up 3.85%.

Shares of Auris Medical Holding AG (EARS) climbed 11% on Tuesday, following completion of patient enrollment in the company's phase III clinical trial of Keyzilen in acute and post-acute inner ear tinnitus.

The study, dubbed TACTT3, is being conducted in Europe, and has enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B).

Top-line results from the TACTT3 trial are expected in the fourth quarter of 2016.

The first phase 3 clinical trial of Keyzilen, dubbed TACTT2, is being conducted primarily in North America, and results from this study are anticipated in August 2016.

EARS closed Tuesday's trading at $4.32, up 11.34%.

Shares of Coherus BioSciences Inc. (CHRS) rose more than 10% on Tuesday, following positive efficacy data of CHS-131 in treatment-naïve, relapsing remitting multiple sclerosis subjects.

According to the company, the trial met the primary endpoint, with CHS-131 demonstrating approximately a 50% decrease in the incidence of new contrast-enhancing (CE) lesions over six months when compared to placebo.

CHRS closed Tuesday's trading at $15.64, up 10.69%.

Shares of Celyad SA (CYAD) plunged 33% on Tuesday after the company's phase III trial evaluating C-Cure for the treatment of heart failure, dubbed CHART-1, failed to reach the primary endpoint.

The company said it will seek a partner to accelerate further development and commercialization of C-Cure.

CYAD closed Tuesday's trading at $28.30, down 33.33%.

Egalet Corp.'s (EGLT) new drug application for ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate is scheduled to be reviewed by an FDA panel on August 4, 2016.

The FDA's final decision on ARYMO ER is set for October 14, 2016.

EGLT closed Tuesday's trading at $4.60, up 4.07%.

Gilead Sciences Inc.'s (GILD) Epclusa has been approved by the FDA, becoming the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus infection, both with and without cirrhosis.

The drug will sport a warning about serious slowing of the heart rate and reduced efficacy when used with certain drugs.

Epclusa is a fixed-dose combination tablet containing Sofosbuvir, a drug approved in 2013, and Velpatasvir, a new drug. It is also Gilead's third Sofosbuvir-based treatment to receive the FDA nod.

GILD closed Tuesday's trading at $82.31, up 5.19%.

An FDA panel has voted 12-11 in favor of cardiovascular mortality benefit for Jardiance for adults with type 2 diabetes and established and established cardiovascular disease.

Jardiance, marketed by Boehringer Ingelheim and Eli Lilly and Co. (LLY) received its first FDA approval in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval of the new indication was based on data from the landmark EMPA-REG OUTCOME trial, which found that Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in adults with T2D and established CV disease.

Lilly's revenues for Jardiance for the first quarter of 2016 were $38.2 million compared to $19.2 million in the year-ago quarter.

LLY closed Tuesday's trading at $75.15, up 0.35%.

XBiotech Inc. (XBIT) has entered into an exclusive licensing agreement with Megapharm Ltd. to commercialize Xilonix in Israel for the treatment of advanced colorectal cancer.

Under terms of the agreement, Megapharm will pay XBiotech an undisclosed upfront fee followed by payments upon the completion of certain commercial and regulatory milestones, including the approval of Xilonix for sale in Israel. In addition, upon this approval, Megapharm will purchase Xilonix from XBiotech at a supply price that is based on a percentage of net sales of the product.

Xilonix is currently under accelerated review by the European Medicines Agency - with a decision on approval expected as early as the fourth quarter of 2016. In the U.S., Xilonix, for advanced colorectal cancer, is in phase III clinical trials.

XBIT closed Tuesday's trading at $19.10, up 1.38%.

Shares of Xencor Inc. (XNCR) leapt over 32% on Tuesday, following collaboration with Novartis (NVS) to develop two compounds XmAb14045 and XmAb13676.

XmAb14045 is being developed for the treatment of acute myeloid leukemia, and XmAb13676 for the treatment of for B-cell malignancies. Both XmAb14045 and XmAb13676 are expected to begin clinical development in 2016.

XNCR closed Tuesday's trading at $16.56, up 32.06%.