ANTH Plunges As Lupus Trial Fails, BMY's Opdivo Is At It Again, FDA Nod For GILD

(RTTNews) - Shares of Anthera Pharmaceuticals Inc. (ANTH) plunged more than 31% on Thursday as the company's phase III trial of Blisibimod for the treatment of systemic lupus erythematosus, dubbed CHABLIS-SC1, failed to meet its primary endpoint.

A phase II study of Blisibimod in IgA nephropathy is underway - with topline data expected next month.

ANTH closed Thursday's trading at $1.90, down 31.65%.

Bristol-Myers Squibb Co.'s (BMY) immunotherapy wonder drug Opdivo, on Thursday, was granted FDA approval for yet another indication - this time, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Opdivo, as a single agent or in combination with Yervoy, is already approved for a number of indications. The drug generated global sales of $942 million in 2015. Thanks to expanding indications, the drug's sales in the first nine months of 2016 are an impressive $2.46 billion.

BMY closed Thursday's trading at $56.66, up 0.64%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has a couple of catalysts to watch out for in the coming months.

A phase II study of Resunab for systemic sclerosis is underway - with top line data expected this quarter.

Resunab is also being explored in the indications of cystic fibrosis and skin-predominant dermatomyositis. The company expects to report topline results from its phase II study of Resunab in cystic fibrosis in Q1 2017.

CRBP closed Thursday's trading at $6.05, down 6.20%.

The FDA has approved Gilead Sciences Inc.'s (GILD) Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease.

Vemlidy sports a boxed warning about the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.

Tenofovir Alafenamide, or TAF in short, has already been approved as part of a fixed dose combination.

Gilead has three FDA-approved TAF-containing FDC (fixed dose combination) tablets namely, Genvoya (a combination of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) - approved in November 2015; Odefsey (a combination of emtricitabine/rilpivirine/tenofovir alafenamide) - approved in March 2016 and Descovy (a combination of emtricitabine/tenofovir alafenamide) - approved in April 2016.

GILD closed Thursday's trading at $77.84, down 0.80%.

Halozyme Therapeutics Inc. (HALO) has inked a broad clinical collaboration agreement with Genentech, a member of the Roche Group, to evaluate its investigational drug PEGPH20 in combination with Genentech's cancer immunotherapy Tecentriq in up to eight different tumor types.

The first study will be a Phase 1b/2 study of Tecentriq in combination with PEGPH20 in six tumor types, and it will be led by Genentech. The second study will be a Phase 1b study of Tecentriq in combination with PEGPH20 and chemotherapy in advanced or metastatic biliary and gallbladder cancers, and it will be led by Halozyme.

HALO closed Thursday's trading at $12.15, up 6.39%.

Neos Therapeutics Inc. (NEOS) is all set to resubmit its New Drug Application for Cotempla XR-ODT for the treatment of attention-deficit/hyperactivity disorder this quarter.

Cotempla XR-ODT was rejected by the FDA last November, and the company was asked to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and the to-be-marketed commercial scale drug product, including an assessment of food effect, and to provide validation and three months of stability data.

The company successfully completed the bioequivalence bridging study for Cotempla XR-ODT as recently as July, 2016.

An NDA for NT-0201, the company's amphetamine XR liquid suspension, which is also for the treatment of attention-deficit/hyperactivity disorder, is expected to be submitted in the fourth quarter of 2016.

NEOS closed Thursday's trading at $7.10, up 11.81%.

Novavax Inc. (NVAX) is trimming its workforce by approximately 30% with immediate effect - a move that is expected to decrease cash burn and support its development priorities through the balance of 2016 and in 2017.

The company expects the restructuring plan to result in a reduction in cash burn of $70 million to $100 million in 2017 relative to 2016.

NVAX closed Thursday's trading at $1.40, down 17.65%.