AMGN Gets FDA Nod, Uncertainty Ends For CEMP, Clock Is Ticking For ANTH

(RTTNews) - Anthera Pharmaceuticals Inc. (ANTH) is all set to report top line data from a phase III study of Blisibimod for the treatment of systemic lupus erythematosus, dubbed CHABLIS-SC1, before November 11, 2016.

The top line data from the CHABLIS-SC1 study will include the primary endpoint evaluation, the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study.

ANTH closed Friday's trading at $2.35, up 11.37%.

The FDA on Friday approved the expanded use of Amgen's (AMGN) Enbrel to treat pediatric patients aged 4-17 with chronic moderate-to-severe plaque psoriasis.

Enbrel in combination with Methotrexate or used alone is already indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis in adults.

The drug logged total sales of $5.36 billion in 2015 up 14% over the prior year. In the first half of 2016, Enbrel sales totaled $2.86 billion compared to $2.46 billion in the prior year period.

AMGN closed Friday's trading at $135.40, up 0.13%.

There has been much speculation about whether Cempra Inc.'s (CEMP) investigational drug Solithromycin will clear the penultimate regulatory hurdle of winning the FDA panel backing. So much so, the stock has lost nearly 60% of its value in the last 4 trading days.

Solithromycin, in intravenous and oral formulation, is being developed for community-acquired bacterial pneumonia, or CABP.

An outside panel of FDA experts, who reviewed Solithromycin on November 4, 2016, voted (7-6) that efficacy results outweigh the risks. The panel members voted unanimously (13-0) that there was substantial evidence of the efficacy of Solithromycin for CABP. The committee also voted (12-1) that the risk of hepatotoxicity with Solithromycin had not been adequately characterized and discussed a variety of potential approaches to further characterize the existing liver safety information on Solithromycin.

The FDA's final decision on oral and intravenous Solithromycin is slated for December 27, and December 28, 2016, respectively.

CEMP closed Friday's trading at $7.55.

Guided Therapeutics Inc. (GTHP.OB) will implement a 1:800 reverse split of its issued and outstanding common stock when the market opens on Monday, November 7, 2016.

The company also announced the elimination of "toxic" convertible securities from its balance sheet by having all preferred stock and debt converted at a fixed price, which according to the company is an important milestone in its ability to fix its capital structure.

GTHP.OB closed Friday's trading at $0.00210, down 44.74%.