AMGN Calls It Quits On Brodalumab, CBMG Rises On Study Data, SKBI Put On Notice

(RTTNews) - Amgen Inc. (AMGN) has called it quits on the deal with AstraZeneca plc (AZN) for co-development and commercialization of Brodalumab, due to events of suicidal ideation and behavior in its clinical program, which the company believes would likely necessitate restrictive labeling for the drug.

Brodalumab has successfully completed three phase III studies in patients with moderate-to-severe plaque psoriasis known by the name AMAGINE programme. Top-line results from AMAGINE-1, comparing Brodalumab with placebo, were released in May 2014. Top-line results from AMAGINE-3 and AMAGINE-2 comparing Brodalumab with Stelara and placebo, were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design.

In other news, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Amgen's Repatha recommending approval for use in certain patients with high cholesterol.

Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

In the U.S., the Biologics License Application for Repatha for the treatment of high cholesterol is scheduled to be reviewed by an FDA panel on June 10, 2015, and a final decision by the regulatory agency is expected on August 27, 2015.

AMGN closed Friday's trading at $163.58, down 0.16%.

Shares of Cellular Biomedicine Group Inc. (CBMG) rose more than 14% on Friday after the company announced encouraging data from its phase I study of Chimeric Antigen Receptor (CAR-T) CD30-positive Hodgkin's lymphoma immuno-oncology clinical development program.

According to the trial results, five out of seven patients responded to the treatment with CD30-directed CAR-T cell therapy and it proved to be safe, feasible and efficient.

The company expects to announce clinical data from its EGFR-HER1-positive advanced lung cancer trial in the third quarter of this year.

CBMG closed Friday's trading at $35.64, up 14.49%.

ERBA Diagnostics Inc. (ERB) has been notified of noncompliance with NYSE MKT continued listing standards for failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2015.

The company said that it is working diligently to regain compliance by August 19, 2015.

ERB closed Friday's trading at $2.79, up 0.99%.

Skystar Bio-Pharmaceutical Co. (SKBI) has been notified that it is not in compliance with Nasdaq Listing Rule 5250(c)(1) since it had not filed its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2015.

The company has time until June 15, 2015 to submit a plan of compliance with the foregoing listing deficiency, and if the plan is approved it may be given up to 180 calendar days or until October 12, 2015 to regain compliance.

SKBI closed Friday's trading at $3.14, up 2.95%.