AstraZeneca share price subdued as manufacturing issue delays potassium drug

on May 27, 2016
Updated: Oct 21, 2019

AstraZeneca (LON:AZN) has suffered a setback with US regulators refusing to approve the pharmco’s new drug for high potassium levels due to a manufacturing issue. In a separate development, the drugmaker reported that an oncology treatment had scored well in a late-stage trial.

As of 09:26 BST, AstraZeneca’s share price had lost 0.30 percent to 3,999.45p, underperforming the benchmark FTSE 100 index which is currently flat at 6,265.51 points. The pharmco’s shares have lost some 10 percent of their value over the past year, and are down more than 13 percent in the year-to-date.
AstraZeneca announced in a statement this morning that the US Food and Drug Administration (FDA) had issued a complete response letter to the company regarding its investigational hyperkalaemia treatment sodium zirconium cyclosilicate. Hyperkalaemia is a potentially life-threatening condition characterised by high potassium levels.

The company noted that the letter referred to observations arising from a pre-approval manufacturing inspection, and that the group was working closely with the FDA to determine the next steps for its drug application. Complete response letters typically outline concerns and conditions which must be addressed so that a drug can get approval.
A spokesman told Reuters that the company hoped to resolve the matter in a ‘timely’ manner. AstraZeneca acquired the hyperkalaemia compound when it bought ZS Pharma for $2.7 billion last year.
The FTSE 100 drugmaker announced in a separate statement today that it had received positive results from a late-stage hormonal therapy trial comparing the Faslodex drug to Arimidex in the treatment of breast cancer. Faslodex 500mg demonstrated superiority compared with Arimidex 1mg, and met its primary endpoint of extended progression-free survival.
The results are a boost for the London-listed pharmco which has outlined oncology as one of its key growth areas.
As of 09:48 BST, Friday, 27 May, AstraZeneca plc share price is 3,999.50p.


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