Amgen Facing Delays (NASDAQ:AMGN)

Amgen Inc is not really sure if they will have to wait or not but many of the biotech investors have speculated that Amgen’s Bone drug may have to face significant delays in the final decision by the Food and Drug Administration. Amgen’s bone drug Denosumab is one of the most closely watched development programs currently in biotech sector. However, the investors feel that since the FDA deadline for its final decision is set to Monday October 19, than there are chances of delay for the final verdict of Amgen’s Denosumab.

Currently, the shares of Amgen are not affected by the delay in decision because Denosumab has proven very effective in many clinical trials, though it relies on a new mechanism of action that inhibits a protein involved in the destruction of bone. Additionally, Denomusab will be the first biologic that will be marketed mainly to primary care doctors rather than specialists. The Wall Street is expecting that the delay over the decision might be around three months as the FDA is busy with other deadlines and they will require more time to analyze the safety records of a new inventive drug like Denosumab.

Amgen is not much worried about the delays as of yet, as they are confident about their new bone drug which has shown positive results in the last six late-stage trials. However, if the regulators and FDA delay it longer than there are a few chances that the shares of Amgen Inc might slip down to some extent until the decision is finally made. Amgen already has a number of other products that are doing good business in the market, but Denosumab has the ability to accelerate the growth and success of Amgen tremendously as it will be one of the best products in the biotech market.