AstraZeneca: Investors will wait 'in vain' for Brilinta approval

AstraZeneca Plc (LON:AZN) shares are lower by 0.93% on the FTSE 100 at 2991.

Equity analysts at Jefferies have this morning maintained their Underperform rating on AstraZeneca shares after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted that the efficacy / safety data did not provide substantial evidence to support approval of AstraZeneca's / Bristol Myers' diabetes drug dapagliflozin.

Investors are seen holding onto AstraZeneca shares in the hope that Brilinta, their next drug due before PDUFA today, will be approved.

Jefferies warn that this waiting could be in vain:

"AstraZeneca consolidates 50% of dapagliflozin gross profits, with partner Bristol-Myers consolidating all sales. We model risk-adjusted sales of $287m for AstraZeneca in 2015E. This represents only 1% of group sales, and 2-3% of group profits in 2015E. Despite this negative decision, we suspect that many investors will wait in hope for the approval of Brilinta before exiting the stock. However, we continue to believe that the potential for non-approval of Brilinta is high and that even if approved the product will have a lackluster launch."

Looking at the markets this morning we see that the FTSE 100 (INDEXFTSE:UKX) is 0.58% higher on the day at 5,823.37.

"For equity indices the bulls are starting to look like they've really run out of steam, something that's been a bit of a recurring theme throughout the year.  On the daily charts a series of double tops, triple tops and what's looking dangerously like some head and shoulder patterns are preventing the FTSE, Dax, S&P and Dow from forging ahead to new highs," warns Simon Denham at spread betting company Capital Spreads.