Biotech: The Week Ahead (07/23 through 07/29)

We preview the potential major trial milestones, presentations and FDA calendar for the biotech sector in the week ahead

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The market continues to be caught between two dynamics. On one hand, one third of the way through way second quarter earnings season and year-over-profits look to be up 20% or better for the S&P 500 for the second quarter in a row. The economy continues to be robust with second quarter GDP growth projected to come in right around 4% when it is reported this upcoming Friday. This would the best level in four years. The jobs market also is percolating with more job openings than individuals to fill them and with weekly jobless claims near 50-year lows.

On the other hand, global trade tensions are escalating steadily and worries about a real 'trade war' increase by the week. Those forces fought a stalemate this week with the S&P 500 and NASDAQ ended the week almost precisely where they started. The main biotech indices posted slight declines.

The main biotech indices also did little in trading last week and at mid-day through trading here on Monday, they remain directionless. The FDA issued important new guidelines last week for getting new biosilimar competition ramp up once blockbuster biologics like Humira come off patent as well as for new less addictive forms of pain management drugs.

So, what is ahead this upcoming week for the biotech sector? We take a look at the important trial milestones, conference presentations and FDA actions that could move small and mid-cap biotech names in the week ahead below.

We have numerous small healthcare events in the week ahead like the 11th International Conference on Vascular Dementia held July 23rd through the 25th in Moscow but no major events.

On Friday, The FDA is set to rule on **Insys Therapeutics' (INSY)**Buprenorphine sublingual spray. In May, the Ad Comm Panel around this compound voted against recommendation. The candidate is being evaluated for moderate-to-severe postoperative pain after bunionectomy. Also on Friday,DURECT Corporation's(DRRX) schizophrenia treatment candidate RBP-7000, which has been licensed to U.K.-based biotech INDIVIOR PLC has its own PDUFA action date.

Finally, Azedra from Progenics Pharmaceuticals (PGNX) to treat two forms of adrenal cancer is scheduled for its PDUFA action date next Monday. However, I would not be shocked if approval comes before the weekend.

The FDA is also set to rule on Elagolix for acute endometriosis-associated pain either in Late July or Early August. No official PDUFA action date was set after the agency pushed back the date approximately three months in early April before a previously scheduled action date. Both primary endpoints were met in trials, but both Neurocrine Biosciences (NBIX) and AbbVie (ABBV) who are partnering on this compound will feel better once they get the official greenlight from the FDA

And those are the major events scheduled for some small and midcap companies across the sector in the week ahead. Happy Hunting.

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