Biotech Stocks Facing FDA Decision In August

(RTTNews) - We are well into the third quarter and past the middle of the year and it is time to take stock of regulatory decisions awaiting some biotech stocks in August. Despite the uncertain macroeconomic environment, the markets have run up, with the S&P 500 Index making new highs session after session. Valuation concerns may keep traders at bay. However, the biotech space is a different cup of tea.

There are several hidden gems in the space that wait to be unearthed and some established names that have a breakthrough product. This monthly article from RTTNews is aimed at alerting traders to trading ideas that can fetch them good returns in the near term.

Before we look forward to the FDA activity of August, the following are some noteworthy developments that occurred on the U.S. regulatory front in July.

Shire's Xiidra passed the FDA muster on its second try on July 11, 2016, becoming the first prescription eye drop for the treatment of both signs and symptoms of dry eye disease in adult patients.

Touted as a possible blockbuster, Xiidra will compete with Allergan's Restasis that was approved in 2002. Restasis helps increase the eyes' natural ability to produce tears, which may be reduced by inflammation due to chronic dry eye disease.

Out of the 15 drug candidates for which FDA/panel decisions have been announced so far in July, eleven received positive news related to their approval while four were sent back to the drawing board - the unlucky four being Elite Pharma's NDA for SequestOX, Medicure's sNDA for Aggrastat, Valeant Pharma's NDA for Vesneo and Ocular's NDA for Dextenza.

Click on to know more about the biotech companies awaiting FDA rulings in August.