Biotech Stocks Facing FDA Decision In July

(RTTNews) - Another busy month on the FDA calendar has gone by but not without its fair share of hurrahs and heartaches. This is not unexpected, given the uncertainties characterizing drug development and approval processes, which in turn manifest as volatility in stocks belonging to the biotech space.

Before we look forward to the FDA activity of next month, here is a gist of what transpired in June.

Three new drugs, including 2 new molecular entities, were approved, while 3 new drug applications were rejected. For the uninitiated, a molecular entity is a drug that contains an active ingredient that has never been approved by the FDA or marketed in the U.S.

Advanced Accelerator Applications USA Inc.'s (AAAP) Netspot and Gilead Sciences Inc.'s (GILD) Epclusa are the two novel drugs that received FDA's blessings in June.

Netspot is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors.

Epclusa, which is a combination of Sofosbuvir and Velpatasvir, is indicated in the treatment of adult patients with chronic hepatitis C virus both with and without cirrhosis. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic hepatitis C virus infection and Gilead's third Sofosbuvir-based regimen, after Sovaldi and Harvoni, both of which are blockbuster drugs.

Given the quirkiness associated with drug development and approval processes, there is perpetual investor interest in these. For those who are looking to capitalize on the volatility, here's a list of biotech stocks awaiting regulatory events in July.