Key FDA Decisions and Trial Results Expected in October

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It is well known that U.S. Food and Drug Administration (FDA) rulings, along with the results from clinical trials, can make or break companies in the biotech and pharmaceutical industries. The companies that subject themselves to the lengthy process of FDA approval or clinical research are taking on a fair amount of risk of failure. However, if a drug is approved or passes a clinical trial, there can be massive upside.

24/7 Wall St. has collected several big FDA decisions and mid-stage to late-stage trials that should be announced in October. We have added what to expect, as well as some color and the trading ranges and price targets.

For the month of October, perhaps the biggest headliner is the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen between October 7 and 11.

Outside of the ESMO, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters, if a company is not deeply financed.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.


Exelixis Inc. (NASDAQ: EXEL) is scheduled to present data from its clinical trials of cabozantinib and cobimetinib, which will be subject to 15 presentations at the ESMO. Detailed results from the company’s CABOSUN trial will be presented at ESMO as a late-breaking abstract in the genitourinary tumors.

Additional poster presentations will detail the investigation of cabozantinib in other cancer settings, including in combination with nivolumab in metastatic urothelial carcinoma and other genitourinary cancers, as well as the evaluation of cobimetinib in combination studies across multiple tumor types.

Shares of Exelixis closed most recently at $12.72, with a consensus price target of $12.67 and a 52-week trading range of $3.55 to $15.58.