Healthcare Business

Key FDA Decisions and Trial Results Expected in October

Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair to a great amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.

The U.S. Food and Drug Administration (FDA) rulings and results from clinical trials can make or break these companies, as proven time and again.

24/7 Wall St. has collected several big FDA decisions and mid-to-late-stage trials that should be coming up in October and added some color, along with the trading range and price target.

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.

Michael M. Morrissey, Ph.D., president and CEO of Exelixis, commented on the ESMO:

This year’s ESMO Congress provides Exelixis and our partners with the opportunity to present data across a broad spectrum of cancers and potential treatment combinations. We look forward to the first presentation of the CABOSUN data, which will provide more detail about the statistically significant and clinically meaningful improvement in progression-free survival for cabozantinib in patients with advanced renal cell carcinoma in the front-line setting. Our focus remains on further examining the potential of our therapies and moving these medicines through clinical development so they are available to patients and physicians as quickly as possible.

Exelixis was last trading at $11.92, with a consensus analyst price target of $10.67 and a 52-week trading range of $3.55 to $12.22.


In February, the FDA accepted Medivation Inc.’s (NASDAQ: MDVN) supplemental New Drug Application (sNDA) for Xtandi in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 Terrain and Strive Studies, to update the relevant clinical sections within the current indication. Xtandi is approved by the FDA for the treatment of patients with mCRPC. The FDA set the PDUFA goal date for Xtandi for October 22.

Shares of Medivation were last seen at $80.97, with a consensus price target of $77.15 and a 52-week range of $26.41 to $80.99.

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