Clinical Trial ConcernsNeither of the cabozantinib studies demonstrated a statistically significant benefit in overall survival.
Intellectual Property IssuesIn the ANDA case between Exelixis and MSN Laboratories ('MSN II'), the judge issued the ruling this morning that the Malate Salt Patents (patents 11,091,439, composition) is not infringed.
Regulatory ChallengesThe FDA is requiring an Oncologic Drugs Advisory Committee meeting to discuss the sNDA for cabozantinib in advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic NET.