Fly News Breaks for April 8, 2016
AZN, CLVS
Apr 8, 2016 | 09:07 EDT
Piper Jaffray analyst Steven Breazzano says today's briefing documents for Tuesday's FDA panel "leave the door open" for approval of Clovis Oncology's (CLVS) rociletinib. The FDA review focuses on the overall risk/benefit of rociletinib versus chemotherapy, not potential competitor, AstraZeneca's (AZN) Tagrisso, as well as the likelihood of predicting clinical benefit in a confirmatory study, Breazzano tells investors in a research note. Clovis, however, will still need to convince the FDA panel of the drug's superiority to chemotherapy, the analyst contends. Nonetheless, he believes rociletinib's commercial is even more uncertain than potential approval after the FDA raised concerns with cardiac adverse events and proposing a blackbox warning. Breazzano reiterates a Neutral rating on Clovis shares. The stock is trading up 17c to $19.34 in the pre-market are initially trading lower following the briefing documents.
News For CLVS;AZN From the Last 2 Days
AZN
Mar 18, 2024 | 08:17 EDT
Checkpoint Therapeutics (CKPT) announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately. Dr. Sharma currently serves as Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca (AZN) Rare Disease.