Tesaro: Color on approval of niraparib treating ovarian cancer
- Wedbush raises tgt to $174 from $164. As expected, niraparib gains early FDA approval with a broad label for ovarian cancer patients as maintenance therapy. With first-mover advantage in the maintenance setting, a lack of requirement for a diagnostic, as well clinical data that is at least as good as AZN's Lynparza in gBRCA patients, they continue to believe that TSRO remains an attractive acquisition candidate.
- FBR & Co raises tgt to $202 from $200. They note TESARO announced that the FDA has approved Zejula (niraparib), an oral, once-daily PARP inhibitor for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy. They note that the approval came in three months before the scheduled PDUFA data of June 30. Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. Following approval, the co has announced a substantial expansion of its Zejula development program and is implementing plans to initiate registration strategies in metastatic ovarian, breast, and lung cancer settings. The co did not comment on pricing, and they continue to expect product pricing will be announced at the time of launch in late April.
- SunTrust raises tgt to $235
- This is a negative for Myriad (MYGN) and a competitive threat to Clovis (CLVS), whose PARP inhibitor Rubraca was approved for the monotherapy treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutations treated with two or more chemotherapiesapproved in ovarian cancer in December.