The PDUFA approval date is January 18, 2019. Subscribe to the IMMU board - it is one of the most active and a lot of knowledgeable folks on the board. There are probably 10 banks following the company, with all expecting approval, but you don't have it until you have it. All have target prices of $30 or higher. thanks for the Tina song.
The below is from a Guggenheim Nov. report.
No FDA-advisory committee meeting (AdCom) ahead of January 18 PDUFA date. Management noted that it was notified by the FDA during a recent mid-cycle review that no Adcom will be called and that the company is working closely and with the FDA to address any outstanding review issues in connection with its BLA for sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC). Recall the PDUFA-date is on January 18, 2019 and the agent has breakthough therapy designation status and priority review. IMMU appears to be launch-ready, focusing on a "high-quality" commercial rollout. In light of the upcoming PDUFA date and potential approval, IMMU is gearing up for the launch of sacituzumab in the US. Mgmt. noted that all 50 experienced sales representatives have now been hired and are being trained. In addition, the commercial leadership team across marketing, sales, sales operations, and market access is now fully staffed and engaged in pre-commercial activities with payers and health plans. On the EU front, IMMU is considering several filing options and is interacting with regulators. A range of options exists according to mgmt, including (1) accelerated approval based on the existing data package, (2) waiting for results from the randomized ASCEND Phase III trial, or (3) a hybrid option, which entails filing earlier with existing data and supplementing Phase III results late during the review cycle. Label extension-enabling trial activities remain on track. The pivotal TROPHY U-01 Phase II trial in metastatic urothelial cancer (mUC) has recently initiated and IMMU plans an interim analysis in 2019. Mgmt is still interacting with regulatory agencies to finalize the design of a Phase III trial in ER+, HER2- breast cancer and also plan initiation of a singleagent basket trial, which could enable expansion into additional registration-enabling single agent cohorts. IMMU today also announced adding 2L NSCLC to the ongoing clinical trial collaboration with AZN, which is focused on evaluation of sacituzumab with Imfinzi. This trial collaboration was initially focused on 1L TNBC and 1L mUC. IMMU also has a trial collaboration with CLVS with the goal to evaluate sacituzumab in combination with Rubraca in TNBC and mUC. Maintaining our BUY rating. IMMU reported 1Q19 cash & equivalents of $580.6M, which mgmt guided to be sufficient to fund operations, research and clinical development activities into 2021. We maintain our PT of $33 and our BUY rating. |
