It has been about a month since the last earnings report for Exelixis, Inc. Shares have lost about Will the recent negative trend continue leading up to its next earnings release, or is EXEL due for a breakout?
Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. The FDA approved a tablet formulation of cabozantinib, distinct from the capsule form under the brand name Cabometyx in April for the treatment of advanced renal cell carcinoma RCC in patients who have received prior anti-angiogenic therapy.
In the fourth quarter, research and development expenses increased Earnings per share came in at 49 cents, up from a loss of 28 cents in and in line with the Zacks Consensus Estimate. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis.
Exelixis inked agreements with Bristol-Myers and Roche Holding to develop cabozantinib in combination with immunotherapy agents in Exelixis and Bristol-Myers initiated a phase III trial, CheckMate 9ER, in July which is evaluating the combination of checkpoint inhibition therapy, combined with a cabozantinib, compared to Sutent.
Meanwhile, updated results from the ongoing phase I trial of cabozantinib in combination with Opdivo, with or without Yervoy, in patients with refractory genitourinary tumors demonstrated an acceptable tolerability profile, and high rates of durable responses in the previously treated metastatic UC and metastatic RCC cohorts. In JanuaryExelixis announced an amendment to the protocol for the phase Ib trial of cabozantinib in combination with Tecentriq in patients with locally advanced or metastatic solid tumors.
The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma. The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.