H.C. Wainwright raised its price target for Aravive (NASDAQ:ARAV) to $12 from $7 after increasing its probability of success for batiraxcept to 55% from 35% for platinum-resistant ovarian cancer (PROC) “to further value our confidence in the pivotal outcome.” The stock closed at $1.68 on March 14.
Analyst Joseph Pantginis writes that the registration-directed Phase 3 trial of batiraxcept plus paclitaxel for PROC recently completed enrollment and top-line results are anticipated in mid-2023. Pending favorable results, a BLA filing is expected by the end of 2023.
Mr. Pantginis said the company recently presented positive updated Phase 1b/2 results at ASCO GU with batiraxcept in clear cell renal cell carcinoma. “Looking forward, the company intends to initiate an integrated Phase 2/3 study, per FDA recommendations, slated to begin the first half of 2023,” he added.
Based on recent Phase 1b data demonstrating that batiraxcept was generally well-tolerated in combination with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma cancer, the company began dosing an additional 6-to-18 patients at higher doses (20 mg/kg and potentially 25 mg/kg) to assess whether a higher dose will increase clinical activity.
Mr. Pantginis said preliminary data from the 20 mg/kg cohort is expected in the second half of 2023.
