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Aravive, Inc. (Nasdaq: ARAV) is a late clinical-stage oncology company committed to developing targeted therapeutics for the treatment of metastatic diseases. With its headquarters in Houston, Texas, the company is at the forefront of cancer research aiming to improve the quality of life and outcomes for patients battling severe forms of cancer.
The company's lead product candidate, batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein designed to inhibit AXL receptor signaling by binding to its ligand GAS6. This mechanism is intended to prevent tumor growth and metastasis, as well as to restore sensitivity to existing anti-cancer therapies. Batiraxcept has received Fast Track Designation from the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer, along with Orphan Drug Designation from the European Commission for platinum-resistant recurrent ovarian cancer.
Despite recent challenges, such as the Phase 3 AXLerate-OC trial not meeting its primary endpoint in platinum-resistant ovarian cancer, Aravive remains committed to analyzing the complete dataset and determining the next steps for their other indications in renal cell carcinoma and pancreatic cancer. The Phase 3 trial involved 366 patients and aimed to evaluate the efficacy and safety of batiraxcept in combination with paclitaxel.
Aravive collaborates with renowned research groups, including The GOG Foundation, Inc. in the U.S. and the European Network for Gynecological Oncological Trials (ENGOT) in Europe. Funded by a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016, the company continues to innovate in the field of oncology.
For more information on their ongoing research and development efforts, please visit their website at www.aravive.com.
Aravive Inc. (Nasdaq: ARAV) has received a $3 million milestone payment from 3D Medicines following the approval of an IND application in China for the AVB-500 Phase 3 trial targeting platinum-resistant ovarian cancer. This approval marks Aravive's second milestone achievement since partnering with 3D Medicines in November 2020. The global trial aims to enroll 300-400 patients across various regions, including China, and evaluates AVB-500's efficacy in combination with paclitaxel. The company is eligible for up to $207 million in future milestones and royalties under the agreement.
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company, will participate in a virtual fireside chat and one-on-one meetings at the 2021 William Blair Biotech Focus Conference on July 15, 2021, at 3:00 PM ET. CEO Gail McIntyre and CMO Reshma Rangwala will be featured speakers. The event will be accessible via a live webcast, with archived replays available for 90 days. Aravive is developing AVB-500, a therapeutic targeting the GAS6-AXL signaling pathway, currently in clinical trials for ovarian and renal cell cancers, and planning a trial for pancreatic cancer in late 2021.
Aravive Inc. (Nasdaq: ARAV) announced positive preliminary results from its Phase 1b trial of AVB-500 in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC). Initial findings indicate that AVB-500, at a dose of 15 mg/kg, was well-tolerated in three evaluable patients. Following these encouraging pharmacokinetics, pharmacodynamics, and safety results, the company plans to expand dosing to three additional patients. The trial is part of a broader clinical strategy, including plans for a Phase 1b/2 trial in metastatic pancreatic cancer later this year.
Aravive, Inc. (Nasdaq: ARAV) announced the appointment of three new board members: Dr. John A. Hohneker, Mr. Sigurd C. Kirk, and Dr. Peter T.C. Ho. This expansion aims to enhance the company's leadership in drug development for treating life-threatening cancers. Dr. Hohneker brings over 30 years of biopharmaceutical experience, Mr. Kirk has extensive corporate business development expertise, and Dr. Ho has held significant roles in oncology and drug development. Aravive continues to advance its AVB-500 program and other oncology initiatives.
Aravive, a clinical-stage oncology company, announced significant updates on May 06, 2021, regarding its developmental pipeline for AVB-500. The first patient has been dosed in registrational Phase 3 and Phase 1b/2 trials for AVB-500 in platinum resistant ovarian cancer and clear cell renal cell carcinoma, respectively. The company plans to expand AVB-500's use as a first-line treatment for pancreatic cancer. The first quarter 2021 revenue was $0.3 million, with a net loss of $8.0 million. Cash reserves stand at $78.7 million, expected to last until late 2022.
Aravive Inc. (Nasdaq: ARAV) has initiated its Phase 3 trial for AVB-500 in platinum-resistant ovarian cancer, having dosed the first patient. The trial, expected to enroll 300-400 patients at about 165 sites across the U.S. and Europe, aims to improve progression-free survival. Previous Phase 1b trials showed AVB-500 to be well-tolerated with promising results. Key endpoints include overall survival and unique interim analysis for randomization. Approval could lead to a Biologics License Application if primary outcomes are met.
Aravive, Inc. (Nasdaq: ARAV) initiated a registrational Phase 3 trial of AVB-500 for platinum-resistant ovarian cancer in 1Q 2021 and dosed the first patient in a Phase 1b/2 trial for clear cell renal cell carcinoma. The company strengthened its balance sheet with a $21 million direct offering and reported $5.7 million in revenue for 2020, up from $4.8 million in 2019. However, operating expenses rose significantly to $36.5 million, leading to a net loss of $30.5 million. Cash reserves stand at $60.5 million, expected to fund operations into 2H 2022.
Aravive, Inc. (Nasdaq: ARAV) announced that new data from its Phase 1b trial of AVB-500 in platinum-resistant ovarian cancer (PROC) will be presented at the 2021 Society of Gynecologic Oncology Annual Meeting from March 19-25, 2021. The updated results show improved progression-free survival and duration of response, and the drug has a tolerable safety profile. Additionally, an investigator-sponsored trial poster on AVB-500 combined with durvalumab will also be presented. The company is focused on advancing its pivotal Phase 3 trial of AVB-500.
Aravive, Inc. (Nasdaq: ARAV) has initiated a Phase 1b/2 clinical trial for AVB-500, targeting patients with advanced clear cell renal cell carcinoma who have not responded to prior treatments. The trial assesses AVB-500's safety and efficacy, particularly its effect on progression-free survival. With kidney cancer being a leading cause of cancer-related deaths in the U.S., this trial aims to provide vital new treatment options. AVB-500 targets the GAS6-AXL pathway, known for its role in tumor growth. The trial will also explore AVB-500 in combination with cabozantinib.
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company, announced its participation in two virtual investor conferences in March 2021. The H.C. Wainwright Global Life Sciences Conference will take place on March 9-10, with Aravive's presentation available for viewing on March 9. The Oppenheimer 31st Annual Healthcare Conference is scheduled for March 18 at 8:00 a.m. ET. Archived presentations will be accessible for 90 days. Aravive is advancing its lead product candidate, AVB-500, which targets tumor growth pathways and has shown promising results in trials for ovarian and renal cancer.
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