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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) announced a registered direct offering of 2,875,000 shares at $7.29 per share, expecting to raise approximately $21 million. The funds will support the clinical development of AVB-500 for ovarian and renal cancer. The offering, with Eshelman Ventures as the participating investor, is set to close by February 18, 2021. CEO Gail McIntyre highlighted confidence in AVB-500's potential in addressing unmet patient needs, with a pivotal Phase 3 trial for ovarian cancer planned to begin soon, aiming to report interim results next year.
Aravive, Inc. (Nasdaq: ARAV) announced its participation in the H.C. Wainwright Virtual BioConnect Conference from January 11-14, 2021. The company will showcase its innovative therapeutics targeting life-threatening diseases, particularly its lead product, AVB-500, which aims to inhibit tumor growth through GAS6-AXL signaling pathways.
The presentation will be available for viewing on January 11, 2021, and can be accessed via their investor relations website, with a 90-day archive for replays.
Aravive, Inc. (Nasdaq: ARAV) announces the resignation of Dr. Ray Tabibiazar from its Board of Directors, effective December 31, 2020. Dr. Tabibiazar, a co-founder of Aravive Biologics, will continue to serve as an advisor while pursuing a new venture. His tenure included leading a reverse merger with Versartis, Inc. and significant input in advancing the lead drug, AVB-500. The company successfully completed a Phase 1b trial of AVB-500 in platinum-resistant ovarian cancer, reporting clinical benefits in all patients in the trial cohort.
Aravive, Inc. (Nasdaq: ARAV) announced FDA guidance on their pivotal Phase 3 trial design for AVB-500 in platinum-resistant ovarian cancer, expected to initiate during 1Q21. The trial aims to evaluate AVB-500's efficacy and tolerability with paclitaxel, enrolling approximately 300-400 patients across 100 sites in the U.S. and Europe. Primary endpoints include progression-free survival, with interim analyses planned after one year. The company hopes successful trial results will support a biologics license application to the FDA.
HOUSTON, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Aravive, a clinical-stage oncology company, will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference. The presentation starts November 23, 2020, with one-on-one investor meetings scheduled for December 3, 2020. Aravive’s lead therapy, AVB-500, targets cancer progression and has shown promising results in a recent Phase 1b trial for platinum-resistant ovarian cancer, where no dose-limiting toxicities were reported. The company plans to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma.
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company, will host a virtual event on November 20, 2020, focused on Ovarian and Renal Cancer. The event will showcase clinical development plans for AVB-500, targeting platinum-resistant ovarian cancer and clear cell renal cell carcinoma. Leading oncologists, including Katherine Fuh and Eric Jonasch, will provide insights on treatment advancements. A live webcast will be accessible on the Aravive website, with a replay available post-event. Aravive's AVB-500 has shown promising results in recent trials, with all patients in the 15 mg/kg cohort experiencing clinical benefits.
Aravive has entered into a collaboration with 3D Medicines to develop and commercialize AVB-500 for oncology in Greater China. The deal includes a $12 million signing payment, potential milestone payments of up to $207 million, and tiered royalties on net sales. AVB-500 targets the GAS6-AXL pathway, previously showing positive Phase 1b trial results in platinum-resistant ovarian cancer. Under the agreement, 3D Medicines will cover all development costs while Aravive retains rights outside Greater China, continuing its development activities elsewhere.
Aravive, Inc. (Nasdaq: ARAV) announced its financial results for Q3 2020, reporting no revenue, down from $4.8 million in Q3 2019. Operating expenses rose to $10.7 million, with a net loss of $10.7 million, or $0.66 per share. The company is set to initiate pivotal trials for AVB-500 in platinum-resistant ovarian cancer and a Phase 1b/2 trial in clear cell renal cell carcinoma in late 2020 or early 2021. As of September 30, 2020, cash and equivalents stood at $54 million, expected to fund operations into 2022.
Aravive, Inc. (Nasdaq: ARAV) announced the appointment of Michael W. Rogers to its Board of Directors, where he will chair the Audit Committee and serve on the Business Strategy Committee. With over 20 years in public company finance and biopharmaceuticals, Rogers aims to enhance Aravive's clinical programs and business strategies. His recent role as CFO at Aerpio Pharmaceuticals adds relevant experience. The company recently completed a Phase 1b trial of its lead therapeutic, AVB-500, in platinum-resistant ovarian cancer, demonstrating positive results with no significant safety concerns.
Aravive, Inc. (Nasdaq: ARAV) announced its participation in two virtual investor conferences in September 2020. The presentations will occur at the Cantor Fitzgerald Global Healthcare Conference on September 15 at 3:20 p.m. ET and the H.C. Wainwright 22nd Annual Global Investment Conference on September 16 at 1:00 p.m. ET. The company will also discuss its lead therapeutic, AVB-500, which targets the GAS6-AXL signaling pathway. A recent Phase 1b trial showed promising results, with 100% clinical benefit in a specific patient cohort. Archived replays of the presentations will be available for 90 days.
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