Tectonic evolution of the Aravalli Mountains

Aravive Announces Top-Line Results from Phase 3 AXLerate-OC Study of Batiraxcept in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Wednesday, August 2, 2023

The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab).

Key Points: 
  • The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab).
  • The Company will continue to evaluate the complete dataset and determine next steps in the development of batiraxcept.
  • In the bevacizumab-naïve population (n=179), the median PFS in the batiraxcept plus paclitaxel arm was 5.4 months, compared to 5.4 months in the paclitaxel arm.
  • In the overall population, the median PFS in the batiraxcept plus paclitaxel arm was 5.1 months, compared to 5.5 months in the paclitaxel arm.

Aravive to Present Updated Clinical Data from Batiraxcept Trials in Renal and Pancreatic Cancer at ESMO Congress 2023

Retrieved on: 
Friday, July 28, 2023

HOUSTON, July 28, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the acceptance of two abstracts for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2023, being held October 20-24, 2023 in Madrid, Spain.

Key Points: 
  • HOUSTON, July 28, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the acceptance of two abstracts for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2023, being held October 20-24, 2023 in Madrid, Spain.
  • Posters will feature clinical data from the Company’s ongoing Phase 1b/2 trials of batiraxcept in clear cell renal cell carcinoma (ccRCC) and pancreatic adenocarcinoma (PDAC).
  • Phase 1b/2 Study of Batiraxcept (BT, AVB-S6-500, an AXL pathway inhibitor) in Combination with Cabozantinib (Cabo) in Patients with Advanced Clear Cell Renal Cell Carcinoma (ccRCC) who Failed First Line (1L) Therapy

Aravive Announces Phase 3 Trial Design for Batiraxcept in Clear Cell Renal Cell Carcinoma

Retrieved on: 
Tuesday, May 16, 2023

HOUSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting.

Key Points: 
  • HOUSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting.
  • “We are very pleased to be advancing batiraxcept into Phase 3 development in ccRCC, having successfully completed our EOP2 meeting with the FDA,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
  • “We believe our trial design and planned endpoint analyses are consistent with the FDA’s guidance, and we look forward to initiating our registrational Phase 3 trial in the second half of 2023.
  • The global trial is planned to be conducted at approximately 100 sites in the U.S. and around the world.

Aravive Reports First Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, May 10, 2023

If successful, the Company plans to submit a BLA by year-end 2023.

Key Points: 
  • If successful, the Company plans to submit a BLA by year-end 2023.
  • In March 2023, preclinical results from a study of batiraxcept in bile duct cancer were published in the peer-reviewed journal Cancers.
  • As of March 31, 2023, cash and cash equivalents were $35.9 million, compared to $53.7 million as of December 31, 2022.
  • The Company anticipates that its current cash and cash equivalents will fund operating plans into the fourth quarter of 2023.

Aravive Announces Poster Presentation on Batiraxcept at 2023 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 26, 2023

HOUSTON, April 26, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the presentation of a poster featuring batiraxcept data in clear cell renal cell carcinoma at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, Illinois and virtually.

Key Points: 
  • HOUSTON, April 26, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced the presentation of a poster featuring batiraxcept data in clear cell renal cell carcinoma at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, Illinois and virtually.
  • In addition, an abstract highlighting batiraxcept data in pancreatic adenocarcinoma was accepted for publication.
  • Phase 2 study of batiraxcept (AVB-S6-500, an AXL inhibitor) as monotherapy, in combination with cabozantinib (cabo), and in combination with cabo and nivolumab (nivo) in patients with advanced clear cell renal cell carcinoma (ccRCC)

Aravive Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 15, 2023

HOUSTON, March 15, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today reported fourth quarter and full year ended December 31, 2022 financial results and provided corporate updates.

Key Points: 
  • HOUSTON, March 15, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today reported fourth quarter and full year ended December 31, 2022 financial results and provided corporate updates.
  • "As we reflect on a productive 2022, Aravive remains committed to driving progress across all aspects of our business," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
  • If those results are positive, the Company plans on submitting a Biologics License Application (BLA) to FDA by year-end 2023.
  • As of December 31, 2022, cash and cash equivalents were approximately $53.7 million, compared to approximately $27.9 million as of September 30, 2022.

Aravive Announces Fast Track Designation of Batiraxcept for Treatment of ccRCC

Retrieved on: 
Tuesday, November 29, 2022

Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs with Fast Track Designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer (ccRCC) study (AVB500-RCC-003; NCT04300140).
  • Batiraxcept has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation by the European Commission in platinum-resistant recurrent ovarian cancer.

Aravive Reports Third Quarter 2022 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, November 10, 2022

HOUSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, the Company),a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today reported financial results for the third quarter ended September 30, 2022 and provided corporate updates.

Key Points: 
  • HOUSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, the Company),a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today reported financial results for the third quarter ended September 30, 2022 and provided corporate updates.
  • Aravive continues to make tremendous progress on all fronts, said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
  • The registration-directed Phase 3 program of batiraxcept in combination with paclitaxel in PROC remains on track to complete enrollment aroundyear-end 2022.
  • Revenues for the three months ended September30, 2022, were approximately $4.9 million, compared to approximately $1.6million for the three months ended June 30, 2022.

Aravive Announces Approximately $41.5 Million Private Placement Financing

Retrieved on: 
Tuesday, October 25, 2022

The private placement is expected to close on October 27th, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The private placement is expected to close on October 27th, subject to the satisfaction of customary closing conditions.
  • The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the Minimum Price requirement (as defined in the Nasdaq rules).
  • MTS Securities, LLC, an affiliate of MTS Health Partners L.P., acted as the exclusive placement agent in the financing.
  • This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Aravive Receives Third Development Milestone from 3D Medicines

Retrieved on: 
Monday, October 10, 2022

HOUSTON, Oct. 10, 2022 (GLOBE NEWSWIRE) -- Aravive Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, today announced that it received a $6 million development milestone payment from its licensee, 3D Medicines Inc.

Key Points: 
  • HOUSTON, Oct. 10, 2022 (GLOBE NEWSWIRE) -- Aravive Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, today announced that it received a $6 million development milestone payment from its licensee, 3D Medicines Inc.
  • Aravives collaboration and license agreement with 3D Medicines Inc. is for the development and commercialization of batiraxcept in oncology indications in Greater China.
  • Under the terms of the agreement, Aravive is eligible to receive up to an aggregate of $207 million in development and commercial milestone payments and royalties.
  • In addition to achieving this $6 million development milestone, the Company had previously received a $9 million in development milestones related to development of batiraxcept for platinum resistant ovarian cancer in the United States and China, as well as a $12 million upfront payment in 2020, totaling $27 million that has been achieved by Aravive from 3D Medicines.