Aravive, Inc. - ARAV STOCK NEWS

Aravive, Inc. (Nasdaq: ARAV) announced the appointment of Carolina Petrini as Chief Commercial Officer effective April 10, 2023. Petrini brings over 25 years of experience in developing commercial strategies, particularly in oncology. CEO Gail McIntyre expressed confidence in her ability to advance Aravive's lead candidate, batiraxcept, amid ongoing trials in platinum-resistant ovarian cancer (PROC) and more. The company notes batiraxcept has received Fast Track Designation from the FDA for two indications. As part of her employment, Petrini received an inducement stock option for 400,000 shares at an exercise price of $1.86, vesting over four years. This strategic appointment aims to enhance the company's commercial structure as it approaches critical clinical data readouts in mid-2023.

Aravive, Inc. (Nasdaq: ARAV) reported robust financial results for Q4 and the full year 2022. Revenues rose to approximately $9.1 million, a significant increase from $7.4 million in 2021. The company completed enrollment for its PROC Phase 3 trial and expects topline data by mid-2023, potentially leading to a Biologics License Application by year-end. Aravive has secured approximately $40 million in funding, strengthening its cash position to $53.7 million as of December 31, 2022. Despite a net loss of $76.3 million for the year, the company is progressing with promising clinical data for batiraxcept across various cancer indications.

Aravive, Inc. (Nasdaq: ARAV) has initiated the dose escalation phase of its Phase 1b/2 trial for pancreatic adenocarcinoma, with preliminary results expected in the second half of 2023. The FDA has granted Orphan Drug Designation (ODD) to batiraxcept for treating pancreatic ductal adenocarcinoma, providing incentives such as tax credits and up to seven years of market exclusivity. Dr. Gail McIntyre emphasized the importance of this designation given the severe unmet need in pancreatic cancer, where the five-year survival rate is only 11%. The ongoing trial is evaluating batiraxcept in combination with gemcitabine and nab-paclitaxel.

Aravive, Inc. (Nasdaq: ARAV) presented updated results from its ongoing Phase 1b/2 trial of batiraxcept for metastatic clear cell renal cell carcinoma (ccRCC) at the 2023 ASCO GU Symposium. The trial involved 26 patients who had previously received immuno-oncology and VEGF-TKI therapies. Updated data show that 85% of patients experienced a reduction in target lesions, while 58% achieved better responses compared to prior treatments. The 9-month progression-free survival rate was 65%. Batiraxcept has been granted Fast Track Designation by the FDA for this indication, indicating significant potential for this therapy.

Aravive, Inc. (Nasdaq: ARAV) announced full enrollment in its Phase 3 trial for batiraxcept combined with paclitaxel to treat platinum-resistant ovarian cancer. The trial aims to assess the efficacy and safety of this treatment in approximately 350 patients across 165 sites in the U.S. and Europe. Topline data is expected mid-2023, with a potential Biologics License Application submission planned for the end of 2023. The company emphasizes the need for effective therapies in this area, as current treatments show low response rates.

Aravive, Inc. (Nasdaq: ARAV) has received Fast Track Designation from the FDA for its lead program, batiraxcept, aimed at treating patients with advanced clear cell renal cell carcinoma (ccRCC) who progressed after prior systemic therapies. Recent Phase 1b data indicated an objective response rate (ORR) of 57% and a median progression-free survival (PFS) of 11.4 months in treated patients. The Fast Track Designation will facilitate closer communication with the FDA on trial designs and expedite drug review processes.

On November 16, 2022, Aravive announced it has regained compliance with Nasdaq's minimum bid price requirement. This follows a notification from Nasdaq on August 9, 2022, indicating that ARAV shares had fallen below the $1.00 threshold. From October 27 to November 10, 2022, ARAV stock closed at $1.00 or greater for 11 consecutive days, leading to the closure of this matter. Aravive is developing targeted therapeutics for metastatic diseases, with its lead product, batiraxcept, in various clinical trials and designated as Fast Track and Orphan Drug by regulatory bodies.

Aravive, Inc. (Nasdaq: ARAV) reported third-quarter financial results for 2022 and outlined significant advancements in clinical trials focused on platinum-resistant ovarian cancer, clear cell renal cell carcinoma, and pancreatic adenocarcinoma. The company secured approximately $41.5 million from a private placement, enhancing its cash position to about $73 million post-funding. Revenues rose to $4.9 million, primarily due to milestone achievements from its collaboration with 3D Medicines. Despite a net loss of $15.7 million, Aravive remains on track with its clinical trials and expects to deliver pivotal data by mid-2023.

Aravive, Inc. has announced a private placement offering to raise approximately $41.5 million. The company will sell 45,178,811 shares priced at $0.9199 each, with additional warrants. This financing includes participation from new and existing investors, including BVF Partners and Eshelman Ventures, expected to close on October 27, 2022. Proceeds will support the pivotal Phase 3 trial in platinum-resistant ovarian cancer and additional trials in related cancers. The company plans to seek shareholder approval for increasing authorized shares within 120 days post-closing.