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AVEO Pharmaceuticals Inc., now operating as AVEO Oncology under LG Chem, is a biopharmaceutical company dedicated to improving the lives of cancer patients through innovative treatments. AVEO's primary focus is on oncology, specifically targeting and commercializing therapies within North America, while leveraging strategic partnerships for development in other regions.
Key product: FOTIVDA® (tivozanib), a next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), is AVEO’s lead candidate, approved by the U.S. FDA in March 2021 for treating relapsed or refractory renal cell carcinoma (RCC) after two or more prior systemic therapies. It boasts a favorable safety profile and significant long-term survival benefits. Initially approved in the European Union and other countries in 2017, FOTIVDA® continues to show promise in clinical settings, with recent trials indicating its efficacy over sorafenib in patients with advanced RCC.
Alongside FOTIVDA®, AVEO's pipeline includes promising candidates like ficlatuzumab, an anti-HGF IgG1 mAb currently in a Phase 3 trial for head and neck squamous cell carcinoma (HNSCC). The company also explores the potential of AV-380 for treating cancer cachexia, supported by a Phase 1 clinical trial. Other early-stage monoclonal antibodies in development include AV-203 targeting ErbB3 and AV-353 targeting Notch 3.
Recent updates include the commencement of the FIERCE-HN trial, evaluating ficlatuzumab in combination with ERBITUX® for HPV-negative recurrent or metastatic HNSCC, and the release of a significant post-hoc analysis from the TIVO-3 trial, reinforcing FOTIVDA®'s durable clinical benefits.
AVEO's commitment to diversity and inclusion, coupled with rigorous scientific research and development under the aegis of LG Chem, underscores its mission to deliver life-enhancing oncology treatments globally.
AVEO Oncology has appointed Jeb Ledell as its new Chief Operating Officer, bringing over 20 years of biotech leadership experience. His role will focus on enhancing operational efficiency and advancing the company's product pipeline. Ledell previously held leadership positions at Enzyvant Therapeutics and Compass Therapeutics, contributing to significant operational successes. CEO Michael Bailey emphasized that Ledell’s expertise will help manage growth and deliver shareholder value as AVEO continues to capitalize on opportunities with its oncology product, FOTIVDA.
AVEO Oncology (NASDAQ: AVEO) recently announced its participation in two virtual investor conferences. The Stifel 2021 Healthcare Conference is scheduled for November 15 at 1:20 p.m. ET, while the 4th Annual Evercore ISI Healthconx Conference will take place on November 30 at 12:35 p.m. ET. Interested investors can access live webcasts and archived recordings on AVEO's website for up to 30 days post-event. AVEO is dedicated to developing treatments for cancer, including its marketed product FOTIVDA® for renal cell carcinoma.
AVEO Oncology reported Q3 2021 revenue of $15.2 million, significantly up from $3.6 million in Q3 2020, driven largely by FOTIVDA® sales of $14.3 million. The company saw a 113% increase in quarterly revenue from the previous quarter, bolstered by the growing demand for FOTIVDA in treating relapsed/refractory renal cell carcinoma. Enrollment for the Phase 3 TiNivo-2 trial of tivozanib in combination with OPDIVO® has begun. Additionally, ficlatuzumab received Fast Track Designation from the FDA. AVEO ended the quarter with $94 million in cash and anticipates maintaining operations for at least 12 months.
AVEO Oncology (Nasdaq: AVEO) announced its third quarter 2021 financial results will be reported on November 8, 2021, with a conference call at 4:30 p.m. ET to discuss the results and business updates. AVEO focuses on oncology and markets FOTIVDA® for treating relapsed or refractory renal cell carcinoma. The company is also developing immuno-oncology combinations involving FOTIVDA and other investigational programs. Forward-looking statements are made with caution, acknowledging risks and uncertainties that could impact actual results.
AVEO Oncology (NASDAQ: AVEO) announced that the FDA granted Fast Track Designation to ficlatuzumab for treating relapsed or recurrent head and neck squamous cell carcinoma. This designation highlights the drug's potential to meet unmet medical needs. The company previously reported positive results from a Phase 2 study showing improved outcomes for certain patients. However, delays in clinical supplies due to material shortages may impact timelines for a registrational study anticipated for 2023. AVEO aims to continue discussions with the FDA regarding pivotal study designs.
AVEO Oncology (Nasdaq: AVEO) announced its participation in two virtual investor conferences. The first is H.C. Wainwright’s 23rd Annual Global Investment Conference on September 13 at 7:00 a.m. ET. The second is the Baird 2021 Global Healthcare Conference on September 14 at 3:10 p.m. ET. A live webcast of the Baird conference will be available on AVEO's website, with a replay accessible for 30 days post-event. AVEO is focused on oncology, marketing FOTIVDA® for renal cell carcinoma and developing immuno-oncology combinations.
AVEO Oncology (Nasdaq: AVEO) reported Q2 2021 financial results, marking a successful first full quarter of FOTIVDA sales, generating $6.7 million net revenue since its launch on March 22, 2021. Total product revenue since launch reached $7.8 million, with 453 prescriptions filled. However, a delay in ficlatuzumab's registrational study start date is expected due to supply shortages, now projected for 2023. AVEO ended Q2 2021 with $102.9 million in cash. It anticipates $40 million in commercial spending this year, with a net loss of $13.6 million reported for the quarter.
AVEO Oncology (Nasdaq: AVEO) announced it will report its second quarter 2021 financial results on August 5, 2021. The management will host a conference call at 4:30 p.m. ET to discuss results and updates. Investors can join the call by dialing (844) 882-7841 for U.S. or (574) 990-9828 internationally, using passcode 3857963. AVEO markets FOTIVDA® for treating relapsed or refractory renal cell carcinoma and is developing additional combinations and investigational programs.
AVEO Oncology (Nasdaq: AVEO) announced a keynote webinar on FOTIVDA® (tivozanib) for treating relapsed or refractory renal cell carcinoma (RCC) on July 16, 2021. Key opinion leaders Dr. Thomas Hutson and Dr. Brian Rini will discuss the Phase 3 TIVO-3 study results and the evolving RCC treatment landscape. The company management will outline the market strategy following FDA approval received in March 2021, highlighting over 300 prescriptions since launch. The webinar will be accessible live via AVEO's website, with a replay available for a limited time.
AVEO Oncology (Nasdaq: AVEO) announced a key opinion leader webinar on ficlatuzumab, an investigational monoclonal antibody targeting hepatocyte growth factor (HGF) for head and neck squamous cell carcinoma (HNSCC), scheduled for June 16, 2021, at 2:00 p.m. ET. Dr. Julie E. Bauman will present findings from a randomized Phase 2 study and discuss treatment needs in HNSCC. AVEO plans to decide mid-year on initiating a Phase 3 study for HPV negative HNSCC post-FDA feedback. Interested parties can access the live webcast on AVEO's website.
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