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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 reported full-year 2020 financial results, highlighting FDA approval of FOTIVDA for advanced renal cell carcinoma (RCC) treatment. The company anticipates launching FOTIVDA by March 31, 2021, and advancing clinical studies, including a pivotal Phase 3 trial in combination with OPDIVO. Despite an increase in cash reserves to $61.8 million, total revenue fell to approximately $6.0 million, down from $28.8 million in 2019. The net loss for 2020 was $35.6 million. AVEO expects to fund operations into 2022 with existing cash, loan drawdowns, and projected revenues from FOTIVDA.
AVEO Oncology announced it will regain rights to AV-203 outside North America after CANbridge Life Sciences voluntarily terminated their collaboration agreement. Effective September 5, 2021, AVEO will receive all preclinical data and materials related to AV-203. This antibody targets ErbB3 and has shown promise in early studies, including one partial response in an NRG1+ patient. AVEO’s strategy also includes advancing other drug candidates, such as FOTIVDA and ficlatuzumab. The reacquisition adds to AVEO's diverse oncology portfolio, aiming for long-term value creation.
AVEO Oncology (Nasdaq: AVEO) has partnered with Bristol Myers Squibb to launch the pivotal Phase 3 TiNivo-2 trial, evaluating FOTIVDA (tivozanib) combined with OPDIVO (nivolumab) for advanced relapsed or refractory renal cell carcinoma (RCC). The trial will enroll approximately 326 patients, focusing on progression-free survival as the primary endpoint. This collaboration follows the recent FDA approval of FOTIVDA for advanced RCC, highlighting AVEO's commitment to exploring its combination potential in oncology.
AVEO Oncology (Nasdaq: AVEO) has announced a $20 million drawdown from a $45 million loan agreement with Hercules Capital, bringing total funds drawn to $35 million. This funding aims to support the U.S. launch of FOTIVDA® (tivozanib), recently FDA-approved for relapsed or refractory renal cell carcinoma. AVEO's cash reserves of $68.8 million, combined with anticipated revenues and further credit under the loan, are expected to sustain operations into 2022.
AVEO Oncology (Nasdaq:AVEO) has appointed Mike Ferraresso as Chief Commercial Officer, overseeing the commercialization of FOTIVDA (tivozanib) for treating advanced renal cell carcinoma. With over 20 years in the pharmaceutical industry, Ferraresso aims to strengthen AVEO's market presence. His previous role involved business analytics and commercial operations, significantly contributing to AVEO's strategic evolution.
FOTIVDA was FDA-approved on March 10, 2021, providing a treatment option after multiple systemic therapies.
AVEO Oncology (NASDAQ: AVEO) announced FDA approval of FOTIVDA® (tivozanib) for treating adults with relapsed or refractory advanced renal cell carcinoma (RCC) after two or more systemic therapies. This approval is pivotal as it marks AVEO's transformation into a commercial-stage company. The TIVO-3 study demonstrated FOTIVDA's superiority over sorafenib, with a median progression-free survival of 5.6 months versus 3.9 months. FOTIVDA will be available in the U.S. by March 31, 2021. Common adverse reactions include fatigue, hypertension, and diarrhea.
AVEO Oncology (Nasdaq: AVEO) announced that CEO Michael Bailey will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. A replay of the pre-recorded presentation will be available on the company's website starting March 9, 2021, and will be archived for 30 days. AVEO is focused on oncology, committed to developing medicines for cancer patients, with its lead product tivozanib already approved in the EU for advanced renal cell carcinoma. The company is also advancing other clinical candidates, including ficlatuzumab and AV-380.
AVEO Oncology (Nasdaq: AVEO) announced that CEO Michael Bailey will participate in a fireside chat at the 2021 SVB Leerink Global Healthcare Conference on February 25, 2021, at 3:00 p.m. ET. Investors can access a live webcast through the investors section of AVEO's website, with a replay available for 30 days post-event. AVEO focuses on oncology treatments, particularly its lead candidate tivozanib, approved in the EU for advanced renal cell carcinoma (RCC), and is in trials for U.S. regulatory approval. The company is also advancing its pipeline of monoclonal antibodies.
AVEO Oncology (Nasdaq: AVEO) has presented analyses from its pivotal TIVO-3 study at the ASCO 2021 Genitourinary Cancers Symposium. This Phase 3 trial compares tivozanib, a next-generation VEGF receptor TKI, to sorafenib for treating third- and fourth-line renal cell carcinoma (RCC). Findings indicate tivozanib could offer significant quality-of-life benefits and superior progression-free survival in patients who previously received axitinib. As AVEO awaits FDA approval for Tivozanib, preparations for a potential U.S. launch are underway, emphasizing the drug's potential role in treating challenging RCC cases.
AVEO Oncology (Nasdaq: AVEO) has secured a commitment letter for an additional $10 million loan from Hercules Capital, increasing its debt facility to $45 million. This amendment to the loan agreement maintains original terms, with a maturity of 36 months, extendable to 48 months, and includes a 12-month interest-only period. A $20 million tranche will be available upon FDA approval for tivozanib’s New Drug Application for renal cell carcinoma, and an additional $10 million is contingent on sales criteria. The FDA's action date for tivozanib is March 31, 2021.
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