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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 (Nasdaq: AVEO) announced that CEO Michael Bailey will participate in a panel discussion at the Cantor Fitzgerald Oncology & HemOnc Conference on September 28, 2022, at 10:40 a.m. ET. The panel, titled “Building Combinations: What are the Novel Ideas?”, will focus on innovative strategies in oncology. AVEO is dedicated to improving cancer treatment and currently markets FOTIVDA® (tivozanib) for advanced renal cell carcinoma. The company emphasizes its commitment to diversity and inclusion in its workforce.
AVEO Oncology (Nasdaq: AVEO) has announced participation in three investor conferences in September 2022, aiming to strengthen investor relations. The events include the Wells Fargo Healthcare Conference from September 7-9, the H.C. Wainwright 24th Annual Global Investment Conference on September 12 at 5:00 p.m. ET, and the Baird 2022 Global Healthcare Conference on September 13 at 11:25 a.m. ET. AVEO is focused on developing innovative cancer treatments, notably FOTIVDA® for advanced renal cell carcinoma, while emphasizing its commitment to diversity and inclusion.
AVEO Oncology reported Q2 2022 net revenues of $25.3 million, primarily driven by FOTIVDA® (tivozanib) U.S. net product revenue of $25.0 million, reflecting a 24% quarter-over-quarter growth. The company reaffirmed its full-year revenue guidance of $100.0 million to $110.0 million. R&D spending guidance has decreased to $50.0 million from an earlier estimate of $60.0 million to $70.0 million. AVEO believes its cash reserves of $77.2 million will sustain operations for over 12 months.
AVEO Oncology (Nasdaq: AVEO) will announce its Q2 2022 financial results on August 4, 2022. Following the report, a conference call will be held at 4:30 p.m. ET for a detailed discussion on the financial outcomes and business updates. The call can be accessed via phone or through a live webcast on AVEO's website. The company is focused on developing FOTIVDA® (tivozanib) for advanced renal cell carcinoma and is exploring further clinical development in immuno-oncology combinations.
AVEO Oncology has announced a collaboration with Eli Lilly to evaluate its investigational drug, ficlatuzumab, in combination with Lilly's ERBITUX (cetuximab) for treating recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This agreement follows a similar deal with Merck KGaA. The potential Phase 3 registry trial is expected to start in the first half of 2023. Positive Phase 2 results indicated that this combination may significantly improve outcomes for patients, especially those with HPV-negative R/M HNSCC. The FDA has granted Fast Track designation for this combination.
AVEO Oncology announced that the National Comprehensive Cancer Network (NCCN) has upgraded FOTIVDA® (tivozanib) to Category 1 status for patients with relapsed or refractory renal cell carcinoma (RCC) who have received two or more prior therapies. This recognition highlights the strong clinical evidence supporting FOTIVDA’s efficacy. Recent data from the Phase 3 TIVO-3 study show significant long-term progression-free survival and overall survival improvements. FOTIVDA is an oral tyrosine kinase inhibitor approved in both the U.S. and EU for advanced RCC treatment.
AVEO Oncology presented promising results for tivozanib at the 2022 ASCO Annual Meeting. Key findings from the exploratory TIVO-3 study indicated a 55% reduction in death risk for patients achieving 1 year progression-free survival compared to sorafenib. Further analysis from a Phase 2 trial revealed a 15.2% overall response rate in difficult-to-treat patients with non-clear cell renal cell carcinoma. The ongoing Phase 3 TiNivo-2 study aims to evaluate tivozanib in combination with nivolumab, enhancing its potential in the second-line treatment market for renal cell carcinoma.
AVEO Oncology (Nasdaq: AVEO) announced participation in a fireside chat at the H.C. Wainwright Global Investment Conference on May 25, 2022, at 1:30 p.m. ET. This event highlights the company’s ongoing commitment to oncology-focused biopharmaceuticals.
AVEO’s marketed product, FOTIVDA® (tivozanib), treats advanced renal cell carcinoma in the U.S. and is under further development for other indications.
Investors can access a live webcast of the discussion on AVEO's website, with a replay available for 30 days.
AVEO Oncology reported Q1 2022 net revenue of $20.9 million, primarily from FOTIVDA®, which saw a 25% increase in prescriptions compared to Q4 2021. The company maintains a full year revenue guidance of $100-$110 million for FOTIVDA. The Phase 3 TiNivo-2 trial is ongoing to evaluate the drug's efficacy in combination with nivolumab. AVEO also reported a net loss of $10.2 million for the quarter, but improved from a $22.1 million loss in Q1 2021. Cash reserves were $79 million as of March 31, 2022.
AVEO Oncology (Nasdaq: AVEO) announced it will report its Q1 2022 financial results on May 5, 2022. The management team will hold a conference call at 8:30 a.m. ET on the same day to discuss the results and provide a business update. FOTIVDA® (tivozanib), the company's marketed product, targets advanced renal cell carcinoma in patients who have received prior systemic therapies. AVEO is also exploring further developments in immuno-oncology and other targeted treatments. The press release contains forward-looking statements with inherent risks and uncertainties.
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