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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 a total 2021 net revenue of $42.3 million, primarily driven by FOTIVDA® (tivozanib) with $38.9 million in U.S. net product revenue since its launch on March 22, 2021. The fourth quarter of 2021 saw U.S. net product revenue rise to $16.8 million, a 26% increase in prescriptions compared to the previous quarter. AVEO expects 2022 FOTIVDA revenue between $100 million and $110 million. Positive long-term data from the TIVO-3 study support the drug's efficacy in advanced renal cell carcinoma.
AVEO Oncology (Nasdaq: AVEO) will report its full year 2021 financial results on March 14, 2022, followed by a conference call at 8:30 a.m. ET. The company focuses on oncology and markets FOTIVDA® for advanced renal cell carcinoma. AVEO is advancing FOTIVDA in immuno-oncology and other combinations, while also working on various investigational programs. The press release includes cautionary notes about forward-looking statements, highlighting potential risks and uncertainties affecting the company's future outlook.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) and AVEO Oncology (NASDAQ: AVEO) announced a research collaboration to develop a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, utilizing Actinium's AWE technology platform with Ac-225. This partnership aims to enhance targeted cell killing in hard-to-treat cancers. AVEO will leverage its expertise in high-affinity antibodies to advance the development of this novel radiotherapy. Both companies are excited about the potential impact on patient outcomes and the expansion of their oncology portfolios.
AVEO Oncology announced significant long-term progression-free survival (PFS) results for FOTIVDA® (tivozanib) presented at the ASCO GU 2022 symposium. Data from the pivotal TIVO-3 study shows that patients receiving FOTIVDA are up to five times more likely to achieve long-term PFS compared to those on Nexavar® (sorafenib). At three and four years, PFS rates were 12% vs. 2% and 8% vs. 0%, respectively. These findings suggest FOTIVDA may become a standard treatment for advanced renal cell carcinoma (RCC) after previous therapies, emphasizing its potential for improved overall survival.
AVEO Oncology (Nasdaq: AVEO) will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 9:20 a.m. ET. A live webcast of the discussion will be available in the investors section of AVEO’s website, with an archive accessible for 30 days post-event. AVEO is focused on oncology, marketing FOTIVDA® for treating relapsed or refractory renal cell carcinoma (RCC). The company is also exploring new immuno-oncology combinations and other clinical development programs.
AVEO Oncology announced positive interim results from the Phase 1b/2 DEDUCTIVE study, demonstrating that tivozanib plus durvalumab is well-tolerated in treatment-naive patients with advanced hepatocellular carcinoma (HCC). Cohort A exhibited a 27.8% partial response rate and a 67.8% disease control rate. The trials in progress include the DEDUCTIVE study's cohort B and the IMMCO-1 study with tivozanib and atezolizumab. These studies aim to explore efficacy in various cancer types, highlighting a promising pipeline for AVEO.
NiKang Therapeutics and AVEO Oncology announced a collaboration for a phase 2 clinical trial evaluating the combination of NiKang's NKT2152 and AVEO's tivozanib in patients with relapsed or refractory clear cell renal cell carcinoma (ccRCC). The trial aims to assess the safety and efficacy of this combination treatment. NiKang will sponsor the trial, co-funded by AVEO, with both companies providing their drugs at no cost. This collaboration leverages the strengths of both companies to potentially enhance treatment options for ccRCC patients.
AVEO Oncology (Nasdaq: AVEO) provided an update on its progress and outlook for 2022, highlighting significant achievements despite challenges from COVID-19. The company remains focused on expanding FOTIVDA® (tivozanib) sales, which continue to grow since its launch in March 2021. AVEO is advancing its clinical pipeline, including the Phase 3 TiNivo-2 trial for RCC and a potential Phase 3 trial for ficlatuzumab in HPV negative HNSCC. Additionally, they secured a $5 million loan facility milestone and made key executive appointments.
AVEO Oncology has announced the manufacturing of ficlatuzumab clinical supply set to begin in 2Q 2022, with a registrational study for HPV negative recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) anticipated in the first half of 2023. This follows a collaboration with Merck KGaA to evaluate ficlatuzumab alongside ERBITUX in treating this patient group, associated with poor outcomes. Positive results were noted in a Phase 2 study demonstrating better responses in patients receiving the combination.
AVEO Oncology (Nasdaq: AVEO) announced its participation in the H.C. Wainwright Virtual BioConnect 2022 Conference from January 10 to 13, 2022. A fireside chat featuring AVEO’s senior management and analyst Swayampakula Ramakanth will be available for on-demand viewing starting January 10 at 7 a.m. EST on the company's website. AVEO markets FOTIVDA® for treating relapsed or refractory renal cell carcinoma and continues to explore its use in various oncology combinations. The press release includes cautionary forward-looking statements regarding potential risks and uncertainties.
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