AVEO AVEO Pharmaceuticals Inc.

8.18
-0.03  -0%
Previous Close 8.21
Open 8.18
52 Week Low 2.2301
52 Week High 10.71
Market Cap $235,659,657
Shares 28,809,249
Float 26,203,673
Enterprise Value $181,247,656
Volume 376,690
Av. Daily Volume 388,182
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Upcoming Catalysts

Drug Stage Catalyst Date
Tivozanib
Third line treatment of patients with renal cell cancer
PDUFA
PDUFA
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Ficlatuzumab and cetuximab
Head and neck squamous cell carcinoma (HNSCC)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
FOTIVDA (Tivozanib) and IMFINZI (Durvalumab) - DEDUCTIVE
Hepatocellular carcinoma (HCC)
Phase 1/2
Phase 1/2
Phase 1/2 trial has moved to Phase 2 part of trial - May 29, 2020. Phase 1b data presented at ASCO GI January 15, 2021. 29% partial response (PR) rate.
AV-380
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial has been initiated.
Ficlatuzumab and cytarabine
Acute myeloid leukemia (AML)
Phase 2
Phase 2
Phase 2 trial discontinued due to COVID-19.
Ficlatuzumab and nab-paclitaxel
Pancreatic ductal adenocarcinoma (PDAC)
Phase 1b
Phase 1b
Phase 1b data noted 29% partial response (PR) rate - January 27, 2020.
Ficlatuzumab
EGFR-mutated Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Announced September 12, 2016 that its Phase 2 trial has been discontinued

Latest News

  1. – Data Presented at the 2021 ASCO GI Cancers Symposium –

    AVEO Oncology (NASDAQ:AVEO) today announced the presentation of results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE clinical trial of tivozanib (FOTIVDA®), AVEO's vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, in combination with IMFINZI® (durvalumab), AstraZeneca's (NASDAQ:AZN) human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with advanced or metastatic hepatocellular carcinoma (HCC). The results are being presented today in a poster session at the 2021 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium being held virtually.

    A total of seven patients…

    – Data Presented at the 2021 ASCO GI Cancers Symposium –

    AVEO Oncology (NASDAQ:AVEO) today announced the presentation of results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE clinical trial of tivozanib (FOTIVDA®), AVEO's vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, in combination with IMFINZI® (durvalumab), AstraZeneca's (NASDAQ:AZN) human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with advanced or metastatic hepatocellular carcinoma (HCC). The results are being presented today in a poster session at the 2021 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium being held virtually.

    A total of seven patients with advanced or metastatic HCC were enrolled in the Phase 1b portion of the study, which was designed to determine the recommended Phase 2 dose and assess preliminary safety and efficacy of the tivozanib/durvalumab combination. Patients received 1.0 mg of tivozanib for 21 days followed by 7 days off therapy combined with 1500 mg of durvalumab every 28 days. The combination was well tolerated, with no dose-limiting toxicities. The combination demonstrated a 29% partial response (PR) rate and 71% disease control rate (PR + stable disease). Completion of enrollment in the ongoing Phase 2 portion of the study, which is expected to enroll up to an additional 30 subjects, is anticipated later this year.

    "With a five-year survival rate of less than 5%, advanced or metastatic HCC represents an area of high unmet need," said Renuka Iyer, M.D., Professor of Oncology and Co-Director, Liver and Pancreas Tumor Center, Roswell Park Comprehensive Cancer Center. "These data demonstrated the tolerability of the tivozanib and immunotherapy combination, and I look forward to its further evaluation in the Phase 2 portion of the study."

    "We believe that data observed in the Phase 1b portion of the DEDUCTIVE study continue to support tivozanib's potential to serve as an attractive VEGFR TKI to use in the immunotherapy combination setting," said Michael Bailey, president and chief executive officer of AVEO. "As we await a decision on our New Drug Application for single agent tivozanib in relapsed or refractory renal cell carcinoma (RCC), we remain focused on executing on our combination strategy, including in metastatic RCC and HCC."

    About Tivozanib (FOTIVDA®)

    Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA® for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company's partner, EUSA Pharma (UK) Limited (EUSA territory). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, tivozanib, is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "design," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO's execution of its clinical and regulatory strategy for tivozanib; AVEO's plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of tivozanib in the United States; the advancement of AVEO's pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential efficacy, safety and tolerability of ficlatuzumab, both as a stand-alone drug candidate and in combination with other therapies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab in areas of unmet need; and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to progression-free survival, the rate of adverse events, overall survival and other information that the FDA may consider to be relevant to an approval determination; AVEO's ability to successfully implement its strategic plans, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA and to obtain and maintain market and third party payor acceptance of tivozanib if it may be approved for commercialization by the FDA; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the launch and commercialization of tivozanib; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO's product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; and AVEO's ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; AVEO's ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates; unplanned capital requirements; uncertainties related to AVEO's ability to access future borrowings under the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO's business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO's quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

    Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

    References

    1. Fotivda (Tivozanib) SmPC August 2017
    2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
    3. Pawlowski N et al. AACR 2013. Poster 3971
    4. Barthelemy et al. ESMO 2018. Poster 878P

    View Full Article Hide Full Article
  2. – Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch –

    – Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028 –

    – Corinne D. Epperly, MD, MPH, Appointed to Board of Directors –

    – Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC Enrollment Complete; Plans to Announce Results and Phase 3 Decision on Track for Mid-2021 –

    – AV-380 Phase 1 Clinical Study Initiated Following FDA's IND Acceptance –

    AVEO Oncology (NASDAQ:AVEO) today highlighted its recent progress and outlined its 2021 outlook.

    "We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma…

    – Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch –

    – Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028 –

    – Corinne D. Epperly, MD, MPH, Appointed to Board of Directors –

    – Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC Enrollment Complete; Plans to Announce Results and Phase 3 Decision on Track for Mid-2021 –

    – AV-380 Phase 1 Clinical Study Initiated Following FDA's IND Acceptance –

    AVEO Oncology (NASDAQ:AVEO) today highlighted its recent progress and outlined its 2021 outlook.

    "We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC), including the addition of Dr. Corinne Epperly to our Board of Directors," said Michael Bailey, president and chief executive officer of AVEO. "If approved, we believe tivozanib has the potential to serve as a new treatment for the rapidly growing population of patients with relapsed or refractory RCC. In support of the further clinical and commercial development of tivozanib, we have identified opportunities to potentially extend its patent exclusivity period."

    Mr. Bailey added: "In addition to our launch preparation, we continue to make great progress advancing our clinical pipeline, with each asset expected to reach an important milestone this year. These include progress in our immunotherapy combination programs for tivozanib, a decision on whether to initiate a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), and the execution of our Phase 1 study of AV-380. We believe 2021 will be a transformational year for AVEO, and we look forward to delivering on a number of milestones designed to enhance our long-term value."

    Key Recent Program Updates and Anticipated 2021 Milestones

    Tivozanib U.S. Regulatory and Commercial Updates

    • Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch. Commercial preparations are well underway to support the potential U.S. launch of tivozanib, AVEO's vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, as a treatment for relapsed or refractory RCC. U.S. sales leadership, sales training, marketing, market access and medical affairs teams as well as distribution capabilities are now in place. Hiring, training, and deployment of the Company's field sales organization is on track for completion ahead of the U.S. Food and Drug Administration's (FDA) New Drug Application Prescription Drug User Fee Act target action date for tivozanib of March 31, 2021.
    • Relapsed/Refractory RCC Disease Awareness Website Launched for U.S. Healthcare Professionals. The Company today announced the recent launch of www.ReimagineRCC.com, a relapsed/refractory RCC disease awareness resource for U.S. healthcare professionals highlighted by the headline: "After multiple prior treatments in renal cell carcinoma (RCC), the journey can quickly become a challenge". The website highlights the need for more robust data and better tolerated treatment options to support the roughly half of patients who receive second line therapy yet do not continue therapy beyond progression.

    Corporate Updates

    • Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028. AVEO holds an exclusive license to two issued U.S. patents for tivozanib, one pertaining to the tivozanib composition of matter, which expires in April 2022, and the other pertaining to a crystalline form of tivozanib, which expires in November 2023. A patent term extension of up to five years may be available under the Hatch-Waxman Act, although only one patent can be extended under the Act. The Company currently intends to file applications for patent term extension on both patents in parallel to provide optionality in its exclusivity strategy. Depending upon which patent the Company ultimately chooses to extend, if a full five year extension is granted for such patent, tivozanib's exclusivity period could reach either April 2027 or November 2028.
    • Corinne D. Epperly, MD, MPH Appointed to Board of Directors. AVEO today announced the appointment of Corinne D. Epperly, MD, MPH, to its Board of Directors. Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A, and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs, and the National Cancer Institute of the NIH.

    Tivozanib Immuno-Oncology Updates

    • Results from Phase 1b/2 TiNivo Study of Tivozanib in Combination with OPDIVO® (nivolumab) in RCC Published in Annals of Oncology. In November 2020, AVEO announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib (FOTIVDA®) in combination with intravenous (IV) nivolumab (OPDIVO®, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC, were published in Annals of Oncology. The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link. AVEO plans to detail next steps in its investigations of the tivozanib-nivolumab combination following potential FDA approval of tivozanib.
    • Results from the Phase 1b Portion of DEDUCTIVE Study to Be Presented Friday, January 15, 2021, at ASCO GI Cancer Symposium. AVEO is also studying tivozanib in combination with IMFINZI® (durvalumab), AstraZeneca's human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first line metastatic hepatocellular carcinoma in the Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase 2, with enrollment expected to complete this year. Results from the Phase 1b portion of the DEDUCTIVE study are expected to be presented at on Friday, January 15, 2021, at 8:00 am ET, at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium.

    Ficlatuzumab Update

    • Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at a Medical Meeting in Mid-2021; Phase 3 Decision on Track for Mid-2021. The Company announced today that enrollment is now complete in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab (ERBITUX®). Ficlatuzumab is AVEO's potent hepatocyte growth factor (HGF) inhibitor antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival (PFS) and overall survival (OS) compared to historical controls.



      Results from the Phase 2 study are expected to be presented at a medical meeting in mid-2021. In that timeframe, the Company plans to announce a Phase 3 decision for ficlatuzumab. In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.

    AV-380 Update

    • Phase 1 Clinical Study Initiated Following U.S. FDA Acceptance of IND Filing. The Company announced today that its investigational New Drug Application (IND) application for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia, has been accepted by the FDA. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. A Phase 1 study in healthy subjects has been initiated.

    About Tivozanib (FOTIVDA®)

    Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA® for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company's partner, EUSA Pharma (UK) Limited (EUSA territory). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, tivozanib, is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "design," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO's planned timing for making tivozanib available to patients in the U.S.; the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO's execution of its clinical and regulatory strategy for tivozanib; AVEO's plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of tivozanib in the United States; the advancement of AVEO's pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential efficacy, safety and tolerability of ficlatuzumab, both as a stand-alone drug candidate and in combination with other therapies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab in areas of unmet need; the potential to extend U.S. patent exclusivity for tivozanib and the timing of such potential extension; and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may consider to be relevant to an approval determination; AVEO's ability to successfully implement its strategic plans, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA and to obtain and maintain market and third party payor acceptance of tivozanib if it may be approved for commercialization by the FDA; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the launch and commercialization of tivozanib; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO's product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; and AVEO's ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; AVEO's ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates; unplanned capital requirements; uncertainties related to AVEO's ability to access future borrowings under the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO's business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in "Cautionary Note Regarding Forward-Looking Statements" in AVEO's September 2020 press release regarding ficlatuzumab, and in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO's quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

    Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

    References

    1. Fotivda (Tivozanib) SmPC August 2017
    2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
    3. Pawlowski N et al. AACR 2013. Poster 3971
    4. Barthelemy et al. ESMO 2018. Poster 878P

    View Full Article Hide Full Article
  3. AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences:

    H.C. Wainwright Virtual BioConnect Conference
    Date: Monday, January 11 – Thursday, January 14

    B. Riley Virtual Oncology Investor Conference
    Date: Wednesday, January 20
    Time: 1:30 PM Eastern Time

    A replay of the pre-recorded H.C. Wainwright presentation can be accessed on Monday, January 11, 2021 in the investors section of the Company's website at www.aveooncology.com, and a live webcast of the B. Riley presentation can be accessed in the same section of the Company's website. A replay of the webcasts will be archived for 30 days following the presentation date.

    About

    AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences:

    H.C. Wainwright Virtual BioConnect Conference

    Date: Monday, January 11 – Thursday, January 14

    B. Riley Virtual Oncology Investor Conference

    Date: Wednesday, January 20

    Time: 1:30 PM Eastern Time

    A replay of the pre-recorded H.C. Wainwright presentation can be accessed on Monday, January 11, 2021 in the investors section of the Company's website at www.aveooncology.com, and a live webcast of the B. Riley presentation can be accessed in the same section of the Company's website. A replay of the webcasts will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, tivozanib, is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory renal cell carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the section titled "Risk Factors" in AVEO's most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release

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  4. AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will present at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 5:20 p.m. Eastern Time. Following the presentation, Mr. Bailey will be joined by other members of AVEO's management team for a question-and-answer session.

    A live webcast of the presentation and question-and-answer session can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that…

    AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will present at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 5:20 p.m. Eastern Time. Following the presentation, Mr. Bailey will be joined by other members of AVEO's management team for a question-and-answer session.

    A live webcast of the presentation and question-and-answer session can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, tivozanib, is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory renal cell carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the section titled "Risk Factors" in AVEO's most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release

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  5. AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will present at the Stifel 2020 Virtual Healthcare Conference on Monday, November 16, 2020 at 11:20 a.m. Eastern Time.

    A live webcast of the presentation can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America…

    AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will present at the Stifel 2020 Virtual Healthcare Conference on Monday, November 16, 2020 at 11:20 a.m. Eastern Time.

    A live webcast of the presentation can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, tivozanib, is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in the U.S. as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the section titled "Risk Factors" in AVEO's most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

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