AVEO AVEO Pharmaceuticals Inc.

4.7
+0.1  (+2%)
Previous Close 4.6
Open 4.59
52 Week Low 2.2301
52 Week High 11.2
Market Cap $121,157,367
Shares 25,805,616
Float 23,200,040
Enterprise Value $99,601,833
Volume 233,214
Av. Daily Volume 816,793
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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)
Hepatocellular carcinoma (HCC)
Phase 1/2
Phase 1/2
Phase 1/2 trial has moved to Phase 2 part of trial - May 29, 2020.
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.
Tivozanib + Opdivo
Renal cell cancer (RCC)
Phase 2
Phase 2
Phase 2 final data presented at ESMO 2019.
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. AVEO Oncology (NASDAQ:AVEO) today announced that it has earned a $2.8 million development milestone payment from partner Kyowa Kirin Co., Ltd. (Kyowa Kirin). The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.

    "This milestone marks an important step forward for AVEO's non-oncology pipeline," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib's potential in non-oncology indications is significant, and we look forward to seeing Kyowa Kirin move this formulation into the clinic."

    Under the terms of AVEO's agreement with Kyowa Kirin, in addition…

    AVEO Oncology (NASDAQ:AVEO) today announced that it has earned a $2.8 million development milestone payment from partner Kyowa Kirin Co., Ltd. (Kyowa Kirin). The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.

    "This milestone marks an important step forward for AVEO's non-oncology pipeline," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib's potential in non-oncology indications is significant, and we look forward to seeing Kyowa Kirin move this formulation into the clinic."

    Under the terms of AVEO's agreement with Kyowa Kirin, in addition to the previously-paid upfront payment of $25 million to AVEO and waiver of AVEO's obligation to make an $18 million milestone payment upon AVEO gaining U.S. marketing approval of tivozanib for renal cell carcinoma, and now the IND development milestone, Kyowa Kirin has also agreed to pay AVEO up to an additional $388 million in potential milestone payments upon the successful achievement of certain development, regulatory, and commercial objectives in non-oncology indications of tivozanib. Kyowa Kirin will also be obligated to make tiered royalty payments on the net sales of a product for these indications, ranging from a high single-digit to low double-digit percent.

    About Tivozanib (FOTIVDA®)

    Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. 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 activity and minimal dose modifications.1,2 AVEO's TIVO-3 trial is supporting a regulatory submission in the U.S. seeking marketing approval of tivozanib as a treatment for relapsed or refractory 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 in non-oncology indications.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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 (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America 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. The words "anticipate," "believe," "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: tivozanib's potential in non-oncology indications; the potential of AVEO to receive future milestone and royalty payments under its agreement with Kyowa Kirin; the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC, following earlier TKI and immunotherapy treatment; 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; 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 determine for approval; 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 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; 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; 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; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; 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.

    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

     

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  2. AVEO Oncology (NASDAQ:AVEO) today announced the closing of its previously announced underwritten public offering of 9,725,000 shares of its common stock, which includes the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at a price to the public of $5.25 per share. The aggregate gross proceeds to AVEO from the offering were approximately $51.1 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

    SVB Leerink and Stifel acted as joint bookrunning managers for the offering…

    AVEO Oncology (NASDAQ:AVEO) today announced the closing of its previously announced underwritten public offering of 9,725,000 shares of its common stock, which includes the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at a price to the public of $5.25 per share. The aggregate gross proceeds to AVEO from the offering were approximately $51.1 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

    SVB Leerink and Stifel acted as joint bookrunning managers for the offering. Baird and H.C. Wainwright & Co. acted as co-lead managers for the offering.

    The shares were offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 30, 2017 and declared effective by the SEC on December 15, 2017.

    A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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 (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. Ficlatuzumab (anti-HGF mAb) is in a randomized Phase 2 confirmatory clinical trial in head and neck cancer and has previously reported promising early clinical data in head and neck cancer, acute myeloid leukemia and pancreatic 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).

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements 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," "estimate," "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 relating to the intended use of proceeds from the public offering. Actual results may differ materially from those projected or implied in these forward-looking statements. You should not place undue reliance on these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Quarterly Report on Form 10-Q for the period ended March 31, 2020, AVEO's final prospectus supplement filed with the SEC on June 17, 2020, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  3. AVEO Oncology (NASDAQ:AVEO) today announced that it has priced its previously announced underwritten public offering of 8,500,000 shares of its common stock at a price to the public of $5.25 per share. The gross proceeds to AVEO from the offering are expected to be approximately $44.6 million before deducting underwriting discounts and commissions and offering expenses. All of the shares in the offering are being sold by AVEO. AVEO has also granted the underwriters a 30-day option to purchase up to an additional 1,275,000 shares of common stock on the same terms and conditions. Closing of the offering is expected to occur on or about June 19, 2020, subject to satisfaction of customary closing conditions.

    The net proceeds of the offering are…

    AVEO Oncology (NASDAQ:AVEO) today announced that it has priced its previously announced underwritten public offering of 8,500,000 shares of its common stock at a price to the public of $5.25 per share. The gross proceeds to AVEO from the offering are expected to be approximately $44.6 million before deducting underwriting discounts and commissions and offering expenses. All of the shares in the offering are being sold by AVEO. AVEO has also granted the underwriters a 30-day option to purchase up to an additional 1,275,000 shares of common stock on the same terms and conditions. Closing of the offering is expected to occur on or about June 19, 2020, subject to satisfaction of customary closing conditions.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

    SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. Baird and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

    The shares are being offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 30, 2017 and declared effective by the SEC on December 15, 2017. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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 (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. Ficlatuzumab (anti-HGF mAb) is in a randomized Phase 2 confirmatory clinical trial in head and neck cancer and has previously reported promising early clinical data in head and neck cancer, acute myeloid leukemia and pancreatic 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).

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements 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," "estimate," "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 relating to the timing of the closing of the public offering and the intended use of proceeds therefrom. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to the satisfaction of customary closing conditions related to the public offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that AVEO will be able to complete the public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the offering, AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Quarterly Report on Form 10-Q for the period ended March 31, 2020, AVEO's preliminary prospectus supplement filed with the SEC on June 15, 2020, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  4. AVEO Oncology (NASDAQ:AVEO) today announced that it has commenced an underwritten public offering of $40.0 million of shares of its common stock. In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional $6.0 million of shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

    SVB Leerink…

    AVEO Oncology (NASDAQ:AVEO) today announced that it has commenced an underwritten public offering of $40.0 million of shares of its common stock. In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional $6.0 million of shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

    SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. Baird and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

    The shares are being offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 30, 2017 and declared effective by the SEC on December 15, 2017. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.

    Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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 (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. Ficlatuzumab (anti-HGF mAb) is in a randomized Phase 2 confirmatory clinical trial in head and neck cancer and has previously reported promising early clinical data in head and neck cancer, acute myeloid leukemia and pancreatic 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).

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements 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," "estimate," "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 relating to AVEO's plans to consummate its proposed public offering and the intended use of proceeds therefrom. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to whether or not AVEO will be able to raise capital through the sale of shares of common stock, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that AVEO will be able to complete the proposed public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the proposed offering, AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Quarterly Report on Form 10-Q for the period ended March 31, 2020, AVEO's preliminary prospectus supplement to be filed with the SEC on June 15, 2020, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  5. - Tivozanib assigned PDUFA target action date of March 31, 2021; FDA indicates that it does not currently plan to convene an ODAC -

    AVEO Oncology (NASDAQ:AVEO) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application…

    - Tivozanib assigned PDUFA target action date of March 31, 2021; FDA indicates that it does not currently plan to convene an ODAC -

    AVEO Oncology (NASDAQ:AVEO) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.

    "The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option," said Michael Bailey, president and chief executive officer. "We look forward to working closely with the FDA over the coming months during their review of our application. In parallel, we continue to focus on commercial-readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval."

    The NDA submission is based on AVEO's pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program. The application is also supported by three additional trials, including an active comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to sorafenib in first line RCC, and two Phase 2 studies, Study 902, the open-label, crossover clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first line RCC. In total, data from over 1,000 clinical trial subjects support the application.

    About Tivozanib (FOTIVDA®)

    Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. 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 relapsed or refractory 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 RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

    About AVEO

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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 (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb) is in a Phase 2 clinical trial in head and neck cancer and has reported early clinical data in pancreatic cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb). For more information, please visit the Company's website at www.aveooncology.com.

    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," "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, and following earlier TKI and immunotherapy treatment; 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 commercialization of tivozanib in the United States and Europe; 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 determine to be relevant to approvability; 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 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; 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; 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; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; 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

     

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