Key Developments: Aveo Pharmaceuticals Inc (AVEO.O)

AVEO.O on Nasdaq

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29 Aug 2014
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Latest Key Developments (Source: Significant Developments)

Aveo and Biodesix partner to co-develop and commercialize Ficlatuzumab with a companion diagnostic for treatment of NSCLC
Thursday, 10 Apr 2014 06:30am EDT 

Aveo Pharmaceuticals Inc and Biodesix, Inc:Enters worldwide agreement to develop and commercialize AVEO's hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix((reg))companion diagnostic test.AVEO will conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test (a serum protein test).Biodesix will fund up to $15 mln of cost.Expects to initiate this clinical study later this year.  Full Article

Aveo and Astellas to End worldwide collaboration & license agreement
Friday, 14 Feb 2014 06:00am EST 

Aveo Pharmaceuticals Inc:Says the company and and Astellas Pharma Inc will end their worldwide collaboration and license agreement for the development and commercialization of investigational agent tivozanib.Says Astellas has exercised its right to terminate the agreement signed in 2011 for strategic reasons, based on the clinical status of the three indications studied.Says additionally, the companies agreed to discontinue the ongoing Phase 2 BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer (CRC).Says the termination of the collaboration will be effective Aug. 11 at which time tivozanib rights will be returned to AVEO.Says in accordance with the collaboration and license agreement, committed development expenses will be shared equally.  Full Article

AVEO Oncology and Astellas Pharma Inc discontinue phase 2 trial of tivozanib in breast cancer
Thursday, 30 Jan 2014 06:30am EST 

AVEO Oncology:Says that AVEO and Astellas Pharma Inc. have jointly decided to discontinue the BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer clinical trial.Says a Phase 2 study in patients with locally recurrent or metastatic triple negative breast cancer (TNBC), due to insufficient enrollment.Says previously announced that enrollment in this study had been slower than anticipated, and enrollment rates did not improve substantially following additional patient recruitment efforts.  Full Article

AVEO Oncology provides update on interim analysis from Tivozanib trial in colorectal cancer
Friday, 13 Dec 2013 06:50am EST 

AVEO Oncology:Says the data from a planned interim analysis of the Phase two BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer (CRC) indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.BATON-CRC, led by Astellas, is an open-label, randomized Phase two study with a primary endpoint evaluating the superiority of tivozanib in combination with modified FOLFOX6.Says data from the planned interim analysis, including biomarker data, are being analyzed, and AVEO and Astellas are in discussions regarding next steps.  Full Article

Aveo Pharmaceuticals Inc announces management change-Form 8-K
Monday, 2 Dec 2013 09:16am EST 

Aveo Pharmaceuticals Inc:Says on Nov. 26, David Johnston, AVEO’s Chief Financial Officer, provided notice to AVEO of his intention to resign from AVEO effective as of Dec. 30 to pursue a new career opportunity.Says AVEO is in the process of commencing an external search for its next Chief Financial Officer. Effective as of Dec. 30.Says Tuan Ha-Ngoc, AVEO’s President and Chief Executive Officer, will assume the role of principal financial officer until a replacement Chief Financial Officer is appointed.  Full Article

Pomerantz Law Firm Reminds Shareholders With Losses on Their Investment in Aveo Pharmaceuticals Inc of Class Action Lawsuit and Upcoming Deadline
Sunday, 7 Jul 2013 10:00am EDT 

Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Aveo Pharmaceuticals Inc and certain of its officers. The class action, filed in United States District Court, District of Massachusetts, and docketed under 1:13-cv-11157, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Aveo between January 3, 2012 and May 1, 2013, both dates inclusive (the Class Period). The Complaint alleges that throughout the Class Period,Defendants conditioned investors to believe that the Company's drug Tivopath or tivozanib, would receive approval from the U.S. Food and Drug Administration (FDA) through a host of materially false and misleading statements regarding its Phase III (TIVO-1) trial design and results. Specifically: (a) the Company failed to disclose to investors that the FDA had recommended to the Company to conduct an additional Phase III trial due to adverse trends in the Company's first study; (b) the Company misled investors regarding the overall safety and efficacy of the product, including failure to disclose the 25% higher rate of death associated with tivozanib therapy compared to the control drug, sorafenib; (c) the Company failed to disclose that almost 90% of the patients studied in TIVO-1 were enrolled from sites in Central and Eastern Europe with inconsistent treatment patterns from those in the US.  Full Article

Law Offices of Todd M. Garber Announces Class Action Lawsuit Against Aveo Pharmaceuticals Inc
Wednesday, 12 Jun 2013 03:27pm EDT 

The Law Offices of Todd M. Garber announced that a class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of a class (the Class) comprising all purchasers of the securities of AVEO Pharmaceuticals, Inc. (AVEO or the Company) between January 3, 2012 and May 1, 2013, inclusive (the Class Period). AVEO engages in discovering, developing, and commercializing targeted cancer therapies. The Complaint alleges that defendants issued materially false and misleading statements throughout the Class Period regarding the Phase III trial design and results for the Company`s drug Tivopath, or tivozanib, for the treatment of advanced kidney cancer. Specifically, defendants misrepresented or failed to disclose that: the U.S. Food and Drug Administration had recommended that the Company conduct an additional Phase III trial due to adverse trends in the Company`s first Phase III trial; there was a 25% higher rate of death associated with tivozanib therapy compared to the control drug, sorafenib; and almost 90% of patients studied in the single Phase III trial were enrolled from sites in Central and Eastern Europe with inconsistent treatment patterns from those in the United States.  Full Article

AVEO Oncology Announces Complete Response Letter Received For Tivozanib New Drug Application In Renal Cell Carcinoma
Monday, 10 Jun 2013 06:30am EDT 

AVEO Oncology announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) informing the Company that the FDA will not approve in its present form the New Drug Application (NDA) for AVEO's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).  Full Article

Aveo Pharmaceuticals Inc To Slash 62% Jobs-Reuters
Tuesday, 4 Jun 2013 06:19pm EDT 

Reuters reported that Aveo Pharmaceuticals Inc said it would cut about 62% of its workforce, or 140 jobs.  Full Article

Rigrodsky & Long, P.A. Files Securities Fraud Class Action Lawsuit Against Aveo Pharmaceuticals Inc
Friday, 31 May 2013 06:39pm EDT 

Rigrodsky & Long, P.A., including former Special Assistant United States Attorney, Timothy J. MacFall, announced that a complaint has been filed in the United States District Court for the District of Massachusetts on behalf of all persons or entities that purchased the common stock of AVEO Pharmaceuticals Inc between January 3, 2012 and May 1, 2013, inclusive (the Class Period), alleging violations of the Securities Exchange Act of 1934 against the Company and certain of its officers (the Complaint). The Complaint alleges that throughout the Class Period, defendants made materially false and misleading statements, and omitted materially adverse facts, about the Company`s business, operations and prospects. Specifically, the Complaint alleges that the defendants concealed from the investing public that: (a) the Company misled investors regarding the overall safety and efficacy of Tivopath, or tivozanib, including by misleading investors regarding the 25% higher rate of death associated with tivozanib therapy compared to the control drug, sorafenib; and (b) the Company failed to disclose that almost 90% of the patients studied in the single Phase 3 trial for tivozanib (TIVO-1) were enrolled from sites in Central and Eastern Europe with inconsistent treatment patterns compared to those in the United States. As a result of defendants` false and misleading statements, the Company`s stock traded at artificially inflated prices during the Class Period.  Full Article

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