Key Developments: Curis Inc (CRIS.OQ)

CRIS.OQ on NASDAQ Stock Exchange Global Market

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1 Aug 2013
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Latest Key Developments (Source: Significant Developments)

Curis Inc To Sell Up To $30,000,000 Common Stock-Form 8-K
Wednesday, 3 Jul 2013 04:00pm EDT 

Curis Inc reported in its Form 8-K that on July 3, 2013 the Company, entered into a Sales Agreement with Cowen and Company, LLC to sell from time to time up to $30,000,000 of the Company’s common stock, par value $0.01 per share, through an at the market equity offering program under which Cowen and Company, LLC will act as sales agent.  Full Article

Curis Inc Announces CUDC-427 (GDC-0917) Phase I Clinical Data
Monday, 3 Jun 2013 07:01am EDT 

Curis Inc announced that Phase I data were presented during an oral session at the American Society of Clinical Oncology's (ASCO) 2013 annual meeting on the Company's clinical candidate CUDC-427 (previously GDC-0917), in patients with refractory cancers. In addition to demonstrating a favorable safety and pharmacokinetic profile, single agent CUDC-427 also showed preliminary signals of clinical activity; including unconfirmed complete responses in 2 patients. CUDC-427 is an oral, small molecule Smac mimetic drug candidate that triggers programmed cell death by selectively antagonizing inhibitor of apoptosis, or IAP, proteins in cancer cells. CUDC-427 was exclusively licensed from Genentech in November 2012, and the results reported were from the Phase I study conducted by Genentech. Preclinical studies demonstrated antitumor efficacy of GDC-0917 (CUDC-427) alone or in combination with other anticancer agents including chemotherapy. In October 2010, Genentech initiated an open-labeled, uncontrolled, dose-escalation, Phase I clinical study of GDC-0917 (NCT01226277; IAM4914g) in patients with refractory solid tumors or lymphoma. The study was designed to assess safety, tolerability and pharmacokinetics of daily, oral doses of GDC-0917. The presentation at ASCO focused on results from this Phase I trial, in which oral GDC-0917 was administered once daily for two weeks on and one week off treatment schedule.  Full Article

Curis Inc Appoints Ali Fattaey, Ph.D. As President
Tuesday, 19 Feb 2013 07:00am EST 

Curis Inc announced the appointment of Ali Fattaey, Ph.D., as President and Chief Operating Officer. Dr. Fattaey will join Curis' senior management team, where he will help guide and further advance Curis' overall corporate strategic goals and will also be responsible for the oversight and implementation of the Company's research and development operations. Dan Passeri will continue to serve as Chief Executive Officer and Michael Gray will continue to serve as Chief Financial Officer.  Full Article

Curis Inc Announces Publication Of CUDC-907 Data In Clinical Cancer Research
Monday, 25 Jun 2012 08:00am EDT 

Curis Inc announced that the journal Clinical Cancer Research published an article on CUDC-907, an orally-available small molecule drug candidate that is designed to simultaneously inhibit PI3K and HDAC. The publication, titled "Cancer network disruption by a single molecule inhibitor targeting both histone deacetylase (HDAC) activity and phosphatidylinositol 3-kinase (PI3K) signaling," was authored by several members of Curis' scientific team and published online by Clinical Cancer Research. The article is expected to be published in the print version of the journal shortly. The publication focused on CUDC-907's potential for further development in various cancers, particularly hematological cancers. The paper noted that CUDC-907 displays potent anticancer activity in both cultured cancer cells and xenograft models and that the molecule may offer therapeutic benefits in multiple cancers through broad signaling network disruption. For example, data show that CUDC-907 durably inhibits both the primary PI3K-AKT-mTOR pathway and also many compensatory signaling molecules that cancer cells often utilize to evade the efficacy of single target kinase inhibitors, including RAF, MEK, MAPK and STAT-3, among others. Curis scientists believe that CUDC-907 may offer improved therapeutic benefit through this simultaneous, sustained disruption of multiple signaling pathways.  Full Article

Curis Inc And Debiopharm Announce Initiation Of Phase Ib Expansion Study Of HSP90 Inhibitor Debio 0932
Thursday, 16 Feb 2012 07:00am EST 

Curis, Inc. and Debiopharm Group announced that Debiopharm has begun treating patients in a Phase Ib clinical trial of Heat Shock Protein 90 (HSP90) inhibitor Debio 0932. Debiopharm recently successfully completed a Phase Ia dose escalation study with Debio 0932 and has indicated that it expects to initiate a combination Phase I/II study in non-small cell lung cancer patients in the second quarter of 2012. Debiopharm initiated a Phase I clinical trial in April 2010 that was designed to evaluate the maximum tolerated dose and safety of Debio 0932. The first part of the study (Phase Ia), an open-label, multi-center dose escalation trial evaluating the safety and tolerability of escalating multiple dose levels of Debio 0932 given daily or every other day as a single agent by oral administration in patients suffering from advanced solid tumors, was recently completed. Debiopharm expects to treat approximately 30 patients as part of the Phase Ib expansion study. The objectives of this study will be to further assess the safety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at the recommended dose level and regimen, and to further assess anti-tumor activity in patients with advanced solid tumors, including patients with non-small cell lung cancer.  Full Article

Curis Inc Announces FDA Approval Of Erivedge (vismodegib) Capsule As First Treatment For Advanced Basal Cell Carcinoma
Monday, 30 Jan 2012 11:27am EST 

Curis Inc announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation. Erivedge is the first and only FDA approved medicine for people with advanced forms of the most common skin cancer. It is being developed and will be commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech.  Full Article

Curis Inc. Announces Agreement With The Leukemia & Lymphoma Society To Develop CUDC-907 For Lymphoma And Multiple Myeloma
Wednesday, 30 Nov 2011 07:00am EST 

Curis Inc. announced that the Company has entered into an agreement under which The Leukemia & Lymphoma Society (LLS) will support Curis`s ongoing development of its oral small molecule dual Pi3K and HDAC inhibitor CUDC-907, for patients with B-cell lymphoma and multiple myeloma. Under the agreement, LLS will fund approximately 50% of the direct costs of the development of CUDC-907, up to $4 million. Curis is currently conducting preclinical studies of CUDC-907 required to file an investigational new drug application (IND) seeking to advance the molecule into a Phase Ia dose escalation clinical trial in B-cell lymphoma and multiple myeloma. Curis expects to file the IND and start patient enrollment in the second half of 2012. If this study is successful, LLS has also agreed to support Curis`s subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis` ongoing investigation of biomarkers for CUDC-907 in these diseases.  Full Article

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