New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 31, 2014
10:58 EDTCRIS, OXBTCuris, Oxygen Bio advance after FDA lifts clinical holds on treatments
Shares of both Curis (CRIS) and Oxygen Biotherapeutics (OXBT) are higher this morning after the Food and Drug Administration lifted clinical holds on treatments being tested by the companies. Curis is a drug discovery and development company that is committed to leveraging signaling pathway drug technologies in seeking to develop next generation network-targeted cancer therapies; Oxygen Biotherapeutics is engaged in the business of developing biotechnology products with a focus on oxygen delivery to tissue. CURIS: Curis said the FDA allowed it to resume testing of CUDC-427, its experimental cancer drug, lifting a November 2013 order halting enrollment in an early-stage trial. The trial was put on partial clinical hold in November following the death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. The company says the monotherapy Phase 1 study will re-open "as soon as possible." Curis President and COO Ali Fattaey said the company believes CUDC-427 has "significant potential" as an anti-cancer agent and that the company expects to proceed with CUDC-427's overall development plan, "including our planned study to investigate CUDC-427 in combination with capecitabine in HER-2 negative advanced breast cancer patients." OXYGEN: Separately, Oxygen Biotherapeutics this morning said it received written confirmation from the FDA that the clinical hold on its Oxycyte development program was lifted following its review of the September 12, 2013, submission to the investigational new drug application for Perfluorocarbon Oxycyte. The FDA said the company has addressed all clinical hold issues. PRICE ACTION: Curis is trading up 7c, or 2.55%, to $2.82 in morning trading. Meanwhile, Oxygen Biotherapeutics is up 25c, or 4.65%, to $5.63.
News For CRIS;OXBT From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 22, 2015
08:20 EDTCRISCuris price target raised to $5 from $3 at Oppenheimer
Subscribe for More Information
January 21, 2015
07:34 EDTCRISCuris to host conference call
Conference call to discuss the Curis-Aurigene transaction will be held on January 21 at 8 am. Webcast Link
06:07 EDTCRISCuris and Aurigene Discovery announce exclusive collaboration agreement
Curis and Aurigene Discovery Technologies announced that they have entered into an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets. The collaboration provides for inclusion of multiple programs, with Curis having the option to exclusively license compounds once a development candidate is nominated within each respective program. The partnership draws from each company's respective areas of expertise, with Aurigene having the responsibility for conducting all discovery and preclinical activities, including IND-enabling studies and providing Phase 1 clinical trial supply, and Curis having responsibility for all clinical development, regulatory and commercialization efforts worldwide, excluding India and Russia, for each program for which it exercises an option to obtain a license. The first two programs under the collaboration are an orally-available small molecule antagonist of programmed death ligand-1 in the immuno-oncology field and an orally-available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 in the precision oncology field. Curis expects to exercise its option to obtain exclusive licenses to both programs and file IND applications for a development candidate from each in 2015. The agreement provides that the parties will collaborate exclusively in immuno-oncology for an initial period of approximately two years, with the option for Curis to extend the broad immuno-oncology exclusivity.In addition Curis has agreed to make payments to Aurigene as follows: For the first two programs: up to $52.5 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any; For the third and fourth programs: up to $50 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any; and for any program thereafter: up to $140.5 million per program, including $87.5 million per program in approval and commercial milestones, plus specified approval milestone payments for additional indications, if any. Curis has agreed to pay Aurigene royalties on any net sales ranging from high single digits to 10% in territories where it successfully commercializes products and will also share in amounts that it receives from sublicensees depending upon the stage of development of the respective molecule.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use