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March 31, 2014
10:58 EDTOXBT, CRISCuris, 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
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November 10, 2014
07:18 EDTCRISCuris provides pipeline update for CUDC-907, CUDC-427, Debio 0932
A total of 41 patients with relapsed/refractory lymphomas or multiple myeloma have been enrolled thus far, with 10 patients continuing to receive treatment in the dose escalation and expansion phases of the single agent, first-in-human Phase 1 clinical study of CUDC-907. The safety profile of CUDC-907 has been consistent with prior reports of diarrhea and thrombocytopenia as the most frequent adverse events, with diarrhea and hyperglycemia identified as dose limiting toxicities. Curis has completed enrollment in all consecutive, escalating dose cohorts at 100, 200 or 300 mg per day in the single-agent Phase 1 study of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphoma. The primary objective of this monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. Curis collaborator Debiopharm has decided that the Phase 1 dose escalation data from the Phase 1/2 HALO study of Debio 0932 in combination with 3 different standard-of-care chemotherapy regimens in an unselected population of patients with advanced or metastatic non-small cell lung cancer were inconclusive, and has opted not to advance Debio 0932 into the Phase 2 portion of the study. No new Debio 0932-related side effects were identified and safety observations were generally consistent with the expected side effects of Debio 0932 and/or the respective chemotherapeutic regimens administered in the study. Curis expects to receive formal notice of termination of the license agreement from Debiopharm shortly and the partners are expected to enter into a transition agreement in the fourth quarter of 2014 regarding the orderly return of the program and all rights to Curis.
07:17 EDTCRISCuris reports Q3 EPS (6c), consensus (4c)
Reports Q3 revenue $1.78M, consensus $4.13M

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