On Thursday, Shares of Collegium Pharmaceutical Inc (NASDAQ:COLL), lost -5.84% to $19.68.
Collegium Pharmaceutical, stated its financial results for the third quarter of 2015 and offered a corporate update.
“During the last few months, Collegium achieved a number of important milestones in moving Xtampza(TM) ER closer to market launch upon final approval,” stated Michael Heffernan, Collegium’s CEO. “We were very encouraged by the FDA Advisory Committees’ unanimous vote in support of approval of Xtampza ER and subsequently the FDA’s tentative approval of the Xtampza ER NDA. Additionally, the commercial team has made noteworthy progress in preparing for a potential April 2016 launch of Xtampza.”
Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, focuses on developing and commercializing abuse-deterrent products that incorporate its DETERx platform technology for the treatment of chronic pain and other diseases. Its lead product candidate is Xtampza, an abuse-deterrent, extended-release, oral formulation of oxycodone, a prescribed opioid medication.
Shares of North Atlantic Drilling Ltd. (NYSE:NADL), declined -9.89% to $0.699, during its last trading session.
North Atlantic Drilling Ltd. is planned to release its third quarter 2015 results on Tuesday November 24th, 2015.
Administration will address highlights from North Atlantic Drilling`s third quarter 2015 results in a conference call to be held at 11:00 a.m. EST / 5:00 p.m. CET on Tuesday November 24th, 2015.
North Atlantic Drilling Limited operates as an offshore drilling services contractor in the North Atlantic region. The company provides harsh environment offshore drilling services to the oil and gas industry primarily in Norway and the United Kingdom.
Finally, Shares of Calithera Biosciences Inc (NASDAQ:CALA), ended its last trade with -9.18% loss, and closed at $7.12.
Calithera Biosciences, declared its financial results for the third quarter ended September 30, 2015. As of September 30, 2015, cash, cash equivalents and investments totaled $81.9 million.
“In the third quarter, we continued to move clinical programs forward with presentations of data at key medical meetings,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “We presented dose expansion monotherapy cohorts for our lead product CB-839 at the AACR-EORTC-NCI meeting, and we are presently opening enrollment across six combination cohorts. For our lead immuno-oncology program, we presented initial preclinical data for CB-1158, an oral, small molecule arginase inhibitor with the potential to treat cancer by blocking the immunosuppression of the tumor micro-environment. We believe that we have multiple opportunities to positively impact clinical outcomes for cancer patients by building a pipeline of novel therapeutic product candidates.”
Third Quarter 2015 and Recent Highlights
- CB-839 Solid Tumor Phase 1 data presented at the AACR-NCI-EORTC meeting. On November 8, 2015, solid tumor phase 1 data were presented at the American Association of Cancer Research (AACR)-National Cancer Institute (NCI)-European Organization for Research and Treatment of Cancer (EORTC) meeting that demonstrated the clinical activity, tolerability and unique mechanism of action of CB-839 as a single agent in patients with solid tumors. Among efficacy-evaluable patients across a range of tumor types treated on the twice daily plan of CB-839 administered with food, 22 of 50 patients (44%) had stable disease (SD) or better lasting at least 3 cycles (63 days). One renal cell carcinoma (RCC) patient has an ongoing partial response (PR; on study > 5 months); this patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the 15 evaluable patients with RCC, 9 (60%) had SD or PR, with four patients remaining on study.
- Arginase inhibitor CB-1158 preclinical data presented at the AACR-NCI-EORTC Meeting. Calithera selected CB-1158 as the clinical candidate for Calithera’s first immuno-oncology program targeting inhibition of arginase, a critical T-Cell immunosuppressive enzyme produced by myeloid-derived suppressor cells in tumors. On November 6, 2015, Calithera presented data at the AACR-NCI-EORTC meeting showing that CB-1158 is a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency. Administration of CB-1158 to mice results in a dose-dependent improvement in tumor arginine levels, compriseent with target inhibition. Evaluation of anti-tumor efficacy in immunocompetent syngeneic mouse models has shown that oral administration of CB-1158 results in noteworthyinhibition of tumor growth, and it combines well with checkpoint inhibitors with no evidence of additional toxicity.
- Augmented Board of Directors. In September 2015, Calithera designated Sunil Agarwal, M.D., Senior Vice President and Chief Medical Officer at Ultragenyx, to the company’s Board of Directors.
Calithera Biosciences, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer in the United States.