On Monday, Shares of Exelixis, Inc. (NASDAQ:EXEL), gained 4.57% to $5.72.
Exelixis, declared that the European Commission (EC) has approved COTELLIC™ (cobimetinib) for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. COTELLIC was discovered by Exelixis and is now the subject of a partnership between Exelixis and Genentech, a member of the Roche Group. Roche sponsored COTELLIC’s EU Marketing Authorization Application, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2015.
“The approval of COTELLIC by the European Commission for use in combination with vemurafenib is an important milestone in the development of new treatments that can assist patients with advanced melanoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to ongoing to execute on our partnership agreement for COTELLIC.”
The approval in the EU is based primarily on results of the phase 3 coBRIM study, which showed that people with formerly untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor COTELLIC in combination with vemurafenib lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) contrast to 7.2 months with vemurafenib alone (hazard ratio [HR]=0.58, 95 percent confidence interval [CI] 0.46-0.72).
Exelixis, Inc., a biopharmaceutical company, develops and sells small molecule therapies for the treatment of cancer in the United States. The company offers COMETRIQ, an inhibitor of multiple receptor tyrosine kinases for the treatment of patients with progressive, metastatic medullary thyroid cancer.
Shares of PDL BioPharma Inc (NASDAQ:PDLI), declined -4.66% to $3.79, during its last trading session.
PDL Bio Pharma, declared that John P. McLaughlin, the company’s president and chief executive officer, will present at the 27th Annual Piper Jaffray Healthcare Conference next week in New York City. The presentation will be webcast live and will occur on Tuesday, December 1, 2015 at 9:30 a.m. EST.
PDL Bio Pharma, Inc. manages a portfolio of patents and royalty assets in the United States and Europe. The company is involved in the humanization of monoclonal antibodies and the discovery of a new generation of targeted treatments for cancer and immunologic diseases.
Finally, Shares of Uniqure NV (NASDAQ:QURE), ended its last trade with -16.53% loss, and closed at $18.78.
uniQure N.V., declared financial results for the third quarter and nine months ending September 30, 2015, and offered an update on its development programs.
“In the last quarter uniQure and our collaborators, a consortium comprising of Institut Pasteur, INSERM, the French Muscular Dystrophy Association and Vaincre les Maladies Lysosomales, have clinically demonstrated proof-of-concept for safely treating a severe lysosomal storage disease, Sanfilippo B, with a gene therapy construct developed by uniQure. The study has shown encouraging signals of clinical benefit. By the second week of January 2016 we hope to declare preliminary top-line results in our Hemophilia B trial,” said Jorn Aldag, Chief Executive Officer of uniQure. “To accelerate our pipeline development we have added two therapeutic area leaders, Charles Richard, Senior Vice President, Neuroscience and Deya Corzo, Senior Vice President, Liver/Metabolism, joining Patrick Most who leads our heart failure program partnered with BMS. Deya and Charlie will lead the preparation for two pivotal studies in 2016.”
uniQure N.V., a biopharmaceutical company, develops adeno-associated virus (AAV) based gene therapies through its technology platform for multiple therapeutic areas. The company offers Glybera for the treatment of patients with lipoprotein lipase deficiency.