Pfizer Inc. (NYSE:PFE) inches up after the company says its New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. Pfizer Inc. (NYSE:PFE) is trading within a 52-week range of $27.87-32.96.Kite Pharma Inc (NASDAQ:KITE), the biopharmaceutical company released encouraging from a Phase 1 clinical trial of anti-CD19 chimeric antigen receptor T cells in patients with acute lymphoblastic leukemia. Shares of Kite Pharma Inc (NASDAQ:KITE) are trading within a 52-week range of $21.00 to $36.19. The trial, conducted by the Pediatric Oncology Branch of the National Cancer Institute, demonstrated that administration of anti-CD19 CAR T cells resulted in a 70% complete response rate in 20 pediatric or young adult patients with relapsed or refractory acute lymphoblastic leukemia, the company said. A total of 60% of the 20 patients achieved a minimal residual disease-negative complete response. Ten patients who had an MRD-negative complete response subsequently underwent hematopoietic stem-cell transplantation, and all 10 remained disease free with a median follow-up of 10 months, it added. KTE-C19 is Kite's most advanced product candidate. It involves genetically modifying a patient's T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.Cancer Genetics Inc (NASDAQ:CGIX), a company focused on developing DNA-based cancer testing, said Monday it has entered into a collaboration with two Columbia University Medical Center researchers to identify more accurate diagnostic and prognostic markers for myelodysplastic syndromes, and new therapies to target this class of bone-marrow cancers. The goal of the collaboration is to develop personalized therapy for MDS patients and to enable accurate prediction of future treatment needs before patients become resistant to their current therapy or before their MDS progresses to the more aggressive acute myeloid leukemia. Cancer Genetics Inc (NASDAQ:CGIX) expects the collaboration to result in a novel, next-generation sequencing based panel for the improved diagnosis and prognosis of MDS and AML.CGIX said it will work with Columbia University's Azra Raza, who has established the largest single repository of MDS samples in the world, which contains approximately 50,000 samples from MDS patients, many of whom were followed for more than 20 years through disease progression and remission. "Significantly, she has been involved in the development and FDA approval of every drug on the market for MDS treatment, as well as dozens of Phase I-III studies on potential MDS-fighting agents," the company said. Shares of CGIX are within a 52-week range of $6.56 to $20.95; the low end of that range was hit Friday.
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