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19:04 EST Avita Medical receives FDA IDE approval to Evaluate RECELL system for vitiligo - Avita Medical announced that the U.S. Food and Drug Administration has approved the company's Investigational Device Exemption application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device for repigmentation of depigmented lesions associated with stable vitiligo. Avita Medical will collaborate with a leading medical center to conduct a pilot study with 10 patients who have vitiligo lesions that have been stable for at least one year. Areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using RECELL to confirm response rates and optimal suspension parameters. The randomized controlled study's primary effectiveness measure is the percent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment. Additional effectiveness data collected over the course of the 24-week study will include degree of repigmentation achieved and patient rating of repigmentation.

15:15 EST China National Medical Products Administration approves BeiGene's Tislelizumab - BeiGene announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration as a treatment for patients with classical Hodgkin's lymphoma who have received at least two prior therapies. The new drug application was previously granted priority review by the NMPA. Following the recent approval of BRUKINSA by the U.S. Food and Drug Administration, tislelizumab is BeiGene's first drug approved in China. Developed by BeiGene scientists, tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcgammaR, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells. In addition, a supplementary new drug application for tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma has been accepted and granted priority review by the Center for Drug Evaluation at the NMPA. The NMPA approval is based on the clinical results from a single-arm, multi-center, pivotal Phase 2 trial BGB-A317-203. Among the patients who were evaluable for responses, with a minimum follow-up of 12 months and a median follow-up of 14 months, the independent review committee-assessed objective response rate was 76.9% and the complete response rate was 61.5%. In the R/R cHL trial BGB-A317-203, the most common adverse reactions reported were pyrexia, hypothyroidism, weight increase, pruritus, decreased white blood cell count, upper respiratory tract infection, increased alanine aminotransferase, rash, decreased neutrophil count, cough, fatigue, and increased blood bilirubin. Grade 3 and above adverse reactions occurring in greater than or equal to 2% of patients included pneumonitis, weight increase, severe skin reactions and hypertension. There was no fatal adverse reaction case reported from BGB-A317-203. BeiGene is currently working with Boehringer Ingelheim to prepare for the commercial supply to launch of tislelizumab in China.