Stockwinners Market Radar for December 10, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:50 EDT Box Office Battle: 'Coco' stays number 1 with $18.3M - Disney (DIS) and Pixar's "Coco" remained number one in its third weekend, grossing another $18.3M for a domestic total of $135.5M. Overseas, the movie earned another $55.3M for a foreign cume of $253M. "Coco", which tells a story about the popular Mexican holiday Dia de Los Muertos, received an A+ CinemaScore and 96% from Rotten Tomatoes. BOX OFFICE RUNNERS-UP: Warner Bros.' (TWX) "Justice League" came in second once again, ending the weekend with $9.6M for a total of $212.1M to date. Behind it was Lionsgate's (LGF.A) "Wonder," with 8.5M from 3,519 theaters in its fourth weekend. James Franco's "The Disaster Artist" placed number four, earning $6.4M from 840 theaters. Rounding out the top five, Disney and Marvel Studios' "Thor: Ragnarok" ended the weekend with $6.3M for a cume of $301.2M. Other publicly traded companies in filmmaking include Viacom (VIAB), Sony (SNE), 21th Century Fox's (FOXA) and Comcast (CMCSA; CMCSK).

18:09 EDT Karyopharm presents positive Selinexor data from STOMP study - Karyopharm Therapeutics announced the presentation of four posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study at the American Society of Hematology 2017 annual meeting. The STOMP study is evaluating selinexor, the company's lead, novel, oral SINE compound, in combination with backbone therapies for the treatment of patients with heavily pretreated multiple myeloma. Two of the presentations feature updated data from the STOMP arms evaluating selinexor plus low dose dexamethasone in combination with either Velcade, or Pomalyst. The other two presentations feature new data from the STOMP arms evaluating Sd with Revlimid and with Darzalex. "The results from the SVd arm of the Phase 1b/2 STOMP study, particularly the high response rates of 83% in the same patient population eligible for the BOSTON study and 84% in proteasome inhibitor (PI)-naive or PI-relapsed patients, together with prolonged progression-free survival, strongly support our ongoing, pivotal Phase 3 BOSTON study," said Sharon Shacham, President and Chief Scientific Officer of Karyopharm. "Overall, the four presentations continue to highlight evidence of strong activity when oral selinexor is combined with the currently available "backbone" myeloma therapies, including PIs, immunomodulatory drugs and anti-CD38 monoclonal antibodies. Oral selinexor continues to demonstrate an expected and manageable tolerability profile, particularly in the SVd regimen where the combination produced higher response rates, paired with lower rates of peripheral neuropathy (PN), compared to the commonly used regimen of Velcade plus dexamethasone. We are delighted to share the results of this research with the medical community at ASH this year."

18:01 EDT ICL completes sale of 50% share of IDE Technologies for $167M - ICL announced that it has completed the sale of its 50% share of IDE Technologies, a desalination and water treatment company. The net proceeds received, after adjustments, amount to approximately $167M. ICL expects to record a capital gain of approximately $40M from the sale in Q4 of 2017. The purchaser of ICL's share is a limited partnership whose limited partners include institutional bodies from the Clal Insurance, the Israel Teachers' Union educational funds' group and Ayalon Insurance and whose general partner is controlled by Avshalom Felber, IDE's CEO.

17:48 EDT Ziopharm announces presentation of data from T-Cell Therapy programs - Ziopharm Oncology (ZIOP) announced data supporting its non-viral approach to rapid manufacture of chimeric antigen receptor-modified T cells to treat patients with cancers were presented at the 59th American Society of Hematology Annual Meeting and Exposition. Ziopharm is advancing its non-viral Sleeping Beauty platform toward point-of-care for very rapid manufacturing of genetically modified CAR+ T cells. Data presented from first- and second-generation SB clinical trials demonstrate safety, tolerability, disease response, long-term survival, and persistence of infused CD19-specific CAR+ T cells. Preclinical studies showed that P-O-C CAR+ T cells co-expressing membrane-bound interleukin-15 and a control switch manufactured within two days do not require activation or propagation in tissue culture to achieve anti-tumor effects and prolonged T-cell survival. Building on these data, the company plans to initiate its first P-O-C clinical trial in 2018. These ASH presentations are based on clinical trials and research being conducted in collaboration with The University of Texas MD Anderson Cancer Center and Intrexon Corporation (XON).

17:37 EDT bluebird bio presents new data from clinical studies of LentiGlobin Gene Therapy - bluebird bio announced data from two studies of its LentiGlobin gene therapy product candidate in patients with transfusion-dependent beta-thalassemia. Data from the Northstar and Northstar-2 studies were presented today at the 59th Annual Meeting of the American Society of Hematology. "Addressing the underlying genetic cause of TDT to restore production of functional hemoglobin can potentially eliminate or reduce the need for chronic blood transfusions in people with this disease, which we expect will reduce the risk of iron overload and associated long-term complications of TDT, and may allow cessation of chelation therapy," said Dave Davidson, chief medical officer, bluebird bio. "Northstar-2 is the first clinical trial to use our refined manufacturing process for LentiGlobin drug product. Early data from this study demonstrates consistently higher in vivo vector copy numbers and HbAT87Q hemoglobin levels, potentially enabling patients to consistently achieve near-normal or normal total hemoglobin levels. It is important to demonstrate the long-term benefit of gene therapy, and follow-up data of up to three years from the first Northstar study show that nearly all patients with non-beta0/beta0 genotypes were transfusion-free. We are engaged with the regulatory authorities in the context of the Breakthrough Designation from FDA, and PRIME and Adaptive Pathways from EMA, and look forward to submitting these data to seek marketing approval for LentiGlobin in TDT."

17:30 EDT Celgene, bluebird bio announce updated results from CRB-401 Phase 1 study - Celgene (CELG) and bluebird bio (BLUE) announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma will be presented in an oral presentation at the American Society of Hematology Annual Meeting. The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose. In the active dose cohorts, median follow-up was 40 weeks, 94% patients achieved an objective response, 89% patients achieved at least a very good partial response, 56% patients achieved a complete response, or unconfirmed complete response, 9 of 10 patients who were evaluable for MRD status were found to be MRD-negative. In the dose-escalation phase, 71%) of patients had cytokine release syndrome, mostly Grade 1 & 2, with 2 patients experiencing Grade 3 CRS. Four patients received tocilizumab, 1 received steroids and in each case the CRS resolved within 24 hours. The most common treatment-emergent Grade 3-4 AEs in 21 infused patients were cytopenias commonly associated with lymphodepleting chemotherapy including neutropenia, anemia and thrombocytopenia. There were two deaths in the active cohorts at 22 and 69 weeks following infusion, respectively. The first was due to cardiac arrest and the second was due to myelodysplastic syndrome; both subjects were in a myeloma CR at their last study assessment prior to death.

17:18 EDT Epizyme presents new biomarker data on Tazemetostat - Epizyme announced that two presentations reinforcing its commitment to identifying predictors of response to tazemetostat beyond EZH2 mutations will be featured at the 59th Annual Meeting & Exposition of the American Society of Hematology. These data from the company's ongoing Phase 2 clinical trial in non-Hodgkin lymphoma highlight exploratory response biomarkers and interim correlative data which may have the potential to further refine the clinical application of tazemetostat. Tazemetostat is a potent, selective, orally available inhibitor of EZH2 and is currently in Phase 2 development for the treatment of patients with follicular lymphoma or diffuse large B-cell lymphoma, both of which are subtypes of NHL.

17:04 EDT Syros Pharmaceuticals announces new preclinical data on SY-1365 - Syros Pharmaceutical announced that new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 inhibitor currently in a Phase 1 clinical trial in advanced solid tumors, show anti-tumor activity in in vitro and in vivo models of blood cancers. Additionally, the data point to a potential biomarker of response to SY-1365 and synergistic activity with a BCL2 inhibitor in preclinical models of acute myeloid leukemia. These data are being presented at the 59th American Society of Hematology Annual Meeting and Exposition. "We believe SY-1365 represents a promising therapeutic approach across a number of solid tumors and blood cancers," said Eric Olson, Chief Scientific Officer of Syros. "These new preclinical data underscore the power of our gene control platform to elucidate the underlying biology and mechanism of action of SY-1365, furthering our ability to identify biomarkers to select the patients most likely to respond and to identify rational combination approaches with the potential to provide a profound benefit for patients." The Phase 1 trial of SY-1365 is a multi-center, open-label trial enrolling patients with advanced solid tumors. The primary objective of the trial is to assess the safety and tolerability of escalating doses of SY-1365, with the goal of establishing a maximum tolerated dose and a recommended Phase 2 dose and regimen. The dose-escalation phase is open and expected to enroll approximately 35 solid tumor patients for whom standard curative or palliative measures do not exist or are no longer effective. Following the dose-escalation phase, expansion cohorts are planned to further evaluate the safety and anti-tumor activity of SY-1365 in patients with transcriptionally driven tumors and to enroll patients with tumors of any histology in a cohort focused on analyzing biopsied tumor tissue.

16:55 EDT Combo of Immune Design G100, Merck Keytruda triggers robust systemic responses - Immune Design (IMDZ) presented data from the randomized Phase 2 trial of its investigational intratumoral TLR4 agonist G100 plus low-dose radiation with or without Keytruda, Merck's (MRK) anti-PD-1 therapy, in follicular non-Hodgkin's lymphoma patients. The G100 Monotherapy and pembrolizumab combination resulted in a 39% objective response rate, with a 57% ORR in those patients who expressed a potential predictive biomarker. These data were presented at the 59th American Society of Hematology Annual. Patients receiving G+P showed a 39% ORR, as compared to 15% in the G100 Monotherapy arm. Pembrolizumab monotherapy in a similar recurrent/refractory FL study showed 11% ORR. Patients receiving G+P also had more frequent and deeper abscopal tumor shrinkage and a trend toward a better progression free survival. A strong association between baseline tumor TLR4 expression and objective clinical response was observed. Because clinical responses were observed in patients with recurrent/refractory disease, treatment failure less than 2 years after rituximab-containing chemotherapy, and high-risk patients based on GELF criteria, G+P may provide a therapeutic option in this unmet medical need population. Enrichment of patients more likely to respond may be attained by selecting for high expression of TLR4. G100 has been granted orphan drug designation by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of FL.

16:43 EDT Kadmon presents updated positive phase 2 data on KD025 in cGVHD - Kadmon announced additional positive findings from an ongoing Phase 2 clinical trial demonstrating that KD025, its Rho-associated coiled-coil kinase 2 inhibitor, was well tolerated and resulted in clinically meaningful responses in patients with chronic graft-versus-host disease, or cGVHD. The results were presented in a poster at the 59th American Society of Hematology (ASH) Annual Meeting. New data from Cohort 2 of the tria showed an Overall Response Rate of 63%, as of a data cutoff date of November 20, 2017. Updated data from Cohort 1 showed an ORR of 65%. While data from Cohort 2 continue to mature, responses were durable in Cohort 1, lasting five months or longer in 70% of patients. Responses were also rapid: 71% of patients across Cohorts 1 and 2 achieved response by the first assessment. Responses were observed across all affected organs, including Complete Responses in upper and lower gastrointestinal tract, mouth, skin, joints, esophagus, eyes and liver. In addition, 64% of patients from Cohorts 1 and 2 were able to reduce steroid dose, and four patients completely discontinued steroids. 83% of patients were able to reduce dose of tacrolimus, another immunosuppressive agent used to treat cGVHD. KD025 was well tolerated, with no drug-related serious adverse events in either cohort.

16:27 EDT Acceleron announces updated results from phase 2 trials of Luspatercept - Acceleron Pharma ((XRLN) announced preliminary results from the ongoing Phase 2 trials with luspatercept in patients with lower-risk myelodysplastic syndromes at the 59th Annual Meeting of the American Society of Hematology. Luspatercept is being developed as part of a global collaboration between Acceleron and Celgene (CELG). "As the Phase 2 results in MDS mature, we are excited to see luspatercept achieving a clinically meaningful erythroid response in over 50% of patients. Luspatercept continues to provide long-term benefit to multiple patients now nearing three years on treatment. These results further reinforce luspatercept's potential to be a transformative treatment option for patients living with lower-risk MDS," said Habib Dable, President and CEO of Acceleron. "We look forward to the upcoming MEDALIST and BELIEVE Phase 3 trial top-line data readouts in mid-2018, and we and Celgene continue to make considerable progress toward initiating the COMMANDS Phase 3 trial during the first half of 2018."

16:10 EDT Blueprint Medicines announces new data from ongoing Phase 1 trial of Avapritinib - Blueprint Medicines announced new data from its ongoing Phase 1 clinical trial of avapritinib, a potent and highly selective KIT and PDGFRalpha inhibitor in development for patients with advanced systemic mastocytosis. The new data from the dose escalation portion of the Phase 1 trial showed strong clinical activity regardless of advanced SM subtype, prior treatment with midostaurin or the presence of additional mutations. As of the data cutoff date of October 4, 2017, the data showed an overall response rate of 72% and a disease control rate of 100% in patients evaluable for response, based on the International Working Group-Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis consensus criteria. As of the data cutoff date, avapritinib was well-tolerated and most adverse events reported by investigators were Grade 1 or 2. In addition, there were no discontinuations due to treatment-related adverse events, and 30 of 32 patients remained on treatment with a median treatment duration of nine months. The data will be presented in an oral presentation during the Plenary Scientific Session at the 59th American Society of Hematology Annual Meeting and Exposition. Based on these data, Blueprint Medicines plans to engage global regulatory authorities in the first half of 2018 to obtain input on registration pathways for avapritinib in patients with advanced SM and patients with indolent and smoldering SM. Subject to regulatory feedback, the company anticipates initiating a registration-enabling clinical trial of avapritinib in patients with advanced SM in the first half of 2018 and a dose escalation and proof-of-concept clinical trial of avapritinib in patients with indolent and smoldering SM in the second half of 2018. In addition, Blueprint Medicines continues to enroll patients in the expansion portion of the ongoing Phase 1 clinical trial in patients with advanced SM with the goal of generating additional data in 2018.

15:53 EDT Crispr Therapeutics announces oral presentation of new data on CTX001 - Crispr Therapeutics announced the presentation of new data on CTX001, an investigational CRISPR gene-edited therapy for patients suffering from beta-thalassemia and sickle cell disease. The data were discussed in an oral presentation at the American Society of Hematology Annual Meeting. Crispr Therapeutics has filed a Clinical Trial Application for CTX001, and is planning to start a Phase 1/2 trial in beta-thalassemia in Europe in 2018. Data presented at ASH demonstrate that Crispr Therapeutics' proprietary Crispr gene-editing approach results in high editing efficiency, with over 90% of the hematopoietic stem cells edited at the target site. A vast majority of these cells are edited on both copies of the gene, which leads to expression levels of fetal hemoglobin of 40%, well above the level believed to be sufficient to ameliorate symptoms in patients with beta-thalassemia and sickle cell disease. Crispr conducted extensive genome-wide off-target assessment including detailed analyses at over 6,000 sites, which showed no off-target editing. Full toxicology analysis also demonstrated that the Crispr gene-editing had no adverse impact on engraftment of the hematopoietic stem cells and no other safety signals.

15:44 EDT Gazit Brazil completes sale of Extra Itaim in Sao Paulo - Gazit-Globe announced that its wholly owned subsidiary, Gazit Brasil, completed the sale of Extra Itaim in Sao Paulo for total proceeds of R$350M realizing a cash gain of R$140M. The sale price represents a gain of R$108M above the IFRS value in Gazit-Globe financial reports as of September 30, 2017.

15:33 EDT Liberty Property announces Q4 dividend of 40c - Liberty Property Trust announced that its board of trustees has declared a cash dividend of 40c per share on the company's common shares of beneficial interest for Q4 of 2017. The dividend will be payable on January 15, 2018 to shareholders of record on January 2, 2018.