Stockwinners Market Radar for November 11, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:22 EDT Mesoblast announces clinically meaningful outcome in NIH trial of MPC-150-IM - Mesoblast announced that results from a 159-patient randomized, sham-controlled Phase 2 trial in end-stage heart failure patients implanted with a left ventricular assist device showed that Mesoblast's allogeneic cell therapy candidate MPC-150-IM achieved significant reduction in major gastrointestinal bleeding episodes and related hospitalizations, a complication affecting up to 40% of LVAD recipients. This clinically meaningful outcome confirms results seen in an earlier 30-patient pilot trial which provided the basis for the Regenerative Medicine Advanced Therapy designation granted to Mesoblast by the United States Food and Drug Administration for MPC-150-IM as adjunctive therapy to LVAD implantation. Under the RMAT designation, Mesoblast received specific guidance from the FDA that reduction in major GI bleeding episodes and related hospitalizations in the current trial is a clinically meaningful outcome with a high unmet need that could meet requirements for an approvable regulatory endpoint. In contrast, the FDA advised that the primary endpoint in the current trial of temporary weaning from full LVAD support is considered a biomarker and is not a clinically meaningful outcome in and of itself. MPC-150-IM is also being evaluated by catheter-based delivery in patients with NYHA Class IIb-III CHF. This ongoing events-driven Phase 3 trial has enrolled approximately 85% of approximately 600 total patients.

18:34 EDT Fate Therapeutics announces dose-escalation clinical data of FATE-NK100 - Fate Therapeutics announced new clinical data for FATE-NK100, an investigational, first-in-class, allogeneic donor-derived natural killer cell cancer immunotherapy, and provided a regulatory update on the development of FT500, a universal, off-the-shelf NK cell product candidate derived from a master induced pluripotent stem cell line, on November 10, 2018. Twenty heavily pre-treated subjects, each presenting with progressive disease at the time of enrollment, have been treated with FATE-NK100 in the dose-escalation phases of three Phase 1 clinical trials. As of a October 22, 2018 data cutoff, one-month follow-up data were available on fourteen subjects, with clinical benefit indicated in seven of these fourteen subjects: In the DIMENSION study for the treatment of advanced solid tumors, one subject at the second dose level and two subjects at the third dose level treated with a single intravenous infusion of FATE-NK100 in the monotherapy regimen had stable disease at one month. These two subjects at the third dose level were each subsequently treated with a second dose of FATE-NK100 and remain on study with ongoing disease control. The study is currently enrolling at the third dose level in the monotherapy regimen, at the second dose level in the cetuximab combination regimen and at the run-in dose level in the trastuzumab combination regimen. In the APOLLO study for the treatment of recurrent ovarian cancer, one subject treated with a single intraperitoneal infusion of FATE-NK100 at the second dose level had stable disease at one month. The subject was subsequently treated with a second dose of FATE-NK100 and maintained disease control for 6.2 months. The study is currently enrolling at the third dose level. In the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia, all three subjects treated with a single intravenous infusion of FATE-NK100 at the second dose level showed complete clearance of leukemic blasts in the bone marrow and achieved a morphologic leukemia-free state at Day 14 following treatment. Each of these three subjects received a single dose of FATE-NK100 only, and the anti-leukemic response in each of these subjects was transient. The study is currently enrolling at the second dose level. No dose limiting toxicities related to FATE-NK100 were reported. One serious adverse event related to FATE-NK100 was reported in the APOLLO study. In addition, the company announced that adventitious agents testing of the master iPSC bank for the clinical production of FT500, a universal, off-the-shelf NK cell product candidate, has been completed. The FT500 master iPSC bank was found to be free of adventitious agents as determined by in vivo and in vitro testing. The company has submitted these results to the U.S. Food and Drug Administration in furtherance of the agency's review of the company's FT500 Investigational New Drug application. Upon allowance by the FDA of the FT500 IND, the company plans to initiate Phase 1 clinical testing of FT500 as a monotherapy and in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This first-in-human study is expected to evaluate the safety and tolerability of multiple doses of FT500 in multiple dosing cycles.

17:41 EDT Box Office Battle: 'Dr. Seuss' The Grinch' wins weekend with $66M - Christmas came early, with Comcast (CMCSA) subsidiary Universal's "Dr. Seuss' The Grinch" opening to $66M from 4,414 North American theaters. The movie, which is the first family event film of the year-end corridor, earned an A- CinemaScore. BOX OFFICE RUNNERS-UP: 21st Century Fox's (FOX, FOXA) "Bohemian Rhapsody" placed number two, ending is second outing with $30.9M. Behind it was Viacom (VIAB) subsidiary Paramount's "Overload," finishing its debut weekend with $10.1M from 2,859 theaters. Disney's (DIS) "The Nutcracker and the Four Realms" placed number four with an estimated $9.6M from 3,766 locations. Rounding out the top five, Sony's (SNE) "The Girl in the Spider's Web: A New Dragon Tattoo Story" earned $8M in its first weekend from 2,929 theaters. Other publicly traded companies in filmmaking include AT&T (T) subsidiary Warner Bros' and Lionsgate's (LGF.A, LGF.B).

17:13 EDT Alibaba generated $30.8B of GMV during 2018 11.11 Global Shopping Festival - Alibaba (BABA) announced that it generated $30.8B of gross merchandise volume on November 11, 2018, an increase of 27% compared to 2017. Cainiao Network processed more than 1B delivery orders and more than 180,000 brands participated in the event. According to the company, over 40% of consumers made purchases from international brands. 237 brands exceeded RMB100M in GMV, including leading international brands Apple (AAPL), Dyson, Kindle (AMZN), Estee Lauder (EL), L'Oreal (LRLCY), Nestle (NSRGY), Gap (GPS), Nike (NKE) and Adidas (ADDYY). Lazada participated in 11.11 as part of the Alibaba ecosystem.

13:41 EDT CCRC announces receipt of non-binding 'going private' proposal at $16 per share - China Customer Relations Centers announced that its board of directors has received a preliminary non-binding proposal letter dated November 10, 2018 jointly submitted by its founder and chairman of the Board, Zhili Wang, and Guangzhou Cornerstone Asset Management, to acquire all of the outstanding shares of CCRC not currently owned by them in a going private transaction for $16 per common share in cash. CCRC's Board has formed a special committee of independent and disinterested directors consisting of Tianjun Zhang, Owens Meng, and Jie Xu, to consider this proposal. The Independent Committee intends to retain a financial advisor and legal counsel to assist it in its work. The Board cautions the company's shareholders and others considering trading in its securities that the Board just received the preliminary non-binding proposal from Wang and Cornerstone, and no decisions have been made by the Independent Committee with respect to CCRC's response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.

13:33 EDT Corvus Pharmaceuticals announces updated results from CPI-444, CPI-006 - Corvus Pharmaceuticals announced updated clinical and biomarker data from ongoing Phase 1/1b studies of its lead programs, CPI-444 and CPI-006. Updated results from its Phase 1/1b clinical trial of CPI-444 in patients with treatment-refractory renal cell carcinoma demonstrated an overall survival of 88% at more than 20 months follow-up with CPI-444 administered in combination with atezolizumab. The clinical data were presented in an oral session at the Society for Immunotherapy of Cancer's 33rd Annual Meeting in Washington, D.C. Additionally, CPI-444 biomarker data from the Phase 1/1b study showing that expression of a novel adenosine gene signature was significantly associated with tumor regression were presented both in the oral presentation and in a poster session at the SITC meeting. Early clinical data from an ongoing Phase 1/1b study evaluating CPI-006 as a monotherapy showing evidence of immune activation of B cells were presented in a poster session. CPI-444, Corvus' lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in Phase 1/1b and 1b/2 clinical trials in patients with various solid tumors as a monotherapy and in combination with Genentech's atezolizumab, an anti-PD-L1 antibody. CPI-006 is a humanized monoclonal antibody directed against CD73. It is currently being evaluated in a Phase 1/1b three-arm clinical trial in patients with a variety of solid tumors as a monotherapy, in combination with CPI-444, and in combination with pembrolizumab, an anti-PD-1 antibody. CPI-444 continues to be well tolerated to date, with observed adverse events similar to previous reports. In the combination arm, adverse events were generally consistent with other anti-PD-L1 therapies. In the monotherapy arm, grade 3 adverse events were infrequent and reversible.

13:24 EDT Amarin announced primary results from Vascepa cardiovascular outcomes trial - Amarin announced the primary results from the Vascepa cardiovascular outcomes trial, REDUCE-IT, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. Cardiovascular benefits appeared not to be influenced significantly by triglyceride levels at baseline or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline. REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reduction on top of statin therapy in a major cardiovascular outcomes trial. REDUCE-IT studied Vascepa 4 grams/day as compared to placebo over a median follow-up time of 4.9 years. The REDUCE-IT study was designed under a special protocol assessment agreement with the U.S. Food and Drug Administration. Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019. Vascepa is a low-cost drug. The majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9 for a 90-day supply prescription of Vascepa.

13:15 EDT Jounce Therapeutics presents data from ICOS program at SITC annual meeting - Jounce Therapeutics announced that reverse translational and biomarker data derived from its ICONIC trial of JTX-2011 and preclinical data from the ICOS program were presented at the Society for Immunotherapy of Cancer's 33rd Annual Meeting, being held November 9-11, 2018 in Washington, D.C. Data presented from ICONIC patients demonstrate the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at ASCO 2018 demonstrating the emergence of ICOS hi CD4 T cells in the bloodstream in all patients with greater than or equal to 30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOS hi CD4 T cells were not observed in patients with primary progressive disease. Follow-up on the initial observation of the emergence of ICOS hi CD4 T cells. Emergence of this cell population, which correlated with clinical benefit in patients treated with both JTX-2011 monotherapy and in combination with nivolumab, was presented at ASCO in June 2018. These data build upon the initial observation and provides further characterization of the emerging cell population as T effector and not T regulatory cells and includes evidence that the cells do not emerge in patients responding to PD-1 monotherapy. Additional in vitro data presented demonstrate that JTX-2011 alone induces a cytokine response from CD4 T cells, only if the T cells have pre-existing ICOS hi characteristics. CTLA-4 inhibition has been shown to induce a population of ICOS hi cells in the bloodstream, while PD-1 inhibitors do not, and these observations further support the biological rationale for the ongoing clinical development of JTX-2011 in combination with ipilimumab. The combination of radiation therapy and treatment with an ICOS agonist antibody led to increased anti-tumor response in an immunogenic mouse tumor model. In a less immunogenic tumor model, response required the combination of ICOS agonist and PD-1 antagonist with radiation, suggesting again that ICOS agonism in combination with modalities that upregulate ICOS, such as with radiation, may represent an attractive regimen for combination immunotherapy of anti-PD-1 resistant tumors.

13:08 EDT Esperion announces presentation of final Study 3 results of Bempedoic Acid - Esperion announced that the final Phase 3 results from Study 3 were presented at the American Heart Association Scientific Sessions in Chicago. This study evaluated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease, or at high risk for ASCVD with hypercholesterolemia, inadequately treated with maximally tolerated background LDL-C lowering therapy who are only able to tolerate less than the approved daily starting dose of a statin and considered statin intolerant. Topline results were previously announced in May 2018. The 24-week, global pivotal Phase 3 randomized, double-blind, placebo-controlled, multicenter study evaluated the LDL-C lowering efficacy and safety of bempedoic acid 180 mg/day versus placebo added to background lipid-modifying therapy in patients with hypercholesterolemia who are considered statin intolerant. The study was conducted at 67 sites in the U.S. and Canada. A total of 345 patients were randomized 2:1 to receive bempedoic acid or placebo. The primary efficacy objective was to assess the 12-week LDL-C lowering efficacy of bempedoic acid versus placebo. Secondary objectives included evaluating the 24-week LDL-C lowering efficacy of bempedoic acid versus placebo, the safety and tolerability of bempedoic acid versus placebo, and its effects on other risk markers after 12 weeks of treatment, including hsCRP. Esperion plans to submit New Drug Applications to the U.S. Food and Drug Administration for bempedoic acid and the bempedoic acid/ezetimibe combination pill for LDL-C lowering indications during the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency during the second quarter of 2019.

13:01 EDT Infinity Pharmaceuticals reports data from MARIO-1 Phase 1b study - Infinity Pharmaceuticals announced that data to be presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer demonstrated preliminary evidence that IPI-549 in combination with Opdivo is clinically active in indications not expected to respond to Opdivo alone. In particular, evidence of reversal of resistance to Opdivo included a partial response in a patient with metastatic melanoma who progressed on immediate prior Opdivo therapy. IPI-549 plus Opdivo also resulted in a 26% reduction of tumor target lesions in a patient with chemotherapy-resistant triple negative breast cancer, a tumor type intrinsically resistant to checkpoint inhibition. The data also included long-term follow up on sustained partial responses in two patients from combination dose escalation: one with microsatellite stable gallbladder cancer and one with adrenocortical carcinoma. The observed early clinical activity from the combination expansion, in addition to findings from the monotherapy cohorts, including associated translational data, support on-mechanism proof of concept for IPI-549. Infinity is evaluating IPI-549 in MARIO-1, a Phase 1b study in approximately 200 patients with advanced solid tumors. Additionally, Infinity is planning to initiate MARIO-275, a global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in approximately 150 checkpoint-inhibitor naive advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy.