Stockwinners Market Radar for June 03, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:41 EDT On The Fly: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. The U.S. and China ended trade talks in Beijing without any announced deals and with Chinese officials refusing to commit to buying more American goods without a Trump administration agreement not to impose further tariffs, according to The New York Times. 2. Bayer's (BAYRY) $62.5B takeover of Monsanto (MON) is set to close on Thursday, according to Reuters, citing Germany's Frankfurter Allgemeine Sonntags Zeitung. Meanwhile, Reuters also reported that Bayer has launched a $7B rights issue, a cornerstone of the financing package for the company's planned takeover of Monsanto. 3. Every year, Apple's (AAPL) Worldwide Developer Conference offers a hint of things to come, Jon Swartz wrote in this week's edition of Barron's. This year's WWDC could serve to remind investors that Apple remains a leader in innovation, even as the iPhone remains a nagging issue, he noted, adding that Apple could assuage concerns next week with new features in augmented reality, artificial intelligence, and cross-platform app development for the iPhone and its Mac computer line. 4. Disney's (DIS) Han Solo origin tale "Solo: A Star Wars Story" stayed at number 1, attracting a modest $29.3M in North America in its second outing. The movie's domestic tally currently stands at $148.9M. Internationally, the film picked up $30.3M for the three days, for an overall global weekend of about $60M. "Solo: A Star Wars Story" earned an A- CinemaScore and sports an 70% Rotten Tomatoes score. 5. Lincoln National (LNC) and Salesforce (CRM) saw positive mentions in Barron's, while Dollar Tree (DLTR) was mentioned negatively.

18:38 EDT Merck, Eisai announce data from LENVIMA/KEYTRUDA combo therapy - Eisai and Merck announced results from presentations of new data and analyses of LENVIMA, an orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy, KEYTRUDA, in four different tumor types: unresectable hepatocellular carcinoma, squamous cell carcinoma of the head and neck, advanced renal cell carcinoma, and advanced endometrial carcinoma. LENVIMA and KEYTRUDA are not approved for use in combination in any cancer types today. Early phase results from Study 116/KEYNOTE-524 support further investigation in unresectable HCC. Study 116/KEYNOTE-524 is a Phase 1b open-label, single-arm multicenter study evaluating the tolerability and safety of the combination of LENVIMA and KEYTRUDA in patients with unresectable HCC, Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, and ECOG performance status of 0 or 1. The primary endpoint was safety; secondary and exploratory endpoints included overall survival, objective response rate, progression-free survival and time to progression using modified Response Evaluation Criteria in Solid Tumors criteria. Tumor assessments of complete or partial response were confirmed greater than or equal to four weeks after initial response. Part 1 evaluated tolerability by assessing dose-limiting toxicities during the first cycle of treatment in patients for whom no other appropriate therapy was available. After tolerability was confirmed, additional patients with no prior systemic therapy for unresectable HCC were enrolled. The expansion part of the study will evaluate ORR and duration of response as measured by mRECIST.

17:18 EDT Jazz Pharmaceuticals presents long-term safety, efficacy data for Xyrem - Jazz Pharmaceuticals announced that Xyrem oral solution, CIII, demonstrated long-term efficacy for up to one year in reducing cataplexy and excessive daytime sleepiness in the global Phase 2/3 EXPRESS study of pediatric patients seven to 17 years of age with narcolepsy. The results were presented in a poster at the 32nd Annual Meeting of the Associated Professional Sleep Societies. In the EXPRESS study, after a two-week double-blind, placebo-controlled withdrawal period, participants entered an open-label safety period for up to 47 weeks, for a total study duration of up to one year. Seventy-nine participants completed greater than or equal to 6 months, and 46 completed one year. Change in weekly number of cataplexy attacks was calculated from daily cataplexy diaries. EDS was assessed by the Epworth Sleepiness Scale for Children and Adolescents at each study visit. The efficacy of sodium oxybate for cataplexy and EDS in pediatric narcolepsy was demonstrated after the two-week double-blind placebo-controlled treatment period and was maintained during open label treatment. The safety profile of sodium oxybate in children and adolescents in this study is similar to that reported in adults, and no new safety concerns were identified following the use of sodium oxybate for up to one year.

17:11 EDT AbbVie announced positive data from Phase 2 CAPTIVATE - AbbVie announced positive data from the Phase 2 CAPTIVATE study evaluating IMBRUVICA, or ibrutinib, in combination with VENCLEXTA in previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma patients. Early results of the combination oral regimen suggest promising activity in treatment-naive CLL/SLL with 77% of the first 30 patients achieving responses with no detectable minimal residual disease after six cycles of the combination therapy. MRD is determined by measuring the number of cancer cells remaining and helps confirm depth of remission. The first 14 CLL/SLL patients to complete the clinical trial combination therapy of 12 cycles achieved responses with no detectable MRD in approximately nine out of 10 patients, with 93% achieving MRD negativity when measuring in peripheral blood and 86 percent with MRD negativity when measuring in the bone marrow. The most common AEs were diarrhea, fatigue, nausea, headache, upper respiratory tract infection and arthralgia. Grade 3 or higher AEs - occurring in greater than or equal to 3% patients - were neutropenia, hypertension, diarrhea and thrombocytopenia. No clinical tumor lysis syndrome occurred and lab TLS was seen in 1 of 164 patients. In treated patients with baseline LDi 5 cm or greater, LDi decreased to less than 5 cm in 43 of 53 patients after ibrutinib lead-in. TLS risk shifted from high to medium/low in 36 of 40 patients, and overall, the proportion of high-risk TLS decreased from 24% at baseline to 3% after ibrutinib lead-in.

17:04 EDT Immunomedics reveals data for Sacituzumab Govitecan in breast cancer - Immunomedics announced results from a Phase 1/2 study of its lead investigational ADC, sacituzumab govitecan, in advanced stage estrogen receptor-positive /human epidermal growth factor receptor 2-negative metastatic breast cancer. In the Phase 1/2 study, 54 patients with ER+/HER2- mBC who received sacituzumab govitecan at a dose of 10 mg/kg on days 1 and 8 of three-week cycles showed a confirmed overall response rate of 31%, based on local investigator assessment in accordance with RECIST 1.1. The estimated median duration of response was 7.4 months, the clinical benefit rate was 48%. At the time of data cutoff on April 30, 2018, seven responders were still receiving sacituzumab govitecan. All patients had received at least two prior treatments for metastatic disease, with a median of three hormonal agents and two chemotherapy regimens. Prior treatments in any setting included taxanes, anthracyclines and CDK 4/6 inhibitors. Patients generally tolerated the treatment with sacituzumab govitecan well, with no treatment-related deaths and only two patients discontinued due to adverse events.

16:53 EDT Merck announced interim results from Cohort A of KEYNOTE-427 - Merck announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma. Interim data showed an overall response rate of 38.2% in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. In a pre-specified, exploratory sub-group analysis based on PD-L1 status, ORR was 50% in patients whose tumors expressed PD-L1. In a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium risk model, ORR was 42% in patients with intermediate/poor prognostic risk. This is the first presentation of Phase 2 data for an anti-PD-1 monotherapy as first-line treatment for advanced clear cell RCC. With a median follow-up of 12.1 months, KEYTRUDA demonstrated an ORR of 38.2%, with a complete response rate of 2.7% and a partial response rate of 35.5%. Additionally, the DCR was 59.1% and 67.2% of patients experienced a reduction in tumor burden. The median time to response was 2.8 months and, at the time of analysis, median DOR was not yet reached. Responses lasting for six months or more were observed in 74.8% of patients. In an analysis of PFS and OS endpoints, the median PFS was 8.7 months and the six-month PFS rate was 60.2%; OS was not reached and the six-month OS rate was 92.7%. The safety of KEYTRUDA was consistent with what has been seen in previous trials among patients treated with KEYTRUDA monotherapy. Treatment-related grade 3-5 adverse events were reported in 30.2% of patients.

16:12 EDT Exelixis announces results from sub-group analyses of Phase 3 CELESTIAL trial - Exelixis announced results from sub-group analyses of the CELESTIAL phase 3 pivotal trial of cabozantinib in advanced hepatocellular carcinoma comparing outcomes by duration of sorafenib treatment in patients whose only prior treatment was sorafenib and outcomes based on age. The findings showed that cabozantinib improved overall survival and progression-free survival compared with placebo irrespective of duration of prior sorafenib treatment or age category. The CELESTIAL trial was the basis for Exelixis' supplemental New Drug Application filed with the U.S. Food and Drug Administration for CABOMETYX, or cabozantinib, tablets as a treatment for patients with previously treated advanced HCC. The Prescription Drug User Fee Act action date for this application is January 14, 2019. On March 28, 2018, our partner Ipsen announced that they received validation of the application for variation to the CABOMETYX marketing authorization from the European Medicines Agency, the European regulatory authority, for the addition of a new indication for patients with previously treated advanced HCC.

16:02 EDT KEYTRUDA plus chemotherapy 'significantly improved' OS in Phase 3 KEYNOTE-407 - Merck announced results from KEYNOTE-407, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer. In this study, the KEYTRUDA plus chemotherapy combination significantly improved overall survival, reducing the risk of death by 36% compared to chemotherapy alone. This is the first time that a combination of an anti-PD-1 therapy and chemotherapy has significantly extended overall survival in the first-line treatment of patients with squamous NSCLC. Findings from pre-specified exploratory analyses showed an OS benefit regardless of PD-L1 expression. The addition of KEYTRUDA to carboplatin plus paclitaxel or nab-paclitaxel chemotherapy also significantly improved progression-free survival, with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination group, compared with chemotherapy alone. As previously announced, data from KEYNOTE-407 have been submitted to the U.S. Food and Drug Administration (FDA) for review. As previously announced, at the first interim analysis, KEYTRUDA plus carboplatin and paclitaxel or nab-paclitaxel showed an ORR of 58.4% compared to 35% for chemotherapy alone. At the time of the second interim analysis, which also included the OS and PFS results announced, the ORR results were similar to the first, alpha-controlled ORR analysis, as follows: 57.9% for the KEYTRUDA combination group compared to 38.4% for the chemotherapy group. The safety of KEYTRUDA in combination with chemotherapy was consistent with the safety profiles of KEYTRUDA and chemotherapy in previous trials among patients with metastatic NSCLC, with no new safety signals identified.

15:51 EDT Hilton, Country Garden Hotels announce strategic partnership - Country Garden Hotels Group and Hilton have announced a strategic partnership which will see numerous Country Garden hotel properties managed by Hilton, primarily with its DoubleTree by Hilton and Hilton Garden Inn brands.

15:44 EDT Celldex presents data from Phase 1/2 study of Varlilumab, Opdivo - Celldex Therapeutics (CLDX) presented two programs at the 2018 American Society of Clinical Oncology Annual Meeting. Data from the Phase 1/2 study of Celldex's varlilumab, a CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb's (BMY) Opdivo, or nivolumab, an anti-PD1 immunotherapy, for patients with ovarian cancer and colorectal cancer, were presented. In addition, an overview of the Phase 2 study of the anti-ErbB3 antibody CDX-3379 in combination with Erbitux in advanced head and neck squamous cell cancer was presented in a "clinical trials in progress" poster session. Varlilumab was featured in an oral presentation that highlighted the ongoing Phase 2 study of varlilumab in combination with Opdivo. The Phase 1/2 study includes cohorts in ovarian cancer, colorectal cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, with data from ovarian cancer and colorectal cancer patients included in the presentation. The majority of patients enrolled in the study had baseline tumors that were mostly "cold" with low expectation of responding to checkpoint inhibition therapy. The combination was well tolerated at all varlilumab dose levels tested. One patient with PD-L1 negative, MSI-high disease experienced a confirmed partial response in the Phase 2 study portion and continues on treatment. Of note, a patient with PD-L1 negative disease, initially considered MMR proficient as determined by standard screening laboratory analysis, achieved a near complete response in the Phase 1 portion of the study, which now continues at 35 months. As part of this study, an additional molecular analysis was conducted on this patient's tumor. The tumor had a high mutational burden and mutations in genes regulating DNA repair, which together likely contributed to the response. DCR was 20%. CDX-3379 was featured in a "clinical trials in progress" poster presentation that highlighted the ongoing Phase 2 study of CDX-3379, a human monoclonal antibody designed to block the activity of ErbB3, in combination with Erbitux in patients with human papillomavirus negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma. The proposed mechanism of action for CDX-3379 sets it apart from other drugs in development in this class due to its ability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope. It has a favorable pharmacologic profile, including a longer half-life and slower clearance relative to other drug candidates in this class. The multicenter, open-label, Simon two-stage design study is expected to enroll approximately 27 patients. The primary objective of the study is objective response rate. Secondary objectives include assessments of clinical benefit response, duration of response, progression-free survival and overall survival, and safety and pharmacokinetics associated with the combination. Four clinical trial sites are currently open to enrollment, and Celldex is targeting to complete enrollment to the first stage of the study by the end of the third quarter of 2018. The company continues to explore potential other opportunities in additional indications where ErbB3 is believed to play a role.

15:34 EDT AstraZeneca's Moxetumomab Pasudotox study meets primary endpoint - AstraZeneca and MedImmune, its global biologics research and development arm, presented results from the Phase III '1053' clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukemia who had received at least two prior lines of therapy. Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response rate, a 41% complete response rate, and a 30% durable CR rate. The majority of patients with a complete response had a durable response and achieved a negative minimal residual disease status. The primary endpoint of the trial was durable CR, which is defined as CR with HR for greater than180 days. The median time to HR was 1 month. The most frequent treatment-related adverse events were nausea, peripheral edema, headache, and pyrexia; 8% had infections and 3% had neutropenia deemed treatment-related. Three patient deaths occurred, none of which were determined to be treatment-related. Treatment-related AEs leading to discontinuation were hemolytic uremic syndrome, capillary leak syndrome, and increased blood creatinine. Seven patients had CLS and seven had HUS; this includes four patients who had both CLS and HUS. CLS and HUS were manageable and reversible. In April 2018, AstraZeneca announced that the Food and Drug Administration accepted the Biologics License Application for moxetumomab pasudotox for the treatment of adult patients with HCL who have received at least two prior lines of therapy. The BLA is based on results from the Phase III '1053' clinical trial. The FDA has granted Priority Review status with a Prescription Drug User Fee Act action date set for the third quarter of 2018.

15:22 EDT Jounce presents preliminary efficacy data from Phase 1/2 ICONIC trial - Jounce Therapeutics presented preliminary data from its ongoing Phase 1/2 ICONIC trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. The ICONIC study is an open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with a fixed dose of nivolumab in patients with advanced solid tumors. Patients were heavily pre-treated with approximately 65% having received 3 or more prior therapies; approximately 65% discontinued during the first three cycles. The Phase 1 portion of ICONIC was a dose escalation study to determine the maximum tolerated dose and recommended Phase 2 dose. The patients in Phase 2 received JTX-2011 0.3 mg/kg every 3 weeks alone or in combination with nivolumab 240 mg every 3 weeks. Preliminary efficacy evaluation included tumor reductions and RECIST responses. JTX-2011 was well tolerated alone and in combination with nivolumab 240 mg every 3 weeks. The overall safety profile observed was consistent with previously reported data from the Phase 1 portion of the ICONIC trial. In a preliminary analysis of evaluable fresh pre-treatment biopsies, rates of disease control and tumor reduction appear higher in subjects with high ICOS scores. An ICOS pharmacodynamic biomarker appears to associate with anti-tumor activity. Based on preliminary signals of clinical activity associated with an ICOS pharmacodynamic biomarker, Jounce is advancing clinical evaluation of JTX-2011. The next steps for the program include continuing to evaluate the ongoing data and the initiation of two new dose escalation cohorts within the ICONIC trial of JTX-2011, one in combination with ipilimumab and one in combination with pembrolizumab. The new ipilimumab combination cohort may enable Jounce to explore a new combination mechanism that is supported by clinical and pre-clinical research. Exploration with pembrolizumab at its approved q3w dose and schedule may allow the company to evaluate JTX-2011in combination with a PD-1 inhibitor in earlier lines of therapy. ICONIC Phase 1 has completed enrollment and Phase 2 is nearing completion of enrollment. Given the pace of enrollment of the combination cohorts in gastric cancer, TNBC, HNSCC, NSCLC and the overall quantity of the data collected, Jounce made the decision to stop recruitment of other solid tumors and of the more slowly enrolling monotherapy and melanoma combination cohorts.

15:06 EDT Deciphera reports updated interim phase 1 clinical study results with DCC-2618 - Deciphera Pharmaceuticals announced the presentation of updated data from its ongoing Phase 1 clinical trial of DCC-2618, the company's broad-spectrum KIT and PDGFRalpha inhibitor, in patients with gastrointestinal stromal tumors at the American Society of Clinical Oncology Annual Meeting 2018, and provided additional clinical and regulatory updates on DCC-2618. The combined 24% ORR and 80% 3-month DCR in second and third line patients receiving DCC-2618 at doses of greater than or equal to100mg per day exceeds previously published results of registrational trials for the currently approved therapies for second line and third line, which have reported ORRs of 7.0% and 4.5%, respectively, and levels of disease control of 60% and 53%, respectively. Initial Objective Response Rates and Disease Control Rates with DCC-2618 at Doses of greater than or equal to100mg Daily in Second and Third Line GIST Patients Exceed Previously Published Results of Registrational Trials for Currently Approved Therapies, as well as the Results Observed in Heavily Pre-Treated GIST Patients Receiving DCC-2618: 24% ORR with DCC-2618 observed to date in second and third line GIST patients is higher than that reported for sunitinib in second line patients or regorafenib in third line patients. These interim results show improved ORR and 3-month DCR in second line GIST patients treated with DCC-2618 compared to fourth and fourth line plus GIST patients treated with DCC-2618. In addition, the company is providing the following clinical and regulatory updates on DCC-2618. Following discussions with regulatory authorities in the U.S. and in Europe, the company has designed INTRIGUE as a randomized, multicenter, open-label, Phase 3 trial in second line GIST. This registration study is expected to enroll approximately 350 patients who will be randomized 1:1 to either DCC-2618 or sunitinib, the current standard of care in second line; with median progression free survival as the primary endpoint.

14:54 EDT G1 Therapeutics presents phase 1b data on G1T38 in combination with Faslodex - G1 Therapeutics announced that preliminary data from its Phase 1b/2a clinical trial of G1T38 in combination with Faslodex, or fulvestrant, showed promising safety, tolerability and efficacy when G1T38 was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative breast cancer. These data were presented in a poster session at the 2018 American Society of Clinical Oncology Annual Meeting. G1T38 is an oral CDK4/6 inhibitor with broad therapeutic potential in many forms of cancer and may serve as backbone therapy for multiple combination regimens. The Phase 1b/2a trial is designed to evaluate safety, tolerability, and establish a recommended Phase 2 dose and schedule for G1T38 administered continuously in combination with Faslodex as a treatment for ER+, HER2- breast cancer. Thirty-three trial participants received G1T38 doses ranging from 200-650 mg once daily and 100-200 mg twice daily. Faslodex 500 mg QD was administered per standard of care. There have been no G1T38-related serious adverse events reported in the trial, and no participants have withdrawn due to adverse events.There have been no Grade 3/4 AEs other than cytopenias. Early efficacy data are promising but immature. Of the 33 participants in the trial, 24 were response evaluable with measurable disease and had at least one on-treatment tumor assessment.

14:41 EDT Puma Biotechnology presents interim results of Phase Ib/II FB-10 clinical trial - Puma Biotechnology announced that interim results from the Phase Ib/II FB-10 clinical trial of Puma's investigational drug PB272, or neratinib, given in combination with the antibody drug conjugate T-DM1 were presented at the 2018 American Society of Clinical Oncology Annual Meeting. The FB-10 study is an open-label, single arm study with a dose escalation phase and an expanded cohort phase to evaluate patients with HER2-positive metastatic breast cancer who had previously been treated with chemotherapy and the combination of trastuzumab and pertuzumab. The primary aim of the Phase Ib portion of the study is to determine the safety and tolerability of the two-drug combination. The primary aim of the Phase II portion of the study is to demonstrate efficacy at the recommended Phase II dose of T-DM1 and neratinib. Study treatment during the Phase Ib portion consisted of the standard dose of T-DM1 at 3.6 mg/kg administered intravenously every 3 weeks and neratinib administered orally at escalating doses of 120, 160, 200 and 240 mg per day continuously. Primary diarrhea prophylaxis with high dose loperamide was administered to all patients. As of the date of the presentation, the study had enrolled 27 patients. Total study enrollment will be a maximum of 63 patients. For the 20 patients who were evaluable for efficacy, the interim objective response rate was 60%. More specifically, the efficacy results from the trial demonstrated that 3 patients had a complete response; 9 patients had a partial response; 2 patients had stable disease; and 6 patients had progressive disease.

14:24 EDT Roche announced results from Phase III IMpower131 study - Genentech, a member of the Roche Group, announced that results from the Phase III IMpower131 study showed TECENTRIQ, or atezolizumab, plus chemotherapy reduced the risk of disease worsening or death by 29% compared with chemotherapy alone in the initial treatment of people with advanced squamous non-small cell lung cancer. The 12-month PFS rate was doubled for people who received the TECENTRIQ combination compared to those who received chemotherapy alone. A statistically significant overall survival benefit was not observed at the interim analysis, and the study will continue as planned. The safety profile of the TECENTRIQ plus chemotherapy combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.