Stockwinners Market Radar for June 16, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:15 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. The Federal Aviation Administration could start flight trials of Boeing's (BA) proposed 737 MAX safety enhancement as early as this week, The Wall Street Journal's Andrew Tangel, Alison Sider and Andy Pasztor wrote. Meanwhile, Reuters' Eric Johnson reported that the head of Boeing said the planemaker had made a mistake in implementing a faulty cockpit warning system on the 737 Max and predicted it would take time to rebuild the confidence of customers in the wake of two fatal crashes. Chairman and CEO Dennis Muilenburg said Boeing failed to communicate "crisply" with regulators and customers, but defended the broad engineering and design approach to nose-down control software at the center of probes into the accidents, the author noted. 2. Deutsche Bank (DB) is preparing a deep overhaul of its trading operations including the creation of a bad bank to hold tens of billions of euros of assets, Financial Times' Stephen Morris and Olaf Storbeck reported. The plan would see the bad bank house or sell assets valued by the lender in its accounts at up to EUR50B after adjusting for risk, the authors noted. Meanwhile, Goldman Sachs (GS) is said to be pulling together four separate units that invest in private companies, real estate and other hard-to-access deals, creating a new unit and planning a fundraising blitz, according to The Wall Street Journal's Liz Hoffman, citing people familiar with the matter. The division's exact makeup will take shape over the next few months, but it is likely to have around $140B in assets, the author noted. 3. Amazon (AMZN) is quitting its meal delivery service, making the shares of GrubHub (GRUB) rise on the news, Jack Hough wrote in this week's edition of Barron's. Online food ordering will rise 20% to $56B this year in the U.S., and 16% to $203B worldwide, predicts market researcher Euromonitor, and the "food fight" extends well beyond restaurant delivery, the author noted. Autonomous driving will eventually solve for the least-scalable part of food delivery-people, and companies that survive the thin-margin years between now and then could enjoy powerful network effects, and rich profits, he contended. 4. Sony's (SNE) "Men in Black: International" debuted to a sluggish $28.5M from 4,200 theaters. Overseas, the spinoff collected $73.7M, making its global haul an estimated $102.2M. The movie received just 27% on Rotten Tomatoes, while sporting a B CinemaScore. 5. United Technologies (UTX), Raytheon (RTN), McKesson (MCK), Cardinal Health (CAH), AmerisourceBergen's (ABC) saw positive mentions in this week's edition of Barron's.

13:41 EDT Elbit Systems awarded $50M contract - Elbit Systems announced that its wholly-owned subsidiary, Elbit Systems - Cyclone, was awarded an approximately $50M contract for the supply of structural parts from composite materials for an aircraft of a customer in North America. The contract will be performed over six years. The contract calls for the supply of a variety of structural parts from composite materials for all the models of one of the customers' leading aircraft platforms.

13:35 EDT Silk Road Medical announces final results for ROADSTER-2 study - Silk Road Medical announced final results for the company's ROADSTER-2 post-marketing study evaluating real world use of the ENROUTE Neuroprotection and Stent Systems in TransCarotid Artery Revascularization procedures. The study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. 70% of patients enrolled in the study were from physicians new to TCAR. Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction at 30 days, at 97.9%. Significant findings from the study showed TCAR to have low rates of 30-day major adverse events. In addition, ROADSTER-2 showed lower rates of acute and permanent cranial nerve injury than is typically observed for patients receiving carotid endarterectomy, the current standard of care.

13:28 EDT Sunesis announces preliminary data from Phase 1b/2 trial of Vecabrutinib - Sunesis Pharmaceuticals announced the presentation of results from the company's Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia and other B-cell malignancies. Preliminary data reported were available from 23 patients treated in the trial thus far. These included 19 CLL patients, two mantle cell lymphoma patients, and two Waldenstrom Macroglobulinemia patients. Patients had received an average of 4 lines of prior therapy, and all patients had progressed on prior BTKi therapy. 61% of CLL patients enrolled had a BTK C481 mutation as of the data cutoff for the poster. Preliminary data on treatment-emergent adverse events were available for 20 patients. The most common TEAEs of any grade were anemia and neutropenia and night sweats, with 5 drug-related Grade 3 adverse events occurring in 3 patients, all in cohort 2. In total, there were 8 serious adverse events in six patients, none of which were considered drug-related. Stable disease was seen in 4 CLL patients, 3 of whom had BTK C481S mutations. Two of these patients, both with BTK C481S mutations, showed decreases of 16% and 47% in index lesions at first assessment by CT scans. The patient with the 47% decrease was one of two evaluable post-venetoclax patients with the BTK C481S mutation. A patient with WM experienced clinical benefit with improvement in B-symptoms but no impact on immunoglobulin M. One patient in cohort 3 continues on treatment in cycle 6. The pharmacokinetic profile of vecabrutinib showed sustained exposure over the dosing interval, with median steady-state trough concentrations increasing with dose. Preliminary data showed near doubling of trough concentrations between doses of 50 mg and 100 mg. Based on the results of the Phase 1A study in healthy subjects, trough levels of greater than1,000 ng/mL are expected to be required for consistent BTK inhibition and greater clinical activity. This is likely achievable with doses higher than 100 mg BID. Vecabrutinib inhibition of BTK phosphorylation was rapid and sustained in patients who had adequate baseline signal for analysis. Decreases in serum concentrations of key cytokines associated with B-cell malignancies, CCL2, CCL3, and CCL4, were observed in most evaluable patients, consistent with inhibition of BTK signaling.

13:23 EDT Apellis presents data from ongoing Phase 2 PLAUDIT study of APL-2 - Apellis Pharmaceuticals announced updated data from its Phase 2 PLAUDIT study of APL-2 in patients with autoimmune hemolytic anemia, including cold agglutinin disease and warm antibody autoimmune hemolytic anemia. Data from the PLAUDIT trial will be presented in an oral presentation at the 24th Annual Congress of the European Hematology Association, held in Amsterdam, the Netherlands. In the ongoing PLAUDIT study, 13 patients with CAD have been enrolled to receive subcutaneous APL-2 treatment, of which 10 patients have been on APL-2 for at least 168 days. The trial has also enrolled 11 patients with wAIHA, 8 of which were Direct Antiglobulin Test C3+; 5 of the C3+ wAIHA patients have been on APL-2 for at least 168 days. Of the 10 patients who reached Day 168: 70% showed a Hb increase of greater than or equal to2 g/dL, 40% had normalized Hb and 80% had Hb greater than or equal to11.0 g/dL at Day 168. Mean Hb increased from 8.9 g/dL at baseline to 11.2 g/dL at Day 168, a 2.4 g/dL increase. Mean Functional Assessment of Chronic Illness Therapy Fatigue Score increased from 29.4 at baseline to 39.1 at Day 168, an improvement of 9.7 points, where a clinically significant increase is 3 or more points. Mean absolute reticulocyte count decreased from 159 X 10/L at baseline to 64 X 10/L at Day 168. Mean indirect bilirubin decreased from 1.6 mg/dL at baseline to 0.4 mg/dL at Day 168. Mean LDH decreased from 500 U/L at baseline to 183 U/L at Day 168. Two heavily transfusion dependent patients did not respond to APL-2 and left the study at Day 56 and 108 respectively. The remaining transfusion dependent patients did not require any transfusions during maintenance treatment with APL-2. One previously non-transfusion dependent patient received an on-study transfusion prior to APL-2 steady-state. One patient is still participating in the study and has not yet reached Day 168. Of the 5 patients with C3+ wAIHA who reached Day 168: Mean Hb increased from 9.0 g/dL at baseline to 11.0 g/dL at Day 168, a 2.0 g/dL increase. Mean FACIT Fatigue Score increased from 38.4 at baseline to 40.8 at Day 168, an improvement of 2.4 points. Mean ARC decreased from 213 X 10/L at baseline to 92 X 10/L at Day 168. Mean indirect bilirubin decreased from 0.8 mg/dL at baseline to 0.3 mg/dL at Day 168. Mean LDH decreased from 241 U/L at baseline to 142 U/L at Day 168. Two of the eight enrolled C3+ wAIHA patients left the study due to lack of response, and one of the eight enrolled C3+ wAIHA subjects is still participating in the study and has not yet reached Day 168. The three enrolled patients who were not DAT C3+ did not show a meaningful response and two have left the study. In both the CAD and C3+ wAIHA populations, APL-2 was generally well tolerated; no serious adverse events related to APL-2 were reported in the PLAUDIT trial. In both the CAD and C3+ wAIHA populations, APL-2 was generally well tolerated; no serious adverse events related to APL-2 were reported in the PLAUDIT trial.

13:06 EDT AstraZeneca announces results from interim analysis of Phase 2 ASCEND trial - AstraZeneca announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association Annual Congress in Amsterdam, showing CALQUENCE significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukemia. The ASCEND trial compared CALQUENCE with the investigator's choice of rituximab combined with idelalisib or bendamustine in patients with relapsed or refractory CLL. At a median follow-up of 16.1 months, results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival for patients treated with CALQUENCE versus IdR or BR, reducing the risk of disease progression or death by 69%. The median time without disease progression or death for patients treated with CALQUENCE has not yet been reached versus 16.5 months in the control arm. At 12 months, 88% of patients on CALQUENCE showed no disease progression compared to 68% for the control arm. The safety and tolerability of CALQUENCE was consistent with its established profile. AstraZeneca recently announced that the Phase III ELEVATE-TN trial met its primary endpoint at interim analysis in patients with previously-untreated CLL and that full results will be reported at a forthcoming medical meeting.

12:59 EDT Blueprint Medicines presents updated EXPLORER trial data for Avapritinib - Blueprint Medicines announced updated data from the ongoing, registration-enabling EXPLORER trial of avapritinib in patients with systemic mastocytosis. The updated data showed a confirmed overall response rate of 77% in advanced SM patients, as assessed by a central review committee of SM clinical experts. In addition, the data showed durable clinical activity across advanced, smoldering and indolent forms of SM, with patients on therapy up to 34 months and responses continuing to deepen over time. Avapritinib was generally well-tolerated, with most adverse events reported by investigators as Grade 1 or 2. These updated data from the EXPLORER trial support Blueprint Medicines' plans to submit a New Drug Application to the U.S. Food and Drug Administration for avapritinib for the treatment of advanced SM in the first quarter of 2020, subject to continued discussions with the FDA regarding the data required to support an NDA submission. Avapritinib has received FDA Breakthrough Therapy Designation for the treatment of patients with advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia. As of the data cutoff date of January 2, 2019, 69 patients were treated with avapritinib in the Phase 1 EXPLORER clinical trial, including seven patients with ASM, 37 patients with SM-AHN, nine patients with MCL, 15 patients with indolent or smoldering SM, and one patient without SM who had chronic myelomonocytic leukemia. Diagnoses were centrally reviewed by a committee of SM experts following an initial assessment by local investigators. Forty-two patients had a prior treatment, including 15 patients who had previously received the multi-kinase inhibitor midostaurin. Thirty-nine patients with advanced SM were evaluable for response by the modified IWG-MRT-ECNM criteria, a rigorous method for assessing clinical response in advanced SM patients with regulatory precedent in the U.S. and Europe. Confirmation of response was defined as a response duration of at least 12 weeks. Evaluable patients generally had more advanced disease at baseline than the overall trial population. In evaluable patients across all doses studied, the confirmed ORR was 77%. Nine patients had complete remission with a full or partial recovery of peripheral blood counts, 18 patients had partial remission and three patients had clinical improvement. No patients had progressive disease as the initial response. In addition, the 12-month duration of response rate was 74%, and 49 patients remained on treatment with durations up to nearly three years. Across all enrolled patients, the median overall survival was not reached. The estimated 24-month OS rate was 78% in all advanced SM patients: 100% in ASM patients, 70% in SM-AHN patients and 88% in MCL patients. Avapritinib demonstrated strong clinical activity in patients with SRSF2, ASXL1 and/or RUNX1 mutation positive genotypes, who historically have particularly poor prognoses. In 22 evaluable patients with S/A/R genotypes, the confirmed ORR was 73% and five patients had a CR/CRh. Nearly all patients had significant declines on objective measures of mast cell burden. Across all patients evaluable on these measures, 100% had a greater than or equal to 50% decline in serum tryptase, 93% had a greater than or equal to 50% reduction in bone marrow mast cells, 84% had palpable spleens become non-palpable, and 88% had a greater than or equal to 50% reduction in KIT D816V mutation allele fraction. Avapritinib showed strong clinical activity in patients with indolent or smoldering SM. Nearly all patients had greater than or equal to50 percent reductions in serum tryptase, bone marrow mast cells and KIT D816V mutation allele fraction. In addition, improvements on these measures were deep and rapid. Thirteen of 15 evaluable patients had normalized serum tryptase levels, and 12 of 13 evaluable patients had complete clearance of mast cell aggregates from the bone marrow. All indolent and smoldering SM patients achieved a greater than or equal to50 percent reduction in serum tryptase by the first post-baseline assessment. Avapritinib was generally well-tolerated with most AEs reported by investigators as Grade 1 or 2. Across all grades, the most common non-hematologic treatment-emergent AEs reported by investigators were periorbital edema, diarrhea, nausea, fatigue, peripheral edema, vomiting, cognitive effects, hair color changes, arthralgia, abdominal pain, dizziness, decreased appetite, pruritis, constipation and dysgeusia. The most common hematologic treatment-emergent AEs reported by investigators were anemia, thrombocytopenia and neutropenia. In addition, intracranial bleeding occurred in six patients with pre-existing thrombocytopenia, a known risk factor for intracranial bleeding, and one patient who had a life-threatening fall prior to intracranial bleeding. Five of these patients resumed and remain on treatment with avapritinib following dose modifications. Updated dose modification procedures have been implemented for patients with thrombocytopenia, and to date, no new intracranial bleeding events have been observed. Cytopenias were the most common Grade 3 and 4 treatment-related AEs. No Grade 5 treatment-related AEs were reported by investigators. Only three patients discontinued treatment with avapritinib due to treatment-related AEs. Nine patients discontinued treatment with avapritinib due to disease progression, with the majority due to either acute myeloid leukemia or associated hematologic neoplasm.