Stockwinners Market Radar for June 04, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

22:25 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. London was struck Saturday by its third terrorist attack in as many months. With less than a week to go before the U.K. general election, Prime Minister Theresa May appeared to offer veiled criticism against companies such as Facebook (FB) and Twitter (TWTR) in calling for scrutiny of online platforms that allow extremists "safe space." 2. The annual meeting of the American Society of Clinical Oncology, or ASCO, kicked off Friday and will continue through Tuesday, already bringing a volume of new clinical data from companies including Loxo Oncology (LOXO), Incyte (INCY), Five Prime (FPRX), Puma Biotech (PBYI) and Dynavax (DVAX). 3. AAA is reportedly raising insurance rates for Tesla's (TSLA) Model S and Model X, saying its analysis of data from the Highway Loss Data Institute and other sources shows outsize claims relative to comparable cars. In statements released to Automotive News, Tesla called the analysis "severely flawed," while the Insurance Institute for Highway Safety said rates should reflect the "costly" repairs of Tesla vehicles. Separately, the Wall Street Journal reported that Toyota (TM) sold its remaining stake in the carmaker some time last year. 4. Time Warner's (TWX) "Wonder Woman" earned $100.5M in its U.S. box office debut, setting a record for female-directed features and perhaps marking a return to form for the studio's superhero efforts after the critically maligned "Batman v Superman." 5. Accenture (ACN), Time Warner, Goodyear (GT) and rising inflation plays Bank of America (BAC), Becton Dickinson (BDX), CME (CME), Johnson & Johnson (JNJ) and Shell (RDS.A) saw positive mention in Barron's, while Express Scripts (ESRX) was discussed cautiously.

20:43 EDT U.K. PM: Cannot allow extremists 'safe space' online - U.K. Prime Minister Theresa May appeared to signal increased scrutiny against online services in the wake of Saturday's attack in London, stating in a speech that "we cannot allow this ideology the safe space it needs to breed. Yet that is precisely what the internet -- and the big companies that provide internet-based services -- provide. We need to work with allied, democratic governments to reach international agreements that regulate cyberspace to prevent the spread of extremism and terrorist planning. And we need to do everything we can at home to reduce the risks of extremism online." Publicly traded companies in the space include Facebook (FB), Twitter (TWTR) and Alphabet (GOOG). Reference Link

19:38 EDT IBM announces partnership with Baheal for Watson in China - IBM announced that Baheal Pharmaceutical Group is extending the reach of Watson for Oncology to clinicians across China through a new multi-year strategic alliance. "As the primary channel partner for Watson for Oncology in China, Baheal will serve a key role in not only accelerating cancer patients' access to cognitive technology, but over time, may also partner to bring Watson for Genomics and other future Watson Health innovation to China," the company said.

19:33 EDT Janssen reports updated analyses of CASTOR, POLLUX studies - Janssen Research & Development announced new data from updated analyses of the pivotal Phase 3 CASTOR and POLLUX clinical studies, demonstrating that DARZALEX in combination with bortezomib and dexamethasone, or lenalidomide and dexamethasone, improved progression-free survival and the overall response rate for previously-treated patients with multiple myeloma, regardless of cytogenetic risk. Additionally, data from the Phase 1b MMY1001 study will show the potential of daratumumab in combination with carfilzomib, lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma. These data represent the first assessment of daratumumab in combination with a next generation proteasome inhibitor and an immunomodulatory agent earlier in the treatment paradigm for multiple myeloma. Specifically, according to follow-up data from the CASTOR study, daratumumab, in combination with bortezomib and dexamethasone, significantly reduced the risk of disease progression or death by 55 percent in patients with high risk cytogenetics compared to Vd alone. Additionally, the daratumumab combination regimen resulted in an ORR of 82 percent vs. 62 percent, with very good partial response or better achieved in 64 percent vs. 35 percent of patients, and CR or better achieved in 34 percent vs. 9 percent of patients. In patients with standard cytogenetic risk the addition of daratumumab reduced the risk of disease progression or death by 74 percent. Additionally, the daratumumab combination regimen resulted in an ORR of 85 percent vs. 64 percent, with VGPR or better achieved in 64 percent vs. 26 percent of patients, and CR or better achieved in 28 percent vs. 8 percent of patients treated with DVd vs. Vd, respectively. The median duration of follow-up was 19.4 months. According to follow-up data from the POLLUX study, daratumumab, in combination with lenalidomide and dexamethasone, reduced the risk of disease progression or death by 47 percent in patients with high risk cytogenetics compared to Rd alone. Additionally, the daratumumab combination regimen resulted in an ORR of 85 percent vs. 67 percent with VGPR or better achieved in 64 percent vs. 31 percent of patients, and CR or better achieved in 38 percent vs. 6 percent of patients. In patients with standard cytogenetic risk, the addition of daratumumab reduced the risk of disease progression or death by 70 percent. Additionally, the daratumumab combination regimen resulted in an ORR of 95 percent vs. 82 percent, with VGPR or better achieved in 85 percent vs. 55 percent of patients, and CR or better achieved in 58 percent vs. 27 percent of patients treated with DRd vs. Rd, respectively. The median duration of follow-up was 25.4 months. A cohort in the Phase 1b MMY1001 EQUULEUS study showed that the overall safety profile of daratumumab in combination with carfilzomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma was consistent with the known safety profiles of D and KRd, respectively. Serious treatment-emergent adverse events, such as pyrexia, influenza and pulmonary embolism, occurred in 46 percent of patients, 14 percent of which were potentially daratumumab-related.

19:28 EDT Sanofi, Regeneron report preliminary data on REGN2810 - Sanofi (SNY) and Regeneron (REGN) announced positive preliminary results with investigational REGN2810, a checkpoint inhibitor targeting PD-1, in patients with advanced cutaneous squamous cell carcinoma. The data is pooled from two expansion cohorts of the REGN2810 Phase 1 trial. Treatment with REGN2810 led to an investigator-assessed overall response rate of 46.2 percent including 2 complete responses, 9 partial responses and 1 unconfirmed partial response, and a disease control rate of 69.2 percent including 12 ORR and 6 stable disease. The median progression free survival and overall survival were not reached at the data cutoff date with a median follow up of 6.9 months. One patient experienced progressive disease during treatment with REGN2810 after the initial response, and two patients were not evaluable due to death considered unrelated to REGN2810. Ten patients remain in response as of the data cutoff date. No apparent association between the objective response and level of PD-L1 (programmed death ligand 1) expression was found.

19:15 EDT Five Prime reports initial data from Phase 1/2 trial of cabiralizumab in PVNS - Five Prime Therapeutics announced that a poster featuring initial clinical data from the ongoing Phase 1/2 clinical trial of cabiralizumab in patients with Pigmented Villonodular Synovitis was presented at ASCO. In terms of efficacy results, the company said that cabiralizumab demonstrates clinical benefit in patients with PVNS at 4mg/kg every two weeks. "Most" patients enrolled at the 4 mg/kg dose prior to the amendment experienced tumor reduction. 5 out of 11 patients had a radiographic response, 4 confirmed. Improvement in median Ogilvie-Harris composite score of pain and function was reported in both responders and non-responders. 12 additional patients enrolled after the amendment were considered efficacy evaluable with evidence of early shrinkage in tumor, but it was too early to assess overall response as of the data cut-off date. Turning to safety, Five said that PK and PD of cabiralizumab support dosing at 4 mg/kg every two weeks or less frequently. No dose-limiting toxicities were observed at doses up to 4mg/kg. 3 out of 11 patients enrolled prior to the protocol amendment discontinued drug due to asymptomatic laboratory elevations of CK. "We plan to have discussions with regulatory authorities about a potential pivotal trial in this orphan indication," the company noted.

19:07 EDT Radius Health reports Phase 1 data on RAD1901 - Radius Health announced positive data from a fully enrolled ongoing Phase 1 study of elacestrant, an oral selective estrogen receptor degrader, in patients with estrogen receptor positive breast cancer. Of the enrolled patients, 22 patients met the RECIST measurable disease criteria at baseline and there were five confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low grade nausea and dyspepsia. "While still early, the single-agent clinical activity and safety profile demonstrated with elacestrant in this heavily pretreated advanced hormone receptor positive breast cancer patient population is encouraging when compared to the results shown for other agents in a similar setting," said Aditya Bardia, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital Cancer Center, Harvard Medical School.

19:03 EDT Zymeworks reports data from Phase 1 ZW25 study - Zymeworks announced results from the dose escalation portion of the first-in-human study of ZW25, a novel Azymetric bispecific antibody targeting two distinct domains of the HER2 receptor. ZW25 was well-tolerated at all dose levels evaluated with single agent anti-tumor activity in patients with advanced HER2-expressing cancers that had progressed after multiple lines of therapy, including HER2-targeted agents. The majority of adverse events were Grade 1 or 2, with no treatment-related serious AEs and no changes in cardiac function. The most common AEs were diarrhea and infusion reactions, reported in 7/16 patients each. Treatment-related Grade 3 AEs occurred in a single patient and included hypophosphatemia, fatigue, and arthralgia. Durable single-agent anti-tumor activity was seen with patients having received up to 8 cycles of treatment at the time of data cut-off. In 14 response-evaluable patients, best overall response was 2 partial response, 4 stable disease, and 8 progressive disease. The majority of patients with measurable disease had a decrease in the size of target lesions. BOR in 8 breast cancer patients was 2 PR, 3 SD including greater than 6 months in one patient, and 3 PD, for an overall disease control rate of 63%. Three of the breast cancer patients developed PD due to brain metastases but maintained systemic disease control at the time of progression. BOR in 4 response-evaluable patients with GE cancers included SD greater than 4 cycles in 1 patient, and 3 PD. Four patients remain active on study. "These results provide the framework for further advancement of ZW25 across multiple cancer indications... We will continue to rapidly advance development across multiple cancer indications," the company said.

18:53 EDT Eisai reports data from 'REFLECT' study, says plans regulatory applications - Eisai announced results from the REFLECT study, a Phase 3 trial evaluating lenvatinib or Lenvima, the company's multiple receptor tyrosine kinase inhibitor, for the first-line treatment of patients with unresectable hepatocellular carcinoma. In the trial, lenvatinib demonstrated non-inferiority in overall survival, the primary endpoint of the study, and also demonstrated statistically significant and clinically meaningful improvements on the secondary endpoints of progression-free survival, time to progression and objective response rate when compared to sorafenib. The median OS for patients treated with lenvatinib was 13.6 months compared to 12.3 months for sorafenib. Median PFS was 7.4 months with lenvatinib with a median TTP of 8.9 months compared to median PFS of 3.7 months and median TTP of 3.7 months on sorafenib. In addition, lenvatinib demonstrated significantly higher ORR of 24% compared to sorafenib, at 9%. Nine percent of patients treated with lenvatinib and 7% of patients treated with sorafenib discontinued treatment due to treatment-related adverse events. Forty-three percent of patients treated with lenvatinib and 30% of patients who received sorafenib experienced serious TEAEs. "Based on these data, Eisai plans to submit regulatory applications for lenvatinib for the potential first-line treatment of patients with unresectable HCC and we look forward to working closely with the FDA and other regulatory bodies worldwide," the company said.

18:41 EDT Bristol-Myers reports data from CheckMate-204 trial - Bristol-Myers Squibb announced efficacy and safety data from CheckMate -204, the first Phase 2 study to evaluate Opdivo plus Yervoy as a potential treatment for patients with melanoma metastatic to the brain. The primary endpoint of intracranial clinical benefit rate, defined as complete response plus partial response plus stable disease greater than or equal to 6 months, was 60% at the median follow-up of 9.2 months among the 75 evaluated patients. A complete IC response was achieved by 21% of patients; 33% had partial responses; and 5% experienced stable disease. The IC objective response rate was 55% with a safety profile consistent with previously reported data in melanoma patients without brain metastases. Treatment-related grade 3/4 adverse events occurred in 52% of patients, with 8% being neurologic in nature, including headaches. Three treatment-related deaths were reported as cardiogenic shock, IC hemorrhage and malignant neoplasm progression.

18:37 EDT Myriad reports data from 'OlympiAD' trial, says plans sPMA filing - Myriad Genetics (MYGN) announced that its BRACAnalysis CDx companion diagnostic test successfully identified BRCA-mutated patients with HER2- metastatic breast cancer in the OlympiAD trial who responded better to treatment with olaparib than standard chemotherapy. The results showed that BRCA-positive patients treated with olaparib had a statistically-significant and clinically-meaningful PFS benefit of compared to the control group. "The collaboration between Myriad and AstraZeneca (AZN) to develop a novel companion diagnostic test for olaparib began in 2007. OlympiAD is the first Phase 3 trial to demonstrate the clinical utility of the BRACAnalysis CDx test outside of ovarian cancer for which the test was approved by the U.S. Food and Drug Administration in Dec. 2014. Based on the robustness of the OlympiaAD results, Myriad plans to submit a supplementary premarket approval application under its existing PMA for BRACAnalysis CDx to include the HER2- metastatic breast cancer indication," the company noted.

18:20 EDT Assured Guaranty files complaint challenging Puerto Rico bond treatments - Assured Guaranty released the following comments regarding the adversary complaint challenging the Commonwealth of Puerto Rico's "illegal diversion" of special revenue bond collateral that secures the payment of bonds issued by the Puerto Rico Highways and Transportation Authority. Two Assured Guaranty bond insurance subsidiaries, Assured Guaranty Municipal Corp. and Assured Guaranty Corp., filed an adversary complaint in Federal District Court in Puerto Rico seeking a judgment declaring that the application of pledged special revenues to the payment of the PRHTA Bonds is not subject to the Title III automatic stay and that the Commonwealth has violated the special revenue protections provided to the PRHTA Bonds under the Bankruptcy Code; an injunction enjoining the Commonwealth from taking or causing to be taken any action that would further violate the special revenue protections provided to the PRHTA Bonds under the Bankruptcy Code; and an injunction ordering the Commonwealth to remit the pledged special revenues securing the PRHTA Bonds in accordance with the terms of the special revenue provisions set forth in the Bankruptcy Code. Irrespective of the Commonwealth's and Oversight Board's actions, payments to holders of PRHTA Bonds insured by Assured Guaranty will continue to be paid without interruption for the life of the bonds. "Assured Guaranty's liquidity and capital position are very strong," the company added.

18:15 EDT Tesaro presents three conference posters on Phase 3 ENGOT-OV16/NOVA trial - Tesaro announced that three posters describing additional data analyses from the Phase 3 ENGOT-OV16/NOVA trial of niraparib were shown at ASCO. First, an analysis was performed to assess PFS and safety in patients who enrolled in the NOVA trial after a PR to their last platinum-based chemotherapy. Approximately 50% of all patients who enrolled in this trial entered with a PR, and results demonstrated that niraparib treatment provided significant benefit to these patients, with a treatment effect similar to that observed in the overall study population in both the gBRCAmut cohort -- HR=0.24 for patients with a PR vs. HR=0.27 for all patients -- and non-gBRCAmut cohort -- HR=0.35 for patients with a PR and HR=0.45 for all patients. The safety profile of niraparib-treated patients with a PR was similar to that of the overall study population. Second, an assessment of platinum resistance status of patients in the NOVA trial was performed. These findings suggest that approximately half of the total NOVA study population had disease that would have been considered platinum-resistant when they began maintenance treatment during the trial. The results of NOVA demonstrate that patients who had developed platinum-resistant disease after their last round of chemotherapy experienced benefit from niraparib maintenance. Third, additional analyses of NOVA assessed the longer-term efficacy of niraparib. Across both the gBRCAmut and non-gBRCAmut cohorts, treatment with niraparib increased the probability of PFS at 12, 18 and 24 months from randomization vs. placebo, as demonstrated by Kaplan-Meier estimates. The similarity in results for PFS2 minus PFS1 between niraparib and placebo suggests that niraparib had no decremental effect on the benefit of subsequent therapy.

18:07 EDT TG Therapeutics reports Phase 3 data on TG-1101 combination in leukemia - TG Therapeutics announced positive results from its Phase 3 GENUINE trial of TG-1101 plus ibrutinib in patients with previously treated high risk Chronic Lymphocytic Leukemia. The trial was powered to show a statistically significant improvement in ORR of 30%, with a minimal absolute detectable difference between the two arms of approximately 20%. The trial met its primary endpoint, demonstrating a statistically significant improvement in Overall Response Rate, as assessed by blinded independent central radiology and hematology review by iwCLL criteria, compared to ibrutinib alone in both the Intent to Treat population and Treated population. The combination was well tolerated and, apart from infusion related reactions, the addition of TG-1101 did not appear to alter the safety profile of ibrutinib monotherapy. Neutropenia, occurring in 9% of patients, was the most commonly reported Grade 3/4 Adverse Event in the combination arm, followed by infusion related reactions and anemia, each reported in 5% of patients. Notably, the majority of infusion related reactions were Grade 1 or 2 in severity, with only 5% Grade 3/4 IRR observed. Median follow-up for this study was approximately 11.4 months. In addition to the improvements in ORR, CR and MRD-negativity, a trend in improvement of Progression Free Survival was observed in the combination arm of TG-1101 plus ibrutinib as compared to ibrutinib alone. "In addition to increasing the overall number of patients that responded to treatment with ibrutinib, adding TG-1101 to ibrutinib increased the number of patients with bone marrow confirmed CR's, MRD negativity in peripheral blood, deepened nodal responses, and resulted in fewer patients progressing on therapy. Collectively, we see the consistent pattern of enhanced benefit as providing a compelling case for combining TG-1101 with ibrutinib in these hard to treat patients with high-risk CLL. We look forward to sharing these data with the FDA later this year to discuss filing for accelerated approval," the company noted.

17:52 EDT NYU says Keytruda found effective in metastatic triple negative breast cancer - The NYU Langone Medical Center announced that Merck's pembrolizumab has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by the center. The trial investigated the drug in two separate cohorts of patients: Cohort A, which included 170 patients with heavily pretreated metastatic triple negative breast cancer regardless of PD-L1 expression, and Cohort B, which included 52 patients with PD-L1-positive tumors who received it as first-line therapy. In Cohort A, pembrolizumab shrunk tumors by more than 30 percent in eight of 170 patients, or five percent, and stabilized the disease in 35, or 21 percent, of those previously treated for mTNBC. Of the eight who experienced tumor reduction, all of them lived at least another year. The remaining patients in this cohort had a lower chance of survival. In Cohort B-those who received pembrolizumab as first-line therapy-12 of 52 patients, or 23 percent, saw tumors shrink by more than 30 percent, while the disease was stabilized in nine of them, or 17 percent. Study presenter Sylvia Adams pointed out that Cohort A is the first phase II study of an immunotherapy for triple negative breast cancer to be reported and represents the largest cohort of patients with mTNBC treated with immunotherapy to date. "The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab's safety and, secondarily, to explore its efficacy as a first-line treatment. Both goals appear to have been met," the center said. Merck funded this clinical trial. Pembrolizumab, marketed under the name Keytruda, was well tolerated by both cohorts at a 200mg dose every three weeks, according to study results. Only 12 percent of patients in Cohort A experienced severe side effects and only eight percent experienced them in Cohort B. The most common side effects in both patient populations were fatigue and nausea. Although side effects led to discontinuation of treatment in seven patients from Cohort A, no patients in Cohort B discontinued treatment due to adverse side effects.

17:39 EDT Matinas BioPharma reports interim data from Phase 2a MAT2203 study - Matinas BioPharma announced that investigators from the National Institutes of Health presented interim data from two patients enrolled in the collaborative Phase 2a clinical study of Matinas' lead anti-infective product candidate MAT2203 for the treatment of chronic refractory mucocutaneous candidiasis. Two out of the two patients with long-standing azole resistant mucocutaneous candidiasis met the primary endpoint of the Phase 2a study, achieving greater than or equal to 50% clinical response with treatment of MAT2203. MAT2203 was well tolerated with majority of adverse events observed being mild in severity and unrelated to study drug. "We are incredibly pleased with the interim safety and efficacy results of this Phase 2a study of MAT2203. While we understand the results are representative of just two patients, these patients are difficult to treat because of their severe underlying immunocompromising condition. With the statistical success hurdle that was prospectively set at a 20% patient-response probability, seeing a clinical response in two out of two patients brings us very close to the 3 out of 16 clinical responders required for the study to meet its primary endpoint," said the company. Specifically, the interim data presented showed that the first two patients in this study, both with Job's Syndrome and long-standing azole resistant mucocutaneous candidiasis for greater than 20 years, achieved greater than or equal to 50% clinical response after 14 days of treatment at an efficacious orally administered dosage of MAT2203, thus meeting the primary endpoint. Clinical efficacy criteria were met at 400mg and 200mg of MAT2203 oral suspension twice daily in patient 01 and patient 02, respectively, with improvement upon exam in clinical symptoms and semi-quantitative fungal cultures of the oral thrush condition. The clinical severity score for oral thrush decreased by 57% for patient 01 and by 85% for patient 02, with corresponding reduction in fungal culture counts. Both patients reported meaningful quality-of-life improvements. MAT2203 was generally well tolerated and there were no signs of nephrotoxicity, hypokalemia or hepatoxicity. Indicators of kidney and liver toxicity remained within normal limits throughout a 6-8 week treatment period. As expected, oral thrush promptly returned after stopping treatment with MAT2203. Both of the patients have elected to enroll in the open-label extension study.

16:43 EDT Box Office Battle: 'Wonder Woman' wins weekend with $100.5M - Time Warner's (TWX) "Wonder Woman" earned $100.5M in its U.S. debut over the June 4 weekend, matching expectations for at least $100M. The latest entry in the DC Comics cinematic universe received an A in audience polls from CinemaScore, holds a critics rating of 93% on Rotten Tomatoes -- significantly higher than the 27% of its most immediate predecessor, 2016's "Batman v Superman" -- and was produced with a reported budget of $149M. In foreign markets, the Gal Gadot-led film took $122.5M. BOX OFFICE RUNNERS-UP: "Captain Underpants: The First Epic Movie," distributed by Fox (FOX) and produced by Comcast's (CMCSA) DreamWorks, opened at $23.5M versus estimates of $28M. The animated children's film was scored B+ in audience polls and holds an 86% critics rating. Taking third place, Disney's (DIS) "Pirates Of The Caribbean: Dead Men Tell No Tales" grossed $21.6M, representing a second-weekend drop of more than 65%. Internationally, the fifth installment in the fantasy adventure series continued its strong showing with receipts of $74M. Rounding out the top five, Disney's "Guardians Of The Galaxy Vol. 2" added $9.7M for a global cumulative total of $817M while Viacom's (VIA) "Baywatch" earned $8.5M. Other publicly traded companies in filmmaking include Lionsgate (LGF.A) and Sony (SNE).

16:00 EDT Eli Lilly reports data from 'MONARCH 2' breast cancer study - Eli Lilly announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase 4 & 6 inhibitor, in combination with fulvestrant, "significantly" improved progression-free survival compared to treatment with fulvestrant alone in women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who have relapsed or progressed after endocrine therapy -- median PFS 16.4 vs. 9.3 months; HR: 0.553. Patients with measureable disease treated with abemaciclib plus fulvestrant achieved an objective response rate of 48.1 percent -- 3.5% complete response -- compared to 21.3 percent, 0% CR in patients treated with fulvestrant alone. Additionally, abemaciclib plus fulvestrant caused a greater degree of tumor shrinkage than fulvestrant alone. No patients in either arm experienced Grade 4 diarrhea, nausea or fatigue, and Grade 4 neutropenia was observed in 2.9 percent versus 0.4 percent of patients in the abemaciclib versus placebo arms, respectively. Severity and frequency of diarrhea generally decreased following one to two cycles, and was managed with loperamide or dose reduction. The majority of patients in the abemaciclib arm with an AE of diarrhea did not require treatment modification, and 2.9 percent of patients discontinued the study drug due to diarrhea.

15:54 EDT QIAGEN says receives global biomarkers license from Johns Hopkins - QIAGEN announced it has received a worldwide license from Johns Hopkins University for biomarkers that have been shown to play key roles in identifying patients who could benefit from novel immune-oncology therapies in cancer treatment. The agreement involves rights to genetic biomarkers to assess microsatellite instability and mismatch repair in all sample and cell types, and will enable QIAGEN -- subject to its exercising certain option rights -- to commercialize molecular testing solutions using next-generation sequencing to assess MSI and MMR status, the company said. QIAGEN reached this agreement prior to the FDA approving in May an I-O therapy to treat advanced solid tumors with MSI and MMR deficiencies, marking the first time that the FDA has cleared a cancer drug for use not tied to the site of a tumor.

15:49 EDT Endologix presents two-year data from Nellix EVAS FORWARD IDE trial - Endologix announced the presentation of two-year clinical data from the Company's Nellix EVAS FORWARD IDE trial that prospectively enrolled patients with abdominal aortic aneurysms who were treated with the Nellix Endovascular Aneurysm Sealing System. Key highlights from the two-year data included: Freedom from all endoleaks 94%, rupture 97%, all-cause mortality 97%, and cardiovascular mortality 99%, among all patients. Highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients. When applying the refined IFUs for Nellix, patients at the two-year follow-up demonstrated a highly encouraging 96% freedom from Type Ia endoleak, migration, and sac growth.

15:42 EDT Agios Pharmaceuticals reports updated Phase 1 data on AG-120 - Agios Pharmaceuticals presented updated data from the dose-escalation and expansion cohorts of the Phase 1 study evaluating single agent AG-120 in isocitrate dehydrogenase-1 mutant positive cholangiocarcinoma at the American Society of Clinical Oncology Annual Meeting. Efficacy data from all 73 treated patients as of the data cut-off showed four patients experienced a confirmed partial response -- one at 300 mg QD and three at 500 mg QD. Forty-one patients experienced stable disease. Landmark analyses of progression free survival at six and 12 months were 38.5% and 20.7% respectively. The median progression free survival was 3.8 months. AG-120 treatment inhibited plasma 2-hydroxyglutarate to within levels found in healthy volunteers, and also reduced 2-HG in tumor biopsies, with 2-HG levels in plasma and tumor biopsies showing a positive correlation. Pathology review of on-study tumor biopsies were conducted in a patient achieving a partial response, which showed morphologic changes suggestive of cellular differentiation which is consistent with the proposed mechanism of action of AG-120. A safety analysis conducted for all 73 treated patients demonstrated that AG-120 was "well-tolerated with a favorable safety profile" in IDH1 mutant positive cholangiocarcinoma patients. No dose limiting toxicities or treatment-related deaths have been observed. Four patients experienced drug-related AEs greater than or equal to grade 3. One patient had a dose reduction for a grade 2 AE of worsening leg cramps that was considered to be possibly drug-related. "These data support further development of AG-120 in our ongoing Phase 3 registration-enabling ClarIDHy study," the company said.

15:23 EDT Bristol-Myers reports interim data from CheckMate-142 trial - Bristol-Myers Squibb announced interim data from CheckMate -142, a Phase 2 multi-cohort trial evaluating Opdivo monotherapy or in combination with Yervoy for the treatment of patients with DNA mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer. These results from the Opdivo and Yervoy combination cohort of the trial included 84 patients who received their first dose at least 6 months prior to analysis. The primary endpoint of investigator-assessed objective response rate was 54.8%. Responses were sustained up to 15.9 months and 85% of responses were ongoing; median duration of response was not yet reached. The 9-month overall survival rate was 87.6% and median OS had not been reached at the time of analysis. The safety profile of the Opdivo plus Yervoy combination included 28.6% of patients with Grade 3/4 treatment-related adverse events. No treatment-related deaths were reported. "We are encouraged by these interim results for Opdivo plus Yervoy," the company said.

15:12 EDT Merck reports finding from mid-stage KEYNOTE-164, 158 studies - Merck announced the first presentation of findings from KEYNOTE-164 and KEYNOTE-158, two phase 2 studies evaluating KEYTRUDA in patients with advanced microsatellite instability-high or mismatch repair deficient solid tumors. The studies showed overall response rates, regardless of histology, with ORR between 28 percent and 38 percent across patients with MSI-H/dMMR colorectal cancer and other advanced MSI-H/dMMR solid tumors, respectively. Of the 61 patients with advanced CRC who were enrolled in KEYNOTE-164, the ORR was 28 percent -- with zero complete responses and 17 partial responses; fourteen had stable disease and 28 had progressive disease -- for an overall disease control rate of 51 percent. Median time to response was four months. Of the 77 patients with any advanced solid tumor, excluding CRC and with at least 27 weeks of follow-up, who were enrolled in KEYNOTE-158, the ORR was 38 percent -- with two complete responses and 27 partial responses; sixteen had stable disease and 24 had progressive disease -- for an overall disease control rate of 58 percent. Median time to response was 2 months. For the PFS analysis, in patients with CRC the estimated 6-month rate was 43 percent and the 12-month rate was 34 percent -- with a median PFS of 2.3 months; in patients with any advanced solid tumor, excluding CRC, the estimated 6-month rate was 45 percent -- with a median PFS of 4.3 months. For the OS analysis, in patients with CRC the estimated 6-month rate was 87 percent and the 12-month rate was 72 percent -- with a median OS not yet reached; in patients with any advanced solid tumor, excluding CRC, the estimated 6-month rate was 73 percent -- with a median OS not yet reached. Median follow-up was 13.2 months and 6.1 months, respectively. At the time of analysis, median duration of response had not been reached in either study. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. There were no treatment-related deaths. In patients with any advanced solid tumor, excluding CRC, there was one death attributed to treatment-related pneumonia by investigator.

14:43 EDT Bristol-Myers reports proof of concept data for BMS-986016 in melanoma - Bristol-Myers Squibb announced proof-of-concept data showing preliminary efficacy for BMS-986016, an investigational anti-lymphocyte-activation gene 3 therapy in combination with Opdivo in patients with advanced melanoma previously treated with anti-PD-1/PD-L1 therapy. In the ongoing expansion study of heavily pretreated patients who were refractory to or relapsed on anti-PD1/PDL1 therapy, the objective response rate was 12.5 percent in evaluable patients. Patients with LAG-3 expression in at least 1 percent of tumor-associated immune cells within the tumor margin had a nearly three-fold improvement in ORR compared to patients with less than 1 percent LAG-3 expression -- 20 percent and 7.1 percent, respectively. As of data cut-off, 212 patients have been treated, including 55 patients with melanoma with prior anti-PD-1/PD-L1 therapy, of which 48 were response evaluable. Treatment-related adverse events of any grade occurred in 45 percent of patients, with 9 percent of patients experiencing Grade 3/4 adverse events. The data reported at ASCO pertain to an expansion cohort in melanoma. "We are very encouraged by these results demonstrating a potential role for anti-LAG3 in this setting and look forward to the ongoing broader investigation of LAG-3 as an alternative therapeutic target and predictive biomarker," the company remarked.

14:29 EDT Loxo announces 'encouraging' proof of concept publication for LOXO-195 - Loxo Oncology announced Saturday the online publication of a new research brief in Cancer Discovery outlining the preclinical rationale for LOXO-195 and clinical proof-of-concept data from the first two patients treated. "This publication highlights the potential for LOXO-195 to extend the period of durable disease control for patients with TRK fusion cancers," said CEO Josh Bilenker. "We believe that today's ASCO presentation establishes larotrectinib as the clear first choice for patients with TRK fusion cancers. However, over time, patients will require new treatment options, since oncogene-addicted metastatic cancers ultimately evade targeted therapies." LOXO-195 will be developed as a sequential treatment, to follow larotrectinib or another TRK inhibitor, to extend the total time of benefit from TRK inhibition. The Cancer Discovery research brief provides "early but encouraging" evidence that the sequential use of larotrectinib followed by LOXO-195 could extend the total duration of disease control for patients with TRK fusion cancers. The brief describes the first two patients with TRK fusion cancers who responded to larotrectinib but later relapsed. An adult with colorectal cancer and a child with infantile fibrosarcoma were biopsied at the time of tumor progression and found to have a solvent front TRK mutation in the existing TRK fusion, which explained the diminished activity of larotrectinib. As no other treatment options exist to address TRK fusion solvent front mutations, Loxo, in collaboration with the FDA, enabled these patients to access LOXO-195 through emergency use Investigational New Drug applications. Both patients responded to LOXO-195, with minimal adverse events reported. A formal LOXO-195 IND was "recently" cleared by the U.S. FDA, and a Phase 1/2 trial is opening globally, the company noted.

14:17 EDT Kayne Anderson MLP reports net assets $2.1B at May 31 - Reports NAV per share $18.42 at May 31. Reports asset coverage ratio with respect to senior securities representing indebtedness 393%, and asset coverage ratio with respect to total leverage 289%.

11:31 EDT Week in review: How Trump's policies moved stocks - Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Trump and his administration with this weekly recap compiled by The Fly: 1. SOLAR SLUMP: Shares of several names in solar power fell Wednesday after reports that President Donald Trump planned to pull out of U.S. commitments to the 2015 Paris Agreement on climate change. Reuters, CNN, Axios, and other publications reported Wednesday that Trump was planning to pull the U.S. out of the Paris Agreement, which the president confirmed the next day. During Wednesday trading following the news, First Solar (FSLR), JinkoSolar (JKS), SunPower (SPWR), Canadian Solar (CSIQ) and JA Solar (JASO) slid in the range of 2% to nearly 5%. 2. MUSK, IGER QUIT COUNCILS: After Trump confirmed the United States' withdrawal from the Paris climate accord on Thursday, he said the U.S. will begin negotiations to re-enter the accord or strike a new deal. During his White House press event, Trump said: "We will see if we can make a deal that's fair. And if we can, that's great. And if we can't, that's fine." Following Trump's announcement, Tesla (TSLA) CEO Elon Musk tweeted that he is "departing presidential councils," while Disney (DIS) CEO Robert Iger said that "as a matter of principle" he has also resigned from the president's council. JPMorgan (JPM) CEO Jamie Dimon, who said he "absolutely" disagrees with the decision to withdraw, did not indicate if he would remain in White House councils but did voice "a responsibility to engage our elected officials to work constructively and advocate for policies that improve people's lives and protect our environment." Other U.S. CEOs who said they were disappointed by, or disagreed with, the decision, include Apple's (AAPL) Tim Cook, Google's (GOOG) Sundar Pichai, Facebook's (FB) Mark Zuckerberg and General Electric's (GE) Jeff Immelt. 3. NO DOUBT!: On Tuesday, President Trump tweeted: "The U.S. Senate should switch to 51 votes, immediately, and get Healthcare and TAX CUTS approved, fast and easy. Dems would do it, no doubt!" Companies that would be influenced by the repeal of Obamacare and enactment of the GOP's Obamacare replacement bill - the American Health Care Act - include Centene (CNC), Molina (MOH), Humana (HUM), Aetna (AET), Anthem (ANTM), UnitedHealth (UNH), WellCare (WCG) and Cigna (CI). "Week in Review" is The Fly's weekly recap of its recurring series of "Trump Effect" exclusive stories.