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

20:02 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. Several pharmaceutical and biotech companies presented data results over the weekend at ESMO Congress in Madrid, Spain. Among them were Amgen (AMGN), Allergan (AGN), Incyte (INCY), Array BioPharma (ARRY), Exelixis (EXEL), Ipsen (IPSEY), Eli Lilly (LLY), Pfizer (PFE), Five Prime (FPRX), MacroGenics (MGNX), Idera Pharmaceuticals (IDRA), Rexahn Pharmaceuticals (RNN), Merck (MRK), Blueprint Medicines (BPMC), Novartis (NVS) and Bristol-Myers (BMY). Meanwhile, Teva Pharmaceutical (TEVA) announced at the 18th Congress of the International Headache Society in Vancouver, Canada that its fremanezumab for the prevention of migraine met primary endpoints in Halo trial. 2. After the devastation caused by Hurricane Harvey on coastal Texas, another storm hit the U.S. hard. Hurricane Irma has knocked out power to more than 2.4M homes and businesses in Florida on Sunday, threatening millions more as it crept up the state's west coast, according to media reports. After making two landfalls and raking the southern half of the state with ferocious winds and torrential rains, the hurricane had been downgraded to a Category 2 storm Sunday afternoon, with maximum sustained winds of 110 mph. With tornadoes watches in effect, the Florida Keys may get hit with 10-20 inches of rain. The Keys and the southwest Florida coast are in the more danger of storm surges of about 10 feet. Meanwhile, Irma is expected to reach Fort Myers by Sunday night, passing the Tampa Bay area before moving to norther Florida on Monday. 3. As Adidas (ADDYY) picks up the pace, Nike (NKE) is losing ground in the sneaker race, and its stumbling stock could fall another 10% or more in the coming year, Jack Hough wrote in this week's edition of Barron's. Hough argued that Nike's problem is twofold, namely the growth of e-commerce which has rattled Nike's retail partners, including Foot Locker (FL), and adidas that seems to have finally figured out how to sell sneakers in the U.S. 4. New Line Cinema and Warner Bros. (TWX) horror movie "It" smashed September box office records with $117.2M from 4,103 theaters in its North American box-office debut over the weekend. Internationally, "It" also scored the biggest opening ever for a horror title, led by the U.K. $12.3M. 5. Altaba (AABA), Carlyle Group (CG), Texas Instruments (TXN), CVS Health (CVS), PNC Financial (PNC), Sysco (SYY) and Medtronic (MDT) saw positive mentions in Barron's.

19:10 EDT Bristol-Myers Opdivo meets primary endpoint in Phase 3 CheckMate-238 study - Bristol-Myers Squibb has announced that treatment with Opdivo, or nivolumab, 3 mg/kg resulted in a significant improvement in recurrence-free survival compared to Yervoy, or ipilimumab, 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection. Opdivo met its primary endpoint, showing a statistically significant improvement of 35% in RFS compared to Yervoy. The 18-month RFS rates for the Opdivo and Yervoy groups, respectively, were 66.4% and 52.7%. Median RFS had not yet been reached for either group at the time of this analysis. This benefit was consistent across key subgroups, including BRAF mutated and BRAF wildtype patients, and no new safety signals were identified in this trial. Adverse events leading to discontinuation were reported in 9.7% of subjects in the Opdivo arm compared to 42.6% of patients in the Yervoy group. There were no treatment-related deaths reported in the Opdivo group and two treatment-related deaths reported in the Yervoy arm that occurred more than 100 days after treatment. Detailed findings from the phase 3 CheckMate -238 study will be highlighted on September 11 during the European Society for Medical Oncology 2017 Congress in Madrid, Spain.

17:47 EDT Knight Transportation, Swift Transportation complete merger - Knight-Swift Transportation (KNX) has announced the completion of the merger with Swift Transportation (SWFT). The company will maintain the distinct Knight and Swift brands and operations while implementing best practices across the enterprise.

17:37 EDT Wal-Mart to match customer donations up to $10M as Irma hits Florida - In response to the severe weather impacting the country, Wal-Mart is committing up to $10M in additional support for 2017 U.S. hurricane relief efforts. This will bring the total committed by Wal-Mart to hurricane relief efforts this year to $30M, building on the support provided in response to Hurricane Harvey that hit the Gulf region two-and-a-half weeks ago. With devastating storms and flooding hitting the United States, and building on the response to raise funds for Hurricane Harvey, Wal-Mart is launching a new customer campaign with the American Red Cross to assist with hurricane relief more broadly. As part of this new effort, Wal-Mart will match customer donations two-to-one with cash and product donations of up to $10M to support American Red Cross disaster-response efforts. These donations will help those impacted by hurricanes in 2017 by providing shelter, food, comfort and emergency assistance.

17:27 EDT Five Prime presents novel B7-H4 therapeutic antibody preclinical research data - Five Prime has announced that an oral poster discussion featuring data related to FPA150, Five Prime's novel B7-H4 antibody, was presented at the European Society for Medical Oncology 2017 Congress. "B7-H4 represents an ideal target for a therapeutic antibody," said Bryan Irving, Senior Vice President of Research at Five Prime. "B7-H4 is expressed in several solid tumor types not typically associated with PD-L1 expression and its expression negatively correlates with patient outcome. Moreover, B7-H4 represents a T cell checkpoint ligand that is not currently targeted by other immuno-oncology agents. As such, we feel that our monoclonal B7-H4 antibody, FPA150, which appears to possess both T cell checkpoint blockade activity and enhanced ADCC, has the potential to be an effective therapeutic by improving anti-tumor immune responses in cancer patients who may not respond well to PD-1 or PD-L1-targeted agents." B7-H4 shares significant homology with other B7 family members, including PD-L1 and PD-L2. B7-H4 is expressed in several human tumors such as carcinomas of the breast, ovary and endometrium, and its expression tends to correlate with poor prognosis. While the receptor for B7-H4 is unknown, it is believed to be expressed on T cells because B7-H4 is described as a ligand capable of directly inhibiting T cell activity. FPA150 is a high affinity, afucosylated B7-H4 monoclonal antibody that has demonstrated potent antibody-dependent cell-mediated cytotoxicity and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo. Five Prime is currently developing FPA150 and IND-enabling studies are ongoing.

17:14 EDT Merck Keytruda continues to show overall survival benefit over chemotherapy - Merck has announced updated results from the phase 3 KEYNOTE-045 trial evaluating Keytruda, or pembrolizumab, the company's anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial carcinoma - a type of bladder cancer - with disease progression on or after platinum-containing chemotherapy. Updated data show that with median follow-up of 22.5 months, Keytruda continues to demonstrate an overall survival benefit over investigator's choice of paclitaxel, docetaxel or vinflunine as a second-line therapy, post-platinum failure, regardless of PD-L1 expression. Findings were presented at the European Society for Medical Oncology 2017 Congress. Analyses of the secondary endpoints showed nearly double the overall response rate with Keytruda compared to chemotherapy in the overall study population, with an ORR of 21.1% in the Keytruda arm and 11.0% in the chemotherapy arm. In patients whose tumors expressed PD-L1, the ORR was 20.3% in the Keytruda arm and 6.7% in the chemotherapy arm. The safety profile of Keytruda was consistent with that observed in previously reported studies.

17:03 EDT Rexahn announces positive RX-3117 Monotherapy preliminary data - Rexahn Pharmaceuticals has announced an update on the safety and efficacy of RX-3117 in an ongoing Phase IIa clinical trial in advanced bladder cancer at the 2017 European Society for Medical Oncology Congress. "The presentation at ESMO, is an update on the first ten patients enrolled into stage 1 of the study, that we reported on earlier in the year," said Peter Suzdak, CEO for Rexahn. "40% of patients are now showing an increase in progression free survival of greater than 5 months - with one patient at 9 months without disease progression. This increase in progression free survival exceeds the pre-set criteria for success. We are very impressed with these preliminary data and we will continue to enroll additional patients into the second stage of the study as we progress RX-3117 through clinical development." The ongoing Phase IIa clinical trial is a multicenter, open-label single-agent study of RX-3117 being conducted at 6 clinical centers in the United States. Patients receive a 700 mg daily oral dose of RX-3117, five times weekly on a three weeks on, one week off dosing schedule in a 28 day cycle for up to eight treatment cycles, or until their disease progresses.

16:35 EDT Air Products, Lu'An Clean Energy to form $1.3B joint venture - Air Products has announced it has signed an agreement to form a $1.3B joint venture with Lu'An Clean Energy, which will significantly expand Air Products' scope of supply serving Lu'An Mining's syngas-to-liquids production in Changzhi City, Shanxi Province, China. Air Products has already invested $300M to build, own and operate four large air separation units to supply the Changzhi City site. Under the new agreement, Air Products will contribute the ASUs and invest a further $500M for a 60% ownership in the new JV. Lu'An will contribute the gasification and syngas clean-up system, will receive $500M of cash and will have a 40% ownership in the new JV. The new joint venture, to be called Air Products Lu'an, will own and operate the ASUs and gasification and syngas clean-up system. The JV will receive coal, steam and power from Lu'An and will supply syngas to Lu'An under a long-term, onsite contract. Closing is expected as soon as possible, pending initial operational start-up and government and regulatory approvals. The Company will hold a conference call on Monday, September 11 to discuss the joint venture.

16:22 EDT Five Prime announces 'encouraging' updated data in Mesothelioma patients - Five Prime has announced updated data from the ongoing Phase 1b trial of FP-1039/GSK3052230 in mesothelioma patients at the European Society for Medical Oncology 2017 Congress. "We are encouraged by the results of FP-1039 in the front-line treatment of malignant pleural mesothelioma, a rare aggressive cancer with a poor prognosis," said Helen Collins, Senior Vice President and Chief Medical Officer of Five Prime. "The majority of patients across all dose levels experienced tumor reduction. While this is single-arm data, we believe the findings compare favorably to historical data for chemotherapy alone. In addition to the safety and efficacy results, duration of progression-free survival correlated positively with increasing expression levels of tumoral FGF2." The mesothelioma arm of the open-label Phase 1b trial evaluated weekly infusions of FP-1039, an FGF ligand trap, in combination with first-line pemetrexed and cisplatin chemotherapy in patients with untreated, unresectable MPM. Following the dose escalation portion of the trial, 15 mg/kg weekly was identified as the maximum tolerated dose for FP-1039 and established as the dose for expansion in patients with MPM.

16:04 EDT Eli Lilly rolls out more positive data for candidate ramucirumab - Eli Lilly presented Phase 3 RANGE data at the European Society for Medical Oncology 2017 Congress. These are the first detailed results from the global, randomized, double-blinded, placebo-controlled RANGE study of CYRAMZA, or ramucirumab, in combination with docetaxel, in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The data showed a statistically significant improvement in progression-free survival in patients treated with ramucirumab plus docetaxel when compared to those who received placebo plus docetaxel, with a 46% prolongation in median PFS. RANGE is the first and only Phase 3 study of any therapy to show superior PFS over chemotherapy in a post-platinum setting in urothelial cancer. Also, ramucirumab is the first anti-angiogenic agent to extend PFS in a Phase 3 trial in urothelial cancer. Patients previously treated with a checkpoint inhibitor were allowed to enroll in the RANGE study. PFS is the trial's primary endpoint, and secondary endpoints include overall survival, objective response rate, disease control rate and patient-reported outcomes. The PFS and ORR demonstrated at this RANGE data readout confirm previously reported results from a Phase 2 study evaluating the combination of ramucirumab and docetaxel in the same patient population. The safety profile observed in the RANGE study at this data readout was consistent with what has previously been observed for ramucirumab. RANGE OS data are immature and final OS results are currently expected in mid-2018. Investigators, patients and Lilly study personnel involved in patient-level decision-making will remain blinded to patient-treatment assignments until that time. Overall, RANGE is the sixth positive Phase 3 trial of ramucirumab to date. Previously completed Phase 3 studies of ramucirumab have demonstrated benefit in advanced forms of gastric, non-small cell lung and colorectal cancer.

15:51 EDT Exelixis, Ipsen announce Cabozantinib met primary endpoint - Exelixis (EXEL) and Ipsen (IPSEY) announced updated results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma with intermediate or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium. Principal investigator Toni Choueiri will present detailed data from late-breaking CABOSUN abstract at the European Society for Medical Oncology 2017 Congress. The data presented at ESMO 2017 included the analysis from a blinded independent radiology review committee, which confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival, as well as an updated investigator-assessed analysis. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant 52% reduction in the rate of disease progression or death. The median PFS for cabozantinib was 8.6 months versus 5.3 months for sunitinib, corresponding to a 3.3 month improvement favoring cabozantinib over sunitinib. The updated 2017 data sets and methods differ from the initial investigator analyses presented in 2016. The comprehensive image collection for IRC review used a later cut-off point than the initial investigator analysis and followed a rigorous IRC review process. The analysis of IRC data applied U.S. Food and Drug Administration guidance for PFS analyses in oncology studies. Both the updated investigator assessment and IRC analysis demonstrated consistent and statistically significant improvement of PFS with cabozantinib as compared to sunitinib. The updated overall survival analysis had a data cut-off of July 1, 2017, and showed a favorable trend for patients randomized to cabozantinib compared to sunitinib that was not statistically significant. Median overall survival was 26.6 months for patients receiving cabozantinib versus 21.2 months for those receiving sunitinib. The most common all-causality grade 3 or 4 adverse events in more than 5 percent of patients for cabozantinib and sunitinib, respectively, were diarrhea, hypertension, fatigue, increased alanine aminotransferase, decreased appetite, palmar-plantar erythrodysesthesia syndrome, decreased platelet count and stomatitis. 21% of patients in the cabozantinib arm and 22% of patients in the sunitinib arm discontinued treatment due to adverse events. Exelixis filed a supplemental New Drug Application based on the CABOSUN data with the FDA for cabozantinib as a treatment for previously untreated advanced RCC on August 16, 2017. Ipsen also submitted to EMA the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on September 8, 2017, Ipsen announced that the EMA validated the application.

14:17 EDT AT&T encourages customers to take advantage of Equifax steps to mitigate breach - AT&T (T) made the following comments related to the announcement by Equifax (EFX) that some of their customer data security measures recently were compromised: "The security of our customers' personal information is paramount to us. For that reason, our security team has been assessing Equifax's data breach since it was announced. There was no breach of AT&T systems or the data we maintain and the perpetrators targeted only Equifax systems. However, we understand that the impacts include current and former consumer and business customers of AT&T. In light of this, we encourage our customers to take advantage of the steps that Equifax is taking to mitigate this breach and to advise and assist its customers. Current and former customers of AT&T should start by visiting www.equifaxsecurity2017.com to confirm if they are potentially affected and to sign up for credit file monitoring and identity theft protection. We will continue to work closely with Equifax as their assessment progresses."