Stockwinners Market Radar for September 09, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

15:38 EDT Internap Houston data center remains 100% operational - Internap has announced that despite widespread flooding and damage caused by Hurricane Harvey in Houston and the surrounding areas, its Houston data center remains 100% operational for its entire product portfolio and the company has pledged resources toward the recovery efforts. Internap's Network Operations Center continues to inspect and monitor the facilities and the services utilized by Internap customers.

15:27 EDT AIR Worldwide estimates U.S. insured losses for Irma between $15B-$50B - Catastrophe modeling firm AIR Worldwide estimates combined insured losses for Hurricane Irma for the U.S. and selected islands in the Caribbean will be between $20B-$65B. For the U.S., AIR's estimated industry insured losses resulting from Hurricane Irma's wind and storm surge range from $15B-$50B. Note that these estimates are based on the NHC's Saturday, September 9, 5:00 a.m. EDT forecast advisory for Irma. For selected islands in the Caribbean, AIR's estimated industry insured losses resulting from Hurricane Irma's wind and precipitation-induced flooding range from $5B-$15B. AIR Worldwide is a Verisk Analytics business.

15:05 EDT Incyte Epacadostat, Merck Keytruda combo underscores durability of response - Incyte Corporation (INCY) announced updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, its selective IDO1 enzyme inhibitor, in combination with Merck's (MRK) Keytruda, or pembrolizumab, in patients with advanced melanoma. Among all patients with advanced melanoma, including treatment-naive and treatment-experienced, data showed an overall response rate of 56% in patients treated with the combination of epacadostat and Keytruda; median progression-free survival was 12.4 months, with PFS rates of 65% at six months, 52% at 12 months, and 49% at 18 months. Results were generally consistent across dosing schedules of epacadostat combined with Keytruda, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial. These results will be presented at the European Society for Medical Oncology 2017 Congress in Madrid, Spain. "The updated results of the ECHO-202 trial support earlier published findings, and continue to suggest that the novel immunotherapy combination of epacadostat plus Keytruda has the potential to offer a favorable efficacy and safety profile for the treatment of patients with advanced melanoma," said Omid Hamid, Chief of Translational Research and Immuno-Oncology and Director of Melanoma Therapeutics, The Angeles Clinic and Research Institute, Los Angeles, California. "Data have shown that combination immunotherapy can offer higher response rates and improved progression-free survival. These results show that this combination has demonstrated increased and durable response rates and improved progression-free survival, compared to what we would expect from Keytruda alone, without sacrificing safety."

14:53 EDT Teva fremanezumab meets primary endpoints in Halo trial - Teva Pharmaceutical has presented new data evaluating fremanezumab, an investigational treatment for the prevention of migraine, at the 18th Congress of the International Headache Society in Vancouver, Canada. Data presented across two platform presentations and five late-breaking abstracts featured detailed, positive efficacy results from pivotal Phase III HALO studies of fremanezumab in chronic and episodic migraine, as well as data from patient-reported outcomes tools in the chronic migraine trial. Across the Phase III HALO studies in chronic and episodic migraine, fremanezumab achieved statistically significant and clinically meaningful results for all 25 primary and secondary analyses in both monthly and quarterly dosing regimens. "The results we have presented at IHC are truly exciting and reflect Teva's commitment to developing and delivering medicines to meet the needs of patients around the world living with chronic diseases," said Ernesto Aycardi, Vice President and Therapeutic Area Head, R&D, Migraine and Headache at Teva. "With our full CM and EM pivotal results presented to the migraine community, we now look forward to filing a BLA in the U.S. later this year, bringing us one step closer to potentially bringing a new, preventive migraine treatment option to patients."

14:31 EDT Amgen, Allergan ABP 980 data adds to totality of evidence of biosimilarity - Amgen (AMGN) and Allergan (AGN) have announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin R trastuzumab biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive, or HER2-positive, early breast cancer. Results from the neoadjuvant efficacy phase of the study, including pathologic complete response assessed both by local investigators and by independent pathology review, were presented during a poster discussion at the European Society for Medical Oncology 2017 Congress. Efficacy, safety and immunogenicity data support ABP 980 as a trastuzumab biosimilar and add to the totality of evidence currently under review by the European Medicines Agency and the U.S. Food and Drug Administration. The co-primary endpoints of the study were risk difference and risk ratio of pathologic complete response in breast tissue and axillary lymph nodes, and the prespecified equivalence margins were about 13% for RD and 0.759 to 1.318 for RR. According to local review, 48% and 40.5% of patients in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response. Frequency, type and severity of adverse events were similar between ABP 980 and trastuzumab. No new safety signals compared to the known safety profile of trastuzumab were detected. Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the FDA and European authorities.

08:44 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. DACA: Earlier this week, President Donald Trump ordered an end to the Deferred Action for Childhood Arrivals, commonly known as DACA, which was created by executive order by former President Obama. The program shields young undocumented immigrants from deportation and with its termination, about 800,000 young adults brought to the U.S. illegally as children will become eligible for deportation. The program is set to be phased out in 6 months, with Trump urging the Congress to pass a replacement before that time. Meanwhile, many have spoken against this decision including Microsoft's (MSFT) president Brad Smith, who issued a statement expressing disappointment with President Trump's move to rescind DACA and urging Congress to protect the "Dreamers" before engaging in tax reform legislation, according to media reports. Apple (AAPL) CEO Tim Cook also tweeted on Wednesday, "#Dreamers contribute to our companies and our communities just as much as you and I. Apple will fight for them to be treated as equals." 2. HARVEY AID, DEBT CEILING: According to several media reports on Wednesday, President Trump decided to side with Democrats on a proposal to attach emergency aid for Hurricane Harvey victims to measures to keep the government funded and suspend its borrowing limit until mid-December. Commenting on the deal, GOP leaders said it was driven by an urge to present a unified government at a time of crisis, The Washington Post wrote. On Thursday, the same publication reported that Trump and Senate Minority Leader Chuck Schumer had agreed to pursue a deal that would permanently remove Congress' requirement to repeatedly raise the debt ceiling. 3. SELF-DRIVING CAR: The Trump administration expects to introduce updated autonomous vehicle guidelines next week in response to automakers' calls to ease regulations so they can put self-driving cars on the roads, Reuters reported on Wednesday, citing sources familiar with the matter. The U.S. House of Representatives will vote on a proposal to speed deployment of self-driving cars that could assist automakers and tech companies, including General Motors (GM), Google's (GOOG, GOOGL) Waymo, Ford (F), Uber and Tesla (TSLA), in their aims to get autonomous vehicles on the market by 2020 or 2021. 4. RUSSIA-U.S. ELECTIONS: Facebook's (FB) Alex Stamos, Chief Security Officer said in a statement earlier this week: "In April, we published a white paper that outlined our understanding of organized attempts to misuse our platform. One question that has emerged is whether there's a connection between the Russian efforts and ads purchased on Facebook. These are serious claims and we've been reviewing a range of activity on our platform to help understand what happened. In reviewing the ads buys, we have found approximately $100,000 in ad spending from June of 2015 to May of 2017 - associated with roughly 3,000 ads - that was connected to about 470 inauthentic accounts and Pages in violation of our policies. Our analysis suggests these accounts and Pages were affiliated with one another and likely operated out of Russia. [...] In this latest review, we also looked for ads that might have originated in Russia [...]. This was a broad search, including, for instance, ads bought from accounts with US IP addresses but with the language set to Russian - even though they didn't necessarily violate any policy or law. In this part of our review, we found approximately $50,000 in potentially politically related ad spending on roughly 2,200 ads. We have shared our findings with US authorities investigating these issues, and we will continue to work with them as necessary." "Week in Review" is The Fly's weekly recap of its recurring series of "Trump Effect" exclusive stories.