Stockwinners Market Radar for September 08, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:27 EDT AstraZeneca: IMFINZI study shows statistically significant improvement in PFS - AstraZeneca and MedImmune, its global biologics research and development arm, announced the full progression-free survival data from a planned interim analysis of the investigational Phase III PACIFIC trial. Results show that IMFINZI demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced, unresectable non-small cell lung cancer who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. Results of the trial, included in the Presidential Symposium I of the European Society of Medical Oncology 2017 Congress in Madrid, Spain, show an improvement in PFS of more than 11 months in patients treated with durvalumab compared to placebo. The PFS improvement with durvalumab was observed across all pre-specified subgroups, including PD-L1 expression status. Patients receiving IMFINZI also had a lower incidence of metastases than those receiving placebo. The PACIFIC trial continues to evaluate overall survival, the other primary endpoint. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The Phase III PACIFIC results are incredibly encouraging for a patient population that until now has been without treatment options. As the first Immuno-Oncology medicine to achieve improvement in progression-free survival in this setting, IMFINZI is showing clear potential to become the new standard of care for patients with locally advanced, unresectable NSCLC who have not progressed following chemoradiation."

18:10 EDT Comerica extends closure of Florida banking centers - Comerica announced that it will extend closures at all of its Florida locations until it is safe to reopen. The decision affects Comerica's banking centers in Fort Lauderdale, Boca Raton, Naples, Palm Beach Gardens, Riviera Beach and Wellington, as well as Comerica offices.

17:55 EDT Whitestone REIT to replace CDI Corp. in the S&P 600 at open on September 13 - AE Industrial Partners LLC is acquiring CDI in a deal expected to be completed on or about that date pending final conditions.

17:47 EDT ARMOUR Residential to replace Brink's in S&P 600 at open on September 18

17:40 EDT Meta Financial will replace ILG in S&P 600 at open on September 18

17:38 EDT ILG to replace Cadence Design in S&P 400 at open on September 18

17:19 EDT Cadence Design to replace Staples in S&P 500

17:09 EDT IHS Markit says Lance Uggla to become COO effective October 1 - According to a regulatory filing, IHS Markit said that, effective as of October 1, 2017, Lance Uggla will become COO in addition to his current position of president and Chief Integration Officer. Uggla's compensation has not changed in connection with his additional position at IHS Markit.

16:51 EDT Karpus Management reports 27.36% passive stake in KCAP Financial

16:42 EDT PhaseRx says principal accounting officer Shing-YinTsui resigns - On September 5, Shing-YinTsui, the senior vice president, finance, secretary and principal accounting officer of PhaseRx , notified the company of her resignation from all positions with the company, effective as of September 15. Upon effectiveness of Ms. Tsui's resignation, Robert W. Overell, the company's president and chief executive officer, will replace Ms. Tsui as the secretary of the company.

16:39 EDT Seven Stars Cloud Group:SSGCG executes non-remunerative distribution - Seven Stars Cloud Group announced, solely for informational purposes, that its largest shareholder, SSGCG, a fully owned subsidiary of Bruno Wu's Sun Seven Stars, executed a Non- Remunerative Distribution of approximately 19.9M cumulative shares of his Seven Stars Cloud common and Preferred A stock holdings. The shares will be distributed pro rata to current minority shareholders of SSGCG. SSGCG's minority shareholders are composed of management, business partners and management of SSC's joint ventures. The Distribution relates solely to Sun Seven Stars and its fully owned subsidiary SSGCG. This Distribution is not related in any manner to Seven Stars Cloud's organizational or share structure and the distribution of shares by Sun Seven Stars/SSGCG does not constitute any type of sale of shares. The distributed shares will be subject to a lock-up period of one year. The minority shareholders receiving shares have agreed that the voting rights on the distributed shares will remain with Sun Seven Stars/SSGCG throughout the entirety of the period they own the shares and for a minimum of one year. Along with the shares Bruno Wu and Sun Seven Stars are retaining, this will amount to approximately 44.9% of the common and preferred share vote and approximately 44% of the fully diluted vote.

16:22 EDT Rayonier Advanced Materials to temporarily suspend operations due to hurricane - Rayonier Advanced Materials announced that it is temporarily suspending operations beginning today at its Fernandina Beach, Florida and Jesup, Georgia facilities as the threat of Hurricane Irma is leading to mandatory evacuations in the area and impacting the supply of raw materials. In preparation for the hurricane, it is in the best interest of the company, its employees and our communities for the facilities to orderly shutdown operations ahead of the storm. The company is coordinating with its suppliers and customers to help ensure a safe and efficient restart of operations. Further updates will be provided as new information becomes available.

16:16 EDT United Continental reports August traffic up 2.3% - United Airlines reported August 2017 operational results. UAL's August 2017 consolidated traffic increased 2.3% and consolidated capacity increased 2.4% versus August 2016. UAL's August 2017 consolidated load factor decreased 0.2 points compared to August 2016. Scott Kirby, president of United Airlines, said, "Our thoughts and prayers are with all of those affected by Harvey and those impacted or currently in the path of Hurricane Irma. We are doing all we can to assist during this extraordinary time, and we stand with all of those affected as they prepare for and recover from these two unprecedented storms. Last month, faced with the devastating impacts of Harvey, as well as other operational issues, our employees rose to the test to make the most of a very challenging month. Thanks to the resilience and spirit of our dedicated employees, our operation in Houston has returned back to 100 percent today, ahead of schedule."

16:08 EDT Jury finds Garmin infringed two Navico patents, must pay $38M in damages - Garmin International announced that a jury verdict was reached in a patent lawsuit brought by Navico against Garmin in the Eastern District of Texas. The jury found that Garmin had willfully infringed two Navico "downscan" patents and awarded damages in the amount of $38M. The court awarded judgment in favor of Garmin on a false advertising claim filed by Navico. "We disagree with the verdict on the patents and will appeal," said Andrew Etkind, Garmin's vice president and general counsel. "We expect to succeed in our appeal, as the Federal patent appeals court has already concluded that Navico's other downscan patents are not valid in view of Humminbird's earlier work." Garmin's appeal of today's jury verdict will be heard by this same appeals court. "Although we are disappointed in the outcome, we continue to stand behind our products," said Cliff Pemble, Garmin's chief executive officer. "Today's jury verdict has no impact on Garmin's dealers and customers as our products will continue to be available to the public."

16:03 EDT Galena to pay $7.55M to resolve false claims allegations, DOJ says - Galena Biopharma will pay more than $7.55M to resolve allegations under the civil False Claims Act that it paid kickbacks to doctors to induce them to prescribe its fentanyl-based drug Abstral, the Department of Justice announced. "Given the dangers associated with opioids such as Abstral, it is imperative that prescriptions be based on a patient's medical need rather than a doctor's financial interests," said Acting Assistant Attorney General Chad A. Readler of the Justice Department's Civil Division. "The Department of Justice intends to vigorously pursue those who offer and receive illegal inducements that undermine the integrity of government health care programs." "The conduct alleged by the government and resolved by today's settlement was egregious because it incentivized doctors to over-prescribe highly addictive opioids," said Acting U.S. Attorney William E. Fitzpatrick for the District of New Jersey. "This settlement constitutes another example of the Department of Justice's ongoing efforts to battle the opioid epidemic on every front." Reference Link

15:22 EDT Polar Asset Management reports 10.06% passive stake in Bellatrix Exploration

15:04 EDT Walt Disney World to close from Saturday until Tuesday or later - Walt Disney World will begin closing its theme parks from Saturday September 9 and "hopes" to resume normal operations on Tuesday September 12, the company stated in an update on Hurricane Irma posted to its website. Reference Link

14:07 EDT Neuberger Berman reports 13.65% passive stake in Fluidigm

13:42 EDT Capital Research takes over 10% stake in Signet Jewelers - Capital Research Global Investors disclosed a 10.2% stake in Signet Jewelers. The firm owns over 6.1M shares of the jewelry retailer. The filing does not allow for activism. Shares of Signet are up 53c to $65.40 in afternoon trading.

13:30 EDT Array Biopharma trading resumes

13:21 EDT Judge proposes approving Level 3-CenturyLink settlement in California - Administrative Law Judge Regina DeAngelis has proposed a decision to grant Application 17-03-016 and provides the authority for the proposed transaction resulting in the Level 3 Operating Entities and WilTel Communications to be transferred from Level 3 Communication (LVLT) to CenturyLink (CTL), according to a post to the site of the California Public Utilities Commission. As a result of the transfer, all of Level 3's subsidiaries, including the Level 3 Operating Entities, will become wholly-owned subsidiaries of CenturyLink. Reference Link

13:08 EDT Users, analysts decry Equifax breach response over info request, lawsuit waiver - Adding to the continuing woes surrounding Equifax's (EFX) major cybersecurity breach, the company appears to have drawn the ire of many users who are perturbed over the credit reporting agency's prompt for users to provide additional personal information in order to learn if they were impacted by the breach. WHAT'S NEW: Following Equifax's announcement of a cybersecurity breach that could potentially impact 143M U.S. consumers, the company established a websited called equifaxsecurity2017.com, where people can find out if they've been affected by the breach. However, in order for users to find out more about their status, Equifax prompts them to enter their last name and the last six digits of their Social Security number, leaving many concerned about further exposing themselves to risk by providing even more personal information that could be comprised. In addition, if one were to provide such information, Equifax gives the user an enrollment date to get a free year of identify theft protection from TrustedID Premier, though the enrollment date might not be for at least a few more days, and Equifax won't be emailing anyone reminders of the date, as it did not request email addresses. Also, terms of use for TrustedID Premier seems to require users to sign away their legal right to sue Equifax. REACTION: Many consumers hoping to learn if they've been affected by this breach have expressed disappointment with Equifax's handling of the situation, with many taking to social media to complain of the credit reporting agency's "audacity" to ask for Social Security numbers after reporting that some people's information may have already been compromised. Others have pointed out that the wait until they can enroll in TrustedID's free year of monitoring is too long and that waiving the right to sue is "problematic" and "ridiculous." Industry experts have also weighed in, with telecommunications industry analyst Jeff Kagan telling the Washington Post that it "doesn't make sense" to "pour more salt on the wound" by asking users to put information on another website and called the move "a big, embarrassing mistake." In addition, Liz Weston, a personal finance expert with NerdWallet, told CBS News that Equifax "had a lot of time to get ready" for such an incident and that the company still has "a long way to go." PRICE ACTION: In afternoon trading, Equifax shares are down over 13% to $123.92.

13:04 EDT Array says 'promising' clinical activity seen in BRAF-mutant CRC study - Array BioPharma and Pierre Fabre announced safety results and initial clinical activity from the safety lead-in of the Phase 3 BEACON CRC study evaluating binimetinib, a MEK inhibitor, encorafenib, a BRAF inhibitor and Erbitux, an anti-EGFR antibody, in patients with BRAF-mutant colorectal cancer whose disease has progressed after one or two prior regimens in the metastatic setting. BRAF-mutant CRC represents a difficult-to-treat subtype of colorectal cancer that impacts 10 to 15% of CRC patients. These data were presented as an e-poster on September 8 at the 2017 European Society for Medical Oncology Congress. As of August 9, 30 patients were treated in the safety lead-in and received the triplet combination of binimetinib, encorafenib and cetuximab. Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high was detected in only one patient. The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study. In addition, promising initial clinical activity was observed, with a confirmed overall response rate, or ORR, of 41%, including a complete response, in patients with the BRAFV600E mutation, a group of patients with historically poor outcomes. The observed ORR was 59% in the 17 patients with the BRAFV600E mutation with only one prior therapy. Out of 28 patients with both a BRAFV600E mutation and a post-baseline assessment, 27 showed tumor regression. In the safety lead-in, the triplet combination was generally well-tolerated. "With these encouraging results, Array continues to enroll the randomized portion of the BEACON CRC study, assessing the efficacy of encorafenib in combination with cetuximab with or without binimetinib compared to cetuximab and irinotecan-based therapy," the company stated.

12:51 EDT Wal-Mart to close some facilities, adjust hours in Florida due to Irma - Walmart stated: "Due to Hurricane Irma's impact on Florida, some facilities will close or adjust hours of operation starting today and through the weekend. The safety of our customers and associates is always our primary concern."

12:47 EDT New York AG launches formal investigation into Equifax breach - New York Atorney General Eric Schneiderman issued a consumer alert following the report that Equifax experienced a breach affecting 143 million Americans and over 8M New Yorkers. "Today, as part of a formal investigation into the incident, Attorney General Schneiderman sent a letter to Equifax seeking additional information about the breach," Schneiderman says in a statement. Reference Link

12:45 EDT Signet Jewelers granted confidential treatment from SEC - Signet Jewelers disclosed an order granting it confidential treatment from the SEC. The statement from the SEC reads, "Signet Jewelers Limited submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the Exhibits to a Form 8-K filed on June 8, 2017, as amended. Based on representations by Signet Jewelers Limited, that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be released to the public for the time period(s) specified: Exhibit 10.1 through June 7, 2022."

12:38 EDT Allergan, Saint Regis Mohawk Tribe enter Restasis patent settlement - Allergan and the Saint Regis Mohawk Tribe announced that the Tribe now owns all Orange Book-listed patents for Restasis 0.05%, and that Allergan has been granted exclusive licenses in the patents related to the product. The Tribe is filing a motion to dismiss the ongoing inter partes review of the Restasis patents based on their sovereign immunity from IPR challenges. The agreement with the Tribe has no impact on the pending abbreviated new drug application patent litigations regarding the Restasis patent family which recently completed a five-day trial in Federal District Court in Marshall, Texas. Under the terms of the agreement, the Tribe will receive $13.75M upon execution of the agreement. Additionally, the Tribe will be eligible to receive $15M in annual royalties. In a unified statement about the agreement with Allergan, the Saint Regis Mohawk Tribal Council stated, "This is a viable and sound opportunity for the Saint Regis Mohawk Tribe to enter into the patent, technology and research sector as part of our overall economic diversification strategy. We realize that we cannot depend solely on casino revenues and, in order for us to be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne community; such as housing, employment, education, healthcare, cultural and language preservation."

12:35 EDT Array Biopharma trading halted, news pending

12:33 EDT Allergan trading halted, news pending

12:13 EDT Target drops after cutting prices on 'thousands' of items - Target said on its website, "If you love Target for incredible exclusive brands, super-chic collaborations and one-stop shopping for pretty much everything on your list, you're going to really love this: We've lowered our prices on thousands of items, from cereal and paper towels to baby formula, razors, bath tissue and more. Sure, there's nothing like that victorious rush of nabbing a spectacular deal, but having to figure out what "As Advertised!" and "Temporary Price Cut" mean or waiting for just the right sale to roll around can be, well ... super frustrating. So, we've put our prices and promotions under the microscope. Our mission? To cut through the clutter and provide guests with great everyday value, while continuing to offer additional savings on the right products at the right times." Shares of Target dropped 3% in afternoon trading to $56.60. Reference Link

11:36 EDT Roche says lampalizumab failed to meet endpoint in Phase III study - Genentech, a member of the Roche (RHHBY), announced that the primary endpoint has not been met in Spectri, the first of two Phase III studies evaluating the safety and efficacy of lampalizumab, an investigational medicine for the treatment of geographic atrophy due to age-related macular degeneration. Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at one year, the company. Given the lack of efficacy, further dosing in patients will be interrupted until the results from the second Phase III study are evaluated, it added. "Geographic atrophy is a progressive and irreversible disease that impairs vision, and there are currently no available treatments," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "While this result is disappointing, we will continue to evaluate results from Spectri to get a clearer understanding of the data as we await the results of our second Phase III study, Chroma, anticipated in November.

11:32 EDT Roche says Spectri study did not meet primary endpoint

11:08 EDT Equifax breach costs seen as high as $680M, but several analysts say buy on dip - Three research firms - Deutsche Bank, JPMorgan,and Evercore ISI - expect the cybersecurity breach at Equifax to have a significant negative impact on the company's financial results. However, all three firms kept Buy ratings or the equivalent on the company. Meanwhile, Deutsche Bank recommended buying shares of Equifax's competitor, TransUnion (TRU), on today's weakness and Macquarie identified several IT security companies that could benefit from the breach. COSTS HARD TO QUANTIFY: Although analyst Kevin McVeigh believes that it's "extremely difficult" to quantify the financial cost of the breach, he estimated that the total bill for Equifax would come to $300M-$400M, or about 10% of its market cap. The stock is dropping much more than 5% due to the "uncertainty" created by the situation, the analyst stated. Due to this uncertainty, he recommended that investors wait before buying Equifax. However, calling Equifax's breach "isolated" and predicting that TransUnion could gain market share in the wake of the incident, McVeigh recommended that investors buy TransUnion shares on any weakness today. JPMORGAN: After speaking with Equifax's CEO, analyst Andrew Steinerman quoted him as saying that he thinks the negative impact of the breach will be limited to the company's business to consumer segment, which only generates about 7% of its revenue. Although the proliferation of security breaches in recent years may have led to a "general numbing" of the public to this phenomenon, the scale of the breach and "the fact that Equifax is a data company" justify a large drop in the stock, the analyst stated. Quoting the company's management as saying that insurance will cover "the majority" of the liability associated with the breach, Steinerman does not "envision a multi-year investment cycle that could shock the P&L." He recommended buying the stock if its decline exceeded 10% and kept an Overweight rating on the shares. EVERCORE: After speaking with Equifax's CEO, Evercore analyst David Togut reported that the company did not alter its "long-term financial model of 7-10% revenue and 10-14% growth in Adjusted EPS on average over a business cycle." The analyst estimated that the breach would cost Equifax from a low of $270M after-tax to a high of $682M, or a range from $2.24 to $5.60 per share after taxes. He emphasized that these expenditures would be one-time costs and would not affect the company's profitability over the longer term. He recommended "aggressively buying shares today on extreme stock weakness." MACQUARIE: Symantec's (SYMC) LifeLock unit could benefit from the incident as more consumers buy identity protection, wrote analyst Sarah Hindlian. Meanwhile, Proofpoint (PFPT), which has "best of breed messaging solutions", and Imperva (IMPV), with its "robust web application security" are also key beneficiaries, the analyst stated. PRICE ACTION: In morning trading, Equifax tumbled 14% to $122.79, TransUnion sank 4% to $47.49, Symantec gained over 4.5%, Proofpoint rose 2% and Imperva advanced 2%.

10:35 EDT Merck: KEYTRUDA plus Pemetrexed, Carboplatin shows continued benefit in ORR - Merck announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA, the company's anti-PD-1 therapy, in combination with pemetrexed and carboplatin in patients with previously untreated advanced nonsquamous non-small cell lung cancer, with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate and progression-free survival for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm. The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone. In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone. "The continued benefit observed with KEYTRUDA plus pem/carbo in overall response rate and progression-free survival reinforce the importance of this combination therapy for the treatment of patients with advanced nonsquamous non-small cell lung cancer, with or without PD-L1 expression," said Dr. Hossein Borghaei, chief of the division of thoracic medical oncology, Fox Chase Cancer Center.

10:17 EDT Amicus receives Notice of Compliance for Galafold from Health Canada - Reference Link

10:02 EDT Seattle Genetics says tisotumab vedotin data support further development - Seattle Genetics announced that preliminary clinical data for tisotumab vedotin from a Genmab-sponsored phase 1/2 clinical trial are being featured in an oral presentation at the European Society for Medical Oncology Congress being held September 8-12. Additional data from the trial will also be presented in a poster session. Tisotumab vedotin is an antibody-drug conjugate targeting tissue factor, which is expressed on a broad range of solid tumors. Among patients with cervical cancer treated in the trial, tisotumab vedotin demonstrated an encouraging response rate and manageable safety profile. Tisotumab vedotin is being co-developed by Seattle Genetics and Genmab. The companies are evaluating next steps in the development of tisotumab vedotin for cervical cancer. The GEN701 study is ongoing and further data, including other solid tumor indications, will be published at a later date.

09:50 EDT Peltz says P&G does not know to operate with small brands - Trian's Nelson Peltz is speaking on CNBC.

09:48 EDT Peltz says P&G needs to figure out how to regain market share - Trian's Nelson Peltz is speaking on CNBC.

09:30 EDT Novartis to be issued priority review voucher for Kymriah - The Food and Drug Administration is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act, authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that Kymriah, manufactured by Novartis Pharmaceuticals, meets the criteria for a priority review voucher. Reference Link

09:23 EDT Diana Shipping announces time charter contract for m/v Ismene - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with DHL Project & Chartering Limited, Hong Kong, for one of its Panamax dry bulk vessels, the m/v Ismene. The gross charter rate is US$12,000 per day, minus a 5% commission paid to third parties, for a period of minimum twelve months to maximum fifteen months. The charter is expected to commence on September 16. The m/v Ismene is currently chartered, as previously announced, to Glencore Grain, Rotterdam, at a gross charter rate of 5,850 per day, minus a 5% commission paid to third parties. The "Ismene" is a 77,901 dwt Panamax dry bulk vessel built in 2013. This employment is anticipated to generate approximately $4.32M of gross revenue for the minimum scheduled period of the time charter.

09:09 EDT Puma Biotechnology announces "positive" results from Phase III ExteNET trial - Puma Biotechnology announced the presentation of positive results from the Phase III clinical trial of Puma's drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain. Neratinib was approved by the FDA in July for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX tablets. The most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in patients with early stage HER2-positive breast cancer. The predefined 5-year invasive disease free survival analysis as a follow-up to the primary 2-year iDFS analysis of the Phase III ExteNET trial was presented.The ExteNET trial randomized 2,840 patients in 41 countries with early stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ, or death for a period of five years after randomization in the trial. The patient characteristics in the trial were well balanced between the neratinib and placebo arms of the trial. For the 1,420 patients in the neratinib arm of the trial, 1,085 were node positive while of the 1,420 patients in the placebo arm of the trial, 1,084 were node positive. Additionally, in the neratinib arm of the trial, 816 patients were hormone receptor positive, and in the placebo arm of the trial, 815 patients were hormone receptor positive. The median time from the last trastuzumab dose to entry into the trial was 4.4 months for the neratinib-treated patients and 4.6 months for the placebo-treated patients. The primary endpoint of the trial was invasive disease free survival. The results of the trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo. The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%. The secondary endpoint of the trial was invasive disease free survival including ductal carcinoma in situ. The results of the trial demonstrated that treatment with neratinib resulted in a 29% reduction of risk of disease recurrence including DCIS or death versus placebo. The 5-year iDFS-DCIS rate for the neratinib arm was 89.7% and the 5-year iDFS-DCIS rate for the placebo arm was 86.8%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 40% reduction of risk of invasive disease recurrence or death versus placebo. The 5-year iDFS rate for the neratinib arm was 91.2% and the 5-year iDFS rate for the placebo arm was 86.8%. For the pre-defined subgroup of patients with hormone receptor negative disease, the results of the trial demonstrated that treatment with neratinib resulted in a hazard ratio of 0.95.

09:04 EDT Ocular Therapeutix names Michael Goldstein CMO - Ocular Therapeutix (OCUL) announced the appointment of Michael Goldstein as CMO. In his role, Dr. Goldstein will oversee the clinical development of the company's product pipeline. Prior to joining Ocular Therapeutix, Dr. Goldstein served as Chief Medical Officer of Applied Genetic Technologies Corp (AGTC), a clinical-stage biotechnology company focused on the development of products for the treatment of rare diseases, with a focus on ophthalmology.

09:02 EDT Trump tells Republicans to start tax cut legislation 'ASAP' - President Trump tweeted, "Republicans must start the Tax Reform/Tax Cut legislation ASAP. Don't wait until the end of September. Needed now more than ever. Hurry!"

08:37 EDT Himax disagrees with Oppenheimer analyst report - Himax Technologies responded to a research report issued by Andrew Uerkwitz, an analyst from Oppenheimer & Co., dated September 7. While Himax respects the research analyst's own opinions, the company reaffirms its financial and operational prospects and would caution investors that the report did not contain any input from the company. "Our business and strategic initiatives remain on track," said Jordan Wu, president and CEO. "We have publicly presented management's view on our businesses including display driver IC segment and 3D sensing opportunities with very consistent messages to the investment community. We also recently announced 3D sensing total solution on August 30. We remain optimistic in our leading position in the 3D sensing supply chain, and have strong confidence that we will achieve the deliverables on the existing and new growth opportunities." The company would like to caution investors that the Oppenheimer analyst has not spoken to the company in the past four months despite multiple offers. The company disagrees with the analyst's view on our business prospects and his statements regarding the company's position within the 3D sensing supply chain.

08:35 EDT Dave & Buster's authorizes additional $100M stock repurchase - Dave & Buster's Entertainment announced an increase in share repurchase authorization. On September 7, the company's board of directors authorized the repurchase of an additional $100M of the company's stock under the existing repurchase program through the end of fiscal 2018. At the end of Q2, the company still had nearly $73M remaining under the existing repurchase authorization. All other terms of the existing share repurchase program remain in effect.

08:32 EDT Badger Meter names Kenneth Bockhorst COO - Badger Meter (BMI) announced that it has appointed Kenneth Bockhorst, to the newly created position of SVP and COO. Bockhorst, who most recently served as EVP of the energy segment of Actuant Corporation (ATU), will assume his role at Badger Meter on or before November 1. As COO, Bockhorst will oversee the company's municipal water and flow instrumentation manufacturing, engineering, sales and marketing and acquisition activities. He will also assume responsibility for the company's continuous improvement initiatives and new product development.

08:11 EDT Merck updates data for KEYTRUDA in patients with advanced gastric cancer - Merck announced the presentation of data from all three cohorts of the registrational, phase 2 KEYNOTE-059 trial investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in patients with advanced gastric or gastroesophageal junction adenocarcinoma, including new data in treatment-naive patients. Overall, results showed antitumor activity and durability of response with KEYTRUDA across multiple lines of therapy, with higher response rates observed in PD-L1-positive patients: In heavily pre-treated patients, KEYTRUDA monotherapy showed an overall response rate of 12% in all patients and 16% in patients with PD-L1 positive tumors. In treatment-naive patients, KEYTRUDA in combination with chemotherapy showed an ORR of 60% in all patients and 69% in patients with PD-L1 positive tumors. In treatment-naive patients with PD-L1 positive tumors, KEYTRUDA monotherapy showed an ORR of 26%. Results presented from KEYNOTE-059 were based on an analysis of efficacy, safety and PD-L1 expression from 315 patients across the study's three cohorts.

08:01 EDT Appliance Recycling regains compliance with Nasdaq Listing Rule - Appliance Recycling Centers of America announced that on September 6, 2017 it received notification from the Listing Qualifications Department of The Nasdaq Stock Market that the company has regained compliance with Listing Rule 5550(a)(2).

07:59 EDT Kroger down 3.3% after reporting Q2 results

07:55 EDT Kroger reports Q2 identical supermarket sales up 0.7%

07:36 EDT Idera says IMO-2125 data demonstrates induction of durable anti-tumor responses - Idera Pharmaceuticals is reporting new pre-clinical data from its ongoing intratumoral IMO-2125 development program at the Third Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference being held in Frankfurt, Germany. In the poster presentation entitled, "Intratumoral IMO-2125 Treatment in Combination with Anti-CTLA4 mAB Induces Durable Anti-Tumor Reponses Associated with Tumor-Specific Memory in Preclinical Studies," presented by Daqing Wang, Ph.D., Principal Scientist & Group Leader, Idera Pharmaceuticals, demonstrated that intratumoral injections of IMO-2125 enhance anti-tumor responses in combination with CTLA4 blockade. Further this study demonstrated the combination of IMO-2125 and anti-CTLA4 achieves prolonged, durable anti-tumor effect. In this study, mice whose tumors completely regressed survived more than one year after the combination treatment was administered. These animals maintained anti-tumor responses upon tumor re-challenge indicative of memory T-cell induction by the combination of IMO-2125 and anti-CTLA4. Additionally, IMO-2125 delivered intratumorally has been shown to mediate tumor microenvironment changes including infiltration of T-cells and immune checkpoint gene up-regulation.

07:31 EDT ALLETE's U.S. Water acquires Tonka Water - U.S. Water, an ALLETE company, announces the acquisition of Tonka Water. Tonka Water, a major supplier of municipal and industrial water treatment systems, has joined the U.S. Water family. The acquisition of Tonka Water will allow U.S. Water to expand its integrated water treatment equipment offerings and applications. Tonka Water's engineers customize water treatment solutions for a variety of applications including surface water, groundwater, water reuse, industrial process water, remediation and advanced wastewater treatment.

07:12 EDT Leap Therapeutics, EORTC to evaluate DKN-01 in combination with atezolizumab - Leap Therapeutics announced an immunotherapy collaboration with the European Organisation for Research and Treatment of Cancer. The cooperative group sponsored clinical trial will evaluate DKN-01 in combination with atezolizumab +/- paclitaxel in advanced esophagogastric malignancies and DKN-01 + atezolizumab in advanced biliary tract cancers at EORTC centers across Europe. Roche will supply atezolizumab to the EORTC for this study collaboration. The study is expected to begin enrolling patients in 2018 and aims to understand the synergy between DKN-01, a Wnt-targeted therapy, and an immune checkpoint inhibitor with and without chemotherapy. The study will explore the efficacy and safety of the combination as well as aim to identify biomarkers.

07:07 EDT Medtronic announces Japanese regulatory approval for IN.PACT Admiral DCB - Medtronic announced that the IN.PACT Admiral Drug-Coated Balloon, or DCB, received approval from the Japanese Ministry of Health, Labour and Welfare, or MHLW, for the treatment of peripheral artery disease, or PAD, in the upper leg - specifically, in the thigh and behind the knee. Before Medtronic can begin commercialization, it must partner with Japanese MHLW to gain reimbursement to ensure broader access to this innovative and clinically-proven therapy.

07:03 EDT Foundation Medicine to present data for its assay measuring bTMB - Foundation Medicine (FMI) announced presentations at the European Society for Medical Oncology Annual Meeting highlighting validation data for its novel assay to measure tumor mutational burden from blood. These presentations will highlight retrospective data analysis from Roche (RHHBY)/Genentech's Phase II POPLAR and Phase III OAK studies that enabled analytic and clinical validation for the bTMB assay. The studies demonstrate that high bTMB as measured by Foundation Medicine's assay is associated with response to atezolizumab in individuals with previously-treated non-small cell lung cancer, potentially offering a new option to expand personalized care options for patients with advanced cancer. Based on these findings, Foundation Medicine also announced today that its bTMB assay will be integrated as part of Roche/Genentech's prospective, randomized Phase III Blood First Assay Screening Trial as a companion diagnostic assay to investigate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients. In the studies presented at ESMO, Foundation Medicine's bTMB assay was analytically validated to determine TMB with high precision and accuracy from as little as one percent tumor content in a blood sample. The assay was used to retrospectively analyze a total of 794 plasma samples from the Phase II POPLAR and Phase III OAK clinical trials. The analysis showed that atezolizumab demonstrated a clear benefit for overall survival. Additionally, there was a correlation between patients with high bTMB in those studies and longer progression-free survival when treated with atezolizumab. In addition, bTMB was not found to correlate with PD-L1 expression levels as measured by tissue-based immunohistochemistry, suggesting that bTMB, like tissue TMB, provides independent and critical predictive information in addition to the information furnished by PD-L1 testing. These new data include insights into the landscape of tissue-based TMB across various types of cancer, which may help further stratify molecular subtypes of disease and guide more personalized treatment. Results will be presented from a study of more than 80,000 solid tumors, a study of more than 22,000 gastrointestinal cancers and a study of more than 2,000 melanoma cases. Together these results reveal pan-tumor and disease-specific alterations that may inform rational selection of immunotherapy. Furthermore, new studies show the prevalence of TMB in subtypes of certain cancers where immunotherapy is not often considered, such as breast and thymic cancers. These findings may help expand the utility of TMB into new indications. .

07:00 EDT Reliance Steel provides update on Hurricane Harvey impact - Reliance Steel provided an update on its operations located in the areas directly impacted by Hurricane Harvey. Reliance currently operates thirteen locations throughout this area, whose total sales represented approximately 4% of Reliance's consolidated net sales in the first half of fiscal 2017. Due to the severe weather conditions, many of these facilities were closed and unable to ship for most of last week, however, no material damage to the facilities, equipment or inventory occurred. As of September 5, 2017, all facilities have been reopened and are operational.

06:59 EDT Checkpoint Therapeutics lung cancer treatment granted orphan status - Checkpoint Therapeutics treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer, or NSCLC, was granted FDA orphan designation, according to a post to the agency's website. Reference Link

06:53 EDT Eli Lilly says galcanezumab shows 'positive' long-term safety results - Eli Lilly announced that treatment with self-administered galcanezumab for up to 12 months demonstrated a positive safety and tolerability profile in patients with migraine, consistent with previous studies. Detailed results from a 12-month, open-label Phase 3 study will be presented today at the 18th Congress of the International Headache Society, or IHC, in Vancouver. Over the 12-month treatment period, galcanezumab was also associated with a statistically significant reduction in the number of monthly migraine headache days with both doses. Notably, there was no clinically meaningful difference in the rate of adverse events between galcanezumab 120 mg and 240 mg dosing groups. Lilly plans to submit a Biologics License Application, or BLA, to the FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

06:35 EDT AkzoNobel creates new structure, sees 2017 EBIT less than previous forecast - AkzoNobel announced a new management structure for its Paints and Coatings business in advance of creating two businesses; Paints and Coatings and Specialty Chemicals. "The new, fully integrated, management structure will increase customer focus, drive further operational excellence, and build greater momentum and speed across the business. It will be based on four regional Paints business units and four integrated Coatings business units with full profit and loss responsibility. The businesses will be served by a world-class integrated," the company said. In addition, AkzoNobel is "implementing a range of measures to mitigate current market challenges." The challenges include "unfavorable foreign exchange rates, continued headwinds for the Marine and Protective Coatings industry, temporary disruption to the manufacturing and supply chain during the third quarter and current margin pressure from greater than expected raw material cost inflation." It added, "Steps already taken, including increased selling prices and additional cost control measures, are expected to enable AkzoNobel to deliver EBIT for 2017 higher than 2016 although by less than the previously communicated increase of EUR 100M."

06:30 EDT Akzo Nobel CFO Maelys Castella steps down - AkzoNobel announces that Maelys Castella, CFO and member of the board of management will step down due to health reasons. Castella is now on a leave of absence. Following an anticipated recovery, Maelys is expected to return to AkzoNobel in a senior management role. The company has announced current group controller Hans De Vriese as interim CFO, while initiating a full internal and external search for a permanent replacement. Reference Link

06:06 EDT Baker Hughes reports August international rig count down 7 to 952 - Baker Hughes, a GE company, announced that the Baker Hughes international rig count for August 2017 was 952, down 7 from the 959 counted in July 2017, and up 15 from the 937 counted in August 2016. The international offshore rig count for August 2017 was 201, down 3 from the 204 counted in July 2017, and down 27 from the 228 counted in August 2016. The average U.S. rig count for August 2017 was 947, down 6 from the 953 counted in July 2017, and up 466 from the 481 counted in August 2016. The average Canadian rig count for August 2017 was 217, up 19 from the 198 counted in July 2017, and up 88 from the 129 counted in August 2016. The worldwide rig count for August 2017 was 2,116, up 6 from the 2,110 counted in July 2017, and up 569 from the 1,547 counted in August 2016.

05:39 EDT Bristol-Myers: two Opdivo trials show three-year survival benefit - Bristol-Myers announced three-year overall survival, or OS, data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer, or NSCLC. In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years versus 6% of those treated with docetaxel. In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years versus 9% of those treated with docetaxel. Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years' minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.

05:34 EDT Immune Design announce interim analysis of ongoing Phase 2 trial - Immune Design (IMDZ) announced that an interim analysis of its ongoing, randomized Phase 2 trial showed that NY-ESO-1+ soft tissue sarcoma, or STS, patients receiving the combination of CMB305 and Genentech's (RHHBY) checkpoint inhibitor, atezolizumab, experienced greater clinical benefit and immune response than those receiving atezolizumab alone. The data will be presented in a poster discussion session at the European Society of Medical Oncology 2017 Congress, September 8-12, 2017 in Madrid, Spain.

05:24 EDT United Therapeutics says FREEDOM-EV study to continue as planned - United Therapeutics announced that the independent data monitoring committee, or DMC, for the FREEDOM-EV study of Orenitram extended-release tablets had completed a pre-specified interim safety and efficacy analysis. The DMC did not identify any new safety concerns associated with Orenitram therapy, and recommended that the trial be continued as planned without modification. FREEDOM-EV is a Phase 3, international, multi-center, randomized, double-blind, placebo-controlled, clinical worsening study of Orenitram in patients with pulmonary arterial hypertension, or PAH, receiving background oral monotherapy study. In accordance with the study protocol and DMC charter, previous interim safety analyses were performed at scheduled intervals throughout the study and this interim safety and efficacy analysis was performed after approximately 75% of the target 205 adjudicated clinical worsening events occurred within the study. United Therapeutics is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is completed. The threshold for stopping the trial early for overwhelming efficacy was intentionally set high with the understanding that a more robust result, based on a larger number of clinical worsening events, could be obtained by the study continuing to completion. The DMC's recommendation to continue as planned reflects its review of all available safety and efficacy data, and was made independently. Neither United Therapeutics nor the FDA has reviewed the interim clinical trial results and neither participated in the DMC's closed session deliberation.