Stockwinners Market Radar for September 25, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:46 EDT Jazz Pharmaceuticals phase 3 study of JZP-258 demonstrates efficacy in cataplexy - Jazz Pharmaceuticals announced that positive data from the Phase 3 study of its investigational medicine, JZP-258, for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy were presented at World Sleep 2019 in Vancouver, Canada. Data from the study were presented in an oral presentation today at 5:00 p.m. PDT and in a poster presentation on September 24. The Phase 3 study of JZP-258 was a global, double-blind, placebo-controlled, randomized-withdrawal, multicenter study evaluating the efficacy and safety of JZP-258 in the treatment of cataplexy and EDS in adults with narcolepsy. The primary endpoint was the change in the weekly number of cataplexy attacks, and the key secondary endpoint was the change in the Epworth Sleepiness Scale score with JZP-258 compared to placebo. "We are pleased with the positive results from the Phase 3 study of JZP-258, which demonstrate the efficacy of JZP-258 for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy," said Jed Black, M.D., senior vice president, Sleep and Neuroscience at Jazz Pharmaceuticals. "These data support the efficacy and overall safety profile of a lower-sodium oxybate formulation for people living with narcolepsy, a chronic condition that may require lifelong therapy. We believe that JZP-258, if approved, will provide a clinically meaningful benefit to patients prescribed oxybate."

18:45 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: AAR Corp (AIR) up 3.1%. DOWN AFTER EARNINGS: Pier1 Imports (PIR) down 10.1%... HB Fuller (FUL) down 7.2%... KB Home (KBH) down 1.1%. LOWER: BioXcel Therapeutics (BTAI) down 15.8% after equity offering... Enanta (ENTA) down 10.2% after disclosing EDP-305 Phase 2a study data... Plymouth Industrial REIT (PLYM) down 6.6% after equity offering. Movers as of 18:30ET.

18:01 EDT Investar Holding raises quarterly dividend 9% to 6c per share - The dividend is payable on October 31 to shareholders of record as of October 7.

17:50 EDT SPDR Gold Shares holdings rise to 924.94MT from 908.52MT - This is the highest level of holdings since November of 2016.

17:32 EDT Lockheed Martin awarded $281.08M Army contract - Lockheed Martin was awarded a $281.08M hybrid, firm-fixed-price and cost reimbursable contract to acquire 18 Sentinel A4 Radar Systems. Three bids were solicited with three bids received. Work will be performed in Liverpool, New York, with an estimated completion date of March 31, 2026. FY19 research, development, test and evaluation funds in the amount of $6.5M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:27 EDT BAE Systems awarded $2.68B Navy contract for procurement of APKWS - BAE Systems was awarded a $2.68B firm-fixed-price, indefinite-delivery/indefinite-quantity contract for the procurement of Advanced Precision Kill Weapon System, or APKWS, II full rate production Lots 8-12. This award procures WGU-59/B units to upgrade the current 2.75-inch rocket system to a semi-active laser guided precision weapon to support Navy, Army, Air Force and foreign military sales requirements to include the governments of Iraq, Lebanon, Netherlands, Jordan, Afghanistan, United Kingdom, Tunisia, Philippines and Australia. Work will be performed in Hudson, New Hampshire and Austin, Texas and is expected to be completed in December 2025. No funds will be obligated at time of award; funds will be obligated on individual delivery orders as they are issued. This contract was not competitively procured pursuant to 10 U.S. Code 2304. The Naval Air Systems Command is the contracting activity.

17:08 EDT KB Home CEO Mezger says 2020 shaping up 'quite solid' - Says Q3 community count increased 18%. Says on track to generate double-digit community count growth in 2019. Says Q4 gross margins to top 19%. Says positioned for margin growth in 2020. Says demand is healthy and supply remains insufficient to meet suppliers needs. Comments taken from Q3 earnings conference call.

17:01 EDT AirNet Technology receives minimum bid price notice from Nasdaq - AirNet Technology announced that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market Inc. on September 24, 2019 indicating that the Company is no longer in compliance with the minimum bid price requirement set forth in Rule 5550a2 of the Nasdaq Listing Rules as the company's closing bid price per American depositary share, each representing ten ordinary shares of the company, has been below $1.00 for a period of 30 consecutive business days. The Nasdaq notification letter does not result in the immediate delisting of the company's securities.

16:37 EDT Brookfield Infrastructure to split Canadian unit - Brookfield Infrastructure announced the intention to create a Canadian corporation in order to provide investors with greater flexibility in how they access BIP's globally diversified portfolio of high-quality infrastructure assets. Brookfield Infrastructure's board intends to distribute to existing unitholders, on a tax-free basis, class A shares of the new corporation, Brookfield Infrastructure Corporation. From an economic and accounting perspective, the transaction will be analogous to a unit split as it will not result in any underlying change to aggregate cash flows or net asset value except for the adjustment for the number of units/shares outstanding. The class A shares will be structured with the intention of being economically equivalent to units of BIP, including identical distributions. The class A shares are intended to allow investors the ability to own the equivalent economic exposure to BIP, including identical distributions, through a traditional corporate structure. Currently, unitholders are expected to receive 0.11 BIPC shares for each unit held of Brookfield Infrastructure in the form of a special distribution.

16:20 EDT Everest Re announces buyout of Salus Systems - Everest Insurance announced today that the company has purchased all outstanding remaining shares of its joint venture partner, Salus System. Salus, founded in January 2017, develops and markets the insurance industry's first collaborative safety management platform, ZERO, a modern-era workplace safety software application designed to engage employees while tracking, observing, and responding to potential hazards in real time.

16:18 EDT Emergent BioSolutions awarded $20M to develop diazepam auto-injector - Emergent BioSolutions announced that it has been awarded approximately $20M to develop and manufacture an auto-injector containing diazepam to treat nerve agent-induced seizures. Emergent's device is being designed for intramuscular buddy-administration for use in military environments and for civilian emergencies. Under the multiple year agreement, awarded through the Medical CBRN Defense Consortium, or MCDC, Emergent will develop a device, conduct studies to demonstrate consistent manufacturing, functionality and usability of the final device, and complete regulatory activities required to obtain approval of the combination product by the FDA.

16:16 EDT Yuma Energy agrees to settlement with former CEO - Yuma Energy announced that the company has executed a settlement agreement with Sam Banks, the former CEO of the company. Yuma made no admission of liability under the settlement agreement but agreed to fully settle the matter by way of compromise. The agreement resolves claims that Banks asserted against Yuma in relation to his termination. "This settlement represents another step in our restructuring process as it eliminates ongoing legal costs and unnecessary management time," said Anthony Schnur, Yuma's interim CEO and Chief Restructuring Officer. "We continue to seek to execute on our objectives of reducing our liabilities, lowering operational costs and improving our balance sheet."

16:15 EDT H.B. Fuller down 7% after Q3 results, FY19 guidance miss estimates

16:13 EDT KB Home reports Q3 home deliveries 3,022 vs. 2,988 last year - Reports Q3 average selling price $381.4K, down 7% from last year citing "community mix shift within the company's West Coast region."

16:11 EDT SS&C to acquire Algorithmics assets from IBM - SS&C Technologies(SSNC) announced it has entered into a definitive agreement to acquire certain Algorithmics and related assets from IBM (IBM). Algorithmics provides leading risk analytic products and services for the financial services industry worldwide. The addition of Algorithmics will extend SS&C's risk analytics and regulatory offering. The acquisition is expected to be completed in the fourth quarter, pending the completion of customary closing conditions.

16:07 EDT H.B. Fuller to realign business from five to three operating segments - H.B. Fuller announced that it will realign its business from five to three operating segments to drive long-term global growth and generate operating efficiencies. This change in operating segments reflects how we will organize the company to make operating decisions and assess business performance. The new structure will be effective with the start of the company's 2020 fiscal year on Dec. 1, 2019, and will be comprised of the following three global business units: Engineering Adhesives; Hygiene, Health and Consumable Adhesives; Construction Adhesives. The company's preliminary target for annualized cost savings potential resulting from this realignment is in the range of $20M-$40M by 2021, with approximately half of the savings to be realized in 2020. Over the next several weeks, the company will continue to review and refine the cost savings impact of the realignment. Further details will be provided on the company's fiscal fourth quarter analyst call in January 2020, upon completion of its business realignment plans.

16:02 EDT Enanta's Phase 2a study of EDP-305 achieved primary endpoint - Enanta Pharmaceuticals announced topline results from its ARGON-1 Phase 2a study of EDP-305 for the treatment of non-alcoholic steatohepatitis. The ARGON-1 study was a 12-week, randomized, double-blind, placebo-controlled Phase 2a study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in a NASH population. The primary objectives of the study were to evaluate change in ALT levels at week 12 and to evaluate the safety and tolerability of EDP-305. Key secondary objectives included change in liver fat content by MRI-PDFF, change in lipids, and pharmacokinetics and pharmacodynamic parameters, including C4 and FGF19. The study's primary endpoint was achieved with a statistically significant ALT reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12. As with our primary endpoint, there was a statistically significant reduction in liver fat content with EDP-305 at the 2.5mg dose as measured by MRI-PDFF. 45% of subjects were MRI-PDFF responders. EDP-305 also exhibited strong target engagement as shown by reductions in C4 and increases in FGF-19 and ALP. A robust GGT reduction was also observed.

15:56 EDT City Holding raises quarterly dividend to 57c from 53c per share - The dividend is payable on October 31 for shareholders of record as of October 15.

15:31 EDT Carnival announces agreements with Bahamas for two new destination projects - Carnival Corporation & plc (CCL, CUK) and two of its cruise line brands signed an agreement with the government of The Bahamas to build two major port developments, the company announced. Under the agreement, Carnival Corporation will develop a new cruise port destination primarily for Carnival Cruise Line on Grand Bahama, and construction of a new addition, including a pier, on the Bahamian island of Little San Salvador, home to Holland America Line's award-winning Half Moon Cay port. The Grand Bahama project will represent an investment of over $100M, and the development on Little San Salvador will be an estimated $80M investment over time, the company said.

14:40 EDT Electronic Arts announces details of VR 'Medal of Honor' game for Oculus Rift - At Oculus Connect 6, Respawn Entertainment, a studio of Electronic Arts (EA) and Oculus from Facebook (FB) revealed "Medal of Honor: Above and Beyond," coming next year exclusively to VR, on the Oculus Rift platform. "Medal of Honor: Above and Beyond" will "deliver its most authentic and immersive World War II experience from the series to date," EA said. The game, which "is being built for Oculus Rift from the ground up by a team comprised of veteran developers of the series," will include unique multiplayer modes and features when it releases in Summer 2020, the company added.

14:35 EDT Amazon introduces eero mesh WiFi system, starting at $99 - Amazon introduced the newest addition to its eero family of devices, the new eero mesh WiFi system. The system "offers simple, reliable WiFi for streaming, gaming, and working from home-all for just $99, or three for $249," said Amazon. "eero is a mesh WiFi system that replaces your existing router and extends WiFi coverage seamlessly throughout your home. A single eero plugs directly in to your modem, while additional eero devices extend your network's range wirelessly or via Ethernet connections," the company added. The new eero is available for U.S. customers starting today and is expanding to Europe. Customers in France, Germany, Italy, Spain, and the United Kingdom will be able to try the new eero and eero Pro in early November, Amazon said.

14:27 EDT Amazon announces Echo Loop smart ring - At Amazon's hardware special event, the company said it would have limitated quantities available at an introductory $129.99 price

14:19 EDT Amazon.com announces Echo Buds wireless earbuds - At Amazon's hardware special event, it announced Echo Buds, which have up to 5 hours of battery life, and up to 20 hours of battery life with the case. They also feature noise reduction, using Bose technology. They support Siri, Google Assistant, and Alexa. Echo Buds are available for pre-order for $129, and will be shipping for the holidays.

14:14 EDT Amazon says pet-tracking device Fetch will be shipping next year

14:09 EDT Amazon.com announces Ring Stick Up Cam - At Amazon's hardware special event, it announced the Ring Stick Up Cam, which is avalable today for $99.99.

14:01 EDT Amazon announces new Echo Flex - At Amazon's hardware special event, it announced the all-new Amazon Echo Flex, which plugs directly into a wall outlet, and has a tiny speaker and two buttons, along with an LED status light and a USB port. The Echo Flex is available for pre-order for $24.99.

13:49 EDT Amazon announces new Echo Glow speaker - At Amazon's hardware special event, it announced the all-new Amazon Glow speaker, featuring a lamp that can change between multiple colors, which is available for pre-order for $29.

13:46 EDT Marathon Petroleum to 'thoroughly evaluate' proposal from activist Elliott - Marathon Petroleum issued a statement regarding the letter and presentation released by Elliott Management to the company's board. Marathon states, "MPC engages in regular communication with its shareholders and welcomes constructive input related to enhancing shareholder value. The company's Board of Directors and management team remain focused on delivering long-term value for shareholders, and will continue to take actions to achieve that objective. MPC's management team and independent Board have a strong track record of taking action to deliver shareholder value. Since becoming an independent company in 2011, MPC has generated total shareholder return of 254%, exceeding the S&P, which has returned 174%. At the same time MPC has returned over $20 billion to shareholders through dividends and share repurchases. Our strong operational results and cash flow generation have allowed us to build upon our commitment to returning capital to our shareholders, having returned approximately $850 million to our shareholders in the second quarter of 2019 and more than $2.1 billion year-to-date through a mix of dividends and share repurchases. We look forward to maintaining an ongoing dialogue with our shareholders as we continue to evaluate opportunities to deliver more value for our shareholders. We will thoroughly evaluate Elliott's proposal and look forward to continuing our constructive engagement around these issues."

13:38 EDT Amazon.com announces new Echo Studio speaker - At Amazon's hardware special event, it announced an all-new Amazon Echo studio that is available for pre-order for $199. The new Echo Studio has three midrange speakers, a directional tweeter, and a 5.25-inch bass driver on the bottom with a bass port. It supports 3D audio, Dolby Atmos.

13:34 EDT TherapeuticsMD jumps over 14% after updating information for presentations - TherapeuticsMD provided a slides presentation earlier which may be used, in whole or in part, and subject to modification, on September 25 and at subsequent meetings with investors or analysts. In the presentation, TherapeuticsMD, which operates as a women's health care product company in the United States noted that the company expanded commercial coverage for Imvexxy with addition of CVS while it is waiting for a commercial coverage decision from Aetna on Imvexxy. Imvexxy and Bijuva data will be presented at the 2019 Annual Meeting of the North America Menopause Society being held September 25-28. In the presentation slide deck TherapeuticsMD guided to FY19 revenue of $29.45M-$34.2M against consensus analyst estimates of 31.58M . Shares of TherapeuticsMD are up over 14% to $4.15 per share in afternoon trading.

13:33 EDT Facebook says Oculus Quest to add hand tracking for VR - Facebook's Oculus unit, via a blog post, announced the addition of "true hand-based input for VR" to its Oculus Quest gaming headset. "Hand tracking on Quest will let people be more expressive in VR and connect on a deeper level in social experiences. Not only will the current community of VR enthusiasts and early adopters benefit from more natural forms of interaction, hand tracking on Quest will also reduce the barriers of entry to VR for people who may not be familiar or comfortable with gaming controllers. Even better, your hands are always with you and always on-you don't have to grab a controller, keep it charged, or pair it with the headset to jump into VR. From entertainment use cases to education and enterprise, the possibilities are massive," the blog post stated. This new technology will launch on Quest in early 2020 as an experimental feature for consumers and an SDK for developers, the company said. Reference Link

13:30 EDT Amazon discusses hardware privacy concerns at company event - Dave Limp, an Amazon hardware executive, spoke at the company's special event about the company's hardware. He said, "Customers interact with Alexa billions of times per week," adding that "Privacy is absolutely foundational to everything we do in and around Alexa." Limp noted that in the last year, Alexa has become 50% more accurate in listening for its wake word, preventing false wakes. Limp then discussed a new feature coming to Alexa -- Home mode, which allows customers to set devices when they're at home to have no recording of audio or video -- and highlighted the Alexa Privacy Hub, which shows your data on a website or in the app. He noted that Amazon was "the first company to let people opt out" of human review of voice recordings, and that Alexa is the only device that allows users to ask it to delete data. Additionally, Limp announced a new feature that allows users to opt in to have voice recordings auto-deleted in three- and 18-month intervals.

13:03 EDT Dropbox announces strategic partnership, $5M investment in BetterCloud - BetterCloud and Dropbox announced a new strategic partnership. The first phase of this partnership involves the development of BetterCloud for Dropbox, a deep integration between the two platforms which will provide advanced data protection and orchestration functionality for Dropbox teams. This new offering for Dropbox customers will allow businesses to enforce custom security policies, scan content for sensitive data, and automate critical processes. Dropbox will resell and distribute BetterCloud for Dropbox as its preferred solution for enabling secure and faster adoption of Dropbox Business. As part of this partnership, Dropbox is making a $5M strategic financial investment in BetterCloud to fuel the growth and development of the platform and its commercial efforts.

13:02 EDT KemPharm should be able to reduce outstanding debt by 40%, CEO says

13:02 EDT GPC 'absolute best partner' for KemPharm, CEO says

12:42 EDT McDonald's 'Apply Thru' allows Amazon's Alexa to to assist in job application - McDonald's (MCD) said in an earlier blog posting: "McDonald's Corporation is now working with a voice millions know and love. Alexa (AMZN) can now assist with the first step of a McDonald's restaurant job application, helping drive talent attraction worldwide through the McDonald's Apply Thru skill. The world's first voice-initiated application process, the McDonald's Apply Thru is available today as part of the recently launched Made at McDonald's global hiring campaign that seeks to drive applications worldwide. "We must continue to innovate and think of creative, and in this case, groundbreaking ways to meet potential job seekers on devices they are already using, like Alexa," said McDonald's Executive Vice President & Chief People Officer David Fairhurst. "Alexa has many of the qualities we look for on our teams - friendly, responsive and fun. I am looking forward to having our application process simplified with Alexa." Reference Link

12:13 EDT Sony's PlayStation launches online store for consoles, accessories, games - Sony's SVP Head of North American Business Operations, SIE Stephen Turvey said in a blog posting: "Hi PlayStation fans, today we're launching our own online store to offer PS4 consoles, accessories, games, and more directly from PlayStation for fans and gift-givers in the US, who can visit a single destination. Integrated within the PlayStation.com website, you can now easily navigate from hardware and game product information pages directly to purchasing these PlayStation products from our store, ranging from PS4, PS4 Pro and PS VR systems and bundles, as well as headsets, DualShock 4 Wireless Controllers, PS VR accessories, a selection of physical games, and voucher codes for PS Plus subscriptions. This site not only provides our fans in the US with the option to purchase these items directly from PlayStation, but is also intended to help gift givers easily find the right product for their friends or family. Fans will find that prices on the new store align with those found at other retailers. PlayStation Plus members who are signed in are also eligible for Free 1-Day Express Shipping." Reference Link

12:00 EDT Forestar Group falls -8.7% - Forestar Group is down -8.7%, or -$1.77 to $18.52.

12:00 EDT Lannett falls -17.4% - Lannett is down -17.4%, or -$2.42 to $11.48.

12:00 EDT R.R. Donnelley rises 15.0% - R.R. Donnelley is up 15.0%, or 46c to $3.50.

11:50 EDT GNC dips after Bloomberg reports debt refinancing looms - Shares of GNC fell to $2.27 per share after Bloomberg reported that the company is assessing debt refinancing options. GNC is currently down 2.8% to $2.45 per share in late-morning trading.

11:29 EDT Match falls 4% to $70.23 after FTC sues over ''fake love interest' ads - Shares of IAC (IAC) are down 2% to $219.82.

11:21 EDT Discovery announces direct-to-consumer cooking product, Amazon partnership - Discovery (DISCA) earlier today announced the launch of Food Network Kitchen, a direct-to-consumer product with streaming technology offering consumers live cooking instruction with culinary experts, grocery and equipment delivery, and over 800 on-demand classes. Food Network Kitchen will launch in late October in the U.S. and will also be available across Apple's (AAPL) operating system and Android mobile devices. Food Network Kitchen will roll out across additional platforms and devices in 2020. The announcement includes a collaboration between Discovery and Amazon (AMZN) to offer Food Network Kitchen through Amazon Alexa and Echo Show, Fire Tablets, Fire TV streaming media devices and Fire TV Edition smart TVs. "Food Network Kitchen brings the top chefs in the world directly to consumers' kitchens through first-of-its-kind live interactive cooking classes, seamless e-commerce transactions, and the richest culinary media ecosystem in the world," said David Zaslav, President and CEO, Discovery. "We are re-imagining the direct-to-consumer experience as not just another entertainment service but as the 'Peloton of Food' accessible to everybody."

11:10 EDT OGE Energy raises quarterly dividend 6% to 38.75c per share - OGE Energy Corp. announced that its Board of Directors has approved an increase in the company's quarterly dividend to 38.75c per share from 36.50c per share, which represents growth of approximately 6% and equates to $1.55 per share annually. The increase is effective with the fourth quarter 2019 dividend and will be paid Oct. 30, 2019, to shareholders of record Oct. 10, 2019.

10:51 EDT Northstar Realty Europe investors approve proposed merger with AXA IM - RA - NorthStar Realty Europe Corp. (NRE) announced that at a special meeting of NRE stockholders held today, its stockholders approved the proposed merger of NRE with and into Nighthawk Merger Sub LLC, a wholly-owned subsidiary of a fund managed by AXA Investment Managers - Real Assets (AXAHY), pursuant to that certain Agreement and Plan of Merger, dated July 3, 2019, by and among CoRE PANEURO 2019 13 S.a.r.l, Nighthawk Merger Sub LLC, NRE, Nighthawk Partnership Merger Sub LLC and NorthStar Realty Europe Limited Partnership. NRE stockholder approval was a condition to the closing of the transactions contemplated by the Merger Agreement. The closing of the merger remains subject to certain other customary closing conditions, but NRE and AXA IM - Real Assets anticipate that the closing of the merger will occur by the end of September or as soon as reasonably practicable thereafter.

10:39 EDT Adial Pharma on track to complete CTA filing for Phase 3 trial by Sept. 30 - Adial Pharmaceuticals provided an update on its clinical activities. The company reported that it is on track to complete its Clinical Trial Application filing to commence the Phase 3 clinical trial of the company's lead drug candidate, AD04, for the treatment of alcohol use disorder in genetically targeted patients, on or before September 30, 2019. The Phase 3 Trial is expected to enroll 290 subjects across approximately 30 selected clinical sites in Sweden, Finland, Estonia, Latvia, Poland, Bulgaria and Croatia. The Trial is a double-blind placebo-controlled trial with the primary objective to evaluate the efficacy of AD04 to reduce alcohol consumption in subjects with AUD that are positive for certain genetic biomarkers. "Commencing a multinational, multicenter Phase 3 Trial is a complex undertaking, and we are pleased to report that we have completed most of the necessary steps, including selection of our CRO and principal investigator, site selection, testing of product materials and much more," stated Monika Rogozinska, Chief Development Officer of Adial Pharmaceuticals. "We look forward to commencing enrollment in the trial, which we believe will further demonstrate the safety and efficacy of AD04 as a treatment for AUD."

10:16 EDT Best Buy CEO says targets 'aggressive but achievable'

10:10 EDT AIM ImmunoTech Inc trading resumes

10:04 EDT Best Buy says FY25 targets assume store count does not materially change - Says growth may not be linear. Sees impact of tariffs normalizing over time.

10:00 EDT Forestar Group falls -8.4% - Forestar Group is down -8.4%, or -$1.70 to $18.59.

10:00 EDT GameStop rises 8.2% - GameStop is up 8.2%, or 41c to $5.42.

10:00 EDT Synnex rises 13.8% - Synnex is up 13.8%, or $13.19 to $108.94.

09:47 EDT VelocityShares 3x Long Natural Gas ETN falls -5.3% - VelocityShares 3x Long Natural Gas ETN is down -5.3%, or -99c to $17.72.

09:47 EDT Lannett falls -19.6% - Lannett is down -19.6%, or -$2.72 to $11.18.

09:47 EDT Philip Morris rises 7.6% - Philip Morris is up 7.6%, or $5.46 to $77.02.

09:39 EDT Premier named as short by Spruce Point, which sees 55%-75% downside risk

09:30 EDT HealthStream appoints Scott Roberts CFO - HealthStream announced that its board of directors has appointed Scott Roberts as CFO and senior VP, effective immediately. Roberts had been serving as interim CFO & VP of accounting and finance since his appointment to that position in February. Roberts joined HealthStream 17 years ago as a CPA from Ernst & Young.

09:22 EDT Consolidated-Tomoka acquires single-tenant property in New York for $7.1M - Consolidated-Tomoka Land (CTO) announced the purchase of an approximately 15,500 square foot building on 1.24 acres in Oceanside, New York, on Long Island, under a long-term lease to Party City Corporation (PRTY), for approximately $7.1M. The Property is situated along a major retail corridor in Oceanside, with a three-mile population of approximately 154,000 and approximately 10 years remaining on the current lease. The initial investment cap rate was above the mid-point of the range in the Company's 2019 guidance. This acquisition was purchased using the Company's unsecured credit facility and is expected to be part of a 1031 like-kind exchange. Including this transaction, the Company, during the first nine months of 2019, has acquired 9 single-tenant income properties for an aggregate of approximately $90M, or 90% of the mid-point of the Company's 2019 guidance for income property acquisitions.

09:15 EDT Crop Infrastructure says eight of 10 hemp pivots 'severly affected' by weeds - CROP INFRASTRUCTURE announced it has completed September site visits in Nevada with its consultants and joint venture partners at the hemp and THC farms where weeds have caused major losses. After drone reconnaissance, and sample plant counts were completed, it was established that eight of 10 of the company's hemp pivots have been severely affected by invasive weeds. In several northern pivots, a herd of antelope also caused significant damage. The company's operating partner had employed a farming method of planting cover crops to keep the weeds away, however, it was not effective with the exception of all but two pivots. The company and joint venture partner are further reviewing the causes of the operational failure. The company has decided to release the leased 850 acres of lost pivoted crops and focus on the remaining pivots covering 500 acres. CROP further announced that the proposed sale of the Nevada THC asset has now lapsed and the agreement has been terminated. CROP will continue to look for suitable joint venture partners, purchasers, or will continue developing and planting the farm in the 2020 season. $51,024.87 has been received in warrant exercises at $0.13 since its previously announcement of the early warrant incentive program. The company said, "As a result of the disappointing harvest and to make CROP more attractive to potential partners the company has been working with its associate companies in order to prepare the exercise options it holds to increase its ownership on its various assets, the strike price of which is $500 each. The company will prepare its books for the audit and accounting implications of increasing its ownership at each subsidiary." CEO Michael Yorke said, "We have been humbled by the realities of commercial scale farming with hard lessons learned, but we are determined to forge ahead and we are readying our teams to complete the harvesting of the remaining hemp in Nevada, and THC in California, Washington and Oklahoma as the October harvest season is just around the corner. The company has always planned to increase its ownership of its various assets, though we had previously looked to do this after the project had achieved a profitable milestone. As state rights become stronger and with banking provisions falling into place, CROP will now look to take a control position just as soon as our accounting department has declared we are in a position to do so."

09:12 EDT Tractor Supply, Citi Retail Services launch 5% back in rewards for cardholders - Tractor Supply Company (TSCO) and Citi Retail Services (C) announced new rewards for Neighbor's Club members who use the Tractor Supply Personal Credit Card, including 5 percent back in rewards and special financing offers. Tractor Supply Personal Credit Cardholders with a membership to Neighbor's Club, the Company's free loyalty program, will get 5 percent back in rewards on regular credit purchases, or they may choose special financing options, including six months financing on purchases of $199 and up, 12 months financing on purchases of $399 and up and major purchase plans up to 48 months. These new benefits are in addition to the compelling benefits that cardholders enrolled in Neighbor's Club have access to, including seasonal rewards, member-only offers, a birthday surprise and more.

09:11 EDT eBay down 3.5% after CEO Devin Wenig steps down, Schenkel named interim CEO - In pre-market trading, shares are down 3.5% to $38.16.

09:08 EDT Flushing Financial leases new Hicksville branch location - Flushing Financial Corporation announced that the Bank has leased a new Hicksville location, at 268 North Broadway. Hicksville, NY. This new full-service location is planned to open in December 2019.

09:07 EDT eBay says previously announced operating review 'is ongoing' - eBay noted that its previously announced operating review is ongoing, and the company expects to provide an update this fall. In addition, eBay's strategic review of its asset portfolio, including StubHub and eBay Classifieds Group, is continuing to move forward with the assistance of Goldman Sachs & Co.

09:05 EDT Boeing board establishes permanent Aerospace Safety Committee - Boeing Chairman, President and CEO Dennis Muilenburg and the Boeing Board of Directors reaffirmed the company's longstanding commitment to aerospace safety and the safety of its products and services. Muilenburg and the board announced the establishment of a permanent Aerospace Safety Committee of the Board of Directors. The board also delivered to Muilenburg and senior company leaders the recommendations of its specially-appointed Committee on Airplane Policies and Processes, which also were adopted by the full board. The board formally approved the creation of the new Aerospace Safety Committee at its August 2019 meeting. The committee's primary responsibility is to oversee and ensure the safe design, development, manufacture, production, operation, maintenance and delivery of the company's aerospace products and services.

09:04 EDT Elliott Management calls for Marathon Petroleum to split into three companies - Elliott Management, which manages funds that collectively own common stock and economic equivalents representing approximately a 2.5% economic interest in Marathon Petroleum, announced that it sent a letter and presentation to the board of directors of Marathon to outline a path forward for Marathon to "remedy the company's chronic underperformance, to improve its businesses and to unlock significant and sustainable value for its shareholders." Elliott previously engaged with the current management extensively regarding ideas to create value, "which concluded with promises from management and the Board that certain steps would be taken to improve performance...that have not been kept, and Elliott continues to believe that Marathon is severely undervalued," the letter said. To unlock the value currently trapped in Marathon's conglomerate structure, Elliott believes the company must immediately initiate a separation into three independent entities, which will create three strong, independent companies: RetailCo would become stand-alone Speedway, which upon separation would be the largest US-listed convenience store operator; MidstreamCo would become stand-alone MPLX, which upon separation would be a top-five US midstream operator by enterprise value; and RefiningCo would become New Marathon, which following the transactions, would be the largest independent merchant refiner by US throughput, Elliott said. Elliott believes that the Board can unlock more than $22B in value for shareholders with no change in the operating assumptions - an increase to today's stock price of ~61%. Further, the board can unlock an incremental $17B in value through achieving the operating full potential of Marathon's world-class asset base - a total potential upside of over 100%, the firm stated in its press release about its letter to the board. In pre-market trading, Marathon shares are up 6% to $58.95.

09:01 EDT eBay names Scott Schenkel as interim CEO - eBay announced that the company's Board of Directors has appointed Scott Schenkel, most recently eBay's Senior Vice President, CFO, as interim CEO. This appointment follows Devin Wenig stepping down as President and CEO, and a director of the company. The eBay Board will undertake a search to identify the company's next CEO, and will consider internal and external candidates. The company also announced that Andy Cring, eBay's Vice President, Global Financial Planning and Analysis, has been appointed to serve as interim CFO.

08:49 EDT Omeros study shows MASP-2 protects against renal injury caused by proteinuria - Omeros announced publication of study results showing that inhibition of mannan-binding lectin-associated serine protease-2, or MASP-2, protects against renal injury caused by proteinuria. The study used an animal model of proteinuria to determine the effect of MASP-2 inhibition on renal injury and fibrotic changes characteristic of proteinuric kidney diseases, including immunoglobulin A, or IgA, nephropathy and lupus nephritis, which can often lead to end-stage kidney disease and dialysis. Both MASP-2-deficient and MASP-2 inhibitor-treated animals demonstrated marked renoprotection and reduction in inflammation from proteinuria with significantly less tubulointerstitial injury when compared to isotype antibody-treated controls. Collectively, these findings indicate that MASP-2 inhibition may be broadly protective in proteinuric nephropathies. Omeros' lead MASP-2 inhibitor narsoplimab is in Phase 3 clinical programs for the treatment of IgA nephropathy and of atypical hemolytic uremic syndrome. In addition, Omeros plans to begin submitting to FDA in the first half of next quarter a biologics license application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company is also preparing a marketing authorization application requesting approval for this same indication in Europe.

08:41 EDT Marimed Hemp signs exclusive agreement with beverage distributor - MariMed announced that the HempEngine group of its MariMed Hemp subsidiary has signed an exclusive agreement with one of the largest beverage distributors located in the Northeast U.S., serving more than 8,500 on- and off-premise locations. Under the terms of the agreement, the HempEngine platform will be placed in locations in Rhode Island and Connecticut that include retailers, liquor stores and supermarkets. These locations will receive the HempEngine turnkey CBD marketing platform, a complete "store-within-a-store" package, pre-stocked with a range of CBD products focused on a location owner's particular criteria. In addition to curated brands, HempEngine includes the tech-enabled re-marketing platform, Sprout. HempEngine supports retailer sales and marketing decisions to maximize returns and sales efficiency. The rollout is expected to begin in October. The HempEngine platform collects real-time data and pre-screens the data for quality and content. It includes an electronic tablet that provides shoppers interactive, educational information about CBD product attributes, benefits and usage at the point-of-sale. HempEngine provides customized marketing solutions that educate, facilitate and drive mainstream CBD distribution.

08:36 EDT Taoping announces strategic partnership with Yifeng Pharmacy Chain - Taoping announced that the Company is launching a strategic partnership with Yifeng Pharmacy Chain, a chain of pharmacy with over 4,000 retail stores in China. As strategic partners, TAOP will place its smart display screens in Yifeng chain stores across the country, and Yifeng will have the options to become owners of Taoping screens and to attract and place advertisements of its suppliers in Taoping Network. TAOP will use its technology platform and technical expertise to provide owners of Taoping screens and advertisement agents with revenue sharing.

08:31 EDT Novelion completes Aegerion transaction, plans to liquidate, dissolve - Novelion Therapeutics, announced that, further to its press release dated September 11, 2019, the acquisition by Amryt Pharma of 100% of the outstanding equity interests of Novelion's reorganized subsidiary, Aegerion Pharmaceuticals as contemplated in Aegerion's First Amended Joint Chapter 11 Plan has been completed. On September 24, 2019, Aegerion completed the Amryt Transaction. The consideration for the Amryt Transaction has been satisfied through the issuance of ordinary Amryt shares, or American depository receipts representing Ordinary Shares, to stakeholders of Aegerion. Through the Amryt Transaction, Novelion has been divested of its operating subsidiary, Aegerion, which operates as a biopharmaceutical business dedicated to developing and commercializing new treatments for individuals living with rare diseases, including the two commercialized drugs in Aegerion's portfolio: lomitapide and metreleptin. In full satisfaction of its claims as creditor under the secured intercompany loan between Aegerion and Novelion, Novelion received American depository receipts representing approximately 14M Ordinary Shares, which currently represents just over 8% of Amryt on a fully-diluted basis. Amryt has issued a press release describing additional details of the Amryt Transaction, including consideration issued to other stakeholders. Novelion received only the Novelion Consideration and did not receive any other equity or property in connection with the Amryt Transaction. In addition, at Closing, Novelion, Amryt and Aegerion entered into a master services agreement whereby Amryt will reimburse Novelion for certain compensation and benefits that Novelion will be paying to two of Novelion's three remaining employees until the earlier of each employee's last date of employment with Novelion and December 31, 2019, in exchange for such employees providing transitional executive and integration services to Amryt during such period. Under the MSA, Amryt will also provide Novelion with certain accounting and reporting support, if requested, for an agreed monthly fee, and certain administrative support at no cost. Effective at the Closing, each of Mark Corrigan, Donald Stern, John Thomas and John Orloff resigned from his respective position as a member of the Novelion Board of Directors, and any committee thereof. Also, upon and in connection with the Closing, Roger Louis will no longer be serving as Novelion's global CCO and Interim Head of Research and Development. Following the Amryt Transaction, Novelion will cease to have any ongoing business operations or sources of revenue. As such, the Novelion Board has called an annual general meeting to, among other things, seek shareholder approval of, the voluntary liquidation and dissolution of Novelion under the Business Corporations Act at a time to be determined by the Novelion Board, Novelion's plan of liquidation and distribution and one or more distributions to shareholders of any remaining property of Novelion under the voluntary liquidation and dissolution, as described in Novelion's preliminary proxy statement filed with the SEC on September 20, 2019.

08:21 EDT LitePoint, NXP Semiconductors collaborate on integrated UWB device test solution - LitePoint, a subsidiary of Teradyne (TER), announced a collaboration with NXP Semiconductors (NXPI) to validate quality of devices that use NXP's recently announced secure fine ranging chipset, SR100T. Customers will be able to use the integrated LitePoint IQgig-UWB solution to help test and calibrate devices enabled with NXP's UWB technology. UWB is a technology addressing security applications in automotive and mobile products through precise positioning. In a solution combined with Bluetooth and near field communication technology, NXP UWB technology was announced in early June and enables precise localization for high anti-counterfeit protection and gives exceptional consumer experience for passive smart access.

08:16 EDT Vera Bradley, Disney Theme Park Merchandise partner for limited-edition pattern - Vera Bradley (VRA) has once again partnered with DISNEY Theme Park Merchandise (DIS) to create a limited-edition novelty pattern called Mickey's Whimsical Paisley, which will launch on September 26, 2019. Vera Bradley's design team collaborated with DISNEY to create Mickey's Whimsical Paisley, an aptly-named playful pattern featuring a motif of large-scale paisley elements intertwined with full-body images of Mickey Mouse, Disney's iconic theme park castle, Mickey-shaped balloons, and tossed confetti, all on a dark background. Mickey's Whimsical Paisley will officially launch with a special in-store event at Vera Bradley's Disney Springs retail location on Thursday, September 26. The Mickey's Whimsical Paisley collection will feature eighteen items, including backpacks, crossbody bags, a tote, large duffel, weekender and various travel items, a plush throw blanket, and several coordinating accessories, with prices ranging from $20 to $140.

08:11 EDT Bio-Path Holdings granted patent related to lipsomal delivery, antisense tech - Bio-Path Holdings announced that the United States Patent and Trademark Office has issued a patent with claims related to the Company's proprietary liposomal delivery and antisense technology, DNAbilize, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. This is the second U.S. patent issued for the Company's platform technology. The new patent, United States Patent No. 10,335,428, titled "P-Ethoxy Nucleic Acids for Liposomal Formulation," which issued July 2, 2019, provides additional claims for the broad protection previously granted in Patent No. US 9,744,187 for application of the DNAbilize technology in the treatment of a variety of cancers, as well as autoimmune and infectious diseases. DNAbilize is a proprietary liposomal nanoparticle delivery and antisense technology designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion.

08:09 EDT W.R. Grace licenses UNIPOL PP Process Technology to Bharat Petroleum - W. R. Grace & Co. has licensed its UNIPOL PP Process Technology to Bharat Petroleum Corporation Limited. Located in Rasayani near Mumbai in Maharashtra, India, the proposed world-scale capacity UNIPOL PP facility will produce 450 KTA of propylene. BPCL intends to manufacture phthalate-free polymer products for the Indian market using the most advanced PP process and catalysts technology available.

08:07 EDT Vaxart announces bivalent norovirus vaccine meets primary, secondary endpoints - Vaxart announced topline results from the randomized, double-blind, placebo-controlled Phase 1b safety, immunogenicity and interference study with its oral tableted bivalent norovirus vaccine in healthy adults. The study met all primary endpoints for safety and demonstrated robust immunogenicity, with 78% - 93% of subjects responding by eliciting IgA antibody secreting cells, a key marker for mucosal immunity and a potential correlate of protection for norovirus disease. Both the oral norovirus GI.1 and GII.4 vaccines were well tolerated, with no treatment-related serious adverse events reported. Most solicited and unsolicited adverse events were mild in severity and there were no significant differences observed between the vaccine and placebo treatment groups. Vaxart's bivalent vaccine demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain for the bivalent cohort of the study, and 86% and 90%, respectively, for the two monovalent cohorts of the study. There was no interference observed in the bivalent arm of the study. The Phase 1b norovirus bivalent vaccine trial enrolled a total of 80 subjects. After enrollment of an open-label sentinel GII.4 group of 5 subjects, the remaining 75 subjects were randomized in a blinded manner to one of 4 treatment groups: 15 subjects in each monovalent group received an oral 5x1010 I.U. dose of either the norovirus GII.4 or GI.1 vaccine, 30 subjects in the bivalent group received a 5x1010 I.U. dose of both the norovirus GII.4 and GI.1 vaccine administered concurrently, and 15 subjects received placebo tablets. The trial was designed to evaluate safety, immunogenicity and interference of Vaxart's oral bivalent norovirus vaccine by comparing the bivalent vaccine group to the two monovalent vaccine groups, as well as the placebo group.

08:06 EDT Metropolitan Bank appoints Imran Riaz as Chief Credit Risk Officer - Metropolitan Bank announced that it has appointed Imran Riaz as its new Senior Vice President and Chief Credit Risk Officer following the retirement of Karen Rojeski, Executive Vice President and Chief Credit Risk Officer of the Bank, which became effective on September 20. Rojeski will remain with the Bank as a consultant to assist with the transition through December 31. Most recently, Riaz served as a Risk and Analytics Consultant at Paras Consulting since October 2016 where he developed credit policy, credit rating models, automating risk rating systems and helped prepare banks to comply with CECL requirements.

08:05 EDT CACI awarded four-year, $197M task order to support aircraft flight operations - CACI announced it has been awarded a more than four-year task order, with a ceiling value of $197M, to support the U.S. Army Fixed Wing Project Office's special electronic mission aircraft flight operations worldwide. Under the task order, CACI will use its technical and training solutions for operational mission support to provide 24/7 surveillance and reconnaissance assistance to U.S. and NATO forces deployed abroad. Awarded under the RS3 contract vehicle, the work represents new work for CACI.

08:03 EDT electroCore anoounces FDA request for more information on 510(k) submission - electroCore announced that the U.S. Food and Drug Administration has requested more information and analysis of the clinical data included in the Company's premarket notification, or "510(k)" submission, seeking an expanded indication for the use of gammaCore. Although the Company has 180 days to respond to FDA's request, the Company expects to meet with the FDA in the fourth quarter to discuss the information request. gammaCore is currently FDA-cleared for the treatment of pain associated with episodic cluster headache and migraine headache, and adjunctive use for the prevention of cluster headache. The data submitted in the 510(k) include the results of the Premium 1 study, a randomized, double-blind, sham-controlled trial of gammaCore recently published in the journal Cephalalgia. Premium 2 is a randomized, double-blind, sham-controlled clinical trial of gammaCore for the prevention of migraine being conducted at approximately 30 sites in the United States. Premium 2 was designed to support an expanded FDA clearance and the commercialization and reimbursement of gammaCore(TM) Currently, the enrollment in Premium 2 is nearing 50% of its target of approximately 400 subjects, and recruitment is expected to conclude in the first half of 2020.

08:02 EDT Catabasis Pharmaceuticals appoints Andrew Komjathy Chief Commercial Officer - Catabasis Pharmaceuticals announced that it has named Andrew Komjathy as Chief Commercial Officer. Komjathy brings to Catabasis more than 30 years of experience in commercial operations and sales including extensive experience in rare diseases. He was most recently Vice President, Commercial Sales at Alkermes.

08:00 EDT AzurRx BioPharma trading resumes

07:41 EDT Altria Group CEO says 'could not reach agreement' with Philip Morris - Altria Group (MO) announced that merger discussions with Philip Morris (PM) have ended. "While we believed the creation of a new merged company had the potential to create incremental revenue and cost synergies, we could not reach agreement," said Howard Willard, Altria's Chairman and CEO. "We look forward to continuing our commercialization of IQOS in the U.S. under our existing arrangement."

07:35 EDT AzurRx BioPharma announces results from Phase 2 trial with MS1819 - AzurRx BioPharma announced positive safety results from its Phase II OPTION Clinical Trial of MS1819 for the treatment of exocrine pancreatic insufficiency in cystic fibrosis. Results showed that the primary efficacy endpoint of coefficient of fat absorption was comparable to the CFA in a prior phase 2 study in patients with chronic pancreatitis, while using the same dose of MS1819. The dose used in both studies was 2 gram/day, which was selected in agreement with FDA as a bridging dose. Although the study was not powered for statistical significance, the data also demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFAs high enough to reach non-inferiority with porcine enzyme replacement therapies. Also, coefficient of nitrogen absorption was comparable between the MS1819 and PERT arms, 93% vs. 97%, respectively, in the OPTION trial. This important finding confirms that protease supplementation is not likely to be required with MS1819 treatment. The Phase II OPTION trial was an open-label, crossover study, conducted in 14 sites in the U.S. and Europe. Patients were first randomized to either the MS1819 arm, where they received a 2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they received their pre-study dose of PERT for three weeks. After three weeks, stools were collected for analysis, and patients were then crossed over to another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were collected again for analysis. Patients were then followed for an additional two weeks for post study safety observation. A total of 32 patients, ages 18 years or older, completed the study. Topline data compared the CFA of the MS1819 treatment phase, 56%, to the CFA of the PERT treatment phase, 86%. In addition, CNAs were 93% in the MS1819 group, compared to 97% in the PERT group. Of note, MS1819 contains no protease. Safety in the OPTION trial was excellent, with no severe adverse events and few overall adverse events. Based upon prior communications with FDA, the Company is planning to meet with the agency before year-end to discuss a Phase IIb/III trial design exploring the use of higher doses and/or enteric-coated capsules to ensure higher MS1819 activity in the duodenum.

07:35 EDT Juul Labs to suspend all broadcast, print, digital advertising in the U.S.

07:34 EDT T2 Biosystems enters distribution agreement for rapid diagnostic technologies - T2 Biosystems announced that it entered into an exclusive distribution agreement that allows the Company to introduce its rapid diagnostic technologies, including the T2Bacteria and T2Candida Panels, in Puerto Rico and the U.S. Virgin Islands, which have approximately 64 hospitals that could benefit from T2's products. T2 Biosystems is the company behind the T2Bacteria Panel, which was the first in-vitro diagnostic test to receive approval for a New Technology Add-on Payment by the United States Centers for Medicare & Medicaid Services. The panel is the only FDA-cleared test to identify sepsis-causing bacterial pathogens directly from whole blood without the need to wait for blood culture, and its counterpart for fungal bloodstream infections is the T2Candida Panel, the first and only FDA-cleared direct-from-whole blood diagnostic for detection of fungal pathogens that are associated with sepsis. Both panels provide results in three to five hours instead of days. The products are two of several panels that are approved or in development that are run on the Company's T2Dx Instrument, which is powered by miniaturized magnetic resonance technology. The distribution agreement follows the recent announcement that T2 Biosystems has been awarded a milestone-based contract of initial value of $6M with a potential value of up to $69M, if all contract options are exercised, from the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

07:33 EDT Juul Labs says CEO Kevin Burns to step down

07:32 EDT Philip Morris, Altria Group end merger talks - Philip Morris (PM) announced that merger discussions with Altria Group (MO) have ended. Andre Calantzopoulos, CEO of PMI, said: "After much deliberation, the companies have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future."

07:30 EDT Philip Morris, Altria Group end merger talks

07:25 EDT AzurRx BioPharma trading halted, news pending

07:13 EDT KVH Industries receives $6.7M in orders for TACNAV tactical navigation systems - KVH Industries announced that it has received two orders totaling $6.7M for its fiber optic gyro-based TACNAV tactical navigation systems for use by military customers. Revenue from one of these orders will be completed in 2019; revenue from the other order is expected to begin in the fourth quarter of 2019 and continue through 2021.

07:11 EDT Rhythm Pharmaceuticals to provide update on R&D programs - Rhythm Pharmaceuticals will announce an update on its Research & Development programs, genetic sequencing efforts and patient finding initiatives at its R&D event in New York City. Rhythm has been collaborating with partners to advance its own initiatives to sequence individuals living with early-onset, severe obesity to uncover more rare genetic disorders of obesity, and develop a better understanding of those disorders currently under study in its pivotal trials and Phase 2 Basket Study. As of June 2019, the Company collected samples from 13,567 individuals with severe obesity, and those samples have yielded 11.7 percent, or 1,584 genetically-identified individuals, who have a rare genetic variant of the MC4R pathway and who may be eligible for inclusion in Rhythm's Phase 2 Basket Study or Rhythm's pivotal Phase 3 trials. Rhythm's genetic sequencing results have identified samples from 29 patients with POMC or LEPR deficiency obesity. This result supports that these conditions are ultra-rare, even among the portion of the population with severe, early-onset obesity. These results are consistent with Rhythm's clinical epidemiology estimates of 100-500 POMC deficiency obesity and 500-2,000 LEPR deficiency obesity patients living in the U.S. Additionally, Rhythm believes the sequencing yield in this cohort supports the Company's prior estimates of greater than 20,000 people living with high-impact heterozygous obesity of the POMC, PCSK1 or LEPR genes in the U.S. Rhythm provided an update on data from its Phase 2 Basket Study of setmelanotide in patients with BBS and Alstrom syndrome. As previously disclosed in January 2019, six of nine enrolled patients with BBS showed weight loss of greater than 10 percent on setmelanotide treatment. As of August 2019, all of these patients either continued to maintain, or increased, their weight loss following approximately two years of treatment, with a mean weight reduction of 22.2 percent. Additionally, five of six patients continued to show a substantial decrease in hunger from baseline. In patients with Alstrom syndrome, the three patients on treatment at the Company's last update in November 2018 have continued on treatment. One of these patients has demonstrated 20 percent weight loss and a 25 percent reduction in hunger score at greater than one year. One patient has not lost weight but has demonstrated a 38 percent decrease in hunger and improved diabetes control at greater than one year, and the third patient achieved 6 percent weight loss without a change in hunger. All three patients plan to continue setmelanotide therapy in the long-term extension trial.

07:07 EDT Equitrans Midstream, EQT Midstream Partners oppose EPA methane rollback - Equitrans Midstream (ETRN) and EQM Midstream Partners (EQM) support the U.S. oil and gas industry's ongoing efforts to reduce methane emissions and; therefore, respectfully oppose the U.S. Environmental Protection Agency's, or EPA, proposed rollback of methane regulations. ETRN and EQM acknowledge that it is not enough to achieve regulatory compliance on methane emissions in order to address the global impacts of climate change. They proactively pursue the implementation of best practices and recognize that reducing their overall carbon footprint and mitigating their operational impact is imperative for the sustainability of the environment, their communities and their business. As a member of the Interstate Natural Gas Association of America, or INGAA, ETRN and other member companies work with regulators to ensure that natural gas pipelines, compressor stations and storage facilities are designed and built safely and operate in ways that minimize methane emissions. ETRN and EQM currently utilize various methane mitigation methods across their operations and are evaluating additional enhancement and mitigation efforts, such as: expansion of the Leak Detection and Repair, or LDAR, program; pneumatic controller upgrades; recompression of pipeline gas prior to maintenance procedures and upgrading existing stations with air or electric starts.

07:04 EDT Achillion receives breakthrough therapy designation from FDA for Danicopan - Achillion Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for danicopan for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria who are sub-optimal responders to a C5 inhibitor alone. The FDA's decision was based on positive safety and efficacy data from the ongoing danicopan Phase 2 PNH combination trial. Interim data was reported at the New Era of Aplastic Anemia and PNH Meeting in May 2019. The top line data from this combination trial is expected in the fourth quarter of 2019. "The FDA's granting of Breakthrough Therapy designation for our lead oral factor D inhibitor, danicopan, underscores the urgent need for new treatment options for patients living with PNH," said CEO Joe Truitt. "Danicopan, with its demonstrated ability to limit both intravascular and extravascular hemolysis with oral administration, has the potential to benefit a significant number of patients with PNH that continue to have an unmet medical need on standard of care. We appreciate the review and decision by the FDA and plan to work closely with the Agency in advancing the development of danicopan into Phase 3 in early 2020."

07:02 EDT Trillium Therapeutics appoints Jan Skvarka as president, CEO - Trillium Therapeutics announced the appointment of Jan Skvarka as president and CEO. Skvarka has also been appointed to the Board of Directors of the company. Before joining Trillium, Skvarka was president and CEO of Tal Medical. Effective September 25, 2019, the Board of Directors adopted the Trillium Therapeutics Inc. 2019 Inducement Stock Option Plan, or the 2019 Inducement Plan, under which Trillium may grant inducement equity awards outside of Trillium's current stockholder-approved stock option and incentive plans. The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Trillium as an inducement material to such individual's entering into employment with Trillium in accordance with Nasdaq Listing Rule 5635(c)(4). In connection with the appointment of Skvarka as CEO, the Board of Directors has granted to Mr. Skvarka an option to purchase 1,800,000 common shares under the 2019 Inducement Plan at an exercise price equal to the closing market price of Trillium's common shares on September 24, 2019. One quarter of the stock options vest 12 months after the date of grant and 1/48th of the remaining options vest each month for the following three years, subject to his continued service with Trillium on such vesting dates. Other terms of the stock option grant are as determined by the Board of Directors and set forth in the 2019 Inducement Plan and applicable award agreement covering such grant.

06:59 EDT VF Corp. provides fiscal 2024 strategic growth plan - VF Corporation is hosting a meeting with investors and analysts in Beaver Creek, Colo., to provide an update to the company's strategic growth plan and key initiatives to deliver long-term sustainable growth and value creation. VF's fiscal 2024 strategic growth plan is an evolution of its 2021 strategic growth plan announced at the 2017 meeting with investors in Boston. The updated five-year growth plan focuses on a slightly modified set of strategic choices. These choices begin with the foundation: 1) transforming into a consumer-minded and retail-centric enterprise in a hyper-digital manner, followed by: 2) driving and optimizing the portfolio; 3) distorting investments to Asia; and, 4) elevating direct channels, while prioritizing digital. Fiscal 2024 financial targets: Revenue through fiscal 2024 is expected to grow at a five-year compounded annual growth rate between 7%-8%, fueled by VF's largest brands and the company's International and Direct-to-Consumer business platforms. Gross margin is expected to exceed 55.5% in fiscal 2024. Operating margin is expected to exceed 15% in fiscal 2024. Earnings per share is expected to grow at a five-year CAGR of between 12%-14% as compared to fiscal 2019 adjusted EPS. The company expects to generate approximately $8B of free cash flow on a cumulative basis between fiscal 2020 and fiscal 2024 and intends to return $10B to shareholders through dividends and share repurchases. VF expects to deliver annual total shareholder return in the 14%-16% range. As part of the Investor Day event, VF is introducing an evolved corporate logo and branding, the company's first such update in 21 years.

06:50 EDT Nacco Industries subsidiary to act as contract miner for Nevada lithium project - Nacco Industries (NC) announced that a subsidiary has entered into a mining agreement to serve as exclusive contract miner for the Thacker Pass lithium project in northern Nevada. Thacker Pass is believed to be the largest known lithium deposit in the U.S. and is 100% owned by Lithium Nevada, a wholly owned subsidiary of Lithium Americas (LAC). The North American Coal Corporation formed a wholly owned subsidiary, Sawtooth Mining, for this project. Sawtooth will design, construct, operate, and maintain the Thacker Pass surface mine, which will supply Lithium Nevada's lithium-bearing claystone ore requirements. The mining agreement provides that Lithium Nevada will reimburse Sawtooth for its operating and mine reclamation costs, and pay Sawtooth a management fee per ton of lithium delivered during the 20-year contract term. During the development of the project, Sawtooth will provide Lithium Nevada $3.5M in cash to assist in project development and provide certain engineering services related primarily to mine design and permitting. Lithium Nevada will pay Sawtooth a success fee upon achievement of certain engineering, construction and production milestones. After Lithium Nevada secures required permits and financing for the project, Sawtooth intends to invest up to $50M on the initial fleet of mining equipment. Lithium Nevada will reimburse Sawtooth's equipment investment over a seven-year period from the equipment acquisition date. Lithium Nevada estimates that it will secure all major permits by the end of 2020, commence plant construction in 2021 and commence production of lithium products in 2023.

06:30 EDT Best Buy says targeting $1B of additional cost cuts by 2025

06:12 EDT Jabil announced repurchase program up to $600M of shares - Jabil yesterday morning announced that its board has authorized a share repurchase program of up to $600M in company common stock. The company said the move was part of its two-year capital allocation framework.

06:11 EDT Novartis says 'understands the FDA's concerns'

06:07 EDT ThyssenKrupp board seeks to oust CEO Guido Kerkhoff - The Personnel Committee of the Supervisory Board of thyssenkrupp AG said in a statement htat it recommends to the Supervisory Board to start negotiations to end the Board mandate of Guido Kerkhoff shortly. After the ending of Guido Kerkhoff's Board mandate, Martina Merz shall be delegated as Chairwoman into the Executive Board on an interim basis - for a duration of not more than 12 months, it said. Additionally, the Personnel Committee recommends to the Supervisory Board to appoint Dr. Klaus Keysberg effective October 1st 2019 as an additional Member of the Executive Board of thyssenkrupp AG responsible for the Business Areas Materials Services and Steel Europe. Further, the Executive Committee of the Supervisory Board of thyssenkrupp AG recommends to the Supervisory Board to elect Professor Dr. Siegfried Russwurm as Chairman of the Supervisory Board as interim successor of Martina Merz - also for a duration of not more than 12 months - upon her delegation as Chairwoman to the Executive Board.

06:03 EDT Best Buy targets FY2025 enterprise revenue of $50B - Best Buy will host an investor update this morning to highlight the progress it has made on its Building the New Blue growth strategy, detail how it plans to move forward with the strategy and discuss the company's long-term financial outlook. To support its Building the New Blue: Chapter Two strategy, Best Buy will invest to drive top- and bottom-line growth while remaining committed to continuing to create efficiencies that help fund these investments and offset potential pressures. Best Buy is setting financial targets for fiscal 2025: Enterprise revenue of $50B, which compares to the company's current fiscal 2020 guidance of $43.1B-$43.6B; Non-GAAP operating income rate of 5.0%, which compares to the company's current fiscal 2020 guidance of flat to slightly up from fiscal 2019's 4.6% non-GAAP operating income rate; $1B of additional cost reductions and efficiencies. Best Buy CFO Matt Bilunas commented, "In this next chapter, our focus continues to be top-line growth. We also believe the initiatives we will outline today, along with a continued focus on cost reductions, will result in operating income rate expansion over the five-year timeframe."

05:58 EDT KBR awarded two contract modifications totaling about $40M - KBR announced that it was awarded two contract modifications totaling almost $40M to upgrade remote tracking stations in the Air Force Satellite Control Network, or AFSCN. The U.S. Air Force Space Command Space and Missile Systems Center awarded these firm fixed price modifications under the existing Hybrid Remote Tracking Station Block Change Contract. KBR was awarded the RBC Hybrid contract in February 2013.

05:21 EDT PG&E to initiate second public safety shutoff in CA - Pacific Gas and Electric Company (PG&E) has been monitoring weather forecasts hourly and has determined a second Public Safety Power Shutoff (PSPS) is necessary for approximately 48,200 customers in the North Bay and Sierra Foothill regions due to continued hot, dry and windy weather conditions. For this second PSPS event, based on elevated weather conditions, including potential fire risk, PG&E will be turning off the power for safety at approximately 2:30 a.m. in the Sierra Foothills, and in the North Bay at approximately 4:30 a.m., both Wednesday. Windy weather conditions are expected to last until 12:00 p.m. on Wednesday, Sept. 25. Wednesday's PSPS event will include 48,200 customers in portions of seven counties: Butte, Napa, Nevada, Placer, Plumas, Sonoma and Yuba. Based on PG&E's established protocols and procedures, PG&E initiated a Public Safety Power Shutoff on Monday, Sept. 23 at 5:00 p.m. impacting approximately 24,000 customers. "Essentially all customers included in Monday's PSPS event were restored today, Tuesday, Sept. 24, as of 6:00 p.m. During the inspection process, four incidents of weather-related equipment damage were identified. Hundreds of PG&E personnel and aerial resources are standing by and ready to respond for inspections, repairs and restoration once the weather subsides. Those crews conducted safety patrols today following Monday's PSPS and have restored power to essentially all customers impacted by the first event. After the dry and windy weather has passed and it is safe to do so, PG&E crews will work to visually inspect each mile of our power lines to ensure they are free from damage and safe to energize. Inspections will take place during daylight hours and, in most cases, we would expect to be able to restore power within 24 to 48 hours after the dry and windy weather has passed. However, depending on weather conditions or if any repairs are needed, outages (weather event plus restoration time) could last longer than 48 hours. For planning purposes, we suggest customers prepare for multiple-day outages."