Stockwinners Market Radar for April 03, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:16 EDT Tesla reports Q1 deliveries of 63K vehicles, up 110% y/y, down 31% q/q - Deliveries were approximately 63,000 vehicles, which was 110% more than the same quarter last year, but 31% less than last quarter. This included approximately 50,900 Model 3 and 12,100 Model S and X. The company states: "Due to a massive increase in deliveries in Europe and China, which at times exceeded 5x that of prior peak delivery levels, and many challenges encountered for the first time, we had only delivered half of the entire quarter's numbers by March 21, ten days before end of quarter. This caused a large number of vehicle deliveries to shift to the second quarter. At the end of the first quarter, approximately 10,600 vehicles were in transit to customers globally. Because of the lower than expected delivery volumes and several pricing adjustments, we expect Q1 net income to be negatively impacted. Even so, we ended the quarter with sufficient cash on hand. Despite pull forward of demand from Q1 2019 into Q4 2018 due to the step down in the federal tax credit, US orders for Model 3 vehicles significantly outpaced what we were able to deliver in Q1. We reaffirm our prior guidance of 360,000 to 400,000 vehicle deliveries in 2019. Given that Tesla vehicle production currently occurs entirely from one factory in the San Francisco Bay Area, but must be delivered to customers all around the world, production could be significantly higher than deliveries, as it was this quarter, when production exceeded deliveries by 22%. Our net income and cash flow results will be announced along with the rest of our financial performance when we announce Q1 earnings. Our delivery count should be viewed as slightly conservative, as we only count a car as delivered if it is transferred to the customer and all paperwork is correct. We count a produced but undelivered vehicle to be in transit if the related customer has placed an order or paid the full purchase price for such vehicle. Final numbers could vary by up to 0.5%. "

19:42 EDT PG&E names Bill Johnson as new CEO and 10 new board directors - PG&E announced the appointment of William "Bill" Johnson as Chief Executive Officer and President and the appointment of 10 new directors to its board. The board appointments will be effective as of the next in-person meeting, which will be held as soon as practicable. The significant changes in leadership reflect PG&E's focus on strengthening its safety culture and operational effectiveness and successfully navigating the Company's Chapter 11 process. Bill Johnson is concluding a more than six-year tenure as President and CEO of the Tennessee Valley Authority, with responsibility for leading the nation's largest publicly owned utility in its mission of providing energy, environmental stewardship and economic development across a seven-state region. Effective as of the next in-person board meeting, which will be held as soon as practicable, Richard Barrera, Jeffrey Bleich, Nora Mead Brownell, Cheryl Campbell, Michael Leffell, Kenneth Liang, Dominique Mielle, Meridee Moore, Kristine Schmidt and Alejandro Wolff will join continuing PG&E directors Fred Fowler, Richard Kelly and Eric Mullins on the board. In connection with these appointments, the remaining directors will be stepping down from the board at that time. The members of the newly constituted board will elect a new Chair of the board and determine committee assignments. All PG&E directors, including the newly appointed directors, will stand for election at the Annual Meeting, scheduled for May 21, 2019. In addition, Bill Johnson will stand for election as a fourteenth director at the upcoming Annual Meeting. Abrams Capital Management, Knighthead Capital Management and Redwood Capital Management engaged in discussions with PG&E's board and management as part of PG&E's CEO selection and board refreshment process and have expressed support for the new CEO and the new board.

19:23 EDT Tesla rolls out latest version of Navigate on Autopilot - Tesla said that, starting today, it is beginning to roll out its latest version of Navigate on Autopilot for "a more seamless active guidance experience." In this new version, drivers will now have the option to use Navigate on Autopilot without having to confirm lane changes via the turn stalk, the car maker said. In the Autopilot settings menu, a driver can press the Customize Navigate on Autopilot button which will now display three additional settings - Enable at Start of Every Trip, Require Lane Change Confirmation, and Lane Change Notification. Through the Enable at Start of Every Trip setting, Navigate on Autopilot can be set to automatically turn on each time a driver enters a navigation route. Once enabled, anytime a driver is on a highway and uses Autopilot with a location plugged into the navigation bar, the feature will be on by default. If a driver selects 'No' to Require Lane Change Confirmation, lane changes will happen automatically, without requiring a driver to confirm them first. Drivers can elect to get notified about an upcoming lane change by receiving an audible chime as well as a default visual prompt. Additionally, all cars made after August 2017 will also have the option to have their steering wheel vibrate for the alert as well, Tesla added. "Through our internal testing and Early Access Program, more than half a million miles have already been driven with the lane change confirmation turned off," the company said. "Our team consistently reviews data from instances when drivers took over while the feature has been in use, and has found that when used properly both versions of Navigate on Autopilot offer comparable levels of safety. We've also heard overwhelmingly from drivers in our Early Access Program that they like using the feature for road trips and during their daily commutes, and we're excited to release the option to the rest of the Tesla family." The car maker added that these new settings will be available to customers who have purchased Enhanced Autopilot or Full Self-Driving Capability. They will begin to roll out today via an over-the-air software update to customers in the U.S., and will be introduced in other markets in the future pending validation and regulatory approval. Reference Link

19:01 EDT MediciNova receives notice of allowance for new patent covering MN-001 - MediciNova, Inc. announced that it has received a Notice of Allowance from the Chinese Patent Office for a pending patent application which covers MN-001 for the treatment of hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia. Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2034. The allowed claims cover the use of MN-001 for reducing a triglyceride blood level, the use of MN-001 for reducing a total cholesterol blood level, and the use of MN-001 for reducing a low density lipoprotein blood level. The allowed claims cover oral administration including liquid and solid dosage forms. Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. commented, "We are very pleased to receive notice that this new patent will be granted and we believe it could substantially increase the potential value of MN-001. Although we have an existing patent that covers the polymorphic form of MN-001 in China, this will be the first method of use patent granted in China for MN-001. We have recently been granted two patents which cover MN-001 for hypertriglyceridemia, hypercholesterolemia and fibrotic diseases in Japan. With these three new patents, we are planning to expand our development efforts in Asia."

18:45 EDT Dominion CEO: There are no plans to cut the dividend - In an interview on CNBC's Mad Money, Dominion CEO Tom Farrell said: We are looking at slowing the rate of the dividend starting next year... There has been no debate about cutting the dividend... We've cut our carbon emissions by 50%.

18:02 EDT Red Robin sees Q1 SSS down 3.6% - As part of its CEO transition announcement earlier, Red Robin's newly appointed interim CEO Pattye Moore stated: "Through the first three periods of the fiscal first quarter ending March 24, 2019, comparable restaurant revenue, using constant currency rates, has decreased 3.6%. This reflects, in part, the challenging weather that affected several regions of the US. The weather impact for these periods, estimated to be 100 to 150 basis points, primarily drove sales performance below our expectations."

17:44 EDT Broadcom VP Kirsten Spears sells over $1.2M in company shares - Broadcom VP Kirsten Spears disclosed in a filing that she had sold 4,000 shares of company stock at an average price of $306.31 on April 1, for a total transaction value of $1,225,224.

17:40 EDT Alex Dillard reports 5.1% passive stake in Dillard's - In a regulatory filing, Alex Dillard disclosed a 5.1% stake in Dillard's, which represents about 1.1M shares. The filing does not allow for activism.

17:33 EDT GrainCorp to sell Australian Bulk Liquid Terminals business to ANZ for $350M - GrainCorp announced it has entered into an agreement to sell its Australian Bulk Liquid Terminals business to ANZ Terminals for a total enterprise value of approximately $350M. The Australian Bulk Liquid Terminals business was acquired by GrainCorp in 2012 as part of the acquisition of Gardner Smith. It operates eight liquid terminals sites across Australia, with a combined storage capacity of approximately 211,000m. The sites specialize in the storage and handling of bulk liquid fats & oils, fuels and chemicals for a range of customers, including GrainCorp Oils. As part of the transaction, GrainCorp Oils will enter into a long-term storage agreement with ANZ Terminals. Reference Link

17:22 EDT Asur reports total March passenger traffic up 7.4% - ASUR announced that total passenger traffic for March 2019 increased 7.4% when compared to March 2018. Passenger traffic rose 3.2% in Mexico, 16.4% in Puerto Rico and 15.4% in Colombia. The recovery in passenger traffic at San Juan Airport, Puerto Rico reflects the impact of Hurricane Maria, which hit the island on September 21, 2017.

17:11 EDT FMR reports 7.624% passive stake in Precision BioSciences - In a regulatory filing, FMR disclosed a 7.624% stake in Precision BioSciences, which represents about 2.45M shares. The filing does not allow for activism.

17:01 EDT West Pharmaceutical opens new sales office in Korea - West Pharmaceutical announced it has expanded its presence in the Asia Pacific region with a new sales office in Korea-West Pharmaceutical Services Korea Ltd. This new office is the result of West's purchase of the distribution business of GIS Korea Ltd, a privately-owned medical device and healthcare products distributor serving the Korean market, who previously served as West's distributor in the region.

16:42 EDT ServiceSource replies to activist investor Cannell Capital's advice to sell firm - ServiceSource issued the following statement in response to the Schedule 13D filed by Cannell Capital and affiliated entities: "ServiceSource welcomes open communication with all its stockholders and values any input and suggestions that may advance our goal of enhancing stockholder value. Members of our Board and management have had constructive discussions with Cannell and we expect to continue that dialogue moving forward." " Late Tuesday, Cannell, a 6.75% active stake holder in ServiceSource, filed a schedule 13D filing as to ServiceSource International to reflect its opinion that repairing the company will be too hard and take too long. This owner, and we suspect other injured owners would be better served by the company immediately launching a process to sell the business.

16:38 EDT Univar settles saccharin DOJ case with $62.5M payment - Univar announced it has paid down debt following the recently completed divestiture of Nexeo's plastics business. Separately, the company has reached an agreement to settle a previously disclosed case with the United States Department of Justice, or DOJ, regarding saccharin. Univar divested its plastics distribution business to an affiliate of One Rock Capital Partners for $640M, subject to customary closing adjustments. Cash proceeds of the transaction were applied to outstanding debt balances. Additionally, Univar Solutions reached a settlement agreement in a previously disclosed case with the DOJ regarding entries of saccharin that allegedly transshipped from the People's Republic of China through Taiwan and entered into commerce of the United States between 2007 and 2012. Under the settlement, Univar agreed to pay $62.5M to fully resolve the matter. The company does not admit any liability and the DOJ will dismiss the complaint in its entirety.

16:34 EDT Triumph Group, IAI agree on transition for G280 aircraft wing production - Triumph Group announced that its Aerospace Structures business unit executed an agreement with its customer, Israel Aerospace Industries, Ltd, or IAI, for the transition of the manufacture of wings for the G280 aircraft. The two parties cooperatively developed detailed transition plans to enable a seamless transition of work. Triumph's contract with IAI will terminate upon completion of the transition of work. Transition activities will commence immediately. Triumph Aerospace Structures has delivered 105 G280 wings since taking over the wing program from Spirit AeroSystems in 2015.

16:31 EDT Snap-On acquires Power Hawk Technologies for $8M in cash - Snap-on announced that it has acquired Power Hawk Technologies for approximately $8M in cash. Based in Rockaway, New Jersey, Power Hawk designs, manufactures and distributes rescue tools and related equipment for a variety of military, governmental, and fire, rescue and emergency operations. Power Hawk will be part of the company's Commercial & Industrial Group.

16:26 EDT Compass Minerals reaches three-year labor pact with Cote Blance mine workers - Compass Minerals announced that a new collective bargaining agreement has been ratified by its Cote Blanche mine employees represented by USW Local 14425. The three-year agreement includes pay rate and benefit enhancements to be more consistent with other U.S.-based Compass Minerals employees as well as features that provide greater operational flexibility for the company.

16:16 EDT DowDuPont announces plans for reverse stock split - DowDuPont announced that its Board of Directors has approved a reverse stock split of the company's common stock. The reverse stock split is intended to increase the market price of DowDuPont's common stock in connection with the company's intended distribution of all of the shares of common stock of its wholly owned subsidiary, Corteva, which holds the company's Agriculture Business, to the holders of the company's common stock on a pro rata basis. The reverse stock split is subject to stockholder approval. If approved, the company expects to implement the reverse stock split effective immediately following the Corteva Distribution.

16:14 EDT Landec sees overall gross margin to increase in FY20 - "For fiscal 2020, revenues and operating income are expected to increase at both Lifecore and Curation Foods compared to fiscal 2019. The growth at Lifecore will continue to be driven by the expansion of its CDMO and HA product development pipeline. The growth in Curation Foods will primarily be coming from a full year of avocado product sales and continued growth in the guacamole category. We also expect our overall gross margin to increase in fiscal 2020 based on the progress in our strategy to drive revenue growth from the change in our product mix to higher margin products. We will share our fiscal 2020 guidance in our fiscal 2019 year end results release in late July and provide growth projections for both Lifecore and Curation Foods in the release," concluded management.

16:10 EDT Claudia Bugno withdraws from STMicroelectronics supervisory board appointment - STMicroelectronics announced that Claudia Bugno, who was proposed to become a new member of the company's supervisory board at its upcoming Annual General Meeting of Shareholders scheduled for May 23, has informed the company that she is no longer available for appointment to its supervisory board. The company will announce an alternative proposed member in due course.

16:05 EDT Sonos names Brittany Bagley as new CFO - Sonos announced that Brittany Bagley will join the company's executive management team as its new Chief Financial Officer, effective April 22, 2019. Bagley replaces current CFO Mike Giannetto who will retire in June, after ensuring an orderly transition. Bagley was previously a Managing Director at global investment firm KKR & Co., where she has held various roles on the technology, media, and telecom private equity team since 2007.

16:03 EDT Amtech Systems to divest solar businesses, focus on semiconductor businesses - Amtech Systems has decided to focus solely on growth opportunities in the company's semiconductor and SiC/LED polishing businesses and intends to sell the company's solar businesses, including its Tempress and SoLayTec subsidiaries. The strategic streamlining is meant to position Amtech to invest in the three semiconductor value chains in which it operates, stop solar losses and enhance the cCompany's cash flow and earnings growth profile, and capture high value for its investments.

16:02 EDT Resources Connection names Tim Brackney COO - Resources Connection announced the appointment of Tim Brackney as President and Chief Operating Officer. "Today, I am delighted to announce the appointment of Tim Brackney as RGP's President and Chief Operating Officer, effective immediately," said CEO Kate Duchene. "Having previously served as the President of North America, Tim moves into this role to drive and align our growth and Go-To-Market strategies across the globe. Tim is an accomplished operator with tremendous work ethic and business acumen. I am excited to embrace the opportunities ahead with Tim as a trusted and valued senior leader."

13:51 EDT FBI reports 2.64M NICS firearm background checks in March - The FBI reported that there were 2,644,851 firearm background checks initiated through the NICS system in March 2019. This compares to 2,767,699 checks in March of 2018 and 2,053,886 in February 2019. Companies in the gun space include Sturm, Ruger (RGR), American Outdoor Brands (AOBC), and Vista Outdoor (VSTO). Reference Link

12:54 EDT M&G Investments asks fthat four new directors be appointed to Methanex board

12:53 EDT M&G Investments sends letter to Methanex shareholders - M&G Investments, the investment manager of approximately 16.5% of the shares of Methanex Corporation, released the following open letter to its fellow shareholders: "Our public engagement regarding Methanex has been focused on our concerns related to capital allocation and corporate governance - namely the Company's risk profile and the Board's oversight of management. This focus has not changed. Neither has our approach: we continue to believe that Methanex and its shareholders would benefit greatly from the addition of new, independent perspectives to the Board... The dynamic on the Board needs to change. Electing our four nominees that we have put forth would improve this dynamic by adding real independence, as well as specific skill-sets and expertise - in the areas of governance, finance and commodities - that will prove valuable... M&G is not pushing for the removal of CEO John Floren. To be clear, we support investment in further capacity, but we do not support taking on undue risk that would make Methanex extraordinarily dependent on the price of methanol. Our nominees will offer meaningful help to the CEO. We are not trying to micromanage the CEO's operational decisions - rather, we are pushing for a Board that exercises more active oversight of management and risk."

12:35 EDT Nielsen strength attributed to blog report on takeover deal nearing - Nielsen Holdings shares are up $1.25, or 5%, to $25.50 in early afternoon trading after Street Insider said that a source told it that the company is "nearing a deal to be acquired by a private equity group in the lows $30s." Two private equity groups submitted final bids and a deal will "likely be announced in the next week or two," the source said, according to Street Insider.

12:00 EDT Irsa Inversiones y Representaciones SA falls -5.5% - Irsa Inversiones y Representaciones SA is down -5.5%, or -59c to $10.18.

12:00 EDT PIMCO High Income Fund falls -5.9% - PIMCO High Income Fund is down -5.9%, or -47c to $7.46.

12:00 EDT TIM Participacoes trading resumes

12:00 EDT China Eastern Airlines rises 17.2% - China Eastern Airlines is up 17.2%, or $6.24 to $42.48.

11:47 EDT Cinedigm Entertainment Group president Sondheim exits as company focus evolves - Cinedigm announced leadership changes within the company's Content Entertainment Group to reflect the company's evolving focus on digital streaming and content aggregation following its recent announcement to acquire Future Today, a leading OTT streaming video platform. Bill Sondheim, the President of Cinedigm Entertainment Group, will be leaving Cinedigm to pursue outside entrepreneurial opportunities. He will continue to provide the company with consulting services. Current Content Entertainment Group Executive Vice President Yolanda Macias and Senior Vice President Dan Coyle will now lead that group, leveraging their combined 50+ years of industry experience and leadership. These moves continue the company's efforts to streamline corporate structure and enhance management effectiveness and synergy.

11:43 EDT PPG announces price increase on automotive refinish products in China - PPG announced that it has implemented a price increase for its automotive refinish products in China. The change was effective April 1 and impacts automotive refinish coatings products in China, as contracts permit. In recent years, PPG has experienced significant cost increases in many areas especially raw materials, logistics and freight. "We have tried to offset rising costs through cost-control measures where possible, but the cumulative effect is having a significant impact on our business," said Pauline Yuen, PPG vice president, automotive refinish coatings, Asia. "We must increase our prices so we can continue to offer exceptional products and services to support the success of our customers." PPG will communicate details of the price increase directly to customers.

11:37 EDT Emerson to invest $49M to build new global headquarters for Branson line - Emerson announced a strategic investment of $49M to build a new global headquarters in Brookfield, Conn., for its Branson assembly technologies product line. The new facility will include laboratories, offices, manufacturing space and a customer experience center. Emerson has purchased a 13-acre parcel in Brookfield's Berkshire Industrial Park, less than two miles from the existing Danbury headquarters and has received local approvals to build on the site. Groundbreaking for the construction of the new facility is currently scheduled for June 2019. The new 140,000-square-foot building will house the 220 professional staff, engineers and production team in the current headquarters. Emerson expects to open its new assembly technologies headquarters in late 2020.

11:10 EDT Verizon turn on 5G Ultra Wideband Network in Minneapolis and Chicago areas - Verizon announced that it has turned on its 5G Ultra Wideband Network in select areas of Minneapolis and Chicago "a week ahead of schedule," allowing its customers to access "a commercial 5G network with the world's first commercially available 5G-enabled smartphone, the moto z3 combined with 5G moto mod." Customers using Verizon's 5G Ultra Wideband network in Chicago or Minneapolis could see speeds of up to 1 Gbps, according to Verizon.

10:52 EDT Acuity Brands says saw some lumpiness in orders in Q2 - Says sees more "favorability" in orders in 2H vs. previous lumpiness. Comments taken from the Q2 earnings conference call.

10:00 EDT Accenture to acquire Droga5, terms not disclosed - Accenture has entered into an agreement to acquire Droga5, one of the world's most innovative and influential creative agencies. The New York-based agency will become part of Accenture Interactive, boosting its capabilities as an Experience Agency able to design, build and run customer experiences that grow brands and businesses. Completion of the acquisition is subject to customary closing conditions, including antitrust clearance. Financial terms of the agreement have not been disclosed.

09:46 EDT PrimeEnergy trading halted, volatility trading pause

09:37 EDT Lipocine seeks injunction against marketing of Clarus Therapeutics' Jatenzo - Lipocine announced that it has filed suit against Clarus Therapeutics in the United States District Court of Delaware alleging that Clarus's Jatenzo product infringes six of Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390; 6,569,463; and 6,923,988. "We have invested significant resources in developing innovations that have led to our importantly held strong intellectual property rights. We will defend those rights when infringed upon," said Lipocine CEO Mahesh Patel.

09:15 EDT Ocean Power wins contract with oil and gas exploration, production company - Ocean Power, or OPT, has signed a contract with an oil and gas exploration and production company to complete a 12-week paid feasibility study that will examine the use of OPT's products and services in monitoring subsea wells during decommissioning activities. The work was issued under a recently announced master service contract and OPT will execute the contract under its innovation and support services vertical.

09:09 EDT Sintx Technologies announces partnership with EU Horizon 2020 - Sintx Technologies announced a partnership with a multi-center European industry-academic group that aims to train future scientists and promote the development of silicon nitride biomedical implants. As partner and senior advisor to the program, Sintx will participate in technical reviews of the program and will host graduate students during the course of the program. Silicon nitride offers the mechanical strength, chemical stability and biocompatibility needed to manufacture spinal implants. To promote research, and to train future scientists, the European Union's Horizon 2020 research and innovation program funded a four year grant targeted specifically at developing spinal implants. In addition to the focus on spinal implants, the program aims to deliver 15 PhD scientists through a comprehensive, multi-center research and training effort.

09:06 EDT BNP Paribas announces investment in Forge Global, strategic collaboration - BNP Paribas announces an equity investment in Forge Global, a marketplace for pre-IPO securities, in addition to a strategic product collaboration. BNP Paribas says: "The collaboration will involve the development and distribution of investment products providing exposure to Pre-IPO / private innovation companies. Angel Rodriguez-Issa, Global Head of Strategic Investments at BNP Paribas Global Markets, joins Forge's board as an observer."

09:04 EDT Marsh & McLennan Agency to acquire Centurion, terms not disclosed - Marsh & McLennan Agency announced that it has reached agreement to acquire Centurion, the Plymouth Meeting, Pennsylvania-based retirement consulting, asset management, and benefit-plan advisory firm. Terms of the transaction, which is expected to close in Q2, were not disclosed.

09:03 EDT Fly Intel: Pre-market Movers - HIGHER: Tellurian (TELL), up 3% after announcing that the company and Total (TOT) have signed a heads of agreement, or HOA, for Total to make a $500M equity investment in the integrated Driftwood project and to purchase 1M tonnes per annum of liquefied natural gas, or LNG, from Driftwood. The HOA specifies that Tellurian and Total enter into a sales and purchase agreement for a further 1.5 mtpa of LNG from Tellurian Marketing's LNG offtake volumes from the proposed Driftwood LNG export terminal... DMC Global (BOOM), up 9% after raising Q1 revenue outlook... e.l.f. Beauty (ELF), up 5% after Jefferies analyst Stephanie Wissink upgraded the stock to Buy from Hold and raised her price target for the shares to $14 from $10. The analyst believes the company's improved merchandising focus will drive a "meaningful reversal" in sales trends... Intelsat (I), up 7% after JPMorgan analyst Philip Cusick upgraded shares to Overweight from Neutral with an unchanged price target of $27. After being overly-optimistic in the fall, the market is now "underpricing the likelihood" of Intelsat and the C-Band Alliance eventually selling spectrum and "reaping substantial proceeds," says the analyst. DOWN AFTER EARNINGS: GameStop (GME), down 14%... Signet Jewelers (SIG), down 2%. ALSO LOWER: Advaxis (ADXS), down 28% after 2.5M share spot secondary priced at $4.00 per share... Qutoutiao (QTT), down 6% after 10M share secondary priced at $10.00 per share.

08:55 EDT Perspecta granted $4.8M contract option for DARPA information security program - Perspecta's research arm, Perspecta Labs, has received a $4.8M contract modification for Phase 2 of the Defense Advanced Research Projects Agency's - DARPA - Secure Handhelds on Assured Resilient networks at the tactical Edge program. Under Phase 2 of the SHARE program, Perspecta Labs will be advancing its VeriNet, Verifiably Secure Named Data Networking-based Coalition Networks, technology which enables secure information sharing between the U.S. and its coalition partners.

08:40 EDT CHF Solutions submits patent application for Aquadex Flex Flow System - CHF Solutions announced the submission of a method of use application to the United States Patent and Trademark Administration for pediatric use of its Aquadex Flex Flow System. Illustrative claims in the application include customizable circuit volume for optimizing pediatric patient hemodynamics and a mechanism to ensure the safety of pediatric patients.

08:35 EDT Omeros announces EBMT case report of resolution of gastrointestinal HSCT-TMA - Omeros Corporation announced the recent presentation of a case report describing resolution of gastrointestinal hematopoietic stem cell transplant-associated thrombotic microangiopathy following narsoplimab treatment under a compassionate-use protocol. The case was presented at the 2019 Annual Meeting of the European Society for Blood and Marrow Transplantation. Omeros is reporting the case to ensure broad availability of the information presented. Narsoplimab, Omeros' antibody to inhibit the lectin pathway of complement, has received breakthrough therapy designation from FDA and is in Phase 3 development for the treatment of HSCT-TMA. The case was presented by Rafael Duarte M.D., Ph.D., F.R.C.P., Associate Professor, Head of Hematopoietic Transplantation and Hemato-oncology Section, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain, and Secretary of the EBMT. Dr. Duarte described an 18-year-old patient with biopsy-proven HSCT-TMA of the gastrointestinal tract causing severe gastrointestinal bleeding requiring transfusions. The patient received narsoplimab, her TMA resolved, and all transfusions have been discontinued. The patient continues to do well after cessation of narsoplimab treatment. Hematopoietic stem cell transplant-associated TMA was a focus of the EBMT meeting program. In addition to the educational course on early transplant complications that included Dr. Duarte's presentation, the program included a review session on renal complications of HSCT-TMA and an Omeros-sponsored symposium entitled "How Do I Diagnose HSCT-TMA." The meeting program also contained several other podium and poster presentations directed to complications related to endothelial injury, which include HSCT-TMA, graft-versus-host disease and diffuse alveolar hemorrhage. Omeros is preparing both a U.S. biologics license application and a European marketing authorization application for narsoplimab in the treatment of HSCT-TMA. The FDA has agreed that a rolling BLA submission is appropriate and discussions with European regulators are ongoing.

08:35 EDT Scynexis' ibrexafungerp featured in six presentations at 29th ECCMID congress - Scynexis announced data demonstrating the potential use of ibrexafungerp as an agent to address multiple serious fungal infections. The collection of data will be presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases, April 13-16, in Amsterdam. Ibrexafungerp, the first representative of a novel family of compounds referred to as "fungerps", is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections. Six presentations will provide additional evidence of antifungal activity of oral ibrexafungerp, including new clinical case studies from the CARES and FURI trials as well as preclinical data. Case studies from the CARES trial, the first study of an investigational agent to treat patients with Candida auris infections, show "favorable" outcomes following treatment with oral ibrexafungerp. Ibrexafungerp shows "strong" clinical activity in difficult-to-treat patients with resistant Candida pathogens in a variety of infections.

08:24 EDT American Shared Hospital announces agreement with Kettering Medical Center - American Shared Hospital announced that it has entered into an agreement with Kettering Medical Center to upgrade its Gamma Knife Perfexion system supplied by AMS in to the Leksell Gamma Knife Icon system. AMS expects to complete the installation in the second half of 2019.

08:18 EDT Varian Medical reports first preclinical results of Flash therapy at AACR - Varian presented publicly, at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, the first pre-clinical results of its research on ultra-high dose rate cancer treatments with protons. Known as Flash therapy, it is a non-invasive therapy for cancer delivering high doses of radiation in ultra-high-speeds and according to the company, represents the potential for a major breakthrough in the treatment of cancer. The preclinical Flash therapy results presented at AACR showed reduced toxicity in healthy tissues and organs. Conducted on a clinical device capable of translation to humans, the Flash therapy preclinical tests, compared to conventional proton treatments, displayed 25%-30% less damage to lung tissue, resulting in less fibrosis of the lung, and an average of 35% reduction in skin dermatitis during treatment.

08:15 EDT Jounce Therapeutics presents preclinical data from JTX-8064 program at AACR - Jounce Therapeutics reported data on JTX-8064, its first tumor-associated macrophage program, at the 2019 American Association for Cancer Research Annual Meeting in Atlanta, GA. The poster presentation includes preclinical data demonstrating the immunotherapeutic properties of JTX-8064 to reprogram immune-suppressive macrophages within the tumor microenvironment. "Today, we presented the characterization of JTX-8064 and the preclinical data for this novel product candidate, demonstrating its potential in re-programming tumor-associated macrophages within the tumor microenvironment to enhance anti-tumor immunity. We believe that LILRB2 functions as an immune checkpoint for macrophages and have demonstrated differentiation from other macrophage-directed approaches," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "New insights from our Translational Science Platform continue to inform JTX-8064 development and we expect to file an Investigational New Drug application and initiate a Phase 1 clinical trial later this year." In a poster titled "Preclinical evaluation of JTX-8064, an anti-LILRB2 antagonist antibody, for reprogramming tumor-associated macrophages," Jounce researchers describe the preclinical evaluation of JTX-8064 including: JTX-8064 is a specific and potent antagonist antibody of LILRB2; LILRB2 binds to its ligands and maintains an immuno-suppressive state in macrophages. JTX-8064 blocks ligand binding to LILRB2 and induces an immune activating state in macrophages that may lead to enhancement of the anti-tumor immune response; Inhibiting LILRB2 induces pro-inflammatory cytokine secretion and a unique transcriptional profile suggestive of an M1-like shift in human macrophages, which is distinct from macrophage-targeted mAbs CSF1R and TIM-3.

08:12 EDT ShockWave Medical completes enrollment of DISRUPT CAD II study - ShockWave Medical has completed enrollment of its DISRUPT CAD II study, a regulatory-required European post-market registry of coronary IVL. IVL is a lesion preparation tool designed to fracture calcium using sonic pressure waves in order to facilitate stent delivery, deployment and expansion. DISRUPT CAD II is a prospective, non-randomized, multicenter, real-world study to confirm the safety and performance results from the DISRUPT CAD I study, which was used to obtain European approval of the ShockWave Coronary IVL System. DISRUPT CAD II enrolled more patients with de novo, calcified, stenotic, coronary arteries at more European centers than the first study to determine if the pervious strong safety results could be replicated in more patients and with more operators in a real-world setting. The study's primary safety endpoint is freedom from in-hospital major adverse cardiac events; patients will also be followed out to 30 days per the protocol.

08:08 EDT Sierra Oncology reports SRA141 preclinical data in poster at AACR - Sierra Oncology reported preclinical data for its novel oral Cdc7 inhibitor, SRA141, in a late-breaking poster being presented at the American Association of Cancer Research - AACR - Annual Meeting 2019 in Atlanta. Eric Brown, Associate Professor of Cancer Biology at the Perelman School of Medicine of the University of Pennsylvania, and member of Sierra's DNA damage response Advisory Committee, said: "Prior studies demonstrated that SRA141 potently and selectively inhibits Cdc7, resulting in robust anti-tumor efficacy in colorectal xenograft models, however, the compound's exact mechanism of action has not been characterized previously. Our findings reveal a potentially novel mechanism of cytotoxicity for Cdc7 inhibitors that is distinct from other agents, and thus SRA141 may herald a new class of cancer therapeutic agents with a differentiated anti-tumor profile."

08:07 EDT IMV Inc. presents preclinical research for immunotherapy program at AACR - IMV (IMV) announced that preclinical research presented at the American Association for Cancer Research Annual Meeting 2019 demonstrated how the mechanism of action of IMV's proprietary DPX technology can enhance a broad spectrum of immune cell infiltration into tumors, which included T cells, Natural Killer cells, and macrophages. Analyses also revealed the differentiated characteristics of the immune cell responses and the potential implications for enhanced anti-tumor efficacy. In the poster titled, T-distributed stochastic neighbor embedding analysis of tumor infiltrating lymphocytes after treatment with a T cell activating therapy identifies a unique population of recruited CD8+ T cells and novel options for combination immunotherapy, IMV researchers used specialized data analytics to examine how DPX-based agents, when combined with cyclophosphamide, induced T cells to infiltrate tumors and attack cancerous cells. The study closely examined the types of immune cell responses and how and why they were able to affect disease. The data indicated that this approach stimulated the infiltration of a broad base of immune cells into tumors, including T cells, NK cells, and macrophages. The specific T cell population that moved into tumors could be grouped based on the co-expression of different checkpoint molecules such as PD-1 and Tim-3. However, those stimulated to infiltrate tumors generally did not express CTLA-4. Researchers also found that combining DPX/CPA treatments with a CTLA-4-blocking antibody increased efficacy in controlling tumor growth in the animal models. The data suggested that this result was due to the antibodies acting on T cells present in the tumors, rather than those induced by treatment. This finding contrasts previously published studies with anti-PD-1 combinations in which treatment directly enhanced DPX-induced T cell responses. IMV's current clinical program includes multiple phase 2 studies assessing the safety and efficacy of its lead candidate, DPX-Survivac, in combination with mCPA and Merck's (MRK) checkpoint inhibitor, Keytruda.

08:04 EDT Aspen Aerogels and BASF partner to produce new thermal insulation product - BASF (BASFY) and Aspen Aerogels (ASPN) are expanding their strategic partnership with the signing of an addendum to their exclusive supply agreement. The addendum provides for the production and supply of a new non-combustible, high-performance thermal insulation product, Slentex, developed for unique applications in the building and construction sector. Aspen has received a second tranche of prepayment from BASF which will be used to support product optimization and new process development. BASF receives exclusive rights to market the newly developed product.

07:49 EDT Embraer signs firm order for 10 E195-E2 jets with Air Peace - Embraer has signed a firm order for 10 E195-E2 jets with Air Peace, Nigeria's largest airline. The order was announced during the Embraer's Africa Airline Business Seminar, in Mauritius. With this order, Air Peace will become the first E-Jets E2 operator in Africa. The contract includes purchase rights for a further 20 E195-E2. With all purchase rights being exercised, the contract has a value of $2.12B, based on current list prices. The order will be included in Embraer's 2019 second-quarter backlog.

07:36 EDT Aptinyx announces preclinical NYX-458 data - Aptinyx announced preclinical data on its novel NMDA receptor modulator, NYX-458, demonstrating reversal of cognitive deficits in a non-human primate model of Parkinson's disease. In the study, healthy non-human primates were trained on a battery of cognitive tests that are components of the Cambridge Neuropsychological Test Automated Battery, or CANTAB, to establish a baseline level of performance. The CANTAB is often used in human clinical studies to assess levels of cognitive performance. Once the baseline cognitive performance was established, a neurotoxin called MPTP was administered chronically at low doses to deplete dopaminergic neurons and induce cognitive deficits similar to those experienced by people with Parkinson's disease. Once a stable deficit was established, the non-human primates received a single dose of vehicle and showed no improvement in cognitive performance. Following the placebo period, the primates were given a single dose of NYX-458 and assessed on the cognitive tests. Administration of NYX-458 resulted in robust, and long-lasting improvements in cognitive performance across the battery of tests. In the variable delayed response, or VDR, assay, an assessment of attention and working memory, the effects observed were statistically significant on day one following a single administration of NYX-458 and remained significant at day twenty-one. NYX-458 was also shown to induce statistically significant cognitive improvements following a second course of MPTP dosing that was administered to deplete additional dopaminergic neurons and re-induce cognitive deficits. In the simple discrimination reversal, or SDR, assay, an assessment of cognitive flexibility or the ability to switch from thinking about one concept to another, administration of NYX-458 resulted in statistically significant improvements in discrimination reversal. The robust improvements observed on cognitive performance were consistent across the battery of cognitive tests, were maintained with daily oral administration of NYX-458, and endured for approximately three months after dosing was discontinued. A separate study evaluated the effects of NYX-458 on motor symptoms and on the anti-parkinsonian effects of levodopa. Such assessments are critical in the development of a pharmacotherapy for Parkinson's disease cognitive impairment, as it is important to ascertain whether the therapy adversely influences motor symptoms and whether it interferes with the benefits of levodopa, which is the standard of care. In this study, a separate cohort of non-human primates was dosed with high doses of MPTP and levodopa in order to cause Parkinson's-like motor impairments and levodopa-induced dyskinesia. After motor impairments were established, the non-human primates were dosed with NYX-458 and assessed on scales measuring activity, Parkinsonian disability and dyskinesia. Administration of NYX-458, either as a monotherapy or in combination with levodopa, did not result in any adverse effects on motor symptoms and did not interfere with the anti-parkinsonian effects of levodopa on the evaluated scales. These results further reinforce the suitability of NYX-458 as a potential treatment for cognitive impairment due to Parkinson's disease and support its further development. Across both studies, no evident tolerability issues were observed with NYX-458. The data presented indicate that NYX-458's novel modulation of NMDA receptors may be a highly effective approach to addressing the cognitive impairment associated with Parkinson's disease, without worsening motor symptoms or interfering with levodopa therapy.

07:34 EDT Moleculin Biotech reports precilinical data in pancreatic cancer candidates - Moleculin Biotech announced that preclinical data supporting activity of its STAT3-inhibiting Immune/Transcription Modulators was presented at the 2019 Annual Meeting of the American Association for Cancer Research in Atlanta. The presentation included data resulting from preclinical evaluation in pancreatic cancer models of STAT3 inhibitors WP1066 and WP1732, both licensed by Moleculin. WP1066 is an orally bioavailable drug currently in Phase I clinical studies in patients with brain tumors. WP1732 is suitable for IV administration and demonstrates high uptake by the pancreas without uptake to the brain. In vitro efficacy of both inhibitors was assessed. The presentation concluded that WP1066 and WP1732 are inhibitors of p-STAT3 with demonstrated in vitro and in-vivo activity against PDAC tumor models, and that preliminary data warrant the further pre-clinical and clinical evaluation of these oncology agents alone and in combination with immunotherapy for pancreatic cancer.

07:21 EDT Signet Jewelers says President and CCO Sebastian Hobbs to step down - In a regulatory filing, Signet Jewelers disclosed that on April 1, it was determined that Sebastian Hobbs will be stepping down as President & Chief Customer Officer of Signet Jewelers Limited on April 4. Hobbs will continue to be employed as an advisor to the CEO until June 30, or such earlier date as determined in accordance with the Agreement.

07:15 EDT BNY Mellon and BlackRock partner for services to common clientes - BNY Mellon (BK) and BlackRock (BLK), through its BlackRock Solutions business, announced a strategic alliance to deliver integrated data, technology, and asset management servicing capabilities to common clients. These new capabilities integrate BNY Mellon's data insights, accounting, and servicing tools into Aladdin, BlackRock's investment and operating platform for investment managers. BlackRock and BNY Mellon will now offer the joint capabilities to common clients. Along with these ready-to-deploy capabilities, BNY Mellon and BlackRock are working together on new solutions.

07:08 EDT Editas Medicine, BlueRock Therapeutics announce cross-licensing agreement - Editas Medicine and BlueRock Therapeutics announced a strategic research collaboration and cross-licensing agreement to combine their respective genome editing and cell therapy technologies to discover, develop and manufacture engineered cell medicines. The combination of these two technologies creates a platform for the discovery of new, engineered cell medicines. As part of the research collaboration, the companies will collaborate to create allogeneic pluripotent stem cell, or PSC, lines utilizing a combination of Editas Medicine's CRISPR genome editing technology and BlueRock's induced pluripotent stem cell, or iPSC, platform. As part of the cross-licensing agreement, BlueRock gains non-exclusive rights to Editas Medicine's CRISPR technology and intellectual property and Editas Medicine gains non-exclusive rights to BlueRock's iPSC and cell differentiation technology and intellectual property, in each of their respective fields. Under the terms of the agreement, each party is responsible for the payment of development, regulatory and commercial milestones to their respective partner for any licensed engineered cell medicine developed in their respective field as well as royalties on global net product sales.

07:06 EDT JBG Smith executes agreements with Amazon for National Landing office space - JBG SMITH (JBGS) announced that it has executed three leases and two Purchase and Sale Agreements with affiliates of Amazon (AMZN) iin conjunction with the creation of Amazon's HQ2 at National Landing in Northern Virginia. These agreements are the result of Amazon's announcement in November 2018 that it had selected JBG SMITH as its partner to house and develop its HQ2 locations after a comprehensive, year-long search that included proposals from 238 cities across North America. Amazon has executed three initial leases totaling 537,000 square feet at three existing JBG SMITH office buildings in National Landing. The leases encompass 88,000 square feet at 241 18th Street South, 191,000 square feet at 1800 South Bell Street, and 258,000 square feet at 1770 Crystal Drive. JBG SMITH expects Amazon to begin moving into 241 18th Street South and 1800 South Bell in 2019, and 1770 Crystal Drive by the end of 2020. JBG SMITH and Amazon have also executed Purchase and Sale Agreements for two of JBG SMITH's National Landing development sites, Pen Place and Met 6, 7, and 8, which will serve as the initial phase of new construction associated with Amazon's HQ2. Subject to customary closing conditions, Amazon will pay $294M for the sites, or $72 per square foot based on their combined development potential of 4.1 million square feet. JBG SMITH, which has flexibility on the timing of closing to facilitate 1031 exchange opportunities, expects to close on the Mets land sales as early as 2019 and on Pen Place as early as 2020. JBG SMITH will also serve as Amazon's developer, property manager, and retail leasing agent for these assets.

07:04 EDT Orion Group appoints Robert Tabb CFO - Orion Group announced the appointment of Robert Tabb as VP and CFO. Tabb has served as interim CFO since November 2, 2018.

07:02 EDT Bruker acquires RAVE LLC, terms not disclosed - Bruker announced that it has acquired the semiconductor mask repair and cleaning business of RAVE LLC, a leading provider of nanomachining and laser photomask repair equipment. For calendar year 2018, the acquired business was profitable and had revenues of approximately $25M. Financial details of the transaction were not disclosed, and the business has now become part of Bruker's semiconductor metrology division.

06:58 EDT National Fuel CEO Ronald Tanski to retire July 1, succeeded by David Bauer - National Fuel CEO and President Ronald Tanski has indicated his intention to retire, effective July 1. He will continue to serve as a member of the board of directors. David Bauer will succeed Tanski as President and CEO of National Fuel. Bauer is a member of National Fuel's executive team since 2004. Bauer has served in numerous positions with National Fuel and its operating subsidiaries and has been President of National Fuel Gas Supply since 2016. Bauer joined National Fuel in 2001.

06:56 EDT Signet Jewelers says plans to close more than 150 stores in FY20 - Company plans to close more than 150 stores in Fiscal 2020 and open 20-25 stores, for a net selling square footage decline of approximately 2.5% - 3.5%.

06:53 EDT Lazard makes executive appointments - Lazard made several leadership appointments, effective June 1. Alexander F. Stern, currently CEO of Financial Advisory and COO of Lazard, will become President of Lazard. Peter R. Orszag, currently Head of M&A, North America, will become CEO of Financial Advisory. Alexandra Soto, in addition to her current role as COO of Financial Advisory, will become Group Executive, Human Capital and Workplace Innovation. Stern will effect the transition of his Financial Advisory responsibilities to Orszag. Orszag will lead the Financial Advisory business. Soto will assume her additional responsibilities in this new corporate executive role as Group Executive, Human Capital and Workplace Innovation. Stern joined Lazard in 1994. He has served as COO of Lazard since November 2008 and as CEO of Financial Advisory since 2015. Orszag was named head of M&A for North America in 2018, after joining Lazard as a Vice Chairman in 2016. Soto joined Lazard in Paris in 1993, and was named COO of Financial Advisory in 2018.

06:51 EDT Northern Dynasty CFO Marchand Snyman resigns, Mark Peters succeeds - Northern Dynasty announced that Mark Peters has joined the company as CFO, replacing Marchand Snyman who has resigned from his role with the company. Peters has more than 18 years of experience in the areas of financial reporting and taxation, working primarily with Canadian and U.S. public corporations. He previously served as CFO for Hunter Dickinson since 2016.

06:39 EDT Akamai expands partnership with Microsoft Azure - Akamai announced it has integrated Akamai's content delivery network, or CDN, capabilities with Microsoft Azure Media Services and Blob Storage. The collaboration will make it easier and more cost effective for media organizations to combine cloud-based video processing with edge delivery, from content preparation to playback. Going forward, Akamai will directly connect its edge network to Azure using a high-speed Azure ExpressRoute connection. This will result in significant efficiencies when storing and delivering content and provide mutual customers with lower, more predictable cost structures between Azure and Akamai's CDN.

06:24 EDT GM, Ford and Toyota join forces to advance self-driving testing, standards - SAE International, along with Ford (F), General Motors (GM) and Toyota (TM) announced they are stepping forward to form the Automated Vehicle Safety Consortium that will "work to safely advance testing, pre-competitive development and deployment of SAE Level 4 and 5 automated vehicles." "The AVSC will fill a critical need by providing a safety framework around which autonomous technology can responsibly evolve in advance of broad deployment. The work will ultimately inform and accelerate the development of industry standards for autonomous vehicles and harmonize with efforts of other consortia and standards bodies throughout the world," the companies said in a statement. The consortium will "leverage the expertise of its current and future members to establish a set of AV safety guiding principles to help inform standards development." The first output from the AVSC will be a roadmap of priorities. The roadmap is intended to be applicable for developers, manufacturers and integrators of automated vehicle technology and focuses on data sharing, vehicle interaction with other road users and safe testing guidelines.

06:08 EDT Toyota to provide nearly 24,000 licenses royalty-free - Toyota announced two measures related to its patents and technical knowledge to further promote the widespread use of electrified vehicles. First, Toyota announced that it will grant royalty-free licenses on nearly 24,000 patents it holds -- including some pending applications -- for vehicle electrification-related technologies. Second, Toyota will provide fee-based technical support to other manufacturers developing and selling electrified vehicles when they use Toyota's motors, batteries, PCUs, control ECUs, and other vehicle electrification system technologies as part of their powertrain systems. Ultimately, by granting royalty-free patents and providing technical support on its vehicle electrification systems, Toyota aims to help further promote the widespread use of electrified vehicles, and in so doing, help governments, automakers, and society at large accomplish goals related to climate change, it said in a statement.

06:04 EDT Achillion reaches threshold enrollment in Phase 2 trials for C3 glomerulopathy - Achillion achieved threshold enrollment in the Phase 2 trials of ACH-4471 for patients with C3 glomerulopathy or C3G, a devastating disease affecting the kidney for which there is no approved therapy. ACH-4471 will be evaluated in the six-month trial with 11 patients and the 12-month open-label trial with 12 patients. The company expects to present data from these two Phase 2 trials, along with real-world C3G data, to the FDA in Q4. The objective of the six and 12-month proof-of-concept trials is to evaluate the safety and efficacy of ACH-4471 in patients diagnosed with C3G. The measures being evaluated include changes in clinical manifestations of C3G including proteinuria and estimated glomerular filtration rate at the end of the treatment period and changes in kidney biopsy from baseline.

06:02 EDT GMS Inc. CEO Mike Callahan to retire, John Turner to succeed - GMS Inc. (GMS) announced that Mike Callahan, President and CEO, has informed the Board of Directors of his decision to retire effective August 2. In addition, the Board has appointed John Turner, Jr. as President, effective May 1. Turner will assume the role of CEO at the time of Callahan's retirement. Turner will join GMS from Dal-Tile Corporation, a subsidiary of Mohawk Industries (MHK), where he currently serves as President, a position he has held since January 2012. Turner brings to GMS almost 30 years of industry experience and a broad range of expertise in operations, sales, customer service, distribution and logistics as well as strategic planning and M&A.

05:42 EDT DelMar receives approval from MDACC for protocol expansion of VAL-083 trial - DelMar Pharmaceuticals announced the University of Texas MD Anderson Cancer Center's, or MDACC, Institutional Review Board, or IRB, has approved a trial protocol amendment to expand DelMar's ongoing Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated glioblastoma, or GBM. The biomarker driven trial, which was originally designed as a single arm study evaluating VAL-083 in patients with MGMT-unmethylated bevacizumab, or Avastin,-naive recurrent GBM, has been expanded to include an additional maintenance-stage treatment group. This protocol amendment, in addition to the Company's ongoing Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM being conducted at Sun Yat-sen University Cancer Center, or SYSUCC, expands DelMar's evaluation range of VAL-083 as a potential treatment for unmethylated GBM patients to include newly-diagnosed, maintenance-stage, and recurrent patients. Maintenance-stage GBM provides the greatest opportunity to control disease progression after radiation therapy, and represents the largest addressable GBM market opportunity for VAL-083 given patients are typically healthier and as such, are able to optimally benefit therapeutically from increased treatment cycles compared to the recurrent treatment setting. Maintenance GBM patients may be able to receive 12+ cycles of VAL-083 versus 5 or 6 cycles for recurrent GBM patients.

05:22 EDT Roche, Spark Therapeutics withdraw, refile premerger notification - Roche (RHHBY) and Spark Therapeutics (ONCE) announced that Roche has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Act in connection with Roche's pending acquisition of Spark. Roche and Spark both filed a Premerger Notification and Report Form under the HSR Act on March 1 with respect to the pending acquisition. On March 18, Roche withdrew the March 1 filing and refiled a Premerger Notification and Report Form. Roche has withdrawn the March 18 filing effective on April 2 and intends to refile a Premerger Notification and Report Form under the HSR Act on or about April 10. Following such refiling, the waiting period applicable to the pending acquisition will expire at 11:59 p.m., New York City time, on or about April 25, but this period may be shortened if the government grants "early termination" of the waiting period, or it may change if Roche voluntarily withdraws and refiles its Premerger Notification and Report Form in order to restart the 15-day waiting period or if the reviewing agency issues a formal request for additional information and documentary material. The parties are working with the government to conduct the review as expeditiously as possible. As a result of the withdrawal and refiling of the Premerger Notification and Report Form, Roche is extending the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock of Spark for $114.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7. The Offer, which was previously scheduled to expire at 12:00 midnight, New York City time, at the end of Wednesday, April 3, is being extended until 12:00 midnight, New York City time, on Thursday, May 2, unless it is extended further under the circumstances set forth in the Agreement and Plan of Merger, dated February 22, by and among Roche Holdings, 022019 Merger Subsidiary, Inc., and Spark. All terms and conditions of the Offer shall remain unchanged during the extended period. Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 p.m., New York City time, on April 2, 2019, the last business day prior to the announcement of the extension of the Offer, approximately 11.26M Shares of Spark had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 29.4% of Spark's outstanding Shares. Shareholders who have already tendered their Shares of Spark do not have to re-tender their Shares or take any other action as a result of the extension of the expiration date of the Offer. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, at least a majority of the outstanding Spark Shares.