Stockwinners Market Radar for September 17, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:08 EDT Superior Energy receives NYSE notice regarding continued listing standard - Superior Energy Services announced that the company was notified by the New York Stock Exchange of its determination to commence proceedings to delist and suspend trading of the company's common stock due to failure to meet the NYSE's $15M, 30-trading day average market capitalization standard. The company anticipates that, effective September 18, 2020, its common stock will commence trading on the OTCQX Market under the symbol "SPNX". The company's transition to the OTCQX Market is not expected to affect the company's business operations.

18:40 EDT Proofpoint CEO: We are executing well - In an interview on CNBC's Mad Money, Gary Steele said he is pleased with Q2 results. "We felt the share buyback was the best way to return capital to shareholders," he noted. "We feel we play a very important role in the stay at home economy. We are well positioned to take advantage of the broader work from home trend," Steele said.

18:27 EDT DavidsTea obtains Claims Process Order for creditor claims - DavidsTea announced that the Quebec Superior Court issued a Claims Process Order establishing the claims procedures for the company's creditors under the Companies' Creditors Arrangement Act. The Order, among other things, sets 5:00 p.m. eastern time on November 6 as the time by which creditors of DavidsTea and of its wholly-owned U.S. subsidiary, must submit their claims to PwC, the Court-appointment Monitor. The Court also extended the stay of all proceedings against the company currently in effect to December 15.

18:01 EDT Air Lease announces delivery of one new Airbus A350-1000 jet - Air Lease Corporation (AL) announced the delivery of one new Airbus (EADSY) A350-1000 aircraft on long-term lease to Virgin Atlantic. Powered by Trent XWB-97 engines, this aircraft is the first of four A350-1000s confirmed to deliver to the airline from ALC's order book with Airbus. "We are pleased to announce this first new A350-1000 aircraft delivery to Virgin Atlantic today," said Steven F. Udvar-Hazy, Executive Chairman of Air Lease Corporation. "Our A350-1000s will replace Virgin Atlantic's Boeing 747 aircraft on routes from London across the Atlantic to modernize the airline's long-haul fleet."

17:21 EDT Raytheon Technologies subsidiary awarded $316.73M Navy contract modification - Collins Aerospace was awarded a $316.73M modification to a previously awarded firm-fixed-price contract. This modification exercises an option for the procurement of 11,313 AN/ARC-210(v) radios for installation in over 400 strategic and tactical airborne, seaborne and land based platforms for the Navy, Marine Corps, Army, Coast Guard, other government agencies and Foreign Military Sales customers. Work will be performed in Cedar Rapids, Iowa, and is expected to be completed by September 2023. No funds are being obligated at time of award. Funds will be obligated on individual delivery orders as they are issued. The Naval Air Warfare Center Aircraft Division is the contracting activity.

17:05 EDT CenterPoint Energy names Jason Wells CFO - CenterPoint Energy announced the appointment of Jason Wells as Executive Vice President and Chief Financial Officer, effective Sept. 28. Wells will oversee the company's Finance organization, including Accounting and Financial Planning, Treasury, Tax, Mergers and Acquisitions, Internal Audit, and Investor Relations. He will report to CenterPoint Energy's President and Chief Executive Officer Dave Lesar and serve on the company's Executive Committee. "I am confident that Jason is the ideal person with the right skillset for this important CFO leadership role. He is a transformational business and finance leader with a proven track record of operating experience in the utility industry," said Lesar. "Jason will be instrumental in providing financial leadership to help drive CenterPoint Energy's utility-focused strategy, while maximizing value for all of our stakeholders. He will also help accelerate further momentum on key internally driven programs that we have already started, such as a focus on standardized processes, employee empowerment and an enhanced culture of continuous improvement to better serve our customers and investors."

17:02 EDT Consolidated Edison CEO John McAvoy to retire, Tim Cawley to succeed in 2021 - Consolidated Edison announced that its board has elected Tim Cawley as Con Edison's president and CEO, effective January 1, 2021. Cawley will also serve as CEO of Con Edison's principal subsidiary, Consolidated Edison Company of New York. After 40 years of service, John McAvoy has decided to retire as president and CEO at the end of the year. He will remain the chairman of the board. McAvoy joined the company in 1980 and has served as president and CEO since 2014. Cawley was appointed president of Consolidated Edison Company of New York in 2018. Prior to this position, he served as president and CEO of Orange and Rockland Utilities for four years.

17:00 EDT Twitter announces improved account security during the 2020 US election - Twitter announced Thursday that it will begin notifying high-profile political accounts to take additional security measures during the upcoming 2020 US election. In a Twitter Safety blog entrance the company said: "Voters, political candidates, elected officials and journalists rely on Twitter every day to share and find reliable news and information about the election, and we take our responsibility to them seriously. As we learn from the experience of past security incidents and implement changes, we're also focused on keeping high-profile accounts on Twitter safe and secure during the 2020 US election. We're taking the additional step of proactively implementing account security measures for a designated group of high-profile, election-related Twitter accounts in the US. Starting today, these accounts will be informed via an in-app notification from Twitter of some of the initial account security measures we will be requiring or strongly recommending going forward." Reference Link

16:37 EDT J & J Snack Foods appoints Ken Plunk as CFO - J & J Snack Foods has appointed Ken Plunk as Senior VP, CFO, effective September 21, reporting to Daniel Fachner, President. Plunk joins J & J from leadership roles at Walmart, Home Depot and Coca-Cola. Dennis Moore, current CFO, whose retirement was announced in April, will remain on as an employee for the next several months to assist with the transition.

16:33 EDT Perspecta to deliver HealthConcourse platform to Defense Health Agency - Perspecta announced that it received an award to deliver a prototype of its proprietary award-winning HealthConcourse digital health platform to the Defense Health Agency in support of its goal to deploy a next-generation electronic health record system for the Military Health System's GENESIS project. The work was awarded through an Other Transaction Agreement from Naval Information Warfare Center Atlantic as part of the Information Warfare Research Project Consortium project. Over the next 12 months, Perspecta will configure its HealthConcourse solution to modernize and migrate patient data to the cloud for the Department of Defense Healthcare Management System Modernization program. The software as a service platform will ensure that MHS beneficiary legacy health care data is available for physicians, researchers and benefits adjudicators throughout the GENESIS transition.

16:30 EDT W.P. Carey raises quarterly dividend to $1.044 per share - The dividend is payable on October 15 to stockholders of record as of September 30.

16:20 EDT Sonoma Pharma surges 21.1% after Health Canada authorizes Nanocyn sale

16:19 EDT ADT announces closing of $450M investment by Google - ADT (ADT) announced that, upon the terms and subject to the conditions set forth in the previously disclosed Securities Purchase Agreement, dated as of July 31, with Google (GOOG), the Company issued and sold in a private placement to Google 54,744,525 shares of Class B common stock, par value $0.01 per share, of the Company for an aggregate purchase price of $450 million. The shares of Class B common stock issued to Google represent approximately 6.6% of the issued and outstanding common stock of the Company on an as-converted basis. The Company expects to use the net proceeds from the Private Placement for further growth initiatives and to reduce debt over time.

16:16 EDT Fuel Tech receives $2.6M insurance reimbursement - Fuel Tech announced it has agreed upon the terms of settlement with its insurance carrier whereby the company will receive $2.6M in proceeds related to an outstanding claim that was previously reported in 2019. The proceeds are expected to be received early in the 2020 fourth quarter. As previously announced, in the fourth quarter of 2019 Fuel Tech reported a $2M charge related to an equipment warranty liability issue with a U.S. customer, and in the second quarter of 2020, the company recorded an incremental net charge of $600,000 related to the claim. The full amount of the insurance recovery is expected to be recorded in Fuel Tech's financial statements in the second half of 2020.

16:14 EDT Ashford Hospitality shareholder Cygnus Capital issues letter - Ashford Hospitality shareholder Cygnus Capital, owning approximately 7.8% of the company's outstanding common stock, issued an open letter to the Company's stockholders urging them to vote at the company's upcoming special meeting of stockholders on October 6, 2020, against the proposals to amend the company's corporate charter and approve the issuance of common stock that are conditions to consummating the proposed exchange offers of all of the company's outstanding preferred stock into shares of the company's common stock. Highlights of the letter include: "(...) We are writing to express our strong opposition to the Company's proposed offers (the "Exchange Offers") to the holders of each series of AHT's preferred stock to exchange all of the shares of Preferred Stock for shares of Common Stock. If all shares of Preferred Stock are exchanged in the Exchange Offers, existing common stockholders will be immediately diluted by approximately 94%. We believe the Company is prematurely undertaking these highly dilutive Exchange Offers, just as the operating performance of the hospitality industry and AHT's peers are showing signs of improvement, because management's interests are not fully aligned with common stockholders. In our view, there are other strategic alternatives that can be explored to address the Company's current liquidity needs and obligations to preferred stockholders until markets can stabilize post-COVID-19. *...( While still depressed, the operating performance of the overall hospitality industry in the United States is rapidly improving as travel restrictions due to COVID-19 ease. (...) Even in the more impacted luxury hospitality segment that makes up a meaningful portion of AHT's asset base, recovery in industry trends has been dramatic and continues to improve each week, according to STR. The slope of the recovery suggests that a near full recover is possible within a year. (...) Comparable asset sales are improving. AHT's appears to have sufficient liquidity to fund operating costs and AHT's overall performance may be improving. (...) the company does not have high exposure to group business, which has been particularly impacted by COVID-19. (...) A management team can temporarily suspend preferred stock dividend payments to focus on its operations and weather the storm for a better economic climate. That is exactly what AHT management should be doing with the Preferred Stock at this time. (...) AHT has a highly conflicted structure where the management of AHT is also the owner of the property/asset management company, in this case another publicly traded company, AINC. (...) We believe AHT management and AINC are operating AHT to maximize AINC's management fees, to the detriment of AHT common stockholders. We note further that AHT, AINC, Lismore, a subsidiary of AINC, and certain other parties are being formally investigated by the SEC relating to certain related party transactions and the company's accounting policies, procedures, and internal controls related to such related party transactions. (...) We believe numerous and less dilutive strategic alternatives exist for AHT to navigate the impact of COVID-19 (...)".

16:11 EDT OneSpan CTO Benoit Grange gets new role, Ajay Keni to succeed - OneSpan (OSPN) announced the appointment of Ajay Keni as its CTO in an effort to transform the financial services market with OneSpan's Trusted Identity platform and solutions. Keni brings more than 20 years of experience and will guide the development and delivery of OneSpan's future product innovations. Keni will build on OneSpan's Trusted Identity cloud strategy to expand its anti-fraud solutions offering which includes identity verification, risk analysis, mobile application security, multifactor authentication, e-signatures and agreement automation. Keni is the former head of product, engineering, quality and DevOps for Oracle's (ORCL) software-delivered and SaaS-delivered identity and access management products. Former OneSpan CTO Benoit Grange will step into the new role of chief technology evangelist and focus on sharing OneSpan's technology vision and industry insights with customers, partners and the broader financial services market.

16:11 EDT J. Alexander's reports Q3 J. Alexander's/Grill SSS down 9.9% - J. Alexander's Holdings reported same store sales results as well as certain other preliminary metrics related to its continuing recovery from the impact of the novel coronavirus outbreak. During the third quarter, the company has continued to see steady guest count recovery and increasing sales across its restaurant base. Sales volumes for the first three weeks of September 2020 averaged approximately 90.0% of 2019 sales for the comparable period. In conjunction with the earnings release for the second quarter of 2020 dated August 4, 2020, the Company estimated the weekly cash burn rate for the third quarter of 2020 would be in the range of $325,000 to $375,000 per week and that the fourth quarter would see an improvement from a cash flow perspective, assuming continued sales improvement. Based on those assumptions, the Company anticipated that it would have adequate liquidity for 2020. The Company has continued to see sales improvements beyond the levels originally anticipated, and as a result has updated its original cash flow projections for the third quarter as well as the fourth quarter of 2020. These estimates, which include the proceeds from the closing of the sale of the Cleveland property on September 10, 2020 as well as required debt service payments and capital expenditure commitments (including the construction of one new location scheduled to be completed in the fourth quarter of 2020 and opened in the first quarter of 2021), now project that the Company will be breakeven to modestly cash flow positive for the third quarter of 2020. For the fourth quarter of 2020 (which contains 14 weeks due to the 53rd week in fiscal 2020), the Company expects to be cash flow positive in the range of $400,000 to $450,000 per week. The cash flow improvements reflected above for the third and fourth quarters of fiscal 2020 include the impact of better than anticipated sales across all concepts, a generally favorable cost of sales environment, continued operational efficiencies achieved at the restaurant level and the deferral of the planned construction start date of the J. Alexander's in Madison, Alabama until January, 2021, among other factors.

16:07 EDT Superior Energy Services trading halted, news pending

16:07 EDT Acutus announces FDA clearance of 2nd generation AcQMap 3D catheter - Acutus Medical announces FDA 510k clearance of the second-generation AcQMap 3D imaging and mapping catheter which builds on its predecessor, improving handling and deliverability. This flagship 3D mapping and navigation catheter combines 48 ultrasound transducers responsible for creating the anatomical geometry and 48 engineered electrodes which enable electrical activation patterns to be displayed along the inner surface of the heart. Compatible with an 0.035" guidewire, the AcQMap catheter is designed to be inserted into the left and right atrium. The AcQMap catheter is the cornerstone of Acutus' innovative mapping platform. It is the world's only integrated high-resolution ultrasound-based imaging and non-contact mapping catheter capable of capturing cardiac imaging information in addition to cardiac activation mapping. This second-generation catheter carries additional benefits such as improved anatomy reconstruction, faster acquisition times and the potential for enhanced procedural efficiencies. The catheter also comes with a reusable and sterilizable cable that can be used up to 10 times, resulting in greater cost savings for health care systems. Customer feedback during development suggested that users perceived anatomy reconstruction to be faster than our generation one catheter*. Dr. Anil Rajendra from Grandview Medical Center in Birmingham, Alabama commented, "the new ergonomic handle and catheter deployment mechanism has the potential to allow me to maneuver the catheter with greater speed, ease and control."

16:06 EDT Qiagen acquires remaining 80% of NeuMoDx Molecular for $248M in cash - Qiagen announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248M in cash. The transaction was completed after Qiagen received U.S. regulatory clearance for the full acquisition. In 2018, Qiagen had purchased a 19.9% stake in NeuMoDx along with the right to acquire the remaining NeuMoDx stake at a price of $234M. The final payment price for this remaining stake includes customary purchase price adjustments for cash, indebtedness and transaction costs. Also as part of the 2018 agreement, Qiagen has distributed the high-throughput NeuMoDx 288 and the medium-throughput NeuMoDx 96 platforms in Europe and other markets outside the U.S. "NeuMoDx's automated molecular testing platforms offer a unique combination of speed, flexibility, throughput and ease of use for molecular diagnostics assays, including laboratory-developed tests," said Thierry Bernard, Chief Executive Officer of Qiagen. "NeuMoDx has built an unparalleled platform that has demonstrated superior value during the coronavirus pandemic. This will expand QIAGEN's portfolio of automated testing solutions and provide another driver for future growth."

16:04 EDT LMP Automotive now available in the Apple App and Google Play Stores - LMP Automotive Holdings (LMPX) is now available in the Apple App (AAPL) and Google (GOOG) Play Stores. Sam Tawfik, the Company's Chairman and Chief Executive Officer commented, "We see the immense opportunity that exists within our industry that we are exploiting through continued focused growth and the activation of our e-commerce sales, subscription, and dealership acquisition strategy. We are seeing a robust acquisition market as we continue to build our pipeline of prospective dealership acquisitions and intend on accelerating our acquisition strategy moving forward. Looking forward, we are as optimistic as ever and focused on our next-generation of innovation and growth as we roll-out e-commerce home delivery, site-to-store, and ship-from-store delivery strategies for our customers and demonstrate the value of our e-commerce hybrid model at the growing list of auto dealerships we intend to acquire".

16:02 EDT Texas Instruments raises quarterly dividend 13% to $1.02 from 90c per share - The higher dividend will be payable November 16 to stockholders of record on October 30, contingent upon formal declaration by the board of directors at its regular meeting in October.

16:00 EDT Campbell Soup names Camille Pierce chief culture officer - Campbell Soup Company appointed Camille Pierce as Vice President and Chief Culture Officer, effective Oct. 26, 2020. In this newly created role, Pierce will lead Campbell's enterprise-wide inclusion and diversity strategy, working across the organization to build a winning team and culture, and aligning the company's I&D goals with business outcomes. She will become a member of the Campbell Leadership Team. Mark Clouse, Campbell's President and Chief Executive Officer, said "We're approaching inclusion and diversity and culture change in a comprehensive and systemic way, by making it a company-wide priority supported by an integrated plan with measurable goals and a multi-year approach. Camille's leadership and expertise will add tremendous value to our team, and she will be critical in our ongoing progress to build an inclusive and winning culture."

14:53 EDT Toll Brothers announces acquisition of private home builder Keller Homes - Toll Brothers announced its expansion into the Colorado Springs market through the acquisition of Keller Homes, a private home building company in Colorado Springs. At the date of acquisition, the company had approximately $44M in backlog consisting of 84 homes with an average price of $520,000. In addition to Keller's existing backlog of 84 homes, Toll Brothers has acquired rights to purchase over 300 lots Keller controls throughout Colorado Springs. Currently, the company has 4 actively selling communities. Douglas C. Yearley, Jr., Toll Brothers' chairman and CEO, stated: "We are thrilled to be joining with Keller Homes. Their team will enable us to continue to expand our operations in Colorado, which is one of our strongest markets. Keller Homes has a great reputation based on nearly four decades in the market. We welcome them to the Toll Brothers family."

14:26 EDT Facebook to no longer show health groups in recommendations - Facebook said in a blog post that, in an effort to prioritize connecting people with accurate health information, it is starting to no longer show health groups in recommendations. People can still invite friends to health groups or search for them. "Facebook Groups, including health groups, can be a positive space for giving and receiving support during difficult life circumstances," the company said. "At the same time, it's crucial that people get their health information from authoritative sources." In addition, Facebook said that, in the coming weeks, it will start archiving groups that have been without an admin for some time. Moving forward, when a single remaining admin chooses to step down, they can invite members to become admins. Reference Link

14:01 EDT Dow Inc. sees Q3 operating rate 'approaching Q1 levels' - In slides for the Credit Suisse Global Basic Materials Virtual Conference, Dow Inc. said is sees a "gradual and uneven economic recovery continuing." In terms of pricing, it said it sees "support for PE from early quarter rising feedstock prices, improving fundamentals, continued low inventories and hurricane impact." In terms of operations, its sees its Q3 "operating rate approaching Q1 levels and lifting incremental margins." In terms of Hurricane Laura, Dow sees "minimal damage with most sites returned to normal operations; potential Q3 impact of approx. $75M primarily in lost margin from downtime."

13:39 EDT A10 Networks reports CFO Tom Constantino leaving company - Earlier, A10 Networks announced that, effective September 17, Tom Constantino will be leaving the company. "Constantino's departure is not the result of any disagreement with the company on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure," A10 stated. Brian Becker, A10's Vice President and Corporate Controller, has been named Interim Chief Financial Officer. "We thank Tom for his years of service to A10 and wish him well in his future endeavors," said Dhrupad Trivedi, President and CEO of A10 Networks. "Brian has been a trusted part of the finance organization and he is well-prepared to continue the initiatives we have in place to drive organic growth and operational efficiency while the Board seeks the ideal permanent CFO."

13:32 EDT Garrett Motion down 12% after report of bankruptcy filing potential

13:11 EDT Universal Electronics authorizes 300,000 share repurchase program - Universal Electronics disclosed that its board authorized a new share repurchase program, which replaces in its entirety the company's previous repurchase program in place prior to September 15, 2020. Pursuant to the repurchase program, the company may, from time to time until November 5, 2020, repurchase up to 300,000 shares of its common stock in privately negotiated and/or open-market transactions.

12:20 EDT Boeing appoints Marc Allen as chief strategy officer - The Boeing Company named B. Marc Allen as chief strategy officer and senior vice president, Strategy and Corporate Development, reporting to President and CEO David Calhoun. The company also announced Christopher Raymond as the company's chief sustainability officer, a newly created position reporting to Executive Vice President, Enterprise Operations and CFO Greg Smith. The appointments are effective Oct. 1. Allen, first appointed to the company's Executive Council in 2014 as president of Boeing International, will now take on responsibility for the enterprise's overarching strategy, including long-term planning; global business and corporate development; and strategic investments, acquisitions and divestitures. He most recently served as president of Embraer Partnership and Group Operations. As Boeing's first chief sustainability officer, Raymond will be responsible for further advancing Boeing's approach to sustainability that is focused on environmental, social and governance priorities, stakeholder-oriented reporting and company performance. Operating within the Enterprise Operations, Finance and Sustainability organization, Raymond will lead a team that collaborates across Boeing's commercial, defense and services businesses and its enterprise functions in support of the company's commitment to responsible and inclusive business practices and positive global impact. Raymond first gained responsibility for Boeing's sustainability strategy in April 2020 when his role leading strategy was expanded to integrate corporate development and deepen the company's focus on environmental and social considerations.

12:18 EDT Facebook introduces Facebook Business Suite - Facebook COO Sherly Sandberg said in a blog post that the company is introducing Facebook Business Suite, a new interface to help businesses save time and stay up to date by managing their pages or profiles across our apps. It allows them to post to Facebook and Instagram at the same time, and manage and receive messages, notifications and alerts in one place. They can also easily see what's working and learn what's resonating with customers with Facebook and Instagram insights. "We're building Facebook Business Suite for small businesses first, but this is a long-term investment to make this the main interface for businesses of all sizes who use Facebook, Messenger, Instagram and WhatsApp," Sandberg said. "It is available for small businesses globally starting today and will expand to larger businesses next year."

12:00 EDT Snowflake falls -7.6% - Snowflake is down -7.6%, or -$19.41 to $234.52.

12:00 EDT Peabody Energy rises 10.7% - Peabody Energy is up 10.7%, or 34c to $3.56.

12:00 EDT Knoll rises 15.8% - Knoll is up 15.8%, or $1.81 to $13.32.

11:55 EDT Zynerba's cannabidiol granted orphan designation by FDA - Zynerba Pharmaceuticals cannabidiol was granted orphan designation by the FDA as a treatment of 22q.11.2 deletion syndrome, according to a post to the agency's website. Reference Link

11:00 EDT NY Governor Cuomo announces insurance fraud action against J&J - New York Governor Andrew M. Cuomo announced the Department of Financial Services has filed charges and initiated administrative proceedings against Johnson & Johnson and its subsidiaries Janssen Pharmaceutica, Inc., Janssen Pharmaceuticals, Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc. - collectively, "Johnson & Johnson." These charges are the fourth set to be filed against opioid manufacturers arising from the ongoing DFS investigation into the creators and perpetrators of the opioid crisis. "The opioid crisis has taken too many lives and New York State will continue to take action against those who helped fuel this public health catastrophe and bring a measure of justice to families who have lost loved ones," Governor Cuomo said. "Misrepresentation of opioids to consumers for profit is inexcusable and we will use every tool necessary to help ensure those responsible are held fully accountable." The DFS Statement of Charges alleges that the Johnson & Johnson Respondents have had a long-standing and multi-faceted leading role in originating, supplying, facilitating, and actively creating a dangerous market for opioids for chronic pain treatment. Their efforts not only supported sales of their own branded opioids but also established under false and fraudulent pretenses an environment that amplified the medical community's acceptance of opioid prescribing, thereby increasing demand for its opioid-related raw materials. Reference Link

10:37 EDT Lumber Liquidators down after Whitney Tilson highlights short report - Shares of Lumber Liquidators moved lower after Empire Financial Research's Whitney Tilton highlighted a short report on the company by a "person in the flooring industry who wishes to remain anonymous."

10:24 EDT AstraZeneca disputes CNN report, says report 'contains inaccuracies' - AstraZeneca is disputing CNN's report, saying the report "contains inaccuracies," including the diagnosis, which is based on preliminary findings. The company says the information shared by CNN "was not obtained from internal documents, but rather sent to investigators and doctors running trials that should not be shared because they contain confidential patient records." Reference Link

10:00 EDT Steelcase rises 7.0% - Steelcase is up 7.0%, or 75c to $11.54.

09:51 EDT AlloVir announces FDA clearance of IND for ALVR109 - AlloVir announced that the U.S. FDA has cleared the Investigational New Drug application for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells. Proof-of-concept clinical trial with ALVR109 to begin in Q4.

09:47 EDT Snowflake falls -12.2% - Snowflake is down -12.2%, or -$31.03 to $222.90.

09:47 EDT Direxion Daily Gold Miners Bear 3X ETF rises 5.5% - Direxion Daily Gold Miners Bear 3X ETF is up 5.5%, or 90c to $17.09.

09:47 EDT Knoll rises 8.2% - Knoll is up 8.2%, or 94c to $12.45.

09:18 EDT General Mills partnership with Gunsmoke Farms to transition 34K acres to organic - General Mills said in a release, "General Mills announced Gunsmoke Farms has received organic certification by the U.S. Department of Agriculture's National Organics Program. Gunsmoke, a 34,000-acre farm outside of Pierre, South Dakota, had been managed conventionally for more than three decades before its transition to organic over the last three years using regenerative agriculture practices. The combination of cover crops, a diverse crop rotation, keeping a living root in the ground year round and minimizing tillage were instrumental in restoring the land to a holistic farming system that now grows spring wheat, winter wheat, alfalfa, oats, peas and Kernza."

09:12 EDT Prudential appoints Susan Johnson as chief marketing officer - Prudential (PRU) announced that Susan Johnson will join the company as chief marketing officer, effective October 5. Johnson will be responsible for leading the company's global marketing and brand strategy and for helping to drive profitable growth for Prudential. Johnson joins Prudential from Truist Financial (TFC), the bank holding company formed in 2019 following the merger of SunTrust Bank and BB&T, where she was corporate executive vice president and chief marketing officer.

09:10 EDT Mack-Cali Realty announces $160M sale of office portfolio in New Jersey - Mack-Cali Realty announced the strategic sale of a 10-building, 1.5M-square-foot commercial portfolio in Morris County, NJ to a joint venture group, including Onyx Equities, Taconic Capital Advisors, L.P., Axonic Capital LLC, and Machine Investment Group for approximately $160M. The portfolio includes nine buildings located in Parsippany, NJ and a building in Madison, NJ.

09:09 EDT Western Union, Isabel Group team up to provide international payment services - Western Union said in a release, "Western Union announces a collaboration between its business division, Western Union Business Solutions, and Isabel Group, a provider of multi-bank services for both businesses and consumers and largest Fintech in Belgium. As part of its partnership, Western Union Business Solutions will provide worldwide connectivity to Isabel Group's multi-banking platform that enables organizations to manage their banking online and perform quick and easy payments. The Isabel 6 platform serves 70,000 professional user clients, and now collectively may access Western Union Business Solutions' unrivaled global payment network across over 200 countries and territories in more than 130 currencies around the world. Western Union Business Solutions' extensive global network, combined with knowledge of local markets, will help enable Isabel platform users to manage international payments simply, effectively, and efficiently. The expertise of Western Union Business Solutions' foreign exchange specialists on currency fluctuation and foreign exchange markets will assist clients in managing international payments and foreign exchange risk through a wide range of hedging product offering."

09:07 EDT Verizon expands connected device plans with Unlimited Plus - Verizon announced the expansion of connected device options with the Unlimited Plus plan, supporting the evolving needs of customers demanding more reliable coverage and backup access when at home or on the go. Unlimited Plus gives customers double the 4G LTE premium data for jetpacks, tablets and laptops, and includes unlimited access to blazing-fast 5G Ultra Wideband speeds when connected on 5G Ultra Wideband devices. Creators and doers can add Unlimited Plus to their existing wireless plan for $30 per month , and existing customers can upgrade their current unlimited connected device plan for just $10 more per month. The new Unlimited Plus plan includes 30 GB of premium 4G LTE data, up from 15 GB in the standard Unlimited plan, so power users can greatly increase their ability to stream video, send files and browse the web at faster speeds. Rather than fighting for Wi-Fi, the extra data helps manage increased needs for remote learning or work with a secure and personal connection. And, our connected device plans will include access to our upcoming 5G Nationwide network.

09:06 EDT Nasdaq grants Borqs' request for continued listing - Borqs Technologies announced it has received a letter dated September 14, 2020 from the Hearings Advisor of the Nasdaq Office of General Counsel as a result of the hearing that took place on August 27, 2020. The Nasdaq Hearings Panel has granted the request of Borqs to remain listed on The Nasdaq Stock Market subject to the condition that on or before September 30, 2020, the Company shall have filed a Form 20-F with the U.S. Securities and Exchange Commission. The Company thanks the Nasdaq Stock Market and intends to comply with the aforementioned condition. The Panel has the right to reconsider the terms of this decision based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company's securities on the Nasdaq Stock Market inadvisable or unwarranted. In addition, the Form 20-F will be subject to review by the Panel, which may, in its discretion, request additional information before determining that the Company has complied with the terms of its decision.

09:05 EDT Abbott launches Libre Sense glucose biosensor for athletes in Europe - Abbott is introducing the world's first glucose sport biosensor, Libre Sense Glucose Sport Biosensor, which is designed for athletes to continuously measure glucose to better understand the correlation between their glucose levels and their athletic performance. The Libre Sense biosensor is based on Abbott's FreeStyle Libre continuous glucose monitoring technology, originally developed for people living with diabetes. Abbott's Libre Sense Glucose Sport Biosensor, with CE Mark, is a consumer over-the-counter product that provides glucose monitoring via a mobile app to athletes 16 and older performing sports such as cycling, running, and swimming, to understand the efficacy of their nutrition choices on training and competition. To obtain glucose readings from Abbott's Libre Sense Glucose Sport Biosensor, athletes will wear the small round biosensor on the back of their upper arm. The biosensor will provide real-time glucose values and can be worn for up to 14 days. Abbott's Libre Sense Glucose Sport Biosensor will be available in the coming weeks directly, initially across eight European countries: Austria, France, Germany, Ireland, Italy, Luxembourg, Switzerland and the United Kingdom.

08:58 EDT Sorrento Therapeutics jumps 25% after FDA clears to proceed with STI-1499 trial - In pre-market trading, shares are up 25% to $10.44.

08:44 EDT Overstock announces California fulfillment center - Overstock.com (OSTK) recently opened a new fulfillment center in Fontana, California, in partnership with UPS Supply Chain Services (UPS). The new fulfillment center further aligns Overstock's logistical footprint with key customers, significantly improving shipping speed, providing more accurate delivery estimates as well as a quicker port to warehouse process. The Fontana, California fulfillment center commenced operations on August 3, 2020.

08:43 EDT CorMedix appoints Paulo Costa to board of directors - CorMedix (CRMD) announced the appointment of Paulo Costa to its Board of Directors. Paulo currently serves as Chairman of the Board of MacroGenics (MGNX).

08:41 EDT Enservco signs non-binding LOI to amend senior revolving credit facility - Enservco announced it has signed a non-binding letter of intent with East West Bank to amend its existing senior revolving credit facility to reduce bank debt by $16M, amend the current facility into a term loan and provide a new working capital revolving line of credit in exchange for equity in Enservco. Under the LOI, the parties will seek to enter into a definitive agreement providing that: EWB would reduce the current loan balance by $16M in exchange for eight million shares of Enservco restricted common stock and 15 million common stock purchase warrants. The current credit facility would be amended to reflect a term loan with a balance of approximately $17M and a new working capital revolving line of credit with no initial balance and a limit of $1M, both bearing interest at an annual rate of 8.25%, of which 3% will accumulate and be paid at maturity on October 15, 2021. The term loan would be interest only with potential for principal payments in the event Enservco reaches certain profit metrics and would mature in October 2021. The revolving line of credit would be based on Enservco's eligible receivables. The restricted common stock issued to EWB will be registered for resale by Enservco with the SEC to be tradeable within six months. The warrants will be exercisable beginning October 15, 2021, at a price of $0.25 per common share, an approximate 92% premium to Enservco's closing stock price on September 16, 2020. Enservco and EWB seek to close the debt restructuring in October 2020. The financial impact on Enservco of this proposed amendment and the recent Cross River conversion of half of its subordinated debt and accrued interest into equity is expected to be substantial. Upon completion, based on its balance sheet as of June 30, 2020, Enservco will have reduced its total debt by nearly 52% - from $35.5M to $18.5M. In addition, the Company's stockholders' equity would experience a positive swing of approximately $17.5M.

08:37 EDT Cardtronics 'continues to see improvement' in business across geographies - Cardtronics announced an update on recent business performance. The Company continues to see improvement in its business across geographies as governments further relax and remove restrictions implemented to mitigate the spread of COVID-19. Same-store withdrawal transaction performance in the U.S. since the beginning of 2020. Edward West, Cardtronics CEO, commented, "Our business continues to improve across our geographies as the restrictions implemented due to COVID-19 are lifted. We are also encouraged by our recent new business execution, solid pipeline of new business opportunities, and strong growth with Fintech partners. We continue to see positive industry trends, with both accelerating bank branch footprint rationalization and consumer demand for cash, with record high levels of cash in circulation. Our end-to-end platform provides the cash solutions that financial institutions need and consumers want." With two and a half months of the third quarter complete, the Company now estimates that its third quarter Adjusted EBITDA will approximate $70 million, reflecting recent business performance and outlook for the remainder of the quarter. Encouraging transaction activity across several markets, continued effective cost management and more favorable exchange rates are helping drive an improved profitability outlook for the third quarter. Included in this estimate are approximately $10 million in incremental benefits in the quarter following the recent legal decision by the Supreme Court in the U.K., removing business rates for certain ATMs. The Company now expects an Adjusted EBITDA margin of approximately 25% for the third quarter.

08:35 EDT Iteris awarded $1.1M contract by City of Moreno Valley - Iteris said in a release, "Iteris announced that it has been awarded a $1.1 million contract by the City of Moreno Valley to supply Iteris' Vantage Vector hybrid video and radar detection systems throughout the Southern California city. With the Vantage Vector hybrid detection system - an all-in-one detection sensor that combines video and radar for stop-bar and advanced zone detection - the City of Moreno Valley will be able to differentiate between vehicles, bicyclists and pedestrians, helping traffic to flow more efficiently and improving safety for all road users, while saving the city money and unnecessary construction by eliminating the need for in-ground hardware. The Vantage Vector detection system also provides robust data for smart mobility applications, automated traffic signal performance measures (ATSPM) software, and adaptive traffic control systems. In addition to its multimodal detection and differentiation capabilities, the Vantage Vector system integrates video detection with high-precision radar sensing technology to provide total coverage of the dilemma zone - the point at which a driver approaching a yellow signal has to make a split-second decision to either unsafely stop and risk a rear-end collision or proceed to cross the intersection, potentially running a red light and risking a right-angle crash. Vantage Vector's advanced dilemma zone detection capabilities mitigate these risks by either extending a signal phase to give drivers more time to react or enabling an all-red phase to avoid collisions while crossing the intersection."

08:33 EDT CVS Health to double COVID-19 drive-thru test sites nationwide by mid-October - CVS Health plans to add more than 2,000 new COVID-19 drive-thru test sites at select CVS Pharmacy locations across the country. With these new locations the company expects to have more than 4,000 operating by mid-October. The new locations will open in waves over the next several weeks. Currently, most test results from specimens collected at CVS test sites across the country will be available within 2 - 3 days.

08:25 EDT Allstate announces estimated August catastrophe losses of $985M - Allstate announced estimated catastrophe losses for the month of August of $985M, pre-tax. Catastrophe losses occurring in August comprised 11 events at an estimated cost of $969M , pre-tax, plus unfavorable prior period reserve reestimates. Estimated catastrophe losses for the month include the impacts of Hurricane Laura and Hurricane Isaias. Allstate previously announced that the impact of PG&E recoveries and July catastrophe losses generated income of $334M, pre-tax, bringing estimated catastrophe losses for July and August 2020 to $651M, pre-tax.

08:22 EDT Principia Biopharma doses first patient in Phase 2A trial of rilzabrutinib - Principia Biopharma announced that the first patient was dosed in an open label two-arm trial to evaluate rilzabrutinib in IgG4-related disease.

08:20 EDT OneSpan, ForgeRock form strategic partnership to secure remote banking - OneSpan has signed a strategic partnership with ForgeRock, to integrate OneSpan technologies into the ForgeRock Identity Platform. The combined solution leverages OneSpan's new integration with ForgeRock Intelligent Access to provide a single, open solution to simplify authentication, as well as risk and fraud management. Together, OneSpan and ForgeRock help banks and financial institutions orchestrate identity and access management while protecting customers from fraud.

08:19 EDT Hepion Pharmaceuticals reports 'positive activity' of CRV431 against SARS-CoV-2 - Hepion Pharmaceuticals said in a release, "Hepion Pharmaceuticals announced that a study of Hepion's CRV431 conducted by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH, demonstrated positive antiviral activity against SARS coronavirus-2 (SARS-CoV-2). Under NIAID's suite of preclinical services, or PCS, and with NIAID funding, Hepion was able to study the impact of CRV431 on SARS-CoV-2. This in vitro study tested CRV431 at concentrations of 0.0032 to 10 microM and a positive control compound, a protease inhibitor, at 0.032 to 100 microgram/ml in Caco-2 cells infected with SARS-CoV-2. CRV431 treatment was found to inhibit production of infectious virus in these cells with almost five-times greater potency than the positive control compound in this study. The concentration of CRV431 required to inhibit virus production by 90% (IC90) was 1.5 microM versus 7.3 microM for the positive control compound. Separate experiments that evaluated cellular toxicities independent of virus infection showed no significant CRV431 cellular toxicity, indicating that CRV431 antiviral activity was due to specific effects on the virus."

08:16 EDT Impact BioMedical completes efficacy testing of 3F Antiviral Biofragrance - Document Security Systems announced its wholly owned subsidiary Impact BioMedical, through its subsidiary Global BioLife, completed efficacy testing of its proprietary 3F Antiviral Biofragrance at a biosafety level 3 containment facility at an independent university. The study demonstrated a 10-fold reduction in COVID-19 viral population on surfaces using 3F Biofragrance. 3F Biofragrance was designed for the Open Air Defense Initiative, a strategy to protect locations where large numbers of people gather or transit such as airports, containment areas, train stations, convention centers, hospitals, and ports of entry. The Open Air Defense Initiative was created as a solution for Event 201, a pandemic exercise conducted in 2019 by the Johns Hopkins Center for Health Security, the World Economic Forum and the Bill and Melinda Gates Foundation. Event 201 highlighted areas where public/private partnerships are vital to respond to a severe pandemic. In addition to COVID-19, 3F Biofragrance is effective against E. coli, MRSA, Influenza, Rhinovirus, and Tuberculosis. In the latest study, 3F Biofragrance demonstrated success as a surface disinfectant, killing the COVID-19 virus in concentrations as low as 1/5000 or 0.02%. In comparison, typical antimicrobial surface disinfectants have concentrations of 0.1% to 1.8%. Impact BioLife is currently in joint development with multiple global cosmetics and consumer products companies for the commercialization of the 3F Biofragrance technology.

08:14 EDT Tabula Rasa supports legislation establishing medication risk prevention program - Tabula Rasa HealthCare announced that on Monday, September 14, TRHC Chairman and CEO, Calvin H. Knowlton, PhD appeared before the New Jersey Senate Health, Human Services and Senior Citizens Committee in support of a proposed amendment to Senate Bill No. 887, the Medicaid Prescription Drug Quality, Cost and Transparency Act. The proposed amendment would establish a medication risk prevention program within New Jersey Medicaid. In the U.S., ADEs contribute to more than 3.5 million physician office visits, 1.3 million emergency room visits, 350,000 hospitalizations, and extended lengths of stay, each year. A recent report from the Lown Institute, a nonpartisan healthcare think tank in Boston, found polypharmacy will lead to the premature death of more than 150,000 older Americans over the next ten years and will contribute to over $62 billion in hospitalizations for older adults alone. Additionally, Dr. Knowlton discussed in his testimony how TRHC's proprietary Medication Risk Mitigation technology, MedWise, cumulatively compares how medications interact together and identifies medication-related risks. A TRHC published study involving nearly 2,000 patients found that a reduction in the MedWise Risk Score resulted in fewer adverse drug events, emergency department visits, and hospitalizations and in lower medical costs.

08:13 EDT Just Energy announces update for closing plan of arrangement - Just Energy Group announced that it is only awaiting the approval of the Federal Energy Regulatory Commission to be able to close the Company's previously announced plan of arrangement. The FERC application was not subject to any interventions, comments or objections. As previously announced, Just Energy has obtained all required stakeholder approvals and the final order from the Ontario Superior Court of Justice enabling the Plan of Arrangement to proceed. The Plan of Arrangement includes a recapitalization that will strengthen and de-risk the business and position Just Energy for sustainable growth as an independent industry leader. The Recapitalization significantly improves Just Energy's financial flexibility with a cash injection of approximately C$100M from its equity raise and, among other things, reduces net debt and preferred shares by approximately C$520M.

08:13 EDT Dr. Reddy's announces Revlimid patent settlement with Celgene - Dr. Reddy's (RDY) announced the settlement of their litigation with Celgene, a wholly owned subsidiary of Bristol-Myers (BMY), relating to patents for Revlimid capsules. In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages are confidential. Dr. Reddy's is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

08:10 EDT Bionano Genomics announces results generated with Saphyr relating to ALS, DM - Bionano Genomics announced that teams from the Mayo Clinic and from the University of Florida have separately released results generated with Saphyr relating to Amyotrophic Lateral Sclerosis and Myotonic Dystrophy, respectively, two severe genetic disorders caused by the expansion of repetitive sequences in the genome. Saphyr identified repeat expansions in patients with ALS and DM that were so large that only Saphyr is capable of sizing them correctly. These findings help increase understanding of the disease-causing mechanisms and may lead to better diagnostic tests, support direct drug development and facilitate better identification of patients who are likely to respond to treatment. In a study published in bioRxiv, a team led by Dr. Eric Wang from the University of Florida used Saphyr to identify genomic variants that determine the severity of neurological symptoms caused by DM. These symptoms, caused by an abnormal processing of a number of brain-expressed genes, correlate with the length of a repeat expansion. The study helped demonstrate that ultra-long DNA analysis technology, such as Bionano's Saphyr, is crucial to enabling the accurate measurement of these repeat expansions. Separately, in an online presentation by Dr. Mark Ebbert from the Mayo Clinic, Saphyr data was used to measure the repeat expansion in the C9ORF72 gene that causes ALS. A large number of repeat sizes were detected in the brains of individual ALS patients, demonstrating how the expanded repeat is unstable and leads to increasingly large expansions. The amount of variation within individuals was previously underestimated due to the lack of accurate measurement techniques. In both cases, the disease-causing repeats were found to be tens of thousands of basepairs in length, too long to be accurately measured by currently available short-read and even long-read sequencing technologies. Additionally, the amount of variation within individual brain samples requires a single-molecule analysis method, like Bionano's genome imaging. The studies provide additional support for the utility of Bionano's single molecule, ultra-long DNA analysis technology in advanced disease research. In contrast, current diagnostic tests for large repeat expansions like the ones typically involved in DM and ALS are imprecise, lack the resolution and sensitivity to determine the size of the expansion and typically require confirmation with outdated methods like Southern Blot.

08:09 EDT National MI announces integration with Lender Price - National Mortgage Insurance Corporation announced that it is fully integrated with Lender Price, a cloud-based product, pricing and eligibility engine provider for the mortgage finance industry. Loan officers now have instant access to National MI's risk-based Rate GPS through the Lender Price PPE platform.

08:08 EDT Blueprint Medicines' BLU-945 shows anti-tumor activity in preclinical study - Blueprint Medicines announced preclinical proof-of-concept data for BLU-945, an investigational precision therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer. The new preclinical data showed BLU-945 "potently and selectively" inhibited triple-mutant EGFR harboring the most common on-target resistance mutations to standard treatments for EGFRm NSCLC, resulting in "robust" anti-tumor activity in multiple lung cancer models. The data were made available at the European Society of Medical Oncology Virtual Congress 2020. In preclinical data, BLU-945 inhibited triple mutant EGFR with sub-nanomolar potency and demonstrated greater than 900-fold selectivity over wild-type EGFR along with excellent overall kinome selectivity. BLU-945 monotherapy resulted in "robust" anti-tumor activity in multiple cell line-derived and patient-derived xenograft models of triple mutant EGFR NSCLC. In addition, BLU-945 treatment in combination with osimertinib or gefitinib resulted in tumor regression in a triple mutant EGFR NSCLC PDX model derived from a patient with progressive disease following five lines of prior therapy. BLU-945 was also highly active in an intracranial disease model. Based on these preclinical proof-of-concept data, Blueprint Medicines plans to develop BLU-945 as a monotherapy and in combination with other agents for the treatment of patients with osimertinib-resistant EGFR NSCLC. The company plans to initiate an international Phase 1 dose-escalation trial of BLU-945 in the first half of 2021. In addition, Blueprint Medicines expects to nominate a brain-penetrant development candidate targeting double mutant EGFR in Q4. The company plans to develop this candidate as both a monotherapy and in combination with BLU-945.

08:08 EDT Veritone awarded $1.3M of subcontracts under USAF program - Veritone said in a release, "Veritone announced that it has been awarded key subcontracts under a U.S. Air Force project that will use Veritone's aiWARE artificial intelligence operating system to increase the speed and accuracy of overhead imagery analysis. AFWERX, the Air Force's innovation unit, awarded a Phase II contract under the Small Business Innovation Research, or SBIR, program to prime contractor alYnmnt. Veritone has been awarded subcontracts for software license and technology development services totaling $1.3 million in support of this program. The Air Force Research Laboratory and AFWERX have partnered to streamline the SBIR process in an attempt to speed up the experience and broaden the pool of potential applicants. Under the terms of the Phase II contract, alYnmnt will develop software integrated with Veritone aiWARE to process overhead imagery using the optimal combination of AI object detection engines. The contract expectation is that aiWARE will significantly increase the speed, accuracy, throughput and productivity of imagery analysts by pre-processing intelligence imagery and video with object detection engines."

08:06 EDT CytRx announces Orphayzme receipt of FDA acceptance of arimoclomol NDA - CytRx highlighted that Orphayzme announced that the FDA has accepted, with priority review, the company's new drug application, or NDA, for arimoclomol for the treatment of Niemann-Pick disease Type C.

08:06 EDT Bed Bath & Beyond expands Google Cloud partnership - Bed Bath & Beyond (BBBY) announced that it has expanded its relationship with Google Cloud (GOOG, GOOGL) through a multi-year collaboration that will accelerate its omni-always transformation, enabling the Company to better serve customers in a digital-first environment as it rebuilds authority in the Home, Baby, Beauty and Wellness markets. To perform this work, Deloitte will serve as strategic transformation services partner. The company has committed to a five-year agreement with Google Cloud to deploy a range of platform solutions to further personalize the shopping experience for customers, enhance fulfilment capacity, and optimize merchandise planning and demand forecasting. Bed Bath & Beyond will leverage a number of Google Cloud technologies, including BigQuery, Spanner, Google Compute Engine and Google Kubernetes Engine, to establish a singular view of customer data across its portfolio of brands.

08:03 EDT Auris Medical initiates review of strategic options - The Company's Board of Directors has started a process to explore, review and evaluate a broad range of potential strategic alternatives. These alternatives include but are not limited to the partnering of its various clinical and preclinical programs, or a sale or merger of the Company, in an effort to unlock the potential of those assets and maximize shareholder value.

08:03 EDT Auris Medical sees 2020 total cash need CHF7M-CHF8.5M - The Company expects its total cash needs in 2020, including project AM-301, to be in the range of CHF 7.0 to 8.5 million for expected total operating expenses of CHF 4.5 to 5.5 million and expected capitalized research and development expenses of CHF 2.5 to 3.0 million.

07:33 EDT Rigel Pharmaceuticals starts Phase 2 trial to evaluate safety of fostamatinib - Rigel Pharmaceuticals announced the start of a multicenter, Phase 2 trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, in collaboration with Inova Health System. Fostamatinib, marketed in the U.S. as TAVALISSE tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia.

07:32 EDT SAIC awarded $185M task order to support USASMDC operations - The U.S. Army awarded SAIC a $185M single-award, cost-plus fixed-fee task order to support the Decision Support Division for the U.S. Army Space and Missile Defense Command, or USASMDC, in the areas of space, space control, high altitude, air and missile defense, and associated cyberspace operations. Under the task order, SAIC will continue to provide system utility analysis and combat development in support of the warfighter with analysis, execution experiments, exercises and war games, and modeling and simulation development and integration support. USASMDC develops and provides current and future global space, missile defense, and high altitude capabilities to the Army, joint force, and their allies and partners, to enable multi-domain combat effects; enhance deterrence, assurance, and detection of strategic attacks; and protect the nation. The prime contract has a one-year base period of performance and one one-year option.

07:31 EDT Third Point Reinsurance announces investment in Arcadian Risk Capital - Third Point Reinsurance announced an investment in Arcadian Risk Capital, a start-up led by John Boylan, a well-known industry executive with a 30-year track record in the global insurance market. Third Point Re will own a minority stake in the newly-formed company. Arcadian has been established as a Managing General Agent and incorporated in Bermuda where the company will initially operate. The new company has plans to open additional offices outside of Bermuda as its operations grow. Arcadian will begin writing business as of October 1, 2020, having already received approval from the Bermuda Monetary Authority. The MGA will initially write Excess Casualty and Professional Lines.

07:26 EDT ADC Therapeutics: Cami associated with clinically relevant modulation of cells - ADC Therapeutics said in a release, "ADC Therapeutics announced the presentation of an on-demand e-poster titled "First-in-Human Study of Camidanlumab Tesirine (ADCT-301, Cami), an anti-CD25 Targeted Therapy in Patients with Advanced Solid Tumors: Pharmacokinetics and Biomarker Evaluation" at the European Society for Medical Oncology Virtual Congress 2020. Preliminary findings indicate that treatment with Cami is associated with clinically relevant modulation of immune cells, both in the circulation and in tumor tissue, with mild to moderate inter-patient variability in tumor tissue. Increases in soluble CD25 and cytokines in serum post-dosing followed a similar pattern to increases in CD4-positive and CD8-positive T cells, suggesting an increase in activated lymphocytes. Changes in lymphocyte subpopulations in the blood resulted in a dose-related increase in the effector T cell (Teff) to regulatory T cell (Treg) ratio."

07:22 EDT Cantel Medical: 'Timing uncertain' on full recovery of elective procedures - While the impact of COVID on elective procedures was significant in Medical and Dental, daily sales rates improved over the course of the fourth quarter ahead of expectations. Estimated procedure volume continuously improved, following a trough in late April, to a level today in the 80% - 85% range of the pre-COVID period and are strengthening. While the company anticipates an eventual full recovery of elective procedures to pre-COVID levels, the timing remains uncertain.

07:17 EDT Provectus presents preliminary data from trial of PV-10, Keytruda - Provectus announced that preliminary response, safety, and immune correlative data from the Company's Phase 1b/2 study of small molecule autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus' proprietary rose bengal disodium, in combination with KEYTRUDA for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade will be presented at the European Society for Medical Oncology Virtual Congress 2020, held online from September 19-21, 2020. This combination therapy study first enrolled and treated CB-naive patients in its main cohort. A subsequent expansion cohort, the subject of the abovementioned ESMO poster presentation, enrolled and treated CB-refractory patients. Intralesional administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death and induce tumor-specific reactivity in circulating T cells.1-3 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with CB.4 In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. Summary CB-Refractory Cohort Data from the ESMO 2020 Presentation: Baseline characteristic: median age of 74 years. Disease characteristics: 60% Stage IV M1b-d; patients were refractory to single- and dual-agent CB treatment. Safety: Consistent with the established patterns for the single-agent use of each drug; principally grades 1 and 2 injection-site reactions for PV-10; principally grades 1 to 3 immune-mediated reactions for KEYTRUDA. Overall patient efficacy: 9% complete response, 36% overall response rate, and 64% disease control rate. Immune correlative analytes from the combination therapy, including damage-associated molecular pattern high mobility group box protein 1 and tumor specific functional T cell activity, exhibited systemic release similar to that previously shown in CB-naive patients receiving single-agent PV-10. Two-year landmark survival data from the CB-Naive Cohort were also presented at the ESMO Virtual Congress 2020. These data included 62% overall survival and median OS not reached; 10% CR and 67% ORR, including 82% ORR for Stage M1b-c patients; and a stable, non-overlapping safety profile equivalent to that of the CB-Refractory Cohort.

07:13 EDT Precision BioSciences, Servier expand CAR T oncology development collaboration - Precision BioSciences announced the companies have added two additional hematological cancer targets beyond CD19 and two solid tumor targets to its CAR T development and commercial license agreement. Under the terms of the existing development and commercial license agreement between Servier and Precision, Servier has selected two hematological and two solid tumor targets beyond those already in Precision's allogeneic CAR T pipeline. Precision intends to leverage its proprietary ARCUS genome editing platform and CAR T development and manufacturing expertise for early-stage research and development activities, including Investigational New Drug filing through the manufacturing of initial clinical trial material for a Phase 2 study. Servier has the right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States. With the addition of these new targets, Precision expects to receive milestone payments in 2020 and 2021. Precision is also eligible for option fees, clinical, regulatory, and sales milestones in addition to royalties on product sales.

07:11 EDT ALX Oncology added to Russell 2000, 3000 Indexes - ALX Oncology Holdings announced that it will be added as a member of the Russell 2000 and 3000 Indexes, effective after the U.S. market opens tomorrow, September 18, 2020, as a part of Russell's quarterly additions of select initial public offering companies.

07:11 EDT Passage Bio announces publication of preclinical gene therapy study data - Passage Bio announced publication of data supporting development of its gene therapy PBFTO2 for patients with frontotemporal dementia caused by mutations in the granulin gene. In the study, a single administration of an optimized adeno-associated virus containing the GRN gene resulted in elevated levels of progranulin in the brain and cerebral spinal fluid, reduced lysosomal storage lesions, normalized lysosomal enzyme expression and corrected microgliosis in a mouse model of progranulin deficiency. These data were published online September 16 in the peer-reviewed scientific journal Annals of Clinical and Translational Neurology. To identify a vector capable of achieving optimal expression levels of GRN, the study also evaluated three AAV serotypes in non-human primates. Following a single intra-cisterna magna injection of the AAV-GRN vectors, all non-human primates, regardless of AAV serotype, showed increased PGRN levels in the CSF. The injections were also well tolerated across serotypes. However, a single administration of an optimized AAV1-GRN vector showed the greatest CSF expression levels, reaching more than 50-fold the normal expression level. AAV1 also appeared to demonstrate extensive transduction of the ependymal cells that line the ventricles of the brain and are involved in the production of CSF. FTD is one of the more common causes of early-onset dementia, causing impairment in behavior, language and executive function, and occurs at similar frequency to Alzheimer's disease in patients younger than 65 years. In approximately 5% to 10% of individuals with FTD, the disease occurs because of mutations in the GRN gene, causing a deficiency of PGRN. PGRN is a complex and highly conserved protein thought to have multiple roles in cell biology, development and inflammation. Emerging evidence suggests that PGRN's pathogenic contribution to FTD and other neurodegenerative disorders relates to its critical role in lysosomal function. Results of the PBFT02 preclinical study were reported in the paper titled, "Adeno-associated virus serotype 1-based gene therapy for FTD caused by GRN mutations," by Christian Hinderer, M.D., Ph.D., and colleagues, including Dr. Wilson, from the Gene Therapy Program, Department of Medicine, University of Pennsylvania Perlman School of Medicine, Philadelphia, PA., an expert in gene transfer technologies. ACTN is an Official Journal of the American Neurological Association.

07:08 EDT Telus expanding high-speed internet service to additional 25,000 homes - TELUS is actively expanding its advanced high-speed wireless and PureFibre networks in Quebec to reach an additional 25,000 homes in 45 remote, low-density communities in the administrative regions of Chaudiere-Appalaches, Gaspesie, Lower St. Lawrence, and North Shore. This ambitious project will boost the economy in the Quebec region while providing local families and businesses with the digital tools they need to adapt their daily lives to the accelerating pace of digital activities during this unprecedented health crisis.

07:07 EDT Fluor given notice to proceed in $10B Hanford site cleanup contract - Fluor announced that the U.S. Department of Energy provided the joint venture between Amentum, Fluor and Atkins-Central Plateau Cleanup Company the notice to proceed on the Central Plateau Cleanup Contract at the Hanford Site near Richland, Washington. The Central Plateau Cleanup Contract is a master indefinite-delivery/indefinite-quantity contract valued at $10B for a period of up to 10 years, including a transition period of at least 60 days. The Central Plateau Cleanup Company brings three nuclear industry companies, Fluor, Amentum and Atkins.

07:05 EDT Bio-Techne, Qiagen announces expansion, extension of exosome partnership - Bio-Techne (TECH) and QIAGEN (QGEN) announced the expansion and extension of a non-exclusive partnership to co-market exosome technology to existing and potential biopharma partners as well as the joint development of new exosome based products. The agreement grants QIAGEN a non-exclusive development license to Bio-Techne's exosome technology for the development of companion in vitro diagnostic products for existing and potential biopharma partners. Following the agreement, both Bio-Techne and QIAGEN will be actively promoting the use of exosome technology to their respective global biopharma partners. The initial phase of the co-marketing agreement lasts 24 months, with the potential to extend longer upon the fulfillment of certain conditions. The two companies also announced the extension and expansion of the existing exclusive collaboration and license agreement that was originally in place between Exosome Diagnostics (now a Bio-Techne company) and QIAGEN. The agreement includes leveraging Exosome Diagnostics' proprietary platforms for biomarker discovery for the joint development of new products and for ongoing marketing activities to promote exosome technologies. The extended collaboration and joint product development agreement ends in 2028 and can be extended if mutually agreed to by both companies.

07:04 EDT Climb Channel Solutions adds CloudSaver to distribution line - Climb Channel Solutions will begin to distribute CloudSaver's managed AWS cost optimization solution. CloudSaver combines its proprietary technology with extensive managed services capabilities to significantly reduce a company's cloud infrastructure spend. CloudSaver is the only authorized AWS consulting partner who offers a fully outsourced cost optimization solution. CloudSaver's team of certified AWS engineers focus entirely on creating value for customers by eliminating unnecessary spend and optimizing resources.

07:03 EDT Moderna announces progress across broad portfolio - Moderna announced progress across its portfolio of pipeline assets being presented at the company's annual R&D Day. "The Moderna team has made significant progress since our last R&D Day 12 months ago. The pipeline has matured with our COVID-19 vaccine in a Phase 3 study and four candidates in Phase 2 studies. We are actively preparing for a potential commercial launch of mRNA-1273, our COVID-19 vaccine, and we continue to expand the breadth of Moderna's platform," said Stephane Bancel, Moderna's CEO. "We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly effective vaccines. In our systemic secreted & cell surface therapeutics core modality, we are sharing positive interim data for repeat dosing of our systemic mRNA therapeutic against chikungunya, which is important progress for our therapeutics modalities, particularly in rare diseases. With our second collaboration with Vertex, we are entering the field of gene editing using Moderna's technology. As we continue to scale for commercialization, we are more committed than ever to our mission to deliver on the promise of mRNA medicines to treat or prevent serious diseases."

07:02 EDT MetLife to acquire Versant Health for $1.68B in all-cash deal

06:58 EDT Hunt Companies Finance Trust increases quarterly dividend 13% to 8.5c per share - Hunt Companies Finance Trust announced the declaration of a cash dividend of 8.5c per share of common stock with respect to Q3, which represents a 13% increase over the Q2 dividend of 7.5c per share. The dividend is payable on October 15 to stockholders of record as of the close of business on September 30.

06:47 EDT Maxar Technologies to build Galaxy 37 geostationary satellite for Intelsat - Maxar Technologies announced it will build the Galaxy 37 geostationary communications satellite for Intelsat. Galaxy 37 is the sixth Intelsat geostationary communications satellite awarded to Maxar in 2020. Galaxy 37 will join four previously ordered satellites from Maxar in helping Intelsat transition its existing media distribution and contribution services-uninterrupted-from the 3.7 to 4.0 gigahertz portion of the C-band, to the 4.0 to 4.2 gigahertz portion of the band, freeing up spectrum for 5G terrestrial wireless services. Galaxy 37 will be based on Maxar's proven 1300-class spacecraft platform, which offers the flexibility and power for a broad range of customer missions. The satellite is scheduled for delivery in 2023.

06:39 EDT Mechel conducts sweeping repairs of washing plants - Mechel said in a release, "Mechel reports that a sweeping campaign of major repairs is being implemented at its mining division's washing plants. The total cost is over 1 billion rubles. The most large-scale repairs in terms of the scope of works are being held at Neryungrinskaya Washing Plant, which is part of Yakutugol Holding Company. The main stage of repair works has been completed in September. As part of the repair campaign, the plant replaced and restored trunk conveyors, as well as conveyors at the finished product loading area. Yakutugol's specialists and contractors assembled three new sizing screens and overhauled nine more. The plant also launched three new centrifuges for removing surplus moisture from coal concentrates. The plant's sludge pumps are being renewed. Five new magnetic roughers are due to be acquired before the end of the year. The plant also plans to repair two drying machines, one of which has been finished in September and the second is due to launch in October."

06:34 EDT Checkpoint Therapeutics' cosibelimab shows 51.4% response rate in MCSCC - Checkpoint Therapeutics announced updated interim results from the ongoing global, open-label, multicohort, Phase 1 clinical trial of its anti-PD-L1 antibody, cosibelimab, in patients with advanced cancers, including the registration-enabling cohort of patients with metastatic cutaneous squamous cell carcinoma. Cosibelimab demonstrated a 51.4% objective response rate and 13.5% complete response rate, which is nearly double the complete response rate observed at the time of previous analysis. This trial, upon successfully meeting the pre-defined endpoints, is intended to support marketing approval application submissions for cosibelimab worldwide. The interim results were presented in an e-poster at the European Society for Medical Oncology Virtual Congress 2020. As part of the interim analysis, 37 mCSCC patients were enrolled and evaluable for efficacy. 51.4% ORR; 13.5% of patients achieved a complete response and 37.8% of patients achieved a partial response. Median duration of response has not yet been reached, with 84.2% of responses ongoing, with the longest response duration at 24 months; responses were durable, with 91.7% of eligible responses having a duration of over 6 months. The trial continues to enroll patients, and full top-line results are expected in mid-2021.

06:33 EDT Eli Lilly, Amgen announce manufacturing collaboration for COVID-19 therapies - Eli Lilly (LLY) and Amgen (AMGN) announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the world should one or more of Lilly's antibody therapies prove successful in clinical testing and receive regulatory approval. "Based on our initial clinical studies, we believe that virus neutralizing antibodies, including LY-CoV-555, could play an important role in the fight against COVID-19," said Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories. "Increasing the manufacturing capacity for our neutralizing antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able to produce many millions of doses even next year."

06:31 EDT Apogee Enterprises announces planned retirement of CEO Joe Puishys - Apogee Enterprises announced that Joseph Puishys has communicated to the Board his intent to retire from his role as CEO and member of the company's Board of Directors effective February 27, 2021, the conclusion of the company's fiscal year. Joe has served as CEO and a member of the company's Board since 2011. The Board has initiated a process to identify the company's next CEO and has retained a leading executive search firm to support the process.

06:07 EDT Mersana reports interim Phase 1 data of XMT-1536 - Mersana Therapeutics reported updated interim safety, tolerability and efficacy data for the ovarian cancer cohort of the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, as part of the 2020 European Society of Medical Oncology Virtual Congress. CEO Anna Protopapas said, "These data further support the continued development of XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, which has recently been granted FDA Fast Track Designation. We are eager to advance XMT-1536 into registration-enabling studies based on its observed antitumor activity and favorable safety profile in an ovarian cancer population with a very poor prognosis and limited treatment options." This interim analysis focused on the ovarian cancer cohort of the Phase 1 expansion study. These data include 47 patients. Key findings include safety profile consistent with previously reported expansion data and no new safety signals observed; most frequently reported treatment-related adverse events were generally Grade 1-2 fatigue, nausea, decreased appetite, vomiting and transient AST elevation; no reported cases of severe neutropenia, peripheral neuropathy or ocular toxicity; continued, significant anti-tumor activity in platinum-resistant and platinum-refractory ovarian cancer and in ovarian cancer previously treated with bevacizumab, PARP inhibitors, or both; an objective response rate of 34%: additionally, 13/29 or 45% of patients achieved stable disease; the disease control rate was 23/29 or 79%; responses appeared to deepen over time, including responses in patients receiving reduced dose levels. reduction in tumor volume was observed in the majority of patients achieving a best response of stable disease. The company expects to define the patient selection strategy based on the total data set from patients treated with XMT-1536.

06:04 EDT 51job receives preliminary, non-binding proposal to acquire company - 51job said in a release, "51job announced that its Board has received a preliminary non-binding proposal letter dated September 17 from DCP Capital Partners to acquire all of the outstanding common shares of the Company for$79.05 in cash per common share. According to the Proposal Letter, the Proposing Buyer intends to fund the consideration payable in the Proposed Transaction with equity capital from the Proposing Buyer and debt financing. The Board plans to evaluate the Proposed Transaction. The Board cautions the Company's shareholders and others considering trading the Company's securities that the Board has just received the Proposal Letter and has not had an opportunity to carefully review or evaluate the proposal, or make any decision with respect to the Company's response to the proposal. There can be no assurance that any definitive offer will be made, that any definitive agreement will be executed relating to the proposed transaction or that this or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law."

06:01 EDT News Corp. announces plans to close Bronx printing plant - News Corp announced Wednesday that it plans to shift the printing of several of its publications in New York to a different facility in the city, a move which will help cut costs and secure production of print editions of The Wall Street Journal, Barron's and the New York Post for years to come. Under the change, the publications would be printed at The New York Times' College Point plant in Queens. This plan would result in the closure of the company's Bronx Print Plant, where the publications are currently printed. Financial details of the arrangement were not released. The company has notified the leadership of the unions representing the employees at the Bronx Print Plant about the plan, and is entering into a period of negotiation with the unions. While the process is underway, the publications will continue to be produced at the Bronx plant. The Bronx Print Plant produces daily print copies of the Journal and The Post, along with Barron's weekly. All three are also printed in a number of other locations around the country. The Journal and The New York Times are currently printed together at plants in Florida, Pennsylvania, Texas, Illinois, Colorado, Utah and California. The decision is part of News Corp's ongoing process of simplifying the structure of the company, which sold its News America Marketing and Unruly businesses within the past year. In August, News Corp began presenting Dow Jones as a separate segment in its quarterly earnings announcements for the first time. Dow Jones produces the Journal and Barron's, as well as Factiva, MarketWatch, Mansion Global, Financial News, Dow Jones Risk & Compliance and Dow Jones Newswires. "This is a difficult but important step towards safeguarding our journalism and securing the printing of our publications well into the future," said Almar Latour, CEO of Dow Jones and Publisher of The Wall Street Journal. "We have been moving rapidly to a more digital environment, and while demand for digital is growing, we also serve an important community of loyal readers who love the print experience. We're committed to providing customers with our trusted news and analysis in the format they prefer." The Bronx Print Plant has more than 400,000 square feet, located on a 16-acre site in the Port Morris section of the Bronx, and was opened in 2001. News Corp will be examining options for the future of the plant.

05:37 EDT Clovis to present data from oncology program at ESMO - Clovis announced the data being presented as e-posters at the European Society for Medical Oncology, or ESMO. These include initial data from the Phase 1b part of the LIO-1 study of lucitanib in combination with Opdivo, new analyses of data from the pivotal Rubraca ARIEL3 and TRITON2 studies, initial data from the Phase 1b part of the SEASTAR study arm of Rubraca with Trodelvy, and the first presentation of preclinical data for FAP-2286 Clovis' novel peptide-targeted radionuclide therapy. Data presented from the Phase 1b part of the Phase 1b/2 LIO-1 study in patients with an advanced solid tumor have identified the recommended starting Phase 2 dose of oral lucitanib to be used in combination with Opdivo and have shown promising signs of antitumor activity. The recommended oral starting dose of lucitanib was established as 6 mg once daily, to be given in combination with Opdivo at a fixed dose of 480 mg intravenously, or IV, once every 28 days. Across three dose levels studied, only one dose-limiting toxicity of Grade 3 proteinuria was observed among 17 patients, and there were no apparent differences in treatment-emergent adverse event, or TEAE, frequencies between dose levels. In this small patient population, TEAEs were consistent with those expected for lucitanib and Opdivo. Grade 3 TEAEs included hypertension, diarrhea and proteinuria; treatment-emergent hypertension was otherwise grade 1 or 2, and readily managed with close monitoring and early hypertensive therapy. No grade greater than or equal to 4 adverse events were reported. Given lucitanib's relatively large inter-patient pharmacokinetic variability, a safety-based dose-titration approach is being used for the Phase 2 part of the study to optimize lucitanib efficacy as well as safety and tolerability. Among the 17 patients treated, 15 were evaluable for RECIST response as of the efficacy cut-off date: these include one patient with a confirmed complete response, one patient with a confirmed partial response, 10 patients have had a best response of stable disease and three patients had progressive disease. As of August 11, seven of the 17 patients remained on study, including the two responders and five of the patients with stable disease. In addition to data from the Phase 1b part of the LIO-1 study, a Trials in Progress, or TiP, poster describing the study design of the Phase 2 part of LIO-1 was presented. The Phase 2 part of the study is currently enrolling patients to evaluate the efficacy and safety of the lucitanib and Opdivo combination in patients with advanced gynecological solid tumors, including ovarian, endometrial and cervical cancers. As described in the e-poster, a safety-based dose-titration approach is being used for lucitanib dosing to manage tolerability and maintain dose intensity. Investigators also presented new safety data analyses from the pivotal Rubraca studies ARIEL3 and pharmacokinetic, or PK, analyses of TRITON2, providing additional information to healthcare professionals that can help support their ovarian and prostate cancer patients being treated with Rubraca. The ARIEL3 data presented in an e-poster reinforce the overall safety profile of Rubraca as a maintenance treatment in patients with recurrent ovarian cancer. After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff, 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm. Prevalence of any-grade nausea declined progressively over the 24-month evaluation period, and prevalence of any-grade anemia/decreased hemoglobin peaked at month 4, decreasing to a plateau after month 8. The first onset of frequently reported TEAEs generally occurred early in treatment. The median duration of the first event of frequently reported TEAEs was generally less than60 days. Population pharmacokinetic, or PK, analyses of 199 men with mCRPC receiving Rubraca in the TRITON2 study suggest there is no difference in Rubraca PK in men with mCRPC and women with ovarian cancer based on a comparison to a previously-developed model that used data from 454 women with ovarian cancer treated with Rubraca. The data in men with mCRPC show that differences among patients in the amount of Rubraca in the blood after administration of Rubraca at a dose of 600 mg twice daily did not appear to impact the efficacy of treatment. Also, a higher maximum concentration of Rubraca in the blood was not associated with increased rates of most safety endpoints analyzed, including hematologic adverse events. These PK data and exposure and safety/efficacy correlations using data from the TRITON2 study support the use of Rubraca in eligible mCRPC patients with a starting dose of 600 mg twice daily. TRITON2 served as the pivotal data supporting the May 2020 FDA approval of Rubraca as the first PARP inhibitor for patients with advanced mCRPC associated with a BRCA mutation. Investigators also presented in an e-poster initial data from the arm of the Phase 1b/2 SEASTAR study evaluating Rubraca in combination with Trodelvy in patients with advanced solid tumors. Data from the Phase 1b part of the study suggest encouraging initial antitumor activity for the novel combination, including patients with prior PARP inhibitor exposure and without a deleterious homologous recombination repair gene mutation. Despite early toxicities, including dose-limiting neutropenia in two of the three patients in the higher dose cohort, all six patients continued treatment for at least 12 weeks, with side effects effectively managed with dose modification and/or growth factor support. One patient remained on treatment as of the August 11 data cut-off date. All patients had a best response of stable disease or better, including three patients with a confirmed partial response. And finally, the first data from a preclinical evaluation of FAP-2286, Clovis' novel peptide-targeted radionuclide therapy to fibroblast activation protein, or FAP, were presented in an e-poster. The data show that FAP-2286 potently and selectively binds FAP. FAP is highly expressed in cancer-associated fibroblasts present in the tumor microenvironment of most epithelial cancers and, in some cancers, its expression has also been observed in the tumor cells. Compelling anti-tumor activity was observed with 177Lu-FAP-2286 in FAP-expressing tumor models. Clovis Oncology plans to submit two investigational new drug applications in late 2020 for use of this novel radionuclide therapy as an imaging and treatment agent, respectively, and the company has planned clinical studies in a broad spectrum of FAP-positive cancers.

05:25 EDT ImmunoGen announces final data from FOWARD II trial at ESMO - ImmunoGen announced final data from the FORWARD II triplet cohort evaluating mirvetuximab soravtansine in combination with carboplatin and Avastin in patients with folate receptor alpha, or FRalpha-positive recurrent, platinum-sensitive ovarian cancer at the European Society for Medical Oncology, or ESMO. In the FORWARD II triplet cohort Phase 1b trial, 41 patients with a median age of 63 years received the combination of full dose mirvetuximab with carboplatin and bevacizumab. Eligibility criteria included patients with recurrent platinum-sensitive ovarian cancer that expressed medium or high levels of FRalpha, who had been treated with up to two prior lines of therapy. 73% of patients had one prior line of therapy and 27% had two prior lines of therapy, while 42% of patients had received prior PARP inhibitors, and 24% had received prior treatment with bevacizumab. In 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of FRalpha who have received up to two prior lines of therapy, the confirmed overall response rate, or ORR, for the triplet was 83%, with a median duration of response, or DOR, of 10.9 months and median progression free survival, or PFS, of 12.8 months. The company said, "These efficacy outcomes are encouraging relative to those reported in less heavily pretreated patient populations for other carboplatin and bevacizumab-based triplets." Mirvetuximab was readily combined and well tolerated with standard dosing of carboplatin and bevacizumab, with a manageable adverse event, or AE, profile as anticipated for this triplet based on the side effect profiles of each agent. Thrombocytopenia, a common adverse event with carboplatin treatment, was the most common cause of drug-related discontinuations. Post-carboplatin, mirvetuximab soravtansine and bevacizumab continuation and maintenance was well tolerated.

05:18 EDT Genocea to present GEN-009 follow-up data at ESMO - Genocea will present additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology, or ESMO. The results build on the Part B findings shared previously, which evaluated the preliminary immunogenicity and efficacy of GEN-009 in combination with standard-of-care checkpoint inhibitor-based regimens, or CPI, in an initial cohort of five patients with advanced solid tumors. All five patients received GEN-009 approximately four months following the start of CPI treatment. New follow-up scans, ranging from 91-233 days post-vaccination, confirm the previously disclosed findings, with tumor reduction or stable outcomes for all five patients, including three RECIST-criteria changes in tumor size after vaccination and likely attributable to GEN-009. The new results continue to suggest GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100% of patients had neoantigen-specific responses elicited by vaccination, in some cases with evidence of epitope spread. No significant adverse side effects were reported, with only mild symptoms associated with the vaccine adjuvant. The company expects to share additional immunogenicity and clinical data from the remaining 10 Part B patients later this year.

05:14 EDT Dasan Zhone, Tektraco Telecom collaborate on gigabit-ready hotels and facilities - Dasan Zhone announced that it is working with Tektraco Telecom on numerous gigabit-ready hotels and facilities and a country-wide, fiber-enabled water monitoring system in Malta. The two partners have leveraged the multi-terabit DZS FiberLAN portfolio to deliver fiber-based solutions.

05:08 EDT Sorrento Therapeutics receives FDA clearance to proceed with STI-1499 trial - Sorrento Therapeutics said in a release, "Sorrento Therapeutics announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies. STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain. Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient. The highest proposed dose (200 mg per patient) in the phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies. The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations. The STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the U.S. program."