Stockwinners Market Radar for May 29, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:26 EDT Humana awarded Medicaid contract from Kentucky CHFS - Humana has been selected by the Kentucky Cabinet for Health and Family Services to continue serving children and adults across the health company's home state of Kentucky through the Department for Medicaid Services. Humana currently provides coordinated medical, wellness, and pharmacy benefits coverage and services to 150,000 Kentucky Medicaid recipients. The new contract supports the company continuing its longstanding community presence, strong provider partnerships, and unique commitment to population health. "The decision by the Commonwealth of Kentucky means a great deal to all of us at Humana. As a company with deep roots in the Commonwealth and a team of 12,000 employees in Kentucky, our commitment to serve our members and improve health across Kentucky is unyielding," said Jeb Duke, Humana's Kentucky-based Medicaid leader. "We were born in the Bluegrass nearly 60 years ago, and we've been fortunate through the years to be able to help our families, friends and neighbors live healthier lives. We commend the state for moving forward with enhancements to Medicaid that will better support people receiving coverage through the program." Under the terms of Kentucky CHFS's agreement, the renewed Medicaid program will begin enrolling eligible Kentuckians in January 2021. The statewide program will provide health care to approximately 1.26 million Medicaid enrollees. The statewide contract term is set to last through 2024, with the potential for an additional six two-year contract extensions.

18:11 EDT Lufthansa board accepts commitments offered by Germany to EU - The Lufthansa Executive Board has decided to accept the commitments offered by Germany to the EU Commission for the stabilization package negotiated with the Economic Stabilization Fund of the Federal Republic of Germany. The scope of the conditions required in the EU Commission's view has been reduced in comparison with initial indications. Lufthansa will therefore be obliged to transfer to one competitor each at the Frankfurt and Munich airports up to 24 take-off and landing rights, i.e. three take-off and three landing rights per aircraft and day, for the stationing of up to four aircraft. For one and a half years, this option is only available to new competitors at the Frankfurt and Munich airports. If no new competitor makes use of this option, it will be extended to existing competitors at the respective airports. The slots will be allocated in a bidding process. The slots can only be taken over by a European competitor that has not itself received any substantial state recapitalization as a result of the corona pandemic. The Supervisory Board must approve the stabilization package negotiated with the WSF, including the commitments to the EU Commission. Subsequent to the Supervisory Board's decision, the company intends to convene an Extraordinary General Meeting in the near future to obtain shareholder approval for the WSF stabilization measures.

17:40 EDT Evolent Health: Passport Health not chosen for Kentucky MCO contract - Evolent Health announced that its partner, Passport Health Plan, received notification from the Kentucky Cabinet for Health and Family Services that Passport has not been awarded a Kentucky Managed Care Organization contract for the next contract period, which commences January 1, 2021. Evolent will support Passport in protesting this decision. Evolent will continue to provide services to Passport until the new Medicaid contracts take effect on January 1, 2021.

17:21 EDT General Dynamics awarded $3.42B Army contract for Hydra-70 rocket systems - General Dynamics was awarded a $3.42B hybrid contract for production and engineering services for Hydra-70 rocket systems. Bids were solicited via the internet with one received. Work locations and funding will be determined with each order, with an estimated completion date of September 30, 2026. U.S. Army Contracting Command is the contracting activity.

16:55 EDT Molina Healthcare wins Kentucky Medicaid contract - Molina Healthcare announced that its Kentucky health plan subsidiary has been selected as an awardee pursuant to the statewide Medicaid managed care RFP issued on January 10 by the Kentucky Cabinet for Health and Family Services, Department for Medicaid Services. The new contract for Molina's Kentucky health plan is expected to begin on January 1, 2021. Molina's Kentucky health plan is one of five managed care organizations selected to offer health care coverage to approximately 1.4M Medicaid beneficiaries through the Commonwealth of Kentucky's TANF, CHIP, and ABD programs.

16:53 EDT Green Growth Brands announces extension of stay under insolvency proceedings - Green Growth Brands provided an update on its insolvency proceedings under the companies' Creditors Arrangement Act, or CCAA. As announced on May 20, the company filed for insolvency protection under the CCAA and obtained an order from the Ontario Superior Court of Justice granting the applicants protection under the CCAA for an initial 10 day period until May 29. On May 29, the court extended the stay period until June 12 and adjourned to June 1 the hearing to consider a motion filed by the company to: increase the amount of the court-ordered charge over the applicants' assets, property and undertakings in connection with the applicants' debtor-in-possession financing agreement with All Js Greenspace; approve the implementation of a sale and investment solicitation process and approve a stalking-horse agreement among the company, All Js and Capital Transfer Agency in its capacity as the debentureholder trustee of the company's $45.5M aggregate principal amount of 15.00% secured convertible debentures that matured May 17 and $23.72M aggregate principal amount of 5.00% secured convertible debentures maturing in 2024 pursuant to which the Secured Credit Bidders would act as stalking-horse bidders under the SISP. The company intends to provide further updates on the CCAA proceedings and SISP process when there are significant developments.

16:42 EDT Exponent authorizes additional $45M share buyback - In a regulatory 8-K filing, Exponent announced it has "authorized an additional $45M for share repurchases adding to the existing $30M available under the current authorization for repurchase. In total, the company now has $75M available to repurchase shares."

16:31 EDT Mercer announces 30 days downtime at Celgar Mill - Mercer International reported that its Celgar mill, in addition to regularly planned maintenance downtime of five days, will be taking approximately 30 days of additional downtime in July. The additional downtime largely results from reduced fiber availability in the mill's procurement area as a result of Covid related sawmill curtailments in British Columbia, the imposition of sawlog equivalent stumpage charges on pulpwood and complex stumpage rules which result in a significant amount of pulp wood already harvested being left to burn in the forest.

16:25 EDT Red Robin up over 7.5% at $14.92 per share after Q1 sales update

16:22 EDT Pfizer shares down 8.4% following Phase 3 PALLAS Ibrance trial update

16:20 EDT Pfizer reports Phase 3 PALLAS Ibrance trial unlikely to meet endpoint - As announced by the Austrian Breast & Colorectal Cancer Study Group and the Alliance Foundation Trials, Pfizer reported that following a preplanned efficacy and futility analysis, the independent Data Monitoring Committee of the collaborative Phase 3 early breast cancer PALbociclib CoLlaborative Adjuvant Study, or PALLAS, determined that the trial is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival, or iDFS. Patients currently receiving Ibrance, or palbociclib, in the study will be advised about next steps by their physicians and long-term follow up of all patients will proceed as planned. No unexpected new safety signals were observed in patients receiving palbociclib. Health authorities and trial investigators have been notified of this decision. When available, the full results from the PALLAS study will be shared with the scientific community at a later date.

16:17 EDT Red Robin reports comparable restaurant revenue up 3.7% in first 8 weeks of Q1 - Reports comparable restaurant revenue down 43.2% in last 8 weeks.

16:13 EDT Fastenal's Dolan sells 15,000 common shares - In a regulatory filing, Fastenal director Michael John Dolan disclosed the sale of 15,000 common shares of the company on May 27 at a price of $40 per share.

16:08 EDT Red Robin CEO says 'very encouraged' by 5 sequential weeks of sales improvement - CEO Paul J.B. Murphy III says, "We are very encouraged by our five sequential weeks of sales improvement through May 24th due to the continued strong growth in off-premise sales and early traction in dine-in sales. We attribute these trends to our enhanced execution, developed around our strategic plan and implemented on an accelerated basis as restaurants re-open, which has resulted in record dine-in and off-premise Guest satisfaction scores. Across our 158 re-opened dining rooms, sales have been positively impacted by the accelerated implementation of our new hospitality model, coupled with strong health and safety standards. Notably, restaurants with re-opened dining rooms are still capturing meaningful off-premise sales, demonstrating the enduring and growing popularity of Red Robin for off-premise occasions."

16:07 EDT Red Robin reports preliminary Q1 revenue $306.1M, consensus $340.99M - Reports Q1 comparable restaurant revenue decreased 20.8% and comparable restaurant guest counts decreased 20.9%.

15:29 EDT PTAB rules in favor of Mylan, invalidating Sanofi Lantus SoloSTAR patents - Mylan N.V. (MYL) announced that the U.S. Patent and Trademark Appeal Board, or PTAB, has ruled in favor of Mylan in inter partes review proceedings finding, all challenged claims of Sanofi's (SNY) Lantus SoloSTAR device patents, U.S. Patent Nos. 8,603,044, 8,992,486, and 9,526,844 unpatentable. The PTAB found three claims of the 9,604,008 patent unpatentable, and two claims to be patentable. However, Mylan has previously obtained a covenant not to sue from Sanofi on the '008 patent and therefore this ruling does not impact Mylan's ability to launch upon final approval from the U.S. Food and Drug Administration. The PTAB also found Sanofi's proposed amended claims for the '486 and '844 patents unpatentable. Mylan CEO Heather Bresch stated: "Today's decision by the U.S. Patent and Trademark Appeal Board invalidating Sanofi's Lantus device patents is another significant milestone clearing the pathway for our insulin glargine product Semglee to come to market for the millions of Americans living with diabetes. We're pleased with the PTAB's decision, which will help bring competition to the marketplace and should reduce the cost of this critical medication."

15:03 EDT Pro-Dex jumps after being among 8 selected by NASA for COVID ventilator - NASA announced that after receiving more than 100 applications, its Jet Propulsion Laboratory has selected eight U.S. manufacturers to make a new ventilator tailored for coronavirus patients. The prototype, which was created by JPL engineers, received an Emergency Use Authorization from the Food and Drug Administration on April 30. Called VITAL, the high-pressure ventilator was designed to use one-seventh the parts of a traditional ventilator. "It offers a simpler, more affordable option for treating critical patients while freeing up traditional ventilators for those with the most severe COVID-19 symptoms," NASA said in a statement. The U.S. companies selected for licenses are: Vacumed, a division of Vacumetrics, Stark Industries, MVent, a division of Minnetronix Medical, iButtonLink, Evo Design,DesignPlex Biomedical, ATRON Group, and Pro-Dex (PDEX). Shares of Pro-Dex are up 67c to $19.92 in afternoon trading. Reference Link

14:57 EDT PRO-DEX among 8 companies selected by NASA for COVID-19 ventilator

14:43 EDT FDA approves Genentech's Tecentriq in combination with Avastin - Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. "We're excited that today's approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The application was reviewed under the FDA's Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world." "The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting," said Dr. Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. "For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile."

14:19 EDT Mack-Cali 'strongly disagrees' with ISS and Glass Lewis recommendations - Mack-Cali Realty issued a statement in response to the reports issued by Institutional Shareholder Services and Glass Lewis & Co. in connection with the company's annual meeting of stockholders scheduled for June 10, stating in part: "Mack-Cali strongly disagrees with ISS' and Glass Lewis's recommendations that shareholders vote on Bow Street Special Opportunities Fund XV, LP and certain of its affiliates' gold proxy card. Doing so would effectively give control of the Board to a 4.5% shareholder and would also likely result in the removal of the CEO during an unprecedented time for the world and real-estate industry. Recognizing that this outcome would be detrimental to the company and its shareholders, Glass Lewis has recommended that shareholders withhold support for several of Bow Street's nominees. Specifically, Glass Lewis noted Bow Street's many potential conflicts of interest and recommended that shareholders oppose efforts by Bow Street to gain control of the Mack-Cali Board of Directors."

13:30 EDT Occidental Petroleum cuts quarterly dividend to 1c from 11c - Occidental Petroleum said today that its board has declared a regular quarterly dividend of 1c per share on common stock payable on July 15, to stockholders of record as of June 15. This is an update to the company's previously announced dividend policy change from March 10, 2020, which reduced the quarterly dividend to 11c per share, the company said in a statement.

13:10 EDT Tyson says 326 of 1,604 team members tested positive for COVID at Texas plant - Tyson Foods announced the results of facility-wide testing for COVID-19 at its Sherman, Texas, case-ready beef and pork facility. Of the 1,604 team members who work at the facility and were tested, 326 tested positive. The total comprises 211 individuals who were tested by the Texas Division of Emergency Management with the National Guard onsite May 13 and 14. The additional 115 were tested when seeking care through their own health care providers. Team members who test positive receive paid leave and may return to work only when they have met the criteria established by both the CDC and Tyson, the company said in a statement. It added, "As it is doing at the Sherman facility, Tyson will disclose verified test results at other plants where it is conducting facility-wide testing to health and government officials, team members and stakeholders as part of its efforts to help affected communities where it operates better understand the coronavirus and the protective measures that can be taken to help prevent its spread." Reference Link

13:04 EDT Baker Hughes reports U.S. rig count down 17 to 301 rigs - Baker Hughes reports that the U.S. rig count is down 17 rigs from last week to 301 with oil rigs down 15 to 222, gas rigs down 2 to 77, and miscellaneous rigs unchanged at 2. The U.S. Rig Count is down 683 rigs from last year's count of 984, with oil rigs down 578, gas rigs down 107, and miscellaneous rigs up 2 to 2. The U.S. Offshore Rig Count is unchanged at 12 and down 11 year-over-year. The Canada Rig Count is down 1 rig from last week to 20, with oil rigs down 1 to 7 and gas rigs unchanged at 13. The Canada Rig Count is down 65 rigs from last year's count of 85, with oil rigs down 37 and gas rigs down 28.

13:01 EDT Baker Hughes reports U.S. rig count down 17 to 301 rigs

12:41 EDT Taubman jumps 3.5% to $41.98 after invite sent for Simon deal vote

12:17 EDT Taubman Centers trading resumes

12:12 EDT Taubman Centers trading halted, volatility trading pause

12:04 EDT Blackstone appoints former Hhead of FDA and CMS as Senior Advisor - Blackstone announced the appointment of Dr. Mark McClellan, a physician and economist who served as both the commissioner of the U.S. Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services, as a Senior Advisor. "Dr. McClellan will bring his expertise across the life sciences, healthcare, economics and public policy sectors to advise across the firm's businesses, with a focus on Blackstone Growth and Blackstone Life Sciences," the company said.

12:00 EDT Triumph Group falls -19.2% - Triumph Group is down -19.2%, or -$1.75 to $7.37.

12:00 EDT Arcus Biosciences rises 13.7% - Arcus Biosciences is up 13.7%, or $3.86 to $32.07.

12:00 EDT Culp, Inc. rises 18.4% - Culp, Inc. is up 18.4%, or $1.25 to $8.04.

11:21 EDT Trump tweets 'REVOKE 230!' in apparent reference to Twitter - In an apparent reference to Twitter (TWTR) and other social media companies, President Trump just tweeted "REVOKE 230!" Earlier this morning, he had tweeted that "Section 230 should be revoked by Congress. Until then, it will be regulated!"Reference Link

10:49 EDT FCC chair asks Twitter if Iran leader violated same rule as Trump - Ajit Pai, chairman of the Federal Communications Commission, said in a tweet, "Serious question for @Twitter: Do these tweets from Supreme Leader of Iran @khamenei_ir violate 'Twitter Rules about glorifying violence'?" Reference Link

10:22 EDT Embraer trading resumes

10:19 EDT Citi CEO: Capital markets 'wide open and running'

10:17 EDT Embraer trading halted, volatility trading pause

10:04 EDT Deere names John Stone President of Construction, Forestry and Power - Deere & Company announced that its board elected John Stone to the position of President, Worldwide Construction & Forestry and Power Systems, effective July 1. Stone who joined the company in 2002 and has managed its global utility tractor product line and headed corporate strategy.

10:00 EDT Triumph Group falls -10.0% - Triumph Group is down -10.0%, or -91c to $8.20.

10:00 EDT Canopy Growth falls -16.6% - Canopy Growth is down -16.6%, or -$3.61 to $18.11.

10:00 EDT Williams-Sonoma rises 10.2% - Williams-Sonoma is up 10.2%, or $7.43 to $80.46.

09:56 EDT Bristol-Myers CEO says 'very much on track' with ide-cel resubmission - During an interview on CNBC, Bristol-Myers CEO Giovanni Cafori said the company is "very much on track" for a resubmission to the FDA for its Biologics License Application for idecabtagene vicleucel, or ide-cel, which should be completed "no later than July." In May, Bristol-Myers and bluebird bio (BLUE) announced that the companies received a Refusal to File letter from the FDA regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma.

09:47 EDT DXC Technology falls -14.1% - DXC Technology is down -14.1%, or -$2.34 to $14.23.

09:47 EDT Canopy Growth falls -20.8% - Canopy Growth is down -20.8%, or -$4.51 to $17.21.

09:47 EDT RYB Education rises 9.8% - RYB Education is up 9.8%, or 28c to $3.13.

09:43 EDT Alibaba first hour presales for 6.18 event up five times versus last year - Alibaba Group on Monday kicked off presales for its annual 6.18 shopping campaign, an event aimed at fueling post-pandemic economic recovery in China. By the end of the first hour of presales, total gross merchandise volume had increased by five times compared to the previous year, while sales in the beauty category exceeded $69.94M just seven minutes into the event, according to Alizila, the news hub for Alibaba Group. Reference Link

09:34 EDT Nevada reports April statewide gaming win down 99.6% to $3.65M - Reports Las Vegas Strip gaming win down 99.3% to $3.4M. Publicly traded companies in the casino space include Boyd Gaming (BYD), Caesars (CZR), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN) and Wynn Resorts (WYNN).

09:30 EDT Tracon highlights updated Envafolimab results in MSI-H/dMMR colorectal cancer - Tracon highlighted data from poster #11511 at the American Society of Clinical Oncology 2020 Virtual Scientific Program, entitled, "Multicenter phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma : Results of expansion cohorts." Investigators from the Alliance for Clinical Trials in Oncology, a broad community of scientists and clinicians who are committed to the prevention and treatment of cancer, reported an impressive 29% confirmed objective response rate in patients (n=14) with highly refractory Undifferentiated Pleomorphic Sarcoma who received Opdivo in combination with Yervoy in a non-comparative randomized trial. TRACON recently reported on the results of poster #3021 at ASCO 2020, entitled "Envafolimab in Advanced Tumors with Mismatch-Repair Deficiency," which was presented by the Company's corporate partners, 3D Medicines and Alphamab Oncology, and showed that single agent envafolimab demonstrated a 30.0% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) or those with advanced gastric cancer who failed at least one prior systemic treatment (n=11), who had at least two on-study tumor assessments. The confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.

09:19 EDT SI-Bone announces Aena positive coverage for MIS SI joint fusion - SI-BONE announced that Aetna has established a positive coverage policy for minimally invasive SI joint fusion. The new policy covers minimally invasive arthrodesis of the sacroiliac joint for sacroiliac joint syndrome and sacroiliac joint pain. This decision was based upon the extensive amount of published clinical evidence demonstrating the safety and effectiveness of the iFuse Implant System, including recently published 5-year results from a long-term prospective study called LOIS. The new policy becomes effective May 28, 2020.

09:15 EDT Aura Minerals expects to gradually resume activites at San Andres, Aranzazu - The company said, "At the Company's San Andres mine, and as previously announced, mining operations were interrupted pursuant to orders of the Honduran government in response to the Pandemic and Aura has reduced its workforce to the minimum in order to maintain tailings and continue to satisfy environmental requirements in connection with operations and other critical activities at the mine. On May 26, 2020, as part of the Honduran government's efforts to reopen the economy , Minerales de Occidente, S.A. de C.V., the Company's subsidiary which owns the surface and mineral rights of the San Andres mine, as well as its main contractor, were granted permission from local authorities to resume operations. The Company expects it will be able to gradually and safely resume activities at San Andres over the next few weeks. At Aranzazu, and also as previously announced, the Mexican government issued a decree requiring the suspension of all non-essential activities in the private and public sectors on March 31, 2020. Accordingly, the Company suspended all non-essential operations at Aranzazu while maintaining only critical activities, as allowed by the decree. On May 12, 2020, mining was deemed an essential activity by the Mexican authorities, and the Company has obtained formal authorization to fully restart operations at Aranzazu on May 27, 2020. The Company expects it will be able to gradually and safely resume activities at Aranzazu over the next few weeks. The gradual ramp-up of activities at San Andres and at Aranzazu will involve the implementation of a series of best practice biosafety protocols and ongoing monitoring of the situation at both sites. A more complete, non-exhaustive description of all actions being taken by the Company at all of its operations as a result of the Pandemic can be found in the Company's management's discussion and analysis for the quarter ending on March 31, 2020."

09:13 EDT Marimed expects to launch Kalm Fusion into Nevada's cannabis market - The company said, "MariMed continues to expect state approval for the transfer of its client The Harvest Foundation medical and adult-use cannabis cultivation license. The Company has recently upgraded the cultivation site located in Clark County and serves the wholesale market. Revenue from cultivation is expected to increase significantly in 2020 and when transfer is approved will be included in MariMed's income reporting. The Company has contracted with a licensed processor for the production and distribution of its Betty's Eddies fruit chews and Kalm Fusion products. MariMed recently launched its award-winning Betty's Eddies edibles into Nevada's adult-use cannabis market and expects to launch Kalm Fusion into Nevada's cannabis market in the near future."

09:11 EDT Marimed expects significant revenue growth from Mass. operations through 2020 - The company said, "Q1 2020 was the first full quarter that MariMed's licensed subsidiary, ARL Healthcare, was fully operational, having received approval in the fourth quarter of 2019 from the Massachusetts Cannabis Control Commission to open its 70,000 square foot cannabis cultivation and production facility in New Bedford, and its medical cannabis dispensary Panacea Wellness in Middleborough. During the first quarter, MariMed completed its first harvest of its proprietary cannabis genetics at its cultivation and production facility, and commenced full scale selling operations in this state's robust cannabis market. Our wholesale business has increased each month as has the revenue from Panacea Wellness Dispensary which opened on December 19, 2019. Since opening, the Company has introduced its proprietary genetics and strains to the Massachusetts medical market under its flower brand Nature's Heritage, as well as its infused product brands Betty's Eddies, Kalm Fusion and "Bourne Baked Goods". The Company recently launched Tropizen Pique, a popular Caribbean cannabis infused hot sauce, and plans to roll out other exclusive brands such as Binske and Tikun Olam, across Massachusetts in 2020. Massachusetts operations are expected to contribute significant revenue growth throughout the remainder of 2020, reflecting the statewide product shortage and continued growth in consumer demand. Massachusetts has deemed dispensaries operating under the medical program essential, allowing MariMed to continue to ensure its medical cannabis patients continue to have access to the medicine they need at this time, unimpeded by COVID-19. Furthermore, the Company was recently granted three provisional adult-use licenses by the CCC for cultivation, production, and a dispensary. The cultivation and production licenses will be utilized at its New Bedford manufacturing facility and the dispensary license at its Panacea Wellness and at two new Massachusetts dispensaries planned for development in 2020. The Company expects to begin selling cannabis products for adult-use in the coming months, pending final inspections by the agency."

09:06 EDT Heartland BancCorp appoints Jim Heimerl, Jack Kenkel to board - Heartland BancCorp announced that at the Company's annual meeting, James R. 'Jim' Heimerl and John G. 'Jack' Kenkel were duly elected as directors of the company, effective May 19, 2020. These individuals were also appointed to the Board of Directors of Heartland Bank in March 2020. Heimerl is the patriarch of Heimerl Farms, a family-run farming operation located northeast of Columbus in Johnstown, Ohio, and one of the largest hog producers in Ohio. Kenkel is the Founder, former President and CEO of Victory Community Bank, Victory Mortgage Corp. and Victory Bancorp.

09:04 EDT Tecogen to voluntarily delist from Nasdaq, transition listing to OTC Markets - Tecogen notified Nasdaq that Tecogen is voluntarily de-listing its shares of common stock from Nasdaq's Capital Market and de-registering its shares under Section 12(b) of the Securities Exchange Act of 1934. The company said in a release, "The Company intends for its shares of common stock to be quoted on the OTC Markets Group Inc.'s OTCQX Best Market. Tecogen has identified cost savings opportunities associated with moving the company's listing to OTC Markets, including reduced annual maintenance fees and potential reductions in the costs and management attention required in connection with certain compliance matters."

08:57 EDT Live Ventures CEO Jon Isaac completes open market share purchase - Live Ventures Incorporated announced that Jon Isaac, its President and CEO, purchased 28,672 shares of the company's common stock for a total purchase price of approximately $263,000. The shares were purchased in the open market on May 28, 2020.

08:56 EDT Pacific Ethanol expects to report positive EBITDA for Q2, FY20

08:52 EDT Tetraphase announces second amendment to merger agreement with AcelRx - Tetraphase Pharmaceuticals (TTPH) announced that it has entered into a second amendment to the Agreement and Plan of Merger, dated March 15, as amended on May 27, to which the Company is a party with AcelRx Pharmaceuticals (ACRX) and its merger subsidiary, to increase the consideration payable to Tetraphase shareholders. Tetraphase said in a release, "Under the amended Merger Agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, $0.5872 in cash and 0.7409 of a share of AcelRx common stock, representing approximately $1.70 in upfront per share value, based on the closing price of AcelRx's common stock as of the close of trading on May 28, 2020, in each case subject to downward adjustment in the event that the Company's closing net cash is less than $5.0 million, and one contingent value right, or CVR, which would entitle the holders to receive potential aggregate payments of up to $16.0 million in cash upon the achievement of certain future XERAVA net sales milestones starting in 2021. Under the terms of the Merger Agreement prior to the second amendment, upon the consummation of the transaction, Tetraphase stockholders were entitled to receive for each share of Tetraphase common stock, $0.2434 in cash and 0.7217 of a share of AcelRx common stock, in each case subject to downward adjustment in the event that the Company's closing net cash is less than $5.0 million, and one CVR, which would have entitled the holders to receive potential aggregate payments of up to $14.5 million in cash or AcelRx stock, at AcelRx's option upon the achievement of future XERAVA net sales milestones starting in 2021. AcelRx proposed the second amendment to the Merger Agreement in response to a proposal from Melinta Therapeutics, on May 27, to acquire Tetraphase for $34.0 million in cash (or $1.52 per share of Tetraphase common stock), plus an additional $16 million in cash potentially payable under CVRs upon the achievement of certain future XERAVA net sales milestones starting in 2021. The boards of directors of Tetraphase and AcelRx have each approved the second amendment to the Merger Agreement. Tetraphase's board of directors has determined that as a result of the second amendment to the Merger Agreement with AcelRx, Melinta's proposal is not superior and recommends the Merger Agreement, as amended by the amendment, to its stockholders. Based on the closing price of AcelRx stock on May 28, 2020, the total upfront consideration to be received by Tetraphase equityholders is valued at approximately $37.0 million, with approximately $18.7 million of this amount allocated to the Company's outstanding common stock warrants. In the merger, Tetraphase stockholders would also be entitled to receive, for each share of Tetraphase common stock, one non-tradeable CVR, the holders of which will be entitled to receive potential payments of up to an additional $16.0 million in cash in the aggregate upon the achievement of net sales of XERAVA(TM) in the United States, payable as follows: (i) $2.5 million upon annual net sales of $20.0 million during 2021, (ii) $4.5 million upon annual net sales of $35.0 million during any year ending on or before December 31, 2024 and (iii) $9.0 million upon annual net sales of $55.0 million during any year ending on or before December 31, 2024. The special meeting of Tetraphase's stockholders to approve the pending transaction is scheduled for June 8, 2020. The transaction is expected to close in June 2020, subject to specified closing conditions, including Tetraphase having a minimum amount of net cash as of the closing and approval by Tetraphase stockholders. Upon the closing of the transaction, Tetraphase will become a privately held company and shares of Tetraphase's common stock will no longer be listed on any public market. Subject to certain limited exceptions, the CVRs will be non-transferable."

08:51 EDT TG Therapeutics announces final results of GENUINE Phase 3 study - TG Therapeutics announced the final results from the GENUINE Phase 3 study evaluating the combination of ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody, plus ibrutinib compared to ibrutinib alone in patients with previously treated high-risk chronic lymphocytic leukemia at the 56th American Society of Clinical Oncology annual meeting. Details of the data presentation are included below. Presentation Title: Effect of Adding Ublituximab to Ibrutinib on PFS, ORR, and MRD Negativity in Previously Treated High-Risk Chronic Lymphocytic Leukemia: Final Results of the GENUINE Phase III Study : The GENUINE trial is an open-label, multicenter, randomized, Phase III study in relapsed or refractory high-risk CLL. This presentation includes data from 117 patients treated with either ublituximab plus ibrutinib or ibrutinib alone. As of the cut-off date of September 1, 2019, patients had a median follow-up time of 41.9 months. The primary endpoint for this trial was overall response rate as determined by an independent review committee. The secondary endpoints included progression free survival and complete response rate as determined by an IRC, and undetectable minimal residual disease assessed by central lab. Efficacy and safety highlights include: The addition of ublituximab to ibrutinib compared to ibrutinib monotherapy significantly improved ORR, complete response/complete response with incomplete blood count recovery rate, and increased rates of uMRD in patients with relapsed/refractory CLL with high-risk cytogenetics. At a median follow-up of 41.9 months, median PFS was not reached in the ublituximab plus ibrutinib arm and was 35.9 months in the ibrutinib monotherapy arm, with del17p/TP53mut patients seeing the greatest difference in PFS. The addition of ublituximab to ibrutinib did not significantly alter the known safety profile of ibrutinib however the combination resulted in slightly higher rates of neutropenia and atrial fibrillation.

08:49 EDT Myovant Sciences announces additional data from Phase 3 HERO study - Myovant Sciences announced additional results from its Phase 3 HERO study of once-daily, oral relugolix in men with advanced prostate cancer in an oral presentation at the American Society of Clinical Oncology's ASCO20 Virtual Scientific Program and simultaneous publication in the New England Journal of Medicine. The data expand on earlier findings from the HERO study, demonstrating the superiority of relugolix to leuprolide acetate across multiple endpoints, and further show that treatment with relugolix was associated with a lower risk of major adverse cardiovascular events compared to leuprolide acetate. Relugolix met the primary endpoint and demonstrated superiority to leuprolide acetate across six key secondary endpoints, all with p-values less than 0.0001. In the primary endpoint responder analysis, 96.7% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels through 48 weeks, compared to 88.8% of men treated with leuprolide acetate. Detailed secondary endpoint data, presented and published today, showed notable differences in the rapid and profound suppression of testosterone, PSA response, and testosterone recovery after discontinuation of treatment. In the relugolix group, testosterone suppression to less than 50 ng/dL was achieved in 56.0% of men by Day 4 and 98.7% by Day 15, compared to 0.0% by Day 4 and 12.1% by Day 15 for men in the leuprolide acetate group. Additionally, in the relugolix group, profound testosterone suppression to less than 20 ng/dL was achieved in 78.4% of men at Day 15, compared to 1.0% at Day 15 for men in the leuprolide acetate group. A higher proportion of men in the relugolix group achieved a 50% reduction in PSA by Day 15 and confirmed at Day 29 compared to those in the leuprolide acetate group. Within 90 days of treatment discontinuation, 54% of men in the relugolix group achieved normal testosterone levels with a mean testosterone level of 288.4 ng/dL, compared to 3% of men in the leuprolide acetate group with a mean testosterone level of 58.6 ng/dL. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events compared to men in the leuprolide acetate group. Additionally, in men with a history of these events, the relugolix group had 80% fewer major adverse cardiovascular events reported compared to the leuprolide acetate group. More than 90% of men in the HERO study had at least one cardiovascular risk factor, including lifestyle risk factors such as tobacco use and obesity, comorbidities such as diabetes and hypertension, and prior history of a major adverse cardiovascular event. As previously reported, the incidence of adverse events in the HERO study was comparable for relugolix and leuprolide acetate groups. The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, mild to moderate diarrhea, and arthralgia. Myovant submitted a New Drug Application to the FDA for relugolix in April 2020, which, if approved, would be the first and only oral gonadotropin-releasing hormone receptor antagonist treatment for men with advanced prostate cancer.

08:47 EDT NextCure presents biomarker data, results form NC318 trial at ASCO - NextCure announced the presentation of biomarker data and updated clinical results from the Phase 1 portion of its ongoing Phase 1/2 monotherapy trial with NC318 at the 2020 Virtual American Society of Clinical Oncology, ASCO20, Annual Meeting. NC318 is a monoclonal antibody targeting Siglec-15 (S15), a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells. "Because this is a trial in progress with limited samples, we cannot draw definitive conclusions, but we believe these early biomarker data provide additional evidence of NC318 activity," said Kevin N. Heller, M.D., NextCure's chief medical officer. "We expect to receive additional insight from the Phase 2 portion of our ongoing trial, which will include additional biomarker analyses."

08:46 EDT Charles & Colvard appoints Don O'Connell as president, CEO - Charles & Colvard announced that its Board of Directors appointed Don O'Connell to the position of President and CEO, effective June 1, 2020. He will also join the Company's Board of Directors. O'Connell, who most recently served as COO and SVP, Supply Chain of Charles & Colvard, succeeds Suzanne Miglucci, who resigned as President and CEO and as a member of the Board of Directors, effective June 1, 2020.

08:44 EDT Affimed N.V. highlights study design of AFM13 REDIRECT Trial - Affimed N.V. shared details of its AFM13 REDIRECT clinical trial design and rationale at the American Society of Clinical Oncology 2020 Annual Meeting, being held in virtual format on May 29-31, 2020. AFM13 is a first-in-class innate cell engager that induces specific and selective killing of CD30-positive tumor cells by engaging and activating NK cells and macrophages thereby leveraging the power of the innate immune system. As detailed in the poster at ASCO, REDIRECT is a registration-directed trial with AFM13 as monotherapy in patients with relapsed/refractory peripheral T cell lymphoma or transformed mycosis fungoides. The study is actively recruiting.

08:41 EDT Iovance presents data for TIL therapy lifileucel in advanced melanoma at ASCO - Iovance Biotherapeutics presented long-term interim data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma during an oral session at the American Society of Clinical Oncology's ASCO20 Virtual Scientific Program. "We are very pleased to present the long term follow up data for lifileucel in melanoma at the ASCO Scientific Program," said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. "The median duration of response has not been reached at 18.7 months of study follow up supporting potential benefit of the one-time treatment of lifileucel TIL therapy in advanced melanoma patients. The latest data at ASCO also demonstrate durable responses with lifileucel across the broad spectrum of our study population, including a wide age range of metastatic melanoma patients who have received prior anti-CTLA-4 and BRAF targeted treatments, and equally in patients with PD-L1 high and low status." Jason Chesney, MD PhD, Director, James Graham Brown Cancer Center, University of Louisville and C-144-01 study investigator stated, "One of the greatest challenges oncologists face today is the treatment of melanoma patients who have progressed on immune checkpoint and BRAF/MEK inhibitors. The preliminary results of the C-144-01 study demonstrate that autologous tumor infiltrating lymphocytes (TILs; lifileucel) induce durable clinical responses in a significant percentage of this moribund population. Importantly, this new study opens the door for trials of TILs in many other cancer types and in combination with our growing repertoire of immunomodulatory agents."

08:40 EDT BeiGene presents updated reslts from Phase 3 trial of zanubrutinib vs. ibrutinib - BeiGene announced follow-up data from the Phase 3 ASPEN trial comparing BRUKINSA to ibrutinib for the treatment of Waldenstrom's macroglobulinemia and long-term follow-up data from a Phase 1/2 study in patients with treatment naive and relapsed/refractory WM, presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program. While the ASPEN trial did not achieve statistical significance on its primary endpoint of superiority in complete response and very good partial response rates for zanubrutinib compared to ibrutinib, zanubrutinib demonstrated a numerically higher VGPR rate, as well as clinically meaningful improvements in safety and tolerability compared to ibrutinib. Additional five-month investigator-assessed follow-up data in the overall patient population reinforced the trend toward higher VGPR rates for zanubrutinib and advantages in safety. In a separate presentation of Phase 1/2 long-term follow-up data, rates of VGPR/CR increased with continued zanubrutinib treatment and the therapy was well tolerated. Data presented from the Phase 3 ASPEN trial include the 201 patients in the randomized cohort of patients with WM and a MYD88 mutation. At data cutoff of August 31, 2019, with 19.4 months median follow-up: The combined CR+VGPR rate as assessed by independent review committee for the overall intent-to-treat population was 28.4% in the zanubrutinib arm and 19.2% in the ibrutinib arm; The combined CR+VGPR rate as assessed by investigators for the overall intent-to-treat population was 28.4% in the zanubrutinib arm and 17.2% in the ibrutinib arm; Most common grade greater than or equal to 3 adverse events for zanubrutinib compared to ibrutinib included hypertension, neutropenia, pneumonia, anemia, and thrombocytopenia; Categories of AEs of interest for BTK inhibitors for zanubrutinib compared to ibrutinib included atrial fibrillation/flutter of any grade, bleeding of any grade, major hemorrhage, diarrhea, hypertension; neutropenia, infection, and second malignancy; Despite higher rates of grade greater than or equal to 3 neutropenia among AEs of interest in the zanubrutinib arm rates of infection were similar in patients taking zanubrutinib and ibrutinib; and In the zanubrutinib arm, four patients discontinued treatment due to AEs and one patient had an adverse event leading to death; in the ibrutinib arm, nine patients discontinued due to AEs and four patients had an adverse event leading to death.After an additional five-months of follow-up with a data cutoff of January 31, 2020, with 24.2 months median follow-up: CR+VGPR as assessed by investigator for zanubrutinib was 30.4% compared to 18.2% for ibrutinib; Categories of AEs of interest for BTK inhibitors for zanubrutinib compared to ibrutinib included atrial fibrillation/flutter of any grade, bleeding of any grade, major hemorrhage, diarrhea, hypertension; and neutropenia. Despite higher rates of grade greater than or equal to 3 neutropenia in the zanubrutinib arm, rates of infection remained similar in patients taking zanubrutinib and ibrutinib; and No additional patients discontinued treatment due to AEs in the zanubrutinib arm, compared to an additional five patients in the ibrutinib arm. No additional patients had an adverse event leading to death in both arms. Additional data from the ASPEN trial presented in an abstract included 28 patients who were centrally determined at study entry to have the MYD88WT or mutation unknown genotype. These patients were enrolled into a non-randomized cohort assigned to receive zanubrutinib 160mg twice daily. As of August 31, 2019, the median follow-up was 17.9 months and 17 patients remained on study treatment. Updated results included: In the 26 centrally confirmed MYD88WT patients, the overall response rate assessed by IRC was 80.8%, with a major response rate of 50.0%, including a VGPR rate of 26.9%; Progression-free survival event-free rate at 12 months was 72.4%; In this cohort of 28 patients with MYD88WT or mutation unknown genotype, the most frequently reported AEs were diarrhea, anemia, contusion, pyrexia, and upper respiratory tract infection. Major hemorrhage was reported in 2 patients, and atrial fibrillation was reported in 1 patient. There were no fatal AEs; and Two patients discontinued zanubrutinib due to adverse events, and 6 patients discontinued due to disease progression. Data presented from the Phase 1/2 trial evaluating zanubrutinib in patients with treatment-naive or relapsed/refractory WM include: As of January 29, 2020, with a median follow-up of 35.3 months, 73% remained on treatment; The ORR was 96% and the VGPR/CR rate was 46%; The proportion of patients achieving a best response of VGPR or CR increased with treatment duration; Three-year PFS event-free rate was 80%, and overall survival was 83%; Reasons for treatment discontinuation included AEs in 13% of patients, disease progression in 10%, and other in 4%; The most commonly reported AEs were upper respiratory tract infection, contusion, cough, and diarrhea; 62.3% of patients experienced at least one grade greater than or equal to3 AE and five patients experienced AEs leading to death;AEs of interest included minor bleeding, hypertension, major hemorrhage, and atrial fibrillation/flutter.

08:38 EDT Celsion DSMB recommends to proceed to Phase II of the Ovation 2 study - Celsion announced the final recommendations of the Data Safety Monitoring Board, DSMB, following completion of the Phase I dose-finding and tolerance portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer. Based on favorable safety data from 15 randomized patients, the DSMB has recommended that the Phase II portion of the OVATION Study proceed with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose limiting toxicities were reported. The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy in order to treat any remaining tumor after the surgery.

08:37 EDT Cardiff Oncology presents new data from Phase 1b/2 trial of onvansertib - Cardiff Oncology announced additional positive efficacy and favorable safety data were featured in a virtual oral poster presentation at the American Society of Clinical Oncology conference. The new data from Cardiff Oncology's ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer continues to demonstrate that primary efficacy endpoint of overall objective response, as measured by tumor regression, is ten-fold greater than current standard-of-care of 4%. To-date, 89% of evaluable patients in the onvansertib trial have achieved a clinical response and the response appears durable with patients having progression-free survival of at least 6 months. Onvansertib has also shown its effectiveness in targeting the most prevalent KRAS mutation subtypes associated with colorectal cancer, which until recently have been considered to be undruggable.

08:34 EDT Heat Biologics presents HS-110/Opdivo combination Phase 2 trial data at ASCO - Heat Biologics (HTBX) presented its latest data at the ASCO Annual Meeting. Heat said in a release, "HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer testis antigens, or CTAs, to elicit a diverse and robust T-cell attack against tumor cells. A Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's (BMY) Opdivo (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer, or NSCLC, is ongoing, with enrollment of this trial completed in July 2019. This data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor, or CPI, naive patients with advanced NSCLC; with a median overall survival, or mOS, of 28.7 months for the intent-to-treat, or ITT, patients. This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction. Exploratory biomarker analyses showed that overlapping CTA expression in patients' tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival."

08:34 EDT Defense Innovation Unit picks Zscaler for secure cloud management project - Zscaler announced that the Defense Innovation Unit, DIU, a U.S. Department of Defense organization, selected Zscaler to deliver a secure cloud management solution. Zscaler will provide zero trust access to protect DIU users and cloud services from cyberthreats no matter where personnel are working or what devices they are using. With a successful DIU prototype, the Zscaler solution has the potential to scale to other DoD organizations through a production Other Transaction agreement. DIU strengthens U.S. national security by accelerating adoption of commercial technology throughout the Department of Defense. The DIU secure cloud management solution, powered by the Zscaler platform, will allow DIU users to securely access SaaS applications across Amazon Web Services, Google Cloud and Microsoft Azure. Zscaler Internet Access (ZIA) and Zscaler Private Access can protect organizations across a multi-cloud environment with a wide range of applications and infrastructure including SaaS, PaaS and IaaS environments. Zscaler is a zero trust leader with proven benefits and leadership including: Security at scale: DIU expects the solution to be able to scale to 500,000 concurrent users and 1 million endpoints. Zscaler is architected to handle an unlimited number of concurrent individual user connections. The Zscaler platform processes more than 100 billion transactions per day, blocks approximately 100 million threats per day and applies approximately 120,000 security updates daily to protect customers.

08:32 EDT Galera announces data from restrospective anaylsis of avasopasem manganese - Galera Therapeutics announced new data from a retrospective analysis of pre- and post-treatment markers of kidney function of patients treated with lead candidate avasopasem manganese in its Phase 2b trial for the reduction of chemoradiation-induced severe oral mucositis. The data are featured in an American Society of Clinical Oncology 2020 Virtual Scientific Program poster presentation now available for on-demand viewing in ASCO's virtual program. Avasopasem is a highly selective small molecule superoxide dismutase mimetic initially being developed for the reduction of radiation-induced toxicity severe oral mucositis. Galera's completed Phase 2b clinical trial evaluated avasopasem in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of concurrent radiation therapy and cisplatin, the current standard of care for head and neck cancer patients, plus either 30 mg or 90 mg of avasopasem or placebo. Each year in the United States, approximately 65,000 patients are diagnosed with head and neck cancer, according to the American Cancer Society, and nephrotoxicity from cisplatin-based chemotherapy occurs in up to 68 percent of head and neck cancer patients treated. The retrospective analysis evaluated changes in kidney function markers in a subset of 52 Phase 2b trial participants and 7 matched comparator patients who all received high dose cisplatin once every three weeks. Post-treatment kidney function markers indicated patients who received 90 mg avasopasem had significantly less cisplatin-induced chronic kidney disease compared to placebo. Specifically, treatment with 90 mg avasopasem demonstrated statistically significant improvements in return of kidney function to normal ranges after chemoradiotherapy, as measured by serum creatinine levels between three and 24 months, estimated glomerular filtration rate between three and 24 months, and blood urea nitrogen levels at three, six and 18 months, compared to placebo. A significant reduction in the incidence of CKD at 12 months, compared to placebo, was also observed.

08:31 EDT AgeX Therapeutics announces collaboration with Sernova - AgeX Therapeutics and Sernova announced a research collaboration where Sernova will utilize AgeX's UniverCyte gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernova's Cell Pouch for the treatment of type I diabetes and hemophilia A. The companies said in a release, "The goal is to eliminate the need for immunosuppressive medications following Cell Pouch cell transplantation. The research collaboration will evaluate whether Sernova's pluripotent stem cell-derived pancreatic islet beta cells engineered with AgeX's UniverCyte technology can evade human immune detection. The complementary combination of technologies could enable the transplantation of therapeutic cells in patients with type I diabetes in an off-the-shelf manner using Sernova's Cell Pouch, without human leukocyte antigen, or HLA, tissue matching or concurrent administration of immunosuppressive medications. With a similar intent, pluripotent stem cell-derived or adult donor-derived human Factor VIII-releasing cells modified with AgeX's UniverCyte will be evaluated in Sernova's hemophilia A program. Under the terms of the agreement, Sernova has been granted a time-limited, non-exclusive research license by AgeX. A commercial license for Sernova to utilize UniverCyte to engineer cellular products for therapeutic and commercial purposes may be negotiated between the companies pending successful study outcomes. Sernova plans to utilize the universal therapeutic cells generated through this research collaboration with its Cell Pouch System, a proprietary, scalable, implantable macro-encapsulation device, which, upon implantation, incorporates with tissue and forms highly vascularized chambers. These chambers become a natural environment in the body to house and favor long-term survival and function of therapeutic cells. The Cell Pouch System has shown initial safety and efficacy indicators in an ongoing Phase I/II clinical study at the University of Chicago and in a preclinical model of hemophilia A when assessed with human cells corrected to produce Factor VIII."

08:30 EDT Rapt Therapeutics announces poster presentation for Phase 1/2 trial of FLX475 - RAPT Therapeutics announced the presentation of a Trials in Progress poster for the ongoing seamless Phase 1/2 clinical trial of FLX475, a small molecule CCR4 antagonist in development for multiple tumor types. The poster was presented at the American Society of Clinical Oncology 2020. The poster presentation detailed previously reported initial Phase 1 healthy volunteer data for FLX475 that demonstrated excellent safety, pharmacokinetics and target engagement. FLX475 is designed to block regulatory T cells from migrating to tumor sites, where they suppress immune system responses to cancer cells, without depleting regulatory T cells in the rest of the body nor immune cells required for an anti-tumor response. A robust pharmacodynamic assay measuring receptor occupancy on circulating regulatory T cells demonstrated that FLX475 achieved exposure levels over the targeted 75%, predicting maximal inhibition of regulatory T cell recruitment into tumors via CCR4 signaling. In addition, levels of FLX475 increased in a dose-proportional manner, with a strong PK/PD correlation observed between drug levels and receptor occupancy. Building on these data, RAPT initiated a seamless Phase 1/2 study of FLX475. The Phase 1 portion of the trial was a standard dose escalation study in patients with many types of cancer, and the Phase 2 portion is evaluating FLX475 both as monotherapy and in combination with a checkpoint inhibitor in patients with "charged" tumors, which are tumors that express high levels of CCR4 ligands, and have a high presence of regulatory T cells and CD8+ effector T cells. RAPT is currently enrolling the Phase 2 portion of the trial in patients with charged tumors, including non-small cell lung cancer, triple negative breast cancer, head and neck squamous cell carcinoma, cervical cancer as well as EBV-positive nasopharyngeal cancer and lymphomas.

08:27 EDT Communications Systems makes minority investment in Quortus - Communications Systems announced that in collaboration with cellXion Ltd., a UK based provider of specialist telecoms solutions, it has made a minority investment in Quortus, "a UK based company that creates agile and feature-rich private wireless networks for enterprises across a wide variety of vertical sectors including healthcare, retail and utilities." Roger Lacey, CEO of CSI noted, "This strategic partnership with Quortus and cellXion will provide our mutual clients with a range of comprehensive solutions designed to help build their mobile edge capabilities and support a wide array of industrial IoT initiatives."

08:27 EDT IMV Inc. reports updated clinical response, data from DeCidE1 study - IMV Inc. reported updated clinical response and translational data from DeCidE1, its Phase 2 study evaluating the safety and efficacy of DPX-Survivac with intermittent low-dose cyclophosphamide, or CPA, in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer. Results from the ongoing study showed prolonged durable clinical responses, alongside favorable tolerability, and strong translational data linking the observed clinical benefit with DPX-Survivac' mechanism of action. As of data cut-off date, May 2, 19 patients were evaluable for efficacy with four patients still receiving treatment. Notably, 18/19 evaluable patients had stage 3 or 4 disease at time of diagnosis, the majority of whom had received greater than three lines of prior therapy and were platinum resistant. Key findings on the safety and efficacy of DPX-Survivac/CPA are: 5/19 patients achieved a PR with tumor regression greater than 30% on target lesions, 15/19 patients achieved disease control, defined as stable disease, or SD, or partial response, or pr, on target lesions.Tumor shrinkage of target lesions was observed in 10 patients. Overall, treatment was well-tolerated. The majority of treatment-related adverse events reported were Grade 1 events and related to reactions at the injection site. Durable clinical benefits lasting six months were observed in seven patients. Seventy-one percent have now reached duration of clinical benefit greater than 10 months including three patients with PR and two patients with SD The two patients with SD are about to reach the one-year mark. Translational analyses on longitudinally collected peripheral blood mononuclear cell, or PBMC, and tumor tissue samples link observed clinical benefit and survivin-specific T cells, supporting DPX-Survivac's mechanism of action. Treatment generated a survivin-specific CD8+ T cell response in PBMC samples of 14/16 evaluable patients. Treatment induced infiltration of survivin-specific T cell clones into the tumors as early as day 56 following treatment, which was shown in an analysis of the TCRss repertoires in five subjects who achieved stable disease.

08:26 EDT Ligand announces expansion of Icagen license agreement with Roche - Ligand Pharmaceuticals (LGND) and Icagen, a Ligand Company, announced the expansion of Icagen's license agreement with Roche (RHHBY) to develop and commercialize small molecule ion channel modulators for the treatment of neurological disorders, by adding a second program to the agreement. "The new program incorporates Icagen's ion channel technology and expertise and is directed at a specific novel ion channel target relevant to neurodegenerative disease. The new program is in addition to ongoing work on another novel CNS target," the company said in a release. "Icagen's collaboration with Roche was a key value-driver in the acquisition of the Icagen business, and we are very pleased to see this expansion and extension of the relationship," said John Higgins, CEO of Ligand. "This type of deal fits perfectly within the Ligand strategy to establish and leverage partnerships with global leaders in the industry as they look to access our technology for their drug discovery and development needs. The Icagen team has been a great addition to Ligand's business."

08:24 EDT Harpoon Therapeutics presents data from dosing trial for TriTAC HPN424 at ASCO - Harpoon Therapeutics presented interim data from the ongoing dose-escalation portion of a Phase 1 trial for HPN424 in patients with metastatic castration-resistant prostate cancer at the American Society of Clinical Oncology 2020 Virtual Scientific Program. HPN424 targets prostate-specific membrane antigen and is based on Harpoon's proprietary Tri-specific T cell Activating Construct platform designed to recruit a patient's own immune cells to kill tumor cells. The presentation highlights interim results in 44 patients across 11 dosing cohorts treated with HPN424 from the ongoing dose escalation portion of a Phase 1 clinical trial. As of the May 11, 2020 cut-off date, initial data demonstrate: HPN424 is generally well-tolerated and support long-term treatment, and cytokine-related adverse events have been transient and manageable. Pharmacokinetic data support weekly dosing and pharmacodynamic data support T cell activation as measured by reduction in circulating tumor cells, increased serum cytokine levels and T cell margination after HPN424 administration. Early signals of clinical activity include eight patients who remained on study treatment for greater than 24 weeks. In addition, eight patients exhibited decreases in PSA levels compared to baseline, including two who showed PSA (prostate-specific antigen) reductions of at least 50%. "We are particularly encouraged by data supporting the predicted mechanism of action of HPN424, and the early signs of clinical activity in this heavily pretreated population," stated Gerald McMahon, Ph.D., President and CEO, Harpoon Therapeutics. "These initial data from our lead program represent the first of four product candidates in our TriTAC clinical portfolio that can provide multiple opportunities to accelerate our pipeline into more advanced clinical studies."

08:23 EDT Deciphera presents data from cohort of Part 2 of rebastinib Phase 1b/2 at ASCO - Deciphera Pharmaceuticals announced the presentation of data from the endometrial cancer cohort of Part 2 of its ongoing Phase 1b/2 clinical trial of rebastinib, the Company's investigational orally administered, potent and selective inhibitor of the TIE-2 kinase, in combination with paclitaxel. Deciphera said in a release, "The presentation, titled "An open-label, multicenter, phase 1b/2 study of rebastinib in combination with paclitaxel in a dose expansion cohort to assess safety and preliminary efficacy in patients with advanced or metastatic endometrial cancer," will be featured during a poster session at the American Society of Clinical Oncology, or ASCO, 2020 Virtual Scientific Program. The Phase 1b/2 study of rebastinib in combination with paclitaxel is a two-part, open-label, multicenter study assessing the safety, tolerability, anti-tumor activity and pharmacokinetics of rebastinib in patients with advanced or metastatic solid tumors. Data previously presented from Part 1 of the study demonstrated encouraging preliminary anti-tumor activity, with objective responses seen across a heavily pre-treated patient population, including patients with prior exposure to paclitaxel. As previously announced, both the endometrial and ovarian cancer cohorts in Part 2 of the study advanced into the second stage of the Simon two-stage design based on demonstrating at least five responses in each cohort."

08:22 EDT Atossa Therapeutics announces publication on SARS-CoV-2 - Dr. Steven Quay, MD, PhD, physician-scientist and CEO of Atossa Therapeutics, Inc. announced that he and Dr. Martin Lee, PhD, Adjunct Professor of Statistics, UCLA Fielding School of Public Health, UCLA, Los Angeles, CA have published a manuscript entitled, "SARS-CoV-2 was spreading in the United States in late December 2019 and may have killed over 440 patients in California and 980 nationwide by mid-January." The manuscript is available here: SARS in the US in Dec 2019. The study identifies a well-accepted epidemiology signal of COVID-19, internet searches for the loss of smell and/or taste, spiking in California the first two weeks of 2020, clearly indicating symptomatic patients in California at that time. The study also identifies about 980 deaths nationwide and 440 deaths in California in early January that were attributed to pneumonia and/or influenza but are likely to have been incorrectly diagnosed and are, with high probability, the first deaths from COVID-19 in the U.S. COVID-19 Survival Manual: A Physician's Guide to Keep You and Your Family Healthy during the Pandemic and Beyond This book is chock-full of lifesaving tips you can't find anywhere else to help you and your family stay safe while sheltering-in-place, as well as how to get back to life in the coming weeks and months.

08:19 EDT Bio-Path Holdings presents trial design of its Phase 2 study of BP1001 at ASCO - Bio-Path Holdings announces the presentation of a poster highlighting the clinical trial design of its Phase 2 study of BP1001 (prexigebersen) at the 2020 American Society of Clinical Oncology, ASCO, Annual Meeting, taking place virtually from May 29-31. The poster, titled, "A Phase II Study of BP1001 (liposomal Grb2 antisense oligonucleotide) in Patients with Hematologic Malignancies," was presented virtually by Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center. The poster describes the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company's lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome, MDS. "This innovative trial design for BP1001 is unique in that it allowed us to adjust our treatment to include newly approved therapies that we believed would be enhanced from combination with our DNAbilize technology. We believe this robust design will provide for the best outcomes for patients and will be the most expeditious route to bringing BP1001 to market. We are delighted o have the design presented and expect that it will enhance visibility for our DNAbilize platform and its versatility among an audience dedicated to bringing new cancer treatments to patients," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

08:16 EDT Marker Therapeutics reports results from MultiTAA-specific T cell therapy - Marker Therapeutics announced updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma. Between June 2018 and December 2019, 13 patients have been treated, each of whom received up to 6 monthly infusions of 1x107 MultiTAA-specific T cells/m2 in conjunction with ongoing first-line chemotherapy and without prior protocol-associated lymphodepletion. For 12 of the 13 patients, sufficient cells for all six planned doses were generated; two doses were available for the remaining patient. Out of the 13 evaluable patients: 4 patients experienced objective responses after administration of MultiTAA cells; 1 patient experienced a radiographic complete response occurring at month 9 after starting chemotherapy; 3 patients experienced partial responses per RECIST occurring at 6-9 months after starting chemotherapy;6 patients experienced stable disease; 1 patient experienced a mixed response (some lesions increased in size and others decreased for a net zero change in size of tumor lesions); 2 patients experienced disease progression; For 9 of the 13 patients, the cancer was controlled for a period longer than historical controls relative to the type of chemotherapy used; 5 patients enrolled in the study were not administered MultiTAA-specific T cells, either because of disease progression (4 patients) which made them ineligible for treatment, or because insufficient starting material from the patient was available for manufacturing (1 patient); Evidence of epitope-spreading was observed in all responders, suggesting that the MultiTAA T cell therapy triggered the recruitment of a broader endogenous immune system response for improved anti-tumor activity; No infusion-related reactions, cytokine release syndrome or neurotoxicity was observed.

08:16 EDT Gilead announces updated results from magrolimab trial - Gilead announced updated results from a single-arm, open-label Phase 1b trial of magrolimab, an investigational anti-CD47 monoclonal antibody, in combination with azacitidine in previously untreated patients with higher-risk myelodysplastic syndrome, or MDS, and previously untreated patients with acute myeloid leukemia, or AML, who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML, a high unmet need population. Results continue to support the clinical activity of magrolimab and azacitidine. The data were presented during an oral session at the American Society of Clinical Oncology, or ASCO. At the time of the data cut-off, 68 patients had been treated with magrolimab plus azacitidine, including 39 patients with previously untreated higher-risk MDS and 29 patients with previously untreated AML. Of 33 MDS patients who were evaluable for efficacy, 91% achieved an objective response including 42% with a complete response, or CR. Responses to magrolimab and azacitidine also deepened over time, as the CR rate with at least six months of follow-up was 56% in MDS patients. In AML, 64% of patients evaluable for efficacy achieved an objective response, including 56% with a CR or a CR with incomplete blood count recovery, or CRi. Notably in TP53-mutant AML, a treatment refractory and poor prognosis population, 75% achieved a CR or CRi. Median duration of response and median overall survival have not yet been reached in MDS, AML or TP53-mutant AML, with a median follow-up of 5.8, 9.4 and 8.8 months, respectively. The safety profile of the combination of magrolimab plus azacitidine was generally consistent with prior reports with no maximum tolerated dose reached. Common all-grade treatment-related adverse events, or AEs, among 68 patients with MDS or AML were anemia, fatigue, neutropenia, thrombocytopenia and infusion reaction. Treatment-related febrile neutropenia occurred in 1.5% of patients. Only one patient discontinued the trial due to a treatment-related AE.

08:15 EDT Corvus presents updated data from Phas 1b/2 trial of ciforadenant - Corvus Pharmaceuticals announced updated results from its Phase 1b/2 clinical trial of ciforadenant, its adenosine A2A receptor antagonist, in patients with advanced refractory renal cell carcinoma. The new data supports and refines the utility of the Adenosine Gene Signature, which was discovered by Corvus, as a predictive biomarker to identify RCC patients most likely to respond to treatment with ciforadenant. The discovery of the AdenoSig was described in a research article published in Cancer Discovery in January 2020. In the publication, for 30 patients with available tumor biopsies, AdenoSig positive patients had a 17% objective response rate by RECIST criteria compared to 0% in AdenoSig negative patients. In the new data, which covers over 50 patients, the ORR remained 17% for the Adenosine Gene Signature and improved to 27% with the refined version of the test, which is based the measurement of CD68 positive myeloid cells, the downstream target of adenosine. The updated data covers 51 RCC patients that were treated with ciforadenant monotherapy or in combination with Genentech's Tecentriq, an anti-PD-L1 antibody, and whose tumors were biopsied to test with the AdenoSig. The data were made available today in an on-demand, electronic poster format for registered participants of the ASCO20 Virtual Scientific Program, which is taking place from May 29-31, 2020. The key updates from the presentation include: 31 patients were positive for the AdenoSig and 20 patients were negative. Patients had a median of three prior therapies, including 86% that failed a prior anti PD-1 therapy. In the AdenoSig positive group, there were five partial responses for an ORR of 17% and six additional patients that had tumor regression not meeting the criteria for a PR. In the AdenoSig negative group, there were no PRs and no patients with tumor regression. In the AdenoSig positive group, the progression free survival curve plateaued at 23% at 40 weeks, compared to declining to 0% in the AdenoSig negative group. In addition, the enrollment of new patients in the study was intended to support the study and refinement of the AdenoSig. As part of this work, Corvus investigators demonstrated that CD68 positive myeloid cells, which are known to be myeloid derived suppressor cells, are the downstream target of adenosine present in the tumor microenvironment. Immunohistochemistry testing showed that an increase of CD68+ myeloid cells in a tumor further enriched the AdenoSig identification of responders to treatment with ciforadenant. This work indicates that the single CD68+ IHC test could potentially be utilized to enrich patient selection for responding patients and as a substitute for the AdenoSig biomarker previously utilized by Corvus. The key data related to CD68 presented in the poster include: CD68 analysis was available for 53 patients, including 15 CD68 positive and 38 CD68 negative patients. All but one patient in the study with a PR were in the CD68+ group. The ORR in the CD68+ group was 26.7%, compared to an ORR of 2.6% in the CD68- group. Treatment with ciforadenant was associated with a reduction of infiltrating CD68+ cells in pre-treatment compared to on-treatment tumor biopsies, supporting the biologic effects of ciforadenant and the potential predictive utility of CD68 to identify RCC patients most likely to respond to treatment with ciforadenant.

08:12 EDT Kura reports data from tipifarnib study of metastatic HRAS mutant HNSCC - Kura Oncology announced updated clinical outcome data from its RUN-HN study, a Phase 2 open-label, single-arm trial of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma, HNSCC, whose disease had progressed after prior therapy. These data are being presented in an oral session at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020. A copy of the presentation is available on Kura's website at www.kuraoncology.com/pipeline/publications. At data cutoff, 21 patients with HRAS mutant HNSCC were enrolled1, of whom 18 were evaluable for efficacy. Nine of the 18 evaluable patients achieved a confirmed partial response for an objective response rateof 50% (95% CI, 26.0 to 74.0), with a median duration of response of 14.7 months. Median progression-free survival was 5.9 months , compared to 2.8 months on the patients' last prior therapy. Median overall survival was 15.4 months (95% CI, 7.0 to 46.4). Patients had a median of two prior lines of therapy. Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab. ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months. "It's encouraging to see robust overall survival data for tipifarnib, which demonstrate a potentially meaningful development for HNSCC patients with HRAS mutations in the advanced setting," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. "These data add to the body of evidence emerging for tipifarnib in second line HNSCC patients, a patient population with very few treatment options and a high unmet need. These results also highlight the importance of tumor genomic profiling to identify patients with HRAS mutations who could potentially be suitable for tipifarnib treatment."

08:12 EDT Phio Pharmaceuticals reports 'positive' data on intratumoral use of INTASYL - Phio Pharmaceuticals announced positive data from in vivo studies that show strong antitumoral efficacy with several of its INTASYL pipeline programs, including PH-762, PH-894 and PH-804. These results show that intratumoral delivery of INTASYL compounds inhibited tumor growth by overcoming the immunosuppressive tumor microenvironment as shown by changes in T cell composition and activation. Therefore, the company believes these pipeline programs show great promise in the treatment of solid tumors. These data were presented during the ASCO 2020 Virtual Scientific Program.

08:11 EDT AstraZeneca reports results from updated CASPIAN trial analysis - Results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca's Imfinzi in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival, or OS, benefit for adults with extensive-stage small cell lung cancer treated in the 1st-line setting. The CASPIAN trial met the primary endpoint of OS in June 2019, reducing the risk of death by 27% which formed the basis of the U.S. FDA approval in March. After a median follow up of more than two years, the latest results for Imfinzi plus chemotherapy showed sustained efficacy, maintaining a 25% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy. In a post-hoc analysis, an estimated 22.2% of patients treated with Imfinzi plus chemotherapy were alive at 24 months versus 14.4% for chemotherapy. For Imfinzi plus chemotherapy, 11% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy alone. Imfinzi plus chemotherapy maintained a high confirmed objective response rate, or ORR, and in a post-hoc analysis, duration of response for Imfinzi at 24 months was 13.5% versus 3.9% for chemotherapy. At 24 months, 12% of patients in the Imfinzi plus chemotherapy arm remained on Imfinzi treatment. The second experimental arm in the CASPIAN trial testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and chemotherapy showed a trend towards OS, but did not reach statistical significance compared to chemotherapy alone.

08:10 EDT Calithera Biosciences to present telaglenastat KEAPSAKE trial poster - Calithera Biosciences announced that an abstract describing a Phase 2 study of telaglenastat, the company's glutaminase inhibitor, will be presented today at the American Society of Clinical Oncology 2020 Virtual Annual Meeting. The KEAPSAKE study will explore telaglenastat versus placebo in combination with a standard-of-care regimen of immunotherapy and chemotherapy as first-line treatment for patients with non-small cell lung cancers with KEAP1/NRF2 mutations. These mutations, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth and poor outcomes to standard-of-care therapy. The ASCO20 poster describes the study design of the Phase 2 KEAPSAKE trial, which is expected to begin enrollment in the third quarter of 2020. In addition, the poster summarizes the clinical outcomes from a retrospective review of NSCLC patients who were enrolled in a prior Phase 1/2 clinical trial, including a subset of patients with a KEAP1 mutation. These patients were progressing on a checkpoint inhibitor at study entry and were treated with telaglenastat plus nivolumab.

08:08 EDT Agios presents updated data from Phase 1 dose-escalation study of vorasidenib - Agios Pharmaceuticals reported updated data from the ongoing Phase 1 study evaluating single agent vorasidenib in isocitrate dehydrogenase-mutant advanced solid tumors, including glioma. Data from the non-enhancing glioma population were featured in an oral presentation at the 2020 American Society of Clinical Oncology annual meeting, which is being held virtually. Vorasidenib, an investigational, oral, selective, brain-penetrant inhibitor of mutant IDH1 and IDH2 enzymes, is currently being evaluated in the registration-enabling Phase 3 INDIGO study as a potential treatment for patients with residual or recurrent Grade 2 non-enhancing glioma. Vorasidenib is being evaluated as a single agent in an ongoing Phase 1 dose-escalation trial in IDH1/2 mutant advanced solid tumors, including glioma. Enrollment was completed in June 2017. As of the March 3, 2020 data cut-off, study design, enrollment and baseline characteristics of the 22 non-enhancing glioma patients are reported below: Seventy-seven percent of patients had World Health Organization classified Grade 2 tumors and 23% had Grade 3 tumors. Ninety-one percent of patients had an IDH1 mutation and 5% had an IDH2 mutation. One patient did not have a biopsy but was confirmed as IDH mutant positive due to 2-HG elevation by magnetic resonance spectroscopy. The median age of these patients is 47 years. Sixty-four percent of patients had received prior systemic therapy. Patients had received a median of two prior systemic therapies. Fifty-nine percent of patients had previously received temozolomide and 36% of patients received prior radiation therapy.Patients received daily doses of vorasidenib ranging from 10 mg to 200 mg. Thirty-six percent of patients remain on treatment. The safety analysis conducted on the 22 patients with non-enhancing glioma as of the data cut-off demonstrated that vorasidenib has a favorable safety profile at dose levels below 100 mg once daily. Safety data for this population are consistent with the results reported for all patients enrolled in this trial at the 2018 ASCO Annual Meeting. The majority of adverse events reported by investigators were mild to moderate, with the most common across all grades being increased alanine aminotransferase, increased aspartate aminotransferase, nausea and headache. Grade 3 or higher AEs were observed in 27% of patients with the most common being increased ALT and AST. AEs of Grade 2 or higher elevated transaminases occurred in seven non-enhancing glioma patients at the higher dose levels and resolved to Grade less than or equal to1 with dose modification or discontinuation. No AEs of Grade 2 or higher elevated transaminases were observed in patients at the lower dose levels. Of the 14 patients who discontinued treatment, 9% discontinued due to an AE. Efficacy data from the 22 non-enhancing glioma patients as of the data cut-off showed: The investigator-reported objective response rate was 18% with one patient exhibiting a partial response and three patients exhibiting minor responses using the Response Assessment in Neuro-Oncology for low-grade glioma criteria. Seventy-three percent of patients achieved stable disease according to the investigator as assessed by RANO-LGG. With 59% of events reported, median progression free survival was 31.4 months. Twenty-four month PFS rate was 55.4%. The median treatment duration was 25.8 months with 68% remaining on treatment for greater than or equal to1 year.

08:06 EDT Ziopharm presents data for controlled IL-12 for rGBM at ASCO - Ziopharm Oncology announced the presentation of final clinical data from its phase 1 monotherapystudy of Controlled IL-12, Ad-RTS-hIL-12 plus veledimex ( as well as updated clinical data from two phase 1 substudies of Ad+V, a monotherapy expansion study (and a combination study with a PD-1 inhibitor, for the treatment of adult recurrent or progressive glioblastoma multiforme (rGBM) at the 2020 American Society of Clinical Oncology ( AnnualMeeting. The results we have seen from the two Controlled IL-12 monotherapy studies are particularly promising, with median overall survival in unifocal patients after monotherapy Ad+V treatment remaining at 16.2 months after longer term follow-up, as well as encouraging preliminary data from the PD-1 combination study where median overall survival has not yet been reached," said Dr. Antonio Chiocca, M.D., Ph.D., Trial Investigator and Professor of Neurosurgery at Harvard Medical School, Surgical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Chairman of Neurosurgery and Co-Director of the Institute for the Neurosciences at Brigham and Women's Hospital. "We also reported three additional partial responses, one in the monotherapy Main study, one in the Expansion study and one in the combination study, bringing the total number of partial responses to five. Observing responses in brain tumors in the setting of recurrence is unusual and highly encouraging, and, along with the survival data, highlight the potential of Ad+V for the treatment of rGBM." Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, added, "According to most recent data, even with the best available therapies, median overall survival for unifocal rGBM patients appears to be 6-12 months. We are therefore heartened by the collection of data presented at ASCO across our three studies, which demonstrate survival benefits beyond a year supported by imaging studies showing tumor regression and biopsies revealing that Ad+V administration turns 'cold' tumors 'hot' by recruiting T cells into the tumor. We look forward to continuing to report follow-up monotherapy and combination phase 1 data, as well as initial data from the ongoing phase 2 study of Ad+V in combination with Libtayo which is nearing completion of enrollment."

08:06 EDT AstraZeneca announces results from Imfinzi plus tremelimumab trial - Results from the global Phase II Study 22 trial testing AstraZeneca's tremelimumab, an anti-CTLA4 antibody and potential new medicine, added to Imfinzi demonstrated promising clinical activity and tolerability in patients with advanced hepatocellular carcinoma, or HCC. In the primary endpoint of the trial evaluating safety, all experimental arms demonstrated an acceptable profile and no new safety signals were identified. Patients treated with a single, priming dose of tremelimumab 300mg added to durvalumab every four weeks achieved a median overall survival, or OS, of 18.7 months in a key secondary endpoint. The OS result for the T300+D regimen was the longest among treatments tested in the trial, which included IMFINZI monotherapy, tremelimumab monotherapy and two regimens of the two combined. In other key secondary endpoints, objective response rate, or ORR, confirmed by independent central review was 24% with the T300+D regimen, and median duration of response was not yet reached at the time of data cut-off. A unique T-cell profile for patients in the T300+D arm was associated with treatment response, suggesting complementary biological activity.

08:04 EDT Pfizer, Astellas Pharma: PROSPER results show XTANDI 'signifcantly extends' OS - Pfizer (PFE) and Astellas Pharma (ALPMY) have announced final results from the overall survival analysis of the Phase 3 PROSPER trial, which evaluated XTANDI plus androgen deprivation therapy versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer. In the trial, XTANDI plus ADT reduced the risk of death by 27% compared to placebo plus ADT. The median OS was 67.0 months for men who received XTANDI plus ADT compared to 56.3 months with placebo plus ADT. OS was a key secondary endpoint of the trial.

07:58 EDT China Index Holdings announces investment in controlling stakes of Credit Rating - China Index Holdings announced that it has entered into an agreement to acquire 100% control of China Index Credit Rating Ltd., a newly registered credit rating company in China, and through a separate agreement, 67% fully diluted shares of Shouzheng Credit Rating Ltd., a credit rating company registered in 2018 in China. The two credit rating companies will lay the foundation for CIH to establish a credible and trustworthy global credit rating house to serve corporate needs in China and overseas, together with CIH's long-established big data, analytics and professional research platforms. CIH has been serving financial institutions and corporations for the past five years by using risk-analysis and modeling on its database and analytics platforms.

07:40 EDT Laurentian Bank appoints Nicholas Zelenczuk to board of directors - Michael Mueller, Chair of the Board of Directors of Laurentian Bank of Canada announced the appointment of Nicholas Zelenczuk as an independent Director of the Bank. Zelenczuk has more than 35 years of experience in banking, capital markets and investment management and has held senior positions in several large corporations in Canada.

07:34 EDT BridgeBio's QED presents data on infigratinib in urothelial carcinoma, CCA - BridgeBio Pharma affiliate QED Therapeutics announced today that it will present data at the American Society of Clinical Oncology 2020 Virtual Scientific Program showing clinical advancement for infigratinib, QED's oral FGFR1-3 inhibitor, in both urothelial carcinoma and cholangiocarcinoma. Title: Infigratinib in advanced/unresectable or metastatic urothelial carcinoma demonstrates consistent treatment response in both first-line and later-line treatment settings. An analysis of response rates in patients with advanced/unresectable or metastatic urothelial carcinoma based on the amount of prior lines of treatment showed consistent response to infigratinib. The objective response rate or all patients was 25%, while the ORR for patients receiving infigratinib as first-line treatment saw a response rate of 31% compared to 24% for patients receiving infigratinib as a second-line or later treatment. All eight patients in the study with upper tract urothelial carcinoma received infigratinib as second-line or later therapy. The response rates were higher for patients with UTUC, with an ORR of 50% and a disease control rate of 100%. In the study, treatment emergent adverse events occurring in greater than30% of patients were: hyperphosphatemia, elevated creatinine, fatigue, constipation, anemia, decreased appetite, dry mouth, and alopecia. Title: A retrospective analysis of post second-line chemotherapy treatment outcomes for patients with advanced or metastatic cholangiocarcinoma and FGFR2 fusions: In a retrospective analysis of a subset of a single-arm Phase 2 study of infigratinib, outcomes from patients with FGFR-fusion-positive bile duct cancer receiving infigratinib as third- and later-line therapy were compared with the tumor response when those same patients received second-line therapy with chemotherapy. Treatment with infigratinib resulted in progression free survival improvements. The median PFS was 6.8 months for third- and later-line infigratinib treatment compared to 4.6 months for second-line chemotherapy.

07:32 EDT China Customer Relations Centers: Going private proposal withdrawn - China Customer Relations Centers announced that the company's board of directors received a letter dated May 25 from Guangzhou Cornerstone Asset Management Co., withdrawing, with immediate effect, the preliminary non-binding going private proposal that Cornerstone, along with Zhili Wang, Chairman and Chief Executive Officer of CCRC, submitted to the Board on November 10, 2018. Subsequently, on May 29, 2020, the Board received a letter from Wang confirming his withdrawal. Wang said, "the withdrawal of the going-private proposal stemmed from Cornerstone's decision to withdrawal from the Consortium."

07:23 EDT Rexford Industrial acquires industrial property for $14.5M - Rexford Industrial announced the acquisition of an infill industrial land site for $14.5M. The acquisition was funded using cash on hand. The company acquired 1055 Sandhill Avenue, located in Carson within the LA-- South Bay submarket, for $14.5M, or $57 per land square foot. The property comprises 158,000 square feet of vacant manufacturing buildings on 5.79 acres of land. The company plans to demolish the existing improvements and construct a new, 32-foot clear 126,013 square foot single-tenant logistics building with 20 dock-high loading positions, ESFR fire sprinklers and an additional adjacent 2.7 acres of excess land for vehicle parking. According to CBRE, the vacancy rate in the 224M square foot LA -- South Bay submarket was 0.8% at the end of the first quarter 2020.

07:21 EDT Akari Therapeutics says ongoing trials disrupted due to coronavirus spread - The company said, "Akari's clinical trial sites are based in areas currently affected by coronavirus. Epidemics such as this can adversely impact the business as a result of disruptions, such as travel bans, quarantines, and interruptions to access the trial sites and supply chain, which could result in material delays and complications with respect to research and development programs and clinical trials. Moreover, as a result of coronavirus, there is a general unease of conducting unnecessary activities in medical centers. As a consequence, ongoing trials have been halted or disrupted. It is too early to assess the full impact of the coronavirus outbreak on trials for nomacopan, but coronavirus is expected to affect Akari's ability to complete recruitment in the original timeframe. The extent to which the coronavirus impacts operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In particular, the continued spread of the coronavirus globally, could adversely impact Akari's operations and workforce, including research and clinical trials and the Company's ability to raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the development of our product candidates and could result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have an adverse impact on the business, financial condition and results of operation."

07:19 EDT Akari Therapeutics pursuing clinical study opportunities in COVID-19 pneumonia - The Company believes nomacopan's dual inhibition of both the complement and leukotriene pathways makes the drug potentially well suited for the treatment of patients with COVID-19 pneumonia and related COVID disease. Leukotriene inhibition is a validated pathway for the treatment of severe lung inflammation and LTB4 is a potent granulocyte and leukocyte attractant which in turn are key drivers of the damaging cytokine storm that underpins acute respiratory distress syndrome. Likewise, there is growing evidence of the role of the complement pathway in the microthrombi and organ damage associated with COVID-19 pneumonia. In pre-clinical lung inflammation models including a study of viral induced lung inflammation, nomacopan showed significant reductions in key lung inflammatory markers such as neutrophils and lung vascular leakage. Likewise in sepsis models nomacopan has shown significant downregulation of a wide range of pro-inflammatory cytokines and chemokines including TNF, IL-6, GM-CSF, IL1alpha, IL1beta, IL17, MCP1, MIP1alpha, MIP1beta which have all been shown to be elevated in patients with COVID-19 disease. Akari is actively pursuing several clinical study opportunities in patients with COVID-19 pneumonia in the UK and U.S. The Company intends to provide additional detail when these programs are finalized and approved.

07:18 EDT Twitter 'doing nothing' on China propaganda, 'will be regulated,' Trump tweets - President Donald Trump tweeted: "Twitter is doing nothing about all of the lies & propaganda being put out by China or the Radical Left Democrat Party. They have targeted Republicans, Conservatives & the President of the United States. Section 230 should be revoked by Congress. Until then, it will be regulated!"

07:16 EDT Aveo Pharmaceuticals DEDUCTIVE trial advances to Phase 2 portion - Aveo (AVEO) announced that the Phase 1b/2 DEDUCTIVE clinical trial evaluating Fotivda, the company's once-daily, potent and selective next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor, in combination with Imfinzi, AstraZeneca's (AZN) human monoclonal antibody directed against programmed death-ligand 1, in patients with hepatocellular carcinoma, or HCC, who have not received prior systemic therapy, has demonstrated that the combination can be administered safely and the study has progressed to the Phase 2 portion of the trial. Advancement of the study into the Phase 2 expansion follows the completion of the Phase 1 dose escalation portion of the trial, where 1.0 mg of tivozanib was administered for 21 days followed by 7 days rest together with 1500 mg of durvalumab every 28 days. The combination was well tolerated, with no dose limiting toxicities. The tivozanib regimen of 1.0 mg daily for 21 days, followed by 7 days off treatment, is the recommended Phase 2 dose for the expansion portion of the trial, which is expected to enroll up to an additional 30 subjects. Results from the study were not available ahead of the abstract deadline for the ASCO virtual scientific program and will be submitted for presentation at an upcoming scientific meeting.

07:15 EDT Akari Therapeutics expects to meet with FDA, EMA on nomacopan for BP in Q3 - In May 2020, Akari announced topline results from its fully recruited Phase II study of nomacopan in BP patients. The study achieved no drug-related serious adverse events with 7 of 9 treated patients showing a rapid and clinically significant reduction in Bullous Pemphigoid Disease Area Index score. Of the 7 responders, 3 showed an 80%+ reduction in BPDAI score and 3 an approximately 40% reduction in BPDAI score within six weeks of starting nomacopan. As announced recently, the European Medicines Agency issued a positive opinion on Akari's application for orphan designation of nomacopan for the treatment of BP. The U.S. Food and Drug Administration granted orphan drug designation for nomacopan for the treatment of BP in September 2019. The Company now expects to meet with the FDA and EMA to discuss a pivotal trial design in the third quarter of 2020.

07:13 EDT Canopy Growth reports Q4 adjusted gross margin 42% - Reported gross margin, including one-time restructuring and other charges, was (85%). Adjusted gross margin, excluding one-time restructuring and other charges and inventory step-up costs, was 42% in Q4 2020, representing an increase of 1,100 bps from Q3 2020. Adjusted gross margin performance in Q4 2020 was positively impacted by higher facility utilization and growth in high margin international medical cannabis sales.

07:11 EDT Aveo presents results from final analysis of Phase 3 TIVO-3 trial - Aveo announced the presentation of results from the final analysis of overall survival, or OS, in its pivotal Phase 3 TIVO-3 trial comparing tivozanib, the company's next-generation vascular endothelial growth factor, or VEGF, receptor tyrosine kinase inhibitor, or TKI, to sorafenib in third and fourth line renal cell carcinoma, or RCC. The results, which have been submitted to the FDA as part of the company's new drug application submitted in March, are being featured at the ASCO virtual scientific program in a poster. As previously announced, the TIVO-3 trial met the primary endpoint of progression free survival, or PFS, and the secondary endpoint of overall response rate, or ORR. The final OS hazard ratio, or HR, which assesses the overall relative risk of death, was 0.97, favoring tivozanib and improving from the previously reported interim HR of 0.99. Updated median OS, representing a single point in time in the OS curve, was 16.4 months for tivozanib and 19.2 months for sorafenib. These OS HR results are similar to those of prior VEGFR TKI vs. VEGFR TKI studies in RCC. Tivozanib was found to be generally well-tolerated, with grade 3 or higher adverse events, or AE, consistent with those observed in previous tivozanib trials. The most common AE in patients receiving tivozanib was hypertension, an AE known to reflect effective VEGF pathway inhibition. Infrequent but severe AEs reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. Dose reductions and interruptions due to AEs were significantly lower for tivozanib vs. sorafenib, despite nearly double the average number of cycles initiated for the tivozanib arm, treatment related AEs leading to permanent discontinuation were 8% for tivozanib vs. 15% for sorafenib.

07:10 EDT Myriad Genetics presents new data on riskScore test - Myriad Genetics announced the presentation of two new studies at the 2020 American Society of Clinical Oncology annual meeting demonstrating the ability of Myriad's riskScore test to provide personalized breast cancer risk information that allows patients and physicians to make better informed clinical treatment decisions. riskScore Presentations at 2020 ASCO: Title: Comprehensive breast cancer risk assessment for CHEK2 carriers incorporating a polygenic risk score and the Tyrer-Cuzick model: In this study, 358,471 women with hereditary cancer risk who were tested with a multigene panel were assessed to find 4,331 women who were carriers of deleterious CHEK2 mutations. These patients were used to develop a mathematical model to assess risk status using family history information and Myriad's riskScore test. This model was then validated in an independent cohort of 459 women. In CHEK2 pathogenic variant carriers, a significant correlation was detected of CHEK2 status with family history and of polygenic risk scores with FH among CHEK2 carriers. Among the patients in the validation cohort, 24.0% of CHEK2 carriers were categorized as low risk , and 62.6% were categorized as moderate risk. For 13.4% of CHEK2 carriers, risk estimation incorporating PRS and TC generated BC risks of greater than 50%, consistent with genes recognized as highly penetrant. Title: Performance of the IBIS/Tyrer-Cuzick Model by Race/Ethnicity in the Women's Health Initiative: In this study, 91,893 women of differing racial identities with no personal history of breast cancer were followed for a median of 18.9 years to assess incidence of breast cancer. 6,836 new cases of breast cancer were diagnosed among the women. The Tyrer-Cuzick model was used to assess risk of breast cancer and then actual cases of breast cancer were compared to expected cases based upon the Tyrer-Cuzick risk assessment. The study found that the Tyrer-Cuzick model was an accurate predictor of breast cancer risk among various ethnicities except for Hispanic women where it overestimated breast cancer risk.

07:08 EDT Apogee Enterprises appoints Nisheet Gupta as CFO - Apogee Enterprises announced that it has selected Nisheet Gupta as the company's next Executive Vice President and CFO, effective June 15. The company said in a release, "Gupta will succeed James Porter, who announced his planned retirement last December. Porter will remain with the company through a short transition period, before beginning his retirement. Nisheet joins Apogee from Land O' Lakes, where he has served as Vice President, Global Finance Operations since 2017."

07:06 EDT Ceridian completes acquisition of Excelity Global - Ceridian announced it has completed the acquisition of Excelity Global Solutions, an Asia-based HCM service provider from the Everstone Group. The acquisition was previously announced on May 5, 2020 and closed and became effective today.

07:04 EDT GTY Technology Holdings budgeting unit selected to implement BFM in New Mexico - GTY Technology Holdings announced that its budgeting unit, Sherpa, has been selected by the state of New Mexico to implement its budgeting formulation and management, or BFM, software solution. The state and Sherpa will collaborate to implement an enterprise budgeting solution featuring flexible budget entry forms, financial and HR system integration, real-time reporting with full auditability and personnel cost forecasting. The State will use BFM to formulate their $18.4B total appropriation budget in a budget process for 150 agencies covering the executive, judicial and legislative branches.

07:00 EDT Northern Dynasty subsidiary Pebble issues statement regarding mine project - Northern Dynasty reported that the company's 100%-owned, U.S.-based subsidiary Pebble Partnership issued the following statement. "A letter issued today by the U.S. Environmental Protection Agency (EPA) confirming the Environmental Impact Statement (EIS) process for the proposed Pebble mine currently being led by the US Army Corps of Engineers (USACE) is proceeding well, and effectively addressing all issues and concerns raised by EPA, the US Fish and Wildlife Service (USFWS) and other cooperating agencies, was hailed by Pebble Partnership CEO Tom Collier as another positive step in the project's permitting process. Collier also noted the letter reflects the EPA's decision not to pursue so-called 3(b) elevation under the Clean Water Act Section 404(q) guidelines. This determination by the EPA is another indication of positive progress for the project. This is on the heels of last of week's announcement from the U.S. Army Corps of Engineers (USACE) indicating their LEDPA determination would be for Alternative 3 - the northern route. We also saw the positive Preliminary Final Environmental Impact Statement earlier this year showing the project can be done responsibly and without harm to the Bristol Bay fishery. The decision last year by EPA to withdraw the Obama administration's pending veto (confirmed by a federal court's recent dismissal of the case brought by NRDC and others attacking that withdrawal), gives us strong reason to believe that EPA will not veto the USACE Record of Decision for the project. Today's decision not to file a 3b letter gives us more reason to believe that there will be no veto. This is consistent with our observation that USACE and EPA, and the other cooperating agencies, have been working well together to resolve all outstanding issues. The recent LEDPA announcement is further tangible evidence of that cooperation as we understand other federal agencies preferred the northern transportation corridor alternative. Our core principle has always been for the project to be done in a way that does not harm the fishery or water resources in Bristol Bay. The draft EIS showed this, the PFEIS shows this and we are confident the final EIS will show this and demonstrate to Alaskans that this is an important project for the state's future. The USACE continues to advance a rigorous and transparent review of all aspects and alternatives of our project. It has involved cooperating agencies from the federal, state, local and tribal governments in its review of the many technical issues facing the project. The permitting process for the project is reasonable and objective. We have always said let science and technical information guide decisions about the project. The EPA decision to not pursue a 3(b) elevation is in line with this notion."

06:38 EDT Thor Industries announces operational update with start of RV travel season - Thor Industries provided a number of operational updates in conjunction with the official start of the North America summer camping and RV travel season. Throughout late-April and May, Thor's companies in North America and Europe resumed operations, with the exception of its production facility in the UK which is expected to open in mid-June. The Thor companies are working closely with key suppliers to minimize any potential disruptions; however, chassis supply constraints within its European supplier base are expected to cause intermittent temporary line shut-downs or reduced output in the near-term. Prior to the onset of the COVID-19, Thor experienced a strong early start to the selling season, with high optimism from both North American and European dealers. Dealer inventory levels were appropriate for the spring season prior to the impact of COVID-19. The "strong" start to the selling season was significantly interrupted by the impact of COVID-19 as Thor temporarily shutdown all of its North American and European operations. Despite the lack of production, during the temporary shut-down of facilities in March and April, dealers continued to sell retail units, further reducing dealer inventory levels. As the company begins to exit the various governmental restrictions, it is now experiencing stronger demand from its independent dealer base. Within the U.S., dealers are now experiencing low inventory levels of certain products. As a result, the company is increasing production volumes where needed to address the higher than originally anticipated dealer demand. As a result of the current business climate and outlook, the company and its subsidiaries have called back a high number of its team members. In addition, the compensation of all employed team members who were subject to reductions in salary and bonuses, including its CEO and other named executive officers, will return to their original terms beginning on June 1. Likewise, Thor's board compensation will also return to their original terms. At the outset of the pandemic, Thor strategically borrowed $250M from its Asset Based Loan facility. The company is repaying that $250M draw based on increased confidence in its outlook.

06:09 EDT Big Lots reports inventory at Q1-end $807M vs. $927M last year - Big Lots said in its Q1 earnings release, "Inventory ended the first quarter of fiscal 2020 at $807 million compared to $927 million for the same period last year with the 13% decrease resulting from strong sales results in most merchandise categories in the quarter. The company ended the first quarter of fiscal 2020 with $312 million of Cash and Cash Equivalents and $437 million of long-term debt, representing a significant improvement in net debt compared to the end of the first quarter of fiscal 2019 when the company had $64 million of Cash and Cash Equivalents and $470 million of long-term debt. During the quarter, out of an abundance of caution, the company chose to draw down additional amounts on its revolving credit facility to provide protection against the unknown potential impacts of the crisis."

05:44 EDT Tuniu appoints Anqiang Chen as Financial Controller - Tuniu announced the promotion of Mr. Anqiang Chen to the Financial Controller of the Company, effective as of May 31. Tuniu said in a release, "Mr. Chen's responsibilities at Tuniu include corporate finance, tax, funding and internal controls. Ms. Maria Yi Xin, who tendered her resignation as the Company's Chief Financial Officer effective as of May 31, 2020, will continue to serve as a consultant to the Company to assist with the transition. Chen joined Tuniu in March 2010. Prior to the financial controller appointment, Mr. Chen previously served as associate vice president in charge of budgeting and working capital management at Tuniu."

05:29 EDT Chi-Med announces NDA acceptance in China for savolitinib - Hutchison China MediTech Limited, or Chi-Med, announced that the New Drug Application, or NDA, for savolitinib for the treatment of non-small cell lung cancer, or NSCLC, with MET Exon 14 skipping mutations has been accepted for review by the China National Medical Products Administration, or NMPA. Chi-Med said in a release, "The NDA is supported by data from an open-label, Phase II registration study. Interim data were presented on the first 50 treated patients at the Chinese Society of Clinical Oncology Annual Meeting in September 2019. An updated analysis with 70 patients in the study will be presented by Professor Shun Lu as part of the American Society of Clinical Oncology 2020 Virtual Scientific Meeting, available on May 29."

05:11 EDT Twitter says Trump 'THUGS' tweet violates glorification of violence policy - Twitter said that President Trump's tweet, where he said "These THUGS are dishonoring the memory of George Floyd, and I won't let that happen. Just spoke to Governor Tim Walz and told him that the Military is with him all the way. Any difficulty and we will assume control but, when the looting starts, the shooting starts," violated its policies regarding the glorification of violence "based on the historical context of the last line, its connection to violence, and the risk it could inspire similar actions today." Twitted added, "We've taken action in the interest of preventing others from being inspired to commit violent acts, but have kept the Tweet on Twitter because it is important that the public still be able to see the Tweet given its relevance to ongoing matters of public importance. As is standard with this notice, engagements with the Tweet will be limited. People will be able to Retweet with Comment, but will not be able to Like, Reply or Retweet it."