Stockwinners Market Radar for June 11, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:55 EDT Endo: Tennessee court issues orders regarding state court default judgment - Endo International announced that the Tennessee Court of Appeals recently issued several orders with respect to a default judgment order on liability entered by the Circuit Court for Sullivan County, Tennessee in April 2021 against its wholly-owned subsidiaries Endo Health Solutions Inc. and Endo Pharmaceuticals in Case No. C-41916, originally captioned as Staubus, et al. v. Purdue Pharma, L.P., et al. Specifically, on June 8, 2021, the Tennessee Court of Appeals declined to review the default judgment order on a discretionary basis on the ground that a contempt judgment becomes final upon the entry of punishment and is immediately appealable as of right. Today, the Tennessee Court of Appeals denied without prejudice the plaintiffs' motion to dismiss Endo's separate appeal as of right from the default judgment order and directed Endo to show cause as to why its appeal should not be dismissed on the procedural ground that portions of the default judgment order were not final. The Tennessee Court of Appeals also denied without prejudice Endo's motion to stay further proceedings in the trial court on the procedural ground that Endo must first seek a stay from the trial court. Matthew Maletta, Endo's Executive Vice President and Chief Legal Officer, commented: "As we previously stated, Endo believes the trial court's default judgment order was procedurally, factually and legally deficient. We therefore promptly appealed that order to the Tennessee Court of Appeals. The orders issued today by the Tennessee Court of Appeals do not dispose of Endo's appeal as of right. We will promptly take the actions directed by the Tennessee Court of Appeals and Endo will continue to seek a stay of further trial court proceedings including, if necessary, in the appellate courts." The company also intends to seek review by the Tennessee Supreme Court of the trial court's order permitting the substitution of new plaintiffs in the case after the Tennessee Court of Appeals denied Endo's application for discretionary review of that order on June 8, 2021.

17:01 EDT Alberton Acquisition receives Nasdaq notice on late 10-Q filing - Alberton Acquisition Corporation announced that it has received a notice from the NASDAQ Stock Market on June 9, 2021 notifying the company that, because its Form 10-Q for the period ended March 31, 2021 was not filed with the Securities and Exchange Commission by the required due date of May 17, 2021, the company is therefore not in compliance with the periodic filing requirements for continued listing set forth in NASDAQ Listing Rule 5250(c)(1). This Notice received has no immediate effect on the listing or trading of the company's shares. Nasdaq has provided the company with 60 calendar days, until August 9, 2021 to submit a plan to regain compliance. If Nasdaq accepts the company's plan, then Nasdaq may grant the company up to 180 days from the prescribed due date for the filing of the 2021 10-Q, or November 22, 2021, to regain compliance. The company expects and intends to submit to NASDAQ the compliance plan by August 9, 2021.

16:33 EDT Lion Group to restate financials for the year ended December 31, 2020 - Lion Group announced in a Current Report on Form 6-K, that as a result of recently issued guidance provided by the Division of Corporate Finance of the SEC on April 12 for all SPAC-related companies regarding the classification of their warrants for accounting and reporting purposes, it will restate its previously issued consolidated financial statements included on the Form 20-F for the year ended December 31, 2020. The restatement pertains to the accounting treatment for public and private warrants issued in connection with the initial public offering of Proficient Alpha Acquisition Corp. and recorded to the company's consolidated financial statements as a result of the Company's merger with PAAC, a SPAC and legal predecessor of the company, and Lion Financial Group Limited on June 16, 2020. Consistent with market practice among SPACs, the company had been accounting for the Public and Private Warrants as equity. However, consistent with the recent SEC Statement, the company intends to restate certain of its historical financial statements such that the Public and Private Warrants are accounted for as liabilities and marked-to-market each reporting period. In general, under the mark-to-market accounting model, as the stock price increases, the fair value of the warrant liabilities increases, and the company recognizes additional non-operating expense in its income statement - with the opposite effect when the stock price declines. The company does not anticipate the restatement to impact its previously communicated non-GAAP operating metrics for 2020. As a result of the restatement and the decrease in the company's stock price over the applicable period, the company expects to recognize incremental non-operating income of approximately $0.8M for the period from June 16, 2020 through December 31, 2020. There will be no impact to the company's previously reported net cash flow.

16:14 EDT Waste Connections general counsel Shea sells 11,000 common shares - In a regulatory filing, Waste Connections general counsel Patrick James Shea disclosed the sale of 11,000 common shares of the company on June 9 at a price of $120.348 per share.

16:06 EDT Novavax reports 'positive' data from COVID-19 Beta variant vaccine studies - Novavax announced preclinical and clinical data on the company's recombinant protein COVID-19 vaccine candidate, NVX-CoV2373, directed against the SARS-CoV-2 Beta variant, which was originally identified in South Africa. The data show that the vaccine demonstrated strong immunogenicity and protection against both the Alpha variant, which was originally identified in the United Kingdom, and the Beta variant as well as the original SARS-CoV-2 in animal and human studies. "While current vaccines are effective against selected SARS-CoV-2 variant strains, newly emerging variants are also being identified that have the ability to overcome vaccine induced immunity," said Matthew Frieman, PhD, Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, who collaborated on these studies. "This work demonstrates that variant vaccines that protect against these newly emerging variants have the potential to be highly effective and may produce broader protection against variants we know of and those that will arise in the future. Clinical trials will provide further evidence on the effectiveness of variant vaccines." The studies compared the Beta-directed vaccine to Novavax' prototype vaccine candidate as standalone, in combination, and as heterologous prime boost vaccine. The findings show a broad array of cellular and humoral responses in animal models against all virus strains evaluated. The Alpha and Beta variant strains have created public health concerns due to increased transmission rates and lower efficacy of current vaccines seen against Beta. Novavax expects to initiate further clinical testing of rS-B.1.351 in the fall of 2021.

15:22 EDT Electronic Arts says no player data accessed during network intrusion - Electronic Arts said in a statement: "We are investigating a recent incident of intrusion into our network where a limited amount of game source code and related tools were stolen. No player data was accessed, and we have no reason to believe there is any risk to player privacy. Following the incident, we've already made security improvements and do not expect an impact on our games or our business. We are actively working with law enforcement officials and other experts as part of this ongoing criminal investigation."

14:45 EDT Power REIT trading resumes

14:34 EDT Lixiang Education Holding Company Ltd (ADS) trading resumes

14:29 EDT Lixiang Education Holding Company Ltd (ADS) trading halted, volatility trading pause

14:00 EDT Franklin Templeton Canada announces approval of fund merger - Franklin Templeton Canada announced that investors have approved the merger of Templeton Global Bond Fund into Templeton Global Bond Fund, which was voted on at a special meeting held virtually today, June 11, 2021. After the close of business on June 25, 2021, Templeton Global Bond Fund will be merged into Templeton Global Bond Fund.

13:42 EDT Moderna sees no causal association of its vaccine with myocarditis, pericarditis - Moderna issued the following statement: "Moderna is aware of reports of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19, including data presented by the U.S. Centers for Disease Control and Prevention on June 10, 2021 at the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee meeting. After carefully reviewing the available safety data to date for Moderna COVID-19 Vaccine for cases of myocarditis and/or pericarditis, Moderna has not established a causal association with its vaccine. The company will continue to closely monitor these reports and is actively working with public health and regulatory authorities to further assess this issue."

13:13 EDT ArcLight Clean Transition announces shareholder approval of Proterra deal - ArcLight Clean Transition Corp. announced that its shareholders have voted to approve the previously announced business combination with Proterra, a company engaged in commercial vehicle electrification technology. Subject to the satisfaction of certain other closing conditions, the business combination is expected to close on June 14, 2021, after which Proterra's common stock and warrants are expected to begin trading on Nasdaq on June 15, 2021 under the new ticker symbols "PTRA" and "PTRAW."

13:02 EDT Baker Hughes reports U.S. rig count up 5 to 461 rigs - Baker Hughes reports that the U.S. rig count is up 5 from last week to 461 with oil rigs up 6 to 365, gas rigs down 1 to 96, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 182 rigs from last year's count of 279, with oil rigs up 166 gas rigs up 18 and miscellaneous rigs down 2.The U.S. Offshore Rig Count is unchanged at 13, unchanged year-over-year. The Canada Rig Count is up 16 from last week to 93, with oil rigs up 16 to 59, gas rigs unchanged at 34. The Canada Rig Count is up 77 rigs from last year's count of 21, with oil rigs up 52, gas rigs up 20.

13:01 EDT Omnicom Media announces sale of ICON International - Omnicom Media Group, a subsidiary of Omnicom Group, announced the sale of ICON International, a specialty media company, to ICON's management team. The sale of ICON is part of Omnicom's continuing realignment of its portfolio of businesses and is consistent with its strategic plan and investment priorities. Commenting on the disposition, John Wren, Omnicom's Chairman & CEO said, "I want to thank the management team and employees of ICON for their years of commitment to Omnicom and wish them continued success." The disposition is not expected to have a material impact on Omnicom's ongoing operating income for the full year 2021.

12:51 EDT X4 reports efficacy, safety data from Phase 1b mavorixafor study - X4 Pharmaceuticals announced earlier today preliminary efficacy and safety data from its ongoing Phase 1b clinical trial of its lead candidate mavorixafor, in combination with ibrutinib, in Waldenstrom's macroglobulinemia patients with both MYD88 and CXCR4 mutations. As of April 15, eight patients had been enrolled in the Phase 1b clinical trial with a median duration of treatment of 156 days. Mavorixafor exposures tracked with sustained and dose-dependent increases in white blood cell counts, confirming target engagement and mavorixafor mechanism of action, and all patients experienced reductions in serum IgM and no patients' disease progressed while on treatment, X4 said in a statement. At six months, mavorixafor plus ibrutinib showed "signs of meaningful reductions in IgM versus comparable, previously published data of ibrutinib monotherapy in double-mutation patients," it added. Patients achieved median reductions of 60%-75% in serum IgM levels normalized to baseline; this compares to published ibrutinib monotherapy reductions of 38%-45% in double-mutation patients. "Despite still being in the low- and mid-dose ranges of mavorixafor, we are already seeing robust decreases in IgM levels - an important signal of clinical response - showing the potential benefit for mavorixafor in combination with ibrutinib. The combination therapy is demonstrating good tolerability and promising results across additional pharmacodynamic parameters, including increases in total hemoglobin and mobilization of white blood cells. We look forward to presenting longer-term data and an expanded data set from this trial later in the year," said X4 Chief Medical Officer Diego Cadavid.

12:32 EDT Zynerba presents sleep data from study of Zygel in DEE, ASD - Zynerba Pharmaceuticals presented a poster today at SLEEP 2021, the 35th Annual Meeting of the Associated Professional Sleep Societies. The poster titled "Impact of ZYN002 Cannabidiol Transdermal Gel on Sleep in Children and Adolescents with Developmental and Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder," shows that in an open-label Phase 2 trial with patients with developmental and epileptic encephalopathies, treatment with Zygel was associated with improved sleep in children with clinically significant sleep disorders at baseline. Furthermore, the children with both DEE and autism spectrum disorder showed more wide-ranging benefits on sleep compared to those with DEE alone. In the open-label Phase 2 trial with Zygel in patients with DEEs aged 3 to less than or equal to17 years, improvements were observed in different aspects of sleep in the two groups. In patients with ASD, improvements compared to baseline were observed over the 26-week study period in sleep breathing, sleep wake transition and the total sleep disturbance scale for children. In patients without ASD , improvement was seen in initiating and maintaining sleep. Zygel was well tolerated in the trial. Most treatment-emergent adverse events were characterized as mild or moderate. Over the 26-week study period, 60.4% participants had greater than or equal to1 related adverse event, with 93% mild/moderate severity.

12:26 EDT Extended Stay shareholders vote to approve merger agreement - Extended Stay America (STAY) announced that preliminary results show holders of a majority of its shares have voted in favor of the previously announced amended merger agreement under which the company will be acquired by funds managed by Blackstone Real Estate Partners (BX) and Starwood Capital for $20.50 per paired share in cash. The results of the vote are preliminary and are subject to certification by the independent inspector of election. Extended Stay intends to disclose the final voting results on a Form 8-K to be filed with the Securities Exchange and Commission as soon as possible following such certification. The closing is currently scheduled for June 16, 2021.

12:00 EDT Yirendai falls -10.2% - Yirendai is down -10.2%, or -54c to $4.78.

12:00 EDT LiveRamp falls -12.7% - LiveRamp is down -12.7%, or -$6.17 to $42.20.

12:00 EDT MagnaChip rises 10.9% - MagnaChip is up 10.9%, or $2.52 to $25.57.

11:49 EDT Amazon raises starting wage in Germany to at least EUR12 per hour - Amazon announced that it intends to increase wages for all logistics employees in Germany from July 2021. The existing wage package is thus supplemented by an entry-level basic wage equivalent to at least EUR12 gross per hour. Employees already receive additional benefits as standard, such as bonus payments, restricted employee shares, free life and disability insurance, special bonuses for overtime and contributions to company pension schemes or the "Career Choice" program, which covers 95 percent of the cost of further training . The company also announced that it would increase the starting wage again in autumn 2022 to at least EUR12.50. "From July every colleague in Germany will earn the equivalent of 12 euros or more per hour, regardless of where they work. In all of our efforts for customers, our employees are the focus. That is why they deserve the best and safest workplace. And that's why we set out to become the best employer in the world, "says Ralf Kleber, Country Manager for Amazon in Germany. "Amazon is a fair employer, treats everyone with respect and offers its employees excellent services and career opportunities from day one. To say the opposite is simply wrong."

11:30 EDT EMA recommends Pfizer's Xeljanz only be used in patients over 65 - Pfizer announced that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended that Xeljanz should only be used in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, if no suitable treatment alternative is available. The recommendation is based on the receipt of data from the post-marketing requirement study ORAL Surveillance in rheumatoid arthritis patients, Pfizer said in a statement.

10:52 EDT State Street launches digital finance division, State Street Digital - State Street Corporation announced on Thursday that it has launched a new division focused on addressing the industry's shift to digital finance. The new division, State Street Digital, will be led by Nadine Chakar, executive vice president. Chakar will report to Lou Maiuri, COO of State Street Corporation. The company said, "The new division will build on State Street's current digital capabilities and will expand to include crypto, central bank digital currency, blockchain, and tokenization. The company's proprietary GlobalLink technology platform will be an integral component of State Street Digital and will be enhanced into a digital multi-asset platform. The objective is to evolve the platform into a multi-asset platform to support crypto assets among other asset classes. The aim will also be to support our peer-to-peer ambitions by creating new liquidity venues for our clients and investors worldwide." Tony Bisegna, global head of portfolio solutions, FX sales and trading, and research for State Street Global Markets, will become head of Global Markets effective September 1, 2021. Bisegna's appointment is part of ongoing succession planning.

10:04 EDT Kraft Heinz to purchase Assan Foods in $100M deal - The Kraft Heinz Company announced that it has reached an agreement to purchase Assan Foods from privately held Turkish conglomerate Kibar Holding in a deal that values the enterprise at approximately $100M. Assan Foods is a sauces-focused business with local manufacturing facilities in Balikesir and Izmir that has been a certified production partner for Kraft Heinz since 2019 and offers Kraft Heinz the opportunity to build its retail and foodservice business across Europe, the Middle East and Africa. Headquartered in Istanbul, Assan Foods was established in Balikesir in 1998 as a Kibar Holding investment in the food sector. Assan Foods manufactures and sells a wide range of products including tomato paste, ketchup, mayonnaise, and pasta and meat sauces that appeal to a variety of international cuisines and are sold under brands such as Colorado, Kingtom, and Oba, as well as private label. With approximately 400 employees, Assan Foods serves the domestic market and exports to around 50 countries on four continents. The deal is subject to customary closing conditions including merger control approval, and is expected to be completed in the second half of 2021.

10:00 EDT Churchill Capital Corp II falls -6.3% - Churchill Capital Corp II is down -6.3%, or -73c to $10.88.

10:00 EDT Washington Prime rises 8.3% - Washington Prime is up 8.3%, or 42c to $5.48.

10:00 EDT MagnaChip rises 12.8% - MagnaChip is up 12.8%, or $2.95 to $26.00.

09:50 EDT Airbnb, Expedia's VRBO announce partnership to address 'party houses' - Airbnb (ABNB) and Vrbo, an Expedia Group (EXPE) company, have announced a partnership to develop the Community Integrity Program, which they call "an industry collaboration to address community safety by sharing important information on listings and strengthening action on the community threat posed by repeat 'party house' offenders." Airbnb and Vrbo plan to work with a trusted third-party intermediary to develop a process that identifies properties that have been permanently removed from each platform due to repeated violations of respective community policies. The information will be available for each company to take the appropriate action. The program is intended to launch in the United States in the coming months, the companies said. Reference Link

09:47 EDT Galecto Inc trading resumes

09:47 EDT Yirendai falls -7.9% - Yirendai is down -7.9%, or -42c to $4.90.

09:47 EDT AMC Entertainment rises 6.7% - AMC Entertainment is up 6.7%, or $2.86 to $45.67.

09:47 EDT MagnaChip rises 15.8% - MagnaChip is up 15.8%, or $3.64 to $26.69.

09:42 EDT Galecto Inc trading halted, volatility trading pause

09:34 EDT Volkswagen: Vendor's security lapse exposed 3.3M drivers' details - Volkswagen says more than 3.3M customers had their information exposed after one of its vendors left a cache of customer data unsecured on the internet. In a letter, Volkswagen said that the vendor used by Volkswagen, its subsidiary Audi, and authorized dealers in the U.S. and Canada, left the customer data spanning 2014 to 2019 unprotected over a two-year window between August 2019 and May 2021. The data contained personal information about customers and prospective buyers, including their name, postal and email addresses, and phone number, Volkswagen said. Reference Link

09:23 EDT Broadstone Acquisition sees Vertical revenue of $192M in 2024, $7.27B in 2028 - Broadstone Acquisition, which has previously announced a business combination agreement to bring Vertical Aerospace Group, a UK-headquartered engineering and aeronautical business developing electric Vertical Take-Off and Landing, or eVTOL, aircraft public, released an investor presentation that includes details on the long-term business plan and projections. Vertical sees annual aircraft production of 50 aircraft by 2024, with revenue of $192M, growing to 2,000 annual aircraft produced and $7.27B of revenue by 2028, the slides indicate. The companies have previously said the transaction is expected to close in second half of 2021 and values the combined company at a pro forma enterprise value of approximately $1.84B, with a pro forma equity value of $2.2B at the $10.00 per share PIPE price.

09:08 EDT Constellation Pharmaceuticals announces posters on ongoing MANIFEST study - Constellation Pharmaceuticals announced that three posters relating to the MANIFEST clinical trial of pelabresib in myelofibrosis were published online in association with the European Hematology Association annual meeting. The data in these posters are based on a data cutoff of September 29, 2020 from the MANIFEST Phase 2 clinical trial and reflect an analysis of pelabresib clinical and translational activity. Translational data, across all three arms of the Phase 2 MANIFEST study, support the disease-modifying potential of pelabresib: Centrally reviewed bone marrow fibrosis pathology conducted in 63 patients showed similar improvements as reported previously for local review of BMF grade. 23 out of 63 patients achieved at least a 1 grade improvement in BMF. Of these patients, 83% achieved improvements in BMF by 24 weeks. 17% of the patients with BMF improvement, improved by at least 2 grades. 31 out of 63 patients were stabilized or had no change, and only 4 out of 63 patients worsened. An increase in BM erythroid progenitor cells and reduction of the number and cluster formation of megakaryocytes in the BM was observed in 59% and 65%, respectively, of 37 samples from patients treated with pelabresib either as a monotherapy or in combination with ruxolitinib. Pelabresib durably reduced inflammatory cytokines such as tumor necrosis factor alpha and interleukin 18 as early as 2 weeks and maintained through 24 weeks of treatment, based on an analysis of patient samples. Arm 3 - CPI-0610 + ruxolitinib interim efficacy subgroup analysis in JAK-inhibitor-naive patients. As previously reported at ASH 2020, 42 of 63 evaluable patients achieved a greater than or equal to35% reduction in spleen volume at 24 weeks. 34 of 60 evaluable patients achieved a greater than or equal to50% reduction in Total Symptom Scores at 24 weeks. Strong response was observed with pelabresib, irrespective of baseline risk status or demographic and disease characteristics. Central pathology review of 27 1L patient bone marrow samples showed at least a one-grade improvement in bone marrow fibrosis in 9 out of 27 patients; in all of these patients, improvement was observed within 6 months of starting treatment. 16 out of 27 patients showed stabilization of bone marrow fibrosis, while only 1 out of 27 patients showed worsening. Arm 1 and 2 - Interim analysis demonstrating that pelabresib monotherapy in JAK-inhibitor-experienced or -ineligible patients, and with pelabresib + ruxolitinib in ruxolitinib-experienced patients, resulted in improvements in anemia: As previously reported at ASH 2020, 3 of 14 evaluable Transfusion Dependent patients in Arm 1A achieved transfusion independence and 13 of 36 evaluable TD patients in Arm 2A achieved transfusion independence. 9 out of 15 evaluable TD patients in Arm 1A, and 25 out of 47 of evaluable TD patients in Arm 2A achieved a greater than or equal to50% reduction in red blood cell transfusions. As of the September 29, 2020 data cutoff, pelabresib was generally well tolerated in MANIFEST, both as monotherapy and in combination with ruxolitinib, and in both JAK-inhibitor-naive and -ineligible as well as JAK-inhibitor-experienced patients. Among the most common treatment-emergent adverse events for CPI-0610 monotherapy in 46 safety-evaluable patients in Arm 1, those that were Grade 3 were thrombocytopenia, anemia, diarrhea, constipation, respiratory tract infection, and weight decrease. Amongst the most common TEAEs, there were no Grade 4. Other Grade 3/4 TEAEs include hyperuricemia, hyperkalemia and dyspnea. Nine patients discontinued treatment because of TEAEs. No Grade 5 events were observed. Among the most common TEAEs in 78 safety-evaluable patients in Arm 2, those that were Grade 3 were thrombocytopenia, anemia, respiratory tract infections, diarrhea, asthenic conditions, and nausea. Amongst the most common TEAEs, Grade 4 events included thrombocytopenia and anemia. Nine patients discontinued treatment due to TEAEs, including six Grade 5 TEAEs, which were acute kidney injury, traumatic subdural hematoma, brain stem hemorrhage, disease progression, congestive heart failure, and transformation to AML. Among the most common TEAEs in 78 safety-evaluable patients in Arm 3, those that were Grade 3 were anemia and thrombocytopenia. Amongst the most common TEAEs, Grade 4 events included thrombocytopenia, anemia, and respiratory tract infection. Two patients discontinued treatment due to TEAEs. In addition, there were two Grade 5 TEAEs, each resulting from multi-organ failure due to sepsis.

09:04 EDT Philip Morris announces up to $7B share repurchase plan, declares $1.20 dividend - The board of directors of Philip Morris authorized a new share repurchase program of up to $7B, with target spending of $5B-$7B over a three-year period expected to commence after the company's Q2 earnings call. The board of directors also declared a regular quarterly dividend of $1.20 per common share, payable on July 12 to shareholders of record as of June 25. The ex-dividend date is June 24.

09:02 EDT Iconix Brand to be acquired in $585M 'Go Private' transaction - Iconix Brand Group announced it has entered into a definitive agreement and plan of merger to be acquired by Iconix Acquisition Corp., an affiliate of Lancer Capital, LLC, in an all-cash transaction that values Iconix at approximately $585M, including net-debt. Upon the terms and subject to the conditions of the agreement, Purchaser will commence a tender offer to acquire all of the outstanding shares of Iconix's common stock for $3.15 per share, in cash. The offer price per share of common stock represents a premium of 28.6% over Iconix's closing share price on June 10, 2021, the last trading day prior to announcement and a premium of approximately 46.5% over the 30-day average volume weighted share price for the period ended June 10, 2021. Shares not tendered in the offer will be acquired in a second-step merger at the same cash price as paid in the offer. Closing of the transaction is conditioned upon, among other things, satisfaction of a minimum tender condition, clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions. Upon completion of the transaction, Iconix will become a private company. Iconix currently expects the transaction to close before the end of the third quarter of 2021. The Iconix board of directors has unanimously approved the transactions contemplated by the agreement, and determined that the agreement and the transactions contemplated by the agreement, are fair to, and advisable and in the best interests of the Company and its stockholders, and recommends the Company's stockholders tender their shares in the offer.

08:50 EDT Snowflake targets product revenue of about $10B by FY29 from $554M in FY21 - In its Investor Day presentation yesterday, Snowflake also targets about 1,400 customers with product revenue over $1M vs. 77 in FY21 and the percentage of product revenue coming from over $1M customers rising to 77% by FY29 from 47%. Reference Link

08:36 EDT Color Star Technology, Movie Planet, Youa to create film series using NFT - Color Star Technology announced on April 23, U.S. Eastern Time, the signing of a Memorandum of Understanding regarding the strategic cooperative development among Color China, a U.S.-based company, Movie Planet, and a South Korea-based company, Youa Group. The three parties expressed interest in jointly developing NFT application for the Hollywood Film Festival and International Film Festival databases. This tripartite cooperation will apply the NFT concept to future Hollywood films, actors, short celebrity videos, and celebrity products, while leveraging NFT to develop technologies for the entertainment industry. As an entertainment technology company, Color Star has always been committed to the integration of technology and entertainment. After the launch of NFT, the company will accelerate its use of blockchain technology and continue to develop new technologies in the areas of film videos, music copyrights, and concert videos. The company has always believed that the entertainment industry is the most suitable field for NFT application. In the future, this technology can help solve many issues arising from copyright sales and new song releases. The cooperation with Movie Planet and Youa Group will enable more people to purchase and collect Hollywood movies, TV series, and music copyrights through the NFT model, while promoting communication and exchanges in the global entertainment industry.

08:34 EDT Shareholder raises concerns over IMV Inc.'s outlook - Further to the press releases issued June 1 and June 4, 2021, the concerned shareholder of IMV Inc. issues this press release to provide a further update and raise additional concerns regarding IMV. The shareholder said, "Since the June 4, 2021 press release, the Concerned Shareholder continues to receive communications from other dissatisfied IMV shareholders who have already cast or have indicated that they intend to cast "withhold" votes for Andrew Sheldon and Julia P. Gregory at the upcoming IMV AGM scheduled for June 18, 2021. A number of shareholders based in North America, Europe and the Middle East have contacted the Concerned Shareholder to express their support for the Concerned Shareholder's call for change. On June 7, 2021, IMV issued a press release announcing that both ISS and Glass Lewis had recommended that shareholders vote for the re-election of all of IMV's proposed nominees and IMV would be proposing a further amendment to its Employee Stock Option Plan to restrict the maximum number of the company's shares that may be subject to awards under the Plan to 8% of IMV's issued and outstanding shares. What IMV declined to mention is that ISS recommended against approving IMV's Plan for three reasons: the Plan is exceedingly expensive; the Plan contains a problematic change-in-control provision; and the CEO's compensation package does not include performance-based equity. ISS' conclusions in this regard align with those of the Concerned Shareholder: IMV has consistently increased cash compensation for the CEO without him having meaningful skin in the game in the form of performance-based compensation components. This is a clear divergence of management incentives and shareholder interests. The concerns raised by ISS, including the lack of a long-term performance incentive for the CEO and problematic change-in-control provisions, demonstrate the lack of proper independent oversight within IMV...Based on IMV's Interim Financial Statements dated March 31, 2021, IMV has cash and cash equivalents of approximately $30.45 million, down 16% from $36.27 million as at December 31, 2020. At that burn rate, IMV will be out of cash to fund ongoing operations by spring 2022. Worse still, shareholders have every reason to expect IMV's cash needs to significantly increase in the second half of 2021 and into 2022. According to IMV's clinical pipeline disclosure, IMV's Maveropepimut-S/CPA treatment for diffuse large B-cell lymphoma is concluding its Phase 2 clinical trial and set to begin a Phase 2b clinical trial soon. IMV's treatments for ovarian cancer and the basket trial for bladder cancer, liver cancer and microsatellite instability high are progressing through Phase 2 clinical trials toward Phase 2b clinical trials. And IMV's treatment for breast cancer is reaching the end of its Phase 1 clinical trial and headed for a Phase 2 clinical trial...Given that IMV will have to raise additional capital, IMV's collapsed share price means that any equity fundraising will be massively dilutive to existing shareholders. While IMV speeds towards a potential highly dilutive financing, cash compensation for management continues to grow steadily, as detailed in the press releases issued by the Concerned Shareholder on June 1 and June 4, 2021. Clearly neither the company's trajectory nor its cash burn rate justify increasing cash compensation and the award of cash bonuses for its executives. This is yet another example of the misalignment between IMV's management incentives and shareholder interests."

08:33 EDT Genco Shipping to jointly study ammonia as alternative marine fuel - Genco Shipping & Trading announced that it has entered into an initial framework to jointly study the feasibility of ammonia as an alternative marine fuel as part of the objective to decarbonize the global shipping industry in-line with the targets established by the International Maritime Organization. Including Genco, a total of 23 companies to date have elected to participate in the study. John Wobensmith, Chief Executive Officer, commented, "Taking steps to decarbonize our essential industry is a critical objective for Genco, and we are pleased to have entered into this joint study together with various blue chip, multi-national companies throughout the maritime supply chain. While there remains quite a bit of work to be done, not only on the development of ammonia fueled vessels but also on the build out of bunkering infrastructure, this joint study is an important and much needed step for the industry. Genco maintains a long-term commitment to reducing emissions and operating our fleet in an environmentally efficient and sustainable manner, and we are proud to participate in this meaningful study."

08:32 EDT LifeMD names Alexander Mironov as President - LifeMD (LFMD) announced it has named Alexander Mironov as President of LifeMD. Mironov most recently at Covis Pharma, a global private pharmaceutical company backed by Apollo Global Management (APO). The Compensation Committee of the company's Board of Directors granted an equity award to Mironov with a grant date of June 10, 2021. Mironov received options to purchase an aggregate of 200,000 shares of LifeMD. The options have an exercise price of $14.04, which is equal to the closing price of LifeMD common stock on June 10, 2021.

08:31 EDT Vystar Corp says Rotmans Furniture to reopen June 16 - Rotmans Furniture has completed Phase 1 of its renovation and will reopen for business on Wednesday, June 16, with savings for all customers as it continues its renovation in select areas. Rotmans closed on June 1 to begin renovation of its 200,000+ sq. ft. facility. Phase 1 of the remodel included a complete redesign of the interior entrance way, a renovation of one bedding area, elimination of flooring products, and a reorganization of the showroom floor to reduce it from 175,000 sq. ft. to 85,000 sq. ft. The space formerly used for the showroom will be repurposed as warehouse space, with added benefits to be announced in the future. Additional updating, painting and trimming of various showroom spaces and exterior will continue through the summer. Rotmans is planning a Grand Reopening Event in the fall after all renovation phases are complete. Rotmans purged its previous inventory during its high impact "Closing to Remodel" sale event that surpassed sales revenue of every quarter in Rotmans' 50+ year history/ Rotmans is resuming taking custom orders that were temporarily suspended during the COVID-19 crisis when most factories were shut down.

08:20 EDT Gold Fields' South Deep Gold Mine, NUM, UASA reach three-year wage pact - Gold Fields' South Deep Gold Mine and the NUM and UASA trade unions have concluded a three-year wage agreement for the period 1 March 2021 to 28 February 2024. The parties believe that the agreement is in the best interest of employees and the mine's long-term sustainability. The agreement provides for the following: Category 4 - 8 employees will receive a wage increase of 8% in year 1, and 8% or CPI (whichever is the greater) in years 2 and 3. Miners, Artisans and Officials will receive a wage increase of 6% in year 1, and 6% or CPI (whichever is the greater) in years 2 and 3. CPI-related increases will also be applied to housing allowances. Living-out allowances will be phased out over the three-year period, as required by the Department of Mineral Resources and Energy, and as the mine rolls out its housing strategy. The total increase of the settlement amounts to an average increase of 6.5% a year over the three-year period. A range of non-wage related issues have also been agreed to, including an alignment of leave and shift configurations, as well as amendments to other conditions of employment with a view to standardise them across all occupational levels and simplifying associated administrative processes.

08:16 EDT Sientra closes previously announced sale of miraDry business to 1315 Capital - Sientra announced it has closed the previously announced sale of its miraDry business to 1315 Capital. The transaction was previously described in the company's Form 8-K filed on May 11. Ron Menezes, President and Chief Executive Officer of Sientra stated: "We are delighted to close our transaction with 1315 Capital. With the sale of the miraDry business, we can now focus on our rapidly growing Breast Products business, and intend to utilize the proceeds from the sale to strategically invest in programs that we believe will grow our market share and advance the art of plastic surgery."

08:13 EDT BioVie closes acquisition of biopharma assets from NuerMedix - BioVie announced the closing of its previously announced acquisition of the biopharmaceutical assets of NeurMedix. The acquired assets include NE3107, a selective inhibitor of inflammatory ERK signaling that reduces neuroinflammation. It is an orally administered first-in-class small molecule that inhibits inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance play fundamental roles in the development of Alzheimer's and Parkinson's Disease, and NE3107 could represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer's and 1 million from Parkinson's. The FDA recently authorized a pivotal US Phase 3 clinical trial for NE3107.

08:10 EDT Genetic Technologies announces grant of foundational pharmacogenomic patent - Genetic Technologies has been granted US Patent No. 11,031,098 - 'Computer Systems and Methods for Genomic Analysis'. The patent application was submitted in 2016, building on a patent family dating back to 2001 and was recently granted to Genetic Technologies and demonstrates an important addition to Genetic Technologies portfolio of intellectual property. The length of time for the patent grant highlights the challenging climate in the United States for the granting of genetic and biotech patents in recent years and is therefore a significant milestone for the Company. This builds on the previous patent granted in June 2020 for 'Methods for assessing risk of developing breast cancer' - No: US 10,683,549. and extends the protection of our portfolio beyond breast cancer for future products. The patent describes efficient methods for identifying variations that occur in the human genome and relating those variations to the genetic basis of disease and drug response. The methods form the basis of Genome-Wide Association Studies, particularly those focused on identifying single nucleotide polymorphisms associated with drug response ie. pharmacogenomic or pharmacogenetic markers. The application and utilization of this patent forms the foundation of a single test covering multiple serious diseases, known as the multitest, that will cover more than 70% of current known mortality and morbidities. This is in the final stages of development currently scheduled for release in Q4 CY21.

08:08 EDT CNH Industrial appoints Gerrit Marx as CEO of On-Highway business - As work proceeds apace to deliver the previously announced spin-off of its On-Highway business, CNH Industrial has named Gerrit Marx as the designated CEO of the new entity, which is expected to assume independent operations in early 2022. The new On-Highway business will include the following brands and their respective activities: IVECO, IVECO ASTRA, IVECO BUS and Heuliez Bus, Magirus, Iveco Defence Vehicles, FPT Industrial and Iveco Capital. Gerrit Marx joined CNH Industrial as President of Commercial and Specialty Vehicles in January 2019.

08:07 EDT Bombardier announces normal course issuer bid - Bombardier announces that it has received approval from the Toronto Stock Exchange to purchase, in the normal course of its activities, from June 15, 2021 to June 14, 2022, up to 62,000,000 Class B shares, representing approximately 2.9% of its Class B shares issued and outstanding as of June 2, 2021. As of June 2, 2021, the Corporation had 2,128,112,189 Class B shares issued and outstanding. All Class B shares purchased will be delivered to a trustee to satisfy future obligations under the Corporation's employee share-based incentive plans. Class B shares purchased under the normal course issuer bid will all be placed in trust with Computershare Trust Company of Canada pursuant to the Amended and Restated Employee Benefit Plans Trust Agreement dated August 6, 2015 between the Corporation and Computershare Trust Company of Canada, as amended, which Class B shares held in trust will eventually be used to settle the Corporation's obligations under its employee share-based incentive plans, including its performance share unit plan and its restricted share unit plan. The NCIB will be conducted through the facilities of the TSX or alternative trading systems, or by exempt offers, private agreements or block purchases. Purchases made on the open market through the facilities of the TSX and alternative trading systems will be at the prevailing market price at the time of acquisition. In the event the Corporation purchases Class B shares by exempt offers, block purchases or private agreements, the purchase price of the Class B shares may be, and will in the case of purchases by private agreement, as may be permitted by the securities regulatory authorities, at a discount to the market price of such Class B shares at the time of acquisition. The average daily trading volume on the TSX for the six-month period ended May 31, 2021 of the Class B shares was 7,457,368. Under TSX rules, a maximum daily repurchase of 25% of this average may be made, representing 1,864,342 Class B shares. In excess of the daily 1,864,342 Class B shares repurchase limit, the Corporation may also purchase, once a week, a block of Class B shares not owned by an insider, which may exceed such daily limit, in accordance with the TSX requirements. Transactions under the NCIB will depend on future market conditions. Bombardier retains discretion as to whether to make purchases under the NCIB, and to determine the timing, amount and acceptable price of any such purchases, subject at all times to applicable TSX and other regulatory requirements . Bombardier will be entering into an automatic share purchase plan in connection with its NCIB that contains parameters regarding how its Class B shares may be repurchased during times when it would ordinarily not be permitted to purchase Class B shares due to regulatory restrictions or self-imposed blackout periods. The automatic share purchase plan has been pre-cleared by the TSX and will be implemented effective as of June 15, 2021. Bombardier believes that the purchase of its Class B shares would be an effective use of its funds and in the best interests of Bombardier and its shareholders. The Corporation believes that buying back Class B shares from time to time at the prevailing market price is an effective strategy to enable it to satisfy its future obligations under its employee share-based incentive plans, including its performance share unit plan and its restricted share unit plan, and avoid dilution that could occur if such obligations were instead satisfied by way of treasury issuances.

08:06 EDT Taoping signs cooperation agreement for East China expansion project - Taoping announces that it has entered into a strategic cooperation framework agreement with Zhenjiang Economic and Technological Development Zone for TAOP's East China expansion project. Pursuant to the agreement, TAOP will set up a wholly-owned subsidiary in ZETDZ with planned registered capital of $30M. ZETDZ will provide support in project construction, coordination, and operation within the scope of support policies, and will fully assist in the operation and development of TAOP's East China Expansion Project. "TAOP's East China Expansion Project mainly includes: establishing the Taoping G cloud data center, mainly serving East China, providing customers with efficient cloud rendering, cloud desktop, cloud gaming and other cloud application services; conducting R&D, production and sales of Taoping digital servers; and launching the Taoping Digital Culture East China Operation Center to expand digital businesses in cloud application services, international education, and new media," the company said.

08:04 EDT MagnaChip confirms $35.00 per share cash offer from Cornucopia Investment - Magnachip Semiconductor confirmed receipt of an unsolicited proposal from Cornucopia Investment Partners on behalf of itself and a group of investors, including financial sponsors led by Tim Crown, Yango financial holdings, Sino-Rock Investment Management Company Limited and Lombarda China Fund, to acquire all of the outstanding shares of Magnachip common stock, par value $0.01 per share, for $35.00 per share in cash. Magnachip's Board of Directors, in consultation with its legal and financial advisors, will carefully review and consider the Proposal. Magnachip, Parent and Merger Sub have reached an agreement whereby, through June 16, 2021, Magnachip will have the right to participate in discussions with Cornucopia in connection with the Proposal for the sole purpose of determining whether the Proposal constitutes or could reasonably be expected to lead to a superior proposal. Magnachip's Board of Directors has not yet made such a determination. In light of the Proposal, Magnachip expects to adjourn the special meeting of stockholders scheduled for 8:00 p.m. Eastern time on June 15 to June 17. The time of the adjourned meeting will be announced on June 15.

08:04 EDT Apollo Global to expand board with Simon, four additional members - Apollo Global Management (APO) announced additional current and anticipated appointments to its Board of Directors. This month, Apollo will add David Simon, currently Chairman of the Board, CEO and President of Simon Property Group (SPG), to its Board of Directors and, upon closing of the previously announced combination of Athene (ATH) and Apollo, four members of Athene's Board of Directors will join the Board of Directors of the combined company. These members include: Athene Chairman and CEO Jim Belardi, as indicated when the merger was announced on March 8, 2021. Athene directors Mitra Hormozi, Marc Beilinson and Lynn Swann will also join the board of the combined company upon closing of the merger, which is expected in January 2022. Siddhartha Mukherjee has informed Apollo that he will not stand for reelection after his term is complete.

08:02 EDT Thoma Bravo commences offer for all outstanding shares, ADSs of Talend - Thoma Bravo and Talend announced that Thoma Bravo has commenced the previously-announced tender offer to acquire all of the outstanding ordinary shares and American Depositary Shares of Talend for $66.00 per ordinary share and ADS in cash, without interest and less any applicable withholding taxes. The tender offer is being made pursuant to the memorandum of understanding between Talend and Thoma Bravo dated March 10, 2021. As previously announced on May 5, 2021, the Talend Board of Directors unanimously determined that the Thoma Bravo offer is consistent with and will further the business objectives and goals of Talend, and is in the best interests of the Company, its employees, and its shareholders, and recommends that all holders of ordinary shares and ADSs accept Thoma Bravo's offer and tender their outstanding shares and/or ADSs to Thoma Bravo. The tender offer is scheduled to expire at 5:00 p.m., New York City time, on July 28, 2021, unless extended or terminated. The closing of the tender offer is subject to the valid tender of ordinary shares and ADSs of Talend representing - together with ordinary shares and ADSs of Talend beneficially owned by Thoma Bravo, if any - at least 80% of the fully diluted ordinary shares and ADSs, as well as the receipt of customary transactional regulatory approvals, and other customary closing conditions.

07:57 EDT Sweet Dream Partnership 2021 acquires DREAM Unlimited restricted shares - Sweet Dream Partnership 202, a general partnership between Sweet Dream Corp. and 2818099 Ontario Inc., corporations that are controlled by Michael Cooper, the President and CRO of Dream Unlimited, announced that it has acquired 111,111 Class A subordinate voting shares of Dream, representing approximately 0.3% of the issued and outstanding Class A subordinate voting shares of Dream. The Restricted Shares will be held in escrow prior to vesting and will vest on the tenth anniversary of the issuance date, provided that certain forfeiture events have not occurred prior to such vesting date. In February 2021, the Board of Directors of Dream approved a grant to SDC of an initial restricted share award in the amount of $1,367,776 pursuant to a new Restricted Share and Restricted Share Unit Plan of Dream to purchase 111,111 Restricted Shares. SDC designated SDP 2021 as its permitted designee to subscribe for the Restricted Shares. Following receipt of shareholder approval of the RS&RSU Plan, on June 10, 2021, Dream issued 111,111 Restricted Shares to SDP 2021 on the terms and conditions set out in the Initial Restricted Share Award Agreement.

07:48 EDT Humacyte expands global partnership with Fresenius Medical Care - Humacyte announces the expansion of the strategic collaboration between Fresenius Medical Care (FMS). Fresenius Medical Care will have the exclusive rights to commercialize Humacyte's 6 millimeter x 42 centimeter human acellular vessel and all improvements thereto, and modifications and derivatives thereof in vascular trauma outside of the United States. Under a Distribution Agreement entered into in June 2018, Fresenius Medical Care obtained the exclusive global rights to commercialize Humacyte's HAVs in the applications of vascular access for hemodialysis and peripheral arterial disease. Under the expanded Distribution Agreement, Fresenius Medical Care and its affiliates will have exclusive rights to develop outside the United States and EU, and to commercialize outside of the United States, Humacyte's HAVs for use in the field of vascular creation, repair, replacement or construction, including renal replacement therapy for dialysis access, the treatment of peripheral arterial disease, and the treatment of vascular trauma. The agreement excludes use of the HAVs by Fresenius Medical Care for coronary artery bypass grafting, pediatric heart surgery, or adhering pancreatic islet cells onto the outer surface of the HAV for use in diabetic patients. Within the United States, Fresenius Medical Care will collaborate with Humacyte in its commercialization of HAVs in the field described above, including adoption of HAVs as a standard of care in patients for which such use is supported by clinical results and health economic analyses. On February 17, 2021, Alpha Healthcare Acquisition (AHAC) and Humacyte announced the execution of a definitive business combination agreement along with a fully committed $175M PIPE financing agreement.

07:34 EDT Ocuphire Pharma announces addition to Russell Microcap Index - Ocuphire Pharma announced that the Company is set to join the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, 2021, according to a preliminary list of additions posted June 4, 2021.

07:33 EDT Fax Capital announces investment in Biosyent - FAX Capital is pleased to announce that it has acquired ownership of 902,000 common shares of BioSyent through the facilities of the Neo Exchange. The Shares were acquired at an average price of $7.50 per Share and an aggregate purchase price of $6,765,000. Immediately prior to the Acquisition, the Company owned 1,219,100 Shares, representing 9.59% of the outstanding Shares. Following the completion of the Acquisition, FAX now owns 2,121,100 Shares, representing 16.69% of the total number of outstanding Shares of BioSyent. The Company currently has no plans or intentions with respect to the acquired Shares of BioSyent and the Shares are being held for investment purposes. In the future, the Company may acquire additional Shares, or dispose of its holdings, both as investment conditions warrant.

07:33 EDT Adamis Pharmaceuticals provides update on clinical trial progress for Tempol - Adamis Pharmaceuticals announced that clinical trial start-up activities are underway for examining the effects of Tempol, which is the company's experimental drug, in the treatment of COVID-19. Adamis is carrying out these activities with a large clinical research organization. The goal of the trial - entitled "A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection" - is to examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study will examine markers of inflammation, symptoms, and the rate of hospitalization for patients taking Tempol versus placebo. Dennis Carlo, CEO of Adamis, commented: "We believe that additional treatment modalities are sorely-needed for COVID-19 due to the surge of virus variants. Because of Tempol's mechanism of action, it may inhibit viral replication of all current and future variants of the virus. The results of the NIH studies further support the importance of our clinical trial. The addition of a well-respected data safety monitoring board to the well-designed trial should further increase the likelihood of meaningful clinical data. We look forward to carrying out this trial and helping produce another potential breakthrough treatment for COVID-19."

07:25 EDT Chindata CEO discusses Super Energy Complex at China Entreprenuers Forum - How to take action on carbon neutrality was discussed during the 2021 China Entrepreneurs Forum. Panelists shared their opinions on their solution to energy transition and carbon emission reduction. Alex Ju, Founder and CEO of Chindata Group, a leading hyperscale data center solution provider in emerging markets, delivered his "Super Energy Complex" proposal by establishing new energy scenarios with data centers as the driver in the fields such as municipal heating, new energy vehicle charging, cold chain logistics, ecological agriculture, and snow sports. "The operation of data centers is a process of energy transferring from cold to heat and vice versa. Then we can think about how to take advantage of those resource slack to further improve the efficiency of energy consumption. The cooling resources from the data centers can be directly supplied to the ice hockey stadium or the ski hall nearby. The same applies to hyperscale data centers around tier-one cities with convenient transportation. It can provide continuous support for large-scale cold chain logistics. On the contrary, the high-temperature hot water from data centers can be connected with municipal pipelines to form a stable energy for heating in winter," Mr. Ju said. The Super Energy Complex will form a "Big Data + Clean Energy + City Service" mode to provide a China's solution for data center carbon neutrality. In this way, data centers will enhance the pace of digitalization in many industries and deliver more values to the digital economy.

07:10 EDT Autolus Therapeutics presents new data on ob-cel in r/r IBCL, r/r adult ALL - Autolus Therapeutics announced a poster presentation related to AUTO1 in relapsed / refractory, or r/r, indolent B cell lymphomas, or IBCL, and included an update of duration of response in r/r adult Acute Lymphoblastic Leukemia, or ALL, patients at the European Hematology Association Virtual Congress 2021. Title: Early safety and efficacy findings of AUTO1, a fast-off rate CD19 CAR, in Relapsed/Refractory Indolent B Cell Lymphomas. Relapsed / refractory indolent B cell lymphomas. As of the data cut-off date of May 17, 13 patients in Cohort D with r/r IBCL had been enrolled in the study. As of the data cut-off date, 9 r/r IBCL patients had received AUTO1 infusion. Three patients were pending infusion and one patient died prior to lymphodepletion due to a Covid-19 infection. Obe-cel was well tolerated and demonstrated a favorable safety profile in adult patients with r/r low grade B-cell lymphoma, despite high disease burden. All treated patients achieved a complete metabolic remission and had robust CAR T engraftment, expansion, and persistence. Grade 1 cytokine release syndrome was reported in 4 patients and Grade 2 CRS in 1 patient. No immune effector cell-associated neurotoxicity syndrome of any grade was observed in the study. At a median follow-up of 6 months, eight of nine patients were disease free at last follow-up with one patient who relapsed at month 6 but was rescued with radiotherapy. Relapse / refractory adult Acute Lymphoblastic Leukemia. As of the data cut-off date of May 17, 20 patients in Cohort A with r/r ALL had received obe-cel. The therapy was well tolerated, with no patients experiencing Grade 3 or higher CRS. Three patients, all of whom had high leukemia burden, experienced Grade 3 ICANS that resolved swiftly with steroids. Of the 20 patients evaluable for efficacy, 17 of patients achieved minimum residual disease-negative complete remission at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival at twelve months and twenty-four months is 50.2% with median EFS not being reached.

07:07 EDT Sanofi says Phase 3 data from CADENZA study met primary composite endpoint - Results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease, or CAD, without a recent history of blood transfusion within the prior six months, will be presented in an oral session at the European Hematology Association 2021 Congress, Sanofi announced. The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study. The primary efficacy outcome was the proportion of patients who met all three of the following components: improvement in hemoglobin greater than or equal to 1.5 g/dL from baseline at treatment assessment timepoint, average of Weeks 23, 25, and 26; avoidance of transfusions from Week 5 through Week 26; and avoidance of other CAD-related therapies beyond what was permitted from Week 5 through Week 26. The secondary efficacy measures assessed improvement from baseline in key indicators of the disease process including hemoglobin, bilirubin, lactate dehydrogenase levels, and quality of life as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Score.

07:05 EDT Equillium announces results from EQUATE study of itolizumab for aGVHD - Equillium announced "positive" topline data from the Phase 1b EQUATE study in first-line acute graft-versus-host-disease, or aGVHD. The EQUATE trial is evaluating itolizumab in severe aGVHD patients concomitant with standard of care, which is typically comprised of high dose corticosteroids. The results were presented this morning in an oral presentation at the European Hematology Association 2021 Virtual Congress. Equillium has received fast track designation from the FDA for the treatment of itolizumab in patients with aGVHD and orphan drug designations from the FDA for both the prevention and treatment of aGVHD. Equillium expects to engage with regulatory agencies in mid-2021 to discuss the company's plans to proceed with a pivotal study in first-line aGVHD. Key findings from EQUATE: Responses were rapid, typically achieved within 15 days and maintained at Day 29 and beyond; across all patients 55% achieved CR and 70% achieved ORR at Day 29; in treatment naive patients 64% achieved CR and 71% achieved ORR at Day 29; responses were durable, with most patients maintaining response off-treatment through six months; patients experienced rapid and robust steroid tapering; across all cohorts average steroid dose reduction was 67% at Day 29 and maintained through six months; overall survival across all treatment groups was 67% at six months; across all cohorts, 60% of patients reported serious adverse events with only 10% of these events reported as treatment related; itolizumab has been well tolerated and adverse events have been consistent with those common in high-risk aGVHD; and optimal dose range observed 0.8 to 1.6 mg/kg; no further dose escalation is anticipated

07:04 EDT TG Therapeutics announces data from Phase 1 study of TG-1701 - TG Therapeutics announced data from TG-1701, the Company's investigational once-daily, oral BTK inhibitor, as a monotherapy and as a triple therapy in combination with ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ, the Company's once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Data from this trial were made available on demand this morning during the 3032 European Hematology Association Virtual Congress. Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib in Chronic Lymphocytic Leukemia and Lymphoma. A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort, 200 mg in a dose-expansion cohort, 300 mg in a CLL dose-expansion cohort, or TG-1701 in combination with U2 in the dose escalation cohort. TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD. Adverse Events of special interest in patients treated with 200 mg and 300 mg QD of TG-1701, included Grade 3 hypertension, atrial fibrillation, and no instances of major bleeding observed. Grade 3 AEs occurring in greater than or equal to10% of patients treated with U2+1701 included diarrhea, neutropenia, ALT increase, and AST increase, and Grade 4 AEs occurring in greater than or equal to10% of patients treated with U2+1701 included neutropenia. At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates were: 95% in CLL, 65% in mantle cell lymphoma, and 95% in Waldenstrom macroglobulinemia. 100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort. At a median follow up of 15.6 months, the 1701+U2 dose escalation resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma, diffuse large B-cell lymphoma and follicular lymphoma.

07:01 EDT CIT Group to sell aviation loan portfolio to KKR - CIT Group (CIT) announced it is selling its aviation loan portfolio to KKR (KKR). This is related to a previously announced definitive agreement for a portfolio that has a committed loan balance of nearly $800M across more than 50 loans for approximately 60 commercial aircraft. The loans have an average yield in the mid-single digits and an average term remaining of approximately four years. The portfolio will be serviced by AV AirFinance Limited, a global commercial aviation loan servicer established by a team of experienced industry professionals together with KKR. As part of the transaction, certain members of CIT's aviation team will also join AV AirFinance where they will focus on servicing and originating loans. The majority of loans have been transferred with the remaining amount expected to be completed by the end of the second quarter. Upon its completion, CIT will have fully exited its aircraft lending business and remains committed to providing banking and advisory services as part of its core Aerospace, Defense and Government Services business. The transaction is being funded by separate accounts managed by KKR.

06:51 EDT Becton Dickinson partners with USA Swimming on COVID-19 testing at events - USA Swimming, the national governing body for the sport of swimming in the United States, and Becton Dickinson have partnered to provide COVID-19 testing at USA Swimming events. Specifically, rapid antigen tests using the BD Veritor Plus System will be conducted at the U.S. Olympic Team Trials - Swimming as an additional safety measure beyond the polymerase chain reaction, or PCR, testing that will also be a part of USA Swimming's COVID-19 mitigation efforts. These tests will also be utilized at 2021-2022 USA Swimming events where testing is required.

06:40 EDT Novan jumps 45% to $13.10 after 'positive' results from Phase 3 study of SB206

06:33 EDT Mustang Bio reports updated interim Phase 1/2 data for MB-106 - Mustang Bio announced updated interim data from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted, autologous CAR T cell therapy for high-risk B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center. The data presented in an e-poster session at the European Hematology Association 2021 Virtual Congress by Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division of Fred Hutch, included safety and efficacy data from the cell manufacturing process that was modified to combine the culture of CD4+ and CD8+ cells. In the 15 patients treated, the overall response rate was 93% with a complete response rate of 67%. In 11 patients with follicular lymphoma, ORR and CR were 91% and 82%, respectively. As of the time of the e-poster submission to EHA2021, all patients who achieved CR remained in remission. One patient with FL had an initial partial response with a later disease progression, had a spontaneous CR and remains in remission. The patient with CLL also had a CR and undetectable measurable residual disease in peripheral blood and bone marrow by flow cytometry on day 28. CAR T persistence was seen in all dose levels and, while expansion was faster in higher DL, the levels were comparable by day 28. From a safety profile perspective, cytokine release syndrome occurred in 6 patients: 3 patients with grade 1 and 3 patients with and none of the 11 patients with FL experienced ICANS of any grade. No grade 3 or higher CRS or ICANS were seen in any patient.

06:16 EDT Concord Medical opens new specialty cancer hospital in Guangzhou - Concord Medical announced that its Guangzhou Concord Cancer Center, or GCCC, which is certified as a tertiary specialty hospital by the National Health Commission, is now in operation.

06:02 EDT Editas Medicine presents data supporting initiation of EDIT-301 Phase 1/2 RUBY - Editas Medicine announced preclinical data supporting the initiation of the EDIT-301 Phase 1/2 RUBY clinical trial to evaluate EDIT-301, a one-time, durable, autologous cell therapy medicine to treat sickle cell disease. EDIT-301 is the first experimental medicine generated using CRISPR/Cas12a gene editing. The company reported the data in an oral presentation at the 26th Congress of the European Hematology Association being held virtually. In these preclinical studies, CD34+ cells from normal donors and sickle cell patient donors were edited at the HBG1 and HBG2 promoters with Editas-engineered highly efficient and specific AsCas12a ribonucleoprotein at research-scale and large-scale. The data demonstrated that high levels of editing were achieved, resulting in robust fetal hemoglobin induction in erythroid cells with no detectable off-target editing. The red blood cells derived from edited sickle cell patient CD34+ cells showed significant reduction of sickling and improved rheological behavior. In addition, data from the company's current Good Manufacturing Practices clinical scale process to support EDIT-301 manufacturing demonstrated successful scale-up production, with consistent and high-level editing of the HBG1 and HBG2 promoters while maintaining high specificity and robust HbF induction. Furthermore, stable and polyclonal long-term engraftment was observed when cells manufactured from the representative scale-up process were infused into immunodeficient mice.

05:56 EDT Archer debuts Maker aircraft live in Los Angeles, virtually - Archer debuted its Maker aircraft both live in Los Angeles and streamed to a global audience on the evening of June 10. The in-person event was held at the Hawthorne Hangar Operations and utilized XR technology to take audiences on a virtual ride on Maker. The company built a 2,400 square feet XR volume space that simulated a commercial flight. With backing from the United Airlines (UAL) commercial order and the recently announced merger with Atlas Crest Investment Corp., the company is valued at $3.8B, Archer said it is in position to continue on its accelerated timeline toward commercial launch in 2024.

05:30 EDT Copa Holdings reports preliminary May traffic statistics - Copa Holdings released preliminary passenger traffic statistics for May. Reports May ASM 970.9M, down 53.4%. Reports May RPM 753.6M, down 58%. Reports May load factor 77.6% down 8.5 percentage points. The company said given the irregular nature of the company's operations starting in March 2020 due to the Covid-19 pandemic, it will compare this and future traffic reports to 2019 statistics.

05:24 EDT PTC Therapeutics announces interim results from RAINBOWFISH trial - PTC Therapeutics (PTCT) announced interim results from the ongoing RAINBOWFISH trial that demonstrated pre-symptomatic infants with spinal muscular atrophy, or SMA, treated with Evrysdi were able to reach motor milestones such as sitting without support, rolling, crawling, standing unaided and walking independently. Additionally, results presented from a 12-month interim analysis of the JEWELFISH safety study demonstrated overall stabilization in motor function and rapid and sustained increases in SMN protein. These patients began treatment with Evrysdi following previous treatments, including Spinraza or Zolgensma and are representative of the real-world, broad and heterogeneous SMA population with a high degree of motor impairment at baseline. Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein, which is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi has been approved for the treatment of patients with SMA, aged two months and older by the FDA and the EMA. Roche (RHHBY) leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi is marketed in the United States by Genentech, a member of the Roche Group.