Stockwinners Market Radar for June 18, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:05 EDT GeoPark responds to letter from former Chair Gerald O'Shaughnessy - GeoPark issued the following statement in response to the letter sent to the Board by its former Chair Gerald O'Shaughnessy: "Since GeoPark's inception, we have always worked to ensure we have the skills, capabilities and necessary tools to become the leading independent E&P Company in Latin America. As we have grown and matured, we have worked deliberately to strengthen our governance profile and, today, our Board has a majority of independent directors and a newly appointed independent chair, consistent with best practices. We have added two new independent directors in the last 12 months and have nominated a third independent director for election at the upcoming Annual General Meeting. We have also instituted a new Board committee with two independent members to oversee strategic matters. Our Board's continued evolution and diversification in recent years is an important and notable achievement, and one that we expect will help us build and deliver value to all shareholders. It is unfortunate that, after 18 years of service as the Chair of GeoPark's Board, Mr. O'Shaughnessy, 72, has chosen to leave the Board and disparage GeoPark with baseless claims. The Board and the management team are focused on the best interests of the company and our shareholders. We maintain an open dialogue with our shareholders and are always open to opportunities that will create value for all shareholders."

17:02 EDT Climate Change Crisis Real Impact I to transfer listing to Nasdaq from NYSE - Climate Change Crisis Real Impact I Acquisition Corporation announced that it intends to voluntarily transfer the listing of its shares of Class A common stock and its warrants to The Nasdaq Global Select Market from the New York Stock Exchange following the completion of its previously announced business combination with EVgo Services, which is expected to close on or around July 1, pending approval by stockholders of CLII at its special meeting for stockholders on June 29. In connection with the closing of the business combination, CLII will change its corporate name to "EVgo Inc." CLII expects its Class A common stock and warrants to commence trading on Nasdaq the day after the closing of the business combination under the symbols "EVGO" and "EVGOW," respectively. The Class A common stock and warrants will continue to trade on the NYSE until the transfer to Nasdaq is complete. The decision to list on Nasdaq was made in connection with the business combination and enables the post-combination company to be listed alongside similar companies that are also listed on Nasdaq. At the closing of the business combination, CLII will also delist its units, Class A common stock and warrants from the NYSE. The Nasdaq listing of the Class A common stock and warrants and the NYSE delisting of the units are subject to the closing of the business combination and the fulfillment of all Nasdaq listing requirements.

16:44 EDT CytRx notes Orphazyme regulatory update from FDA on arimoclomol - CytRx Corporation (CYTR) noted that Orphazyme A/S (ORPH) announced it has received a Complete Response Letter, or CRL, from the FDA following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C, or NPC. CytRx's drug candidate, arimoclomol, was sold to Orphazyme in exchange for milestone payments and royalties. Orphazyme's announcement disclosed that the FDA issued the CRL based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data are needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA. A primary endpoint of the phase 2/3 clinical trial was progression in disease severity as measured by the 5-domain NPCCSS. This is a disease-specific measure of disease progression consisting of the five clinically most relevant domains to patients with NPC, caregivers and physicians. Orphazyme CEO Christophe Bourdon stated: "We are disheartened by the outcome of the FDA's review, given the urgent need for a new therapeutic option for NPC, but we remain committed to working with the regulators, with the goal of delivering arimoclomol to families managing this challenging disease. We will focus our efforts on pursuing the European regulatory approval, with CHMP opinion expected in Q4 2021 and potential Marketing Authorization in Q1 2022. We are assessing the potential path forward in the U.S. in partnership with the FDA. In the short-term, we will need to reduce our costs substantially and freeze all company efforts not related to clinical and regulatory activities to support approval for NPC." The outcome of the FDA decision has significant influence on Orphazyme's outlook for FY21. Orphazyme's cash position at year-end 2021 is now expected to be approximately $8, where it was previously $56M.

16:31 EDT Pyxis Tankers announces receipt of Nasdaq notice - Pyxis Tankers Inc. announced that on June 16, 2021, it received a notification letter from the Nasdaq Stock Market, stating that, for a period of 30 consecutive business days, the company's common shares closed below the minimum bid price of $1.00 per share, as required for continued listing on Nasdaq. The company has until December 13, 2021 to regain compliance with the Minimum Bid Price Requirement. The company can cure this deficiency if the closing bid price of its common shares is $1.00 per share or higher for at least ten consecutive business days during the Compliance Period. The company intends to regain compliance with the minimum bid price requirement within the Compliance Period and is considering all available options, including a reverse stock split. During this time, the company's common shares will continue to be listed and traded on the Nasdaq Capital Market, and this notice will have no effect on the operations of the company's business. If the company does not regain compliance during the Compliance Period, it may be eligible for an additional 180 calendar day compliance period. If the Nasdaq staff concludes that the company will not be able to cure the deficiency or if the company is otherwise not eligible, the company's common shares will be subject to delisting by Nasdaq.

15:35 EDT Delta restores service to all pre-COVID Africa markets - Delta announced in a post to its corporate news hub that the airline will make its return to South Africa with nonstop service between Atlanta and Johannesburg beginning Aug. 1, more than a year after pausing flights due to COVID-19. "The return of the airline's longest nonstop flight marks the milestone of Delta restoring service to all its pre-COVID markets in Africa, which include Accra, Ghana; Dakar, Senegal; and Lagos, Nigeria," Delta said. Reference Link

13:02 EDT Baker Hughes reports U.S. rig count up 9 to 470 rigs - Baker Hughes reports that the U.S. rig count is up 9 from last week to 470 with oil rigs up 8 to 373, gas rigs up 1 to 97, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 204 rigs from last year's count of 266, with oil rigs up 184 gas rigs up 22 and miscellaneous rigs down 2. The U.S. Offshore Rig Count is unchanged at 13, up 2 year-over-year. The Canada Rig Count is up 24 from last week to 117, with oil rigs up 15 to 74, gas rigs up 9 to 43. The Canada Rig Count is up 100 rigs from last year's count of 17, with oil rigs up 69, gas rigs up 31.

12:41 EDT Austria's FCA approves Adevinta-eBay classifieds deal - Following an announcement by the Austrian Federal Competition Authorities, Adevinta ASA confirmed that the FCA has approved the remedies proposed by Adevinta and eBay to resolve the competition concerns raised by the FCA in relation to Adevinta's acquisition of eBay Classifieds Group, the global classifieds arm of eBay. The remedies proposed by Adevinta and eBay address the FCA's concern that the transaction could potentially lessen competition in the Austrian market between eBay.at and Willhaben, Adevinta's joint venture business in Austria. The commitments include a reduction by eBay of its financial interest in Adevinta to at least 33% within 18 months following closing of the transaction, so as to reduce its indirect economic interest in Willhaben. Additionally, Adevinta has agreed to prevent the flow of information about Willhaben to eBay, as well as to restrict eBay's potential influence over the strategic operations of Willhaben. Approval of the remedies from the FCA marks a significant milestone, as all regulatory approvals required for closing of the transaction have now been received. Consequently, Adevinta is pleased to announce that closing of the transaction will be initiated shortly and is expected to complete on or about 25 June 2021. Adevinta will make a further announcement once the transaction has been completed.

12:34 EDT Novartis reports data from completed two-copy cohort of Phase 3 SPR1NT trial - Novartis announced data it said reinforces the "transformational benefit of Zolgensma" gene therapy for spinal muscular atrophy, or SMA. New late-breaker data from the completed two-copy cohort of the Phase 3 SPR1NT clinical trial demonstrate age-appropriate milestone development in presymptomatic children with SMA without respiratory or nutritional support of any kind, and with no serious, treatment-related adverse events, the company said. The completed Phase 3 STR1VE-EU trial demonstrated rapid improvements in motor function following treatment with Zolgensma, and the majority of patients achieved motor milestones not observed in the natural history of SMA Type 1. Safety remained consistent with previously reported data. All children treated presymptomatically in the SPR1NT two-copy cohort achieved event-free survival, were independent of respiratory and nutritional support and met the primary endpoint of sitting independently for greater than or equal to30 seconds, including 11/14 who achieved this milestone within the World Health Organization window of normal development. A majority of patients went on to stand independently, 11/14, and walk independently, 9/14, most within the typical range of normal development. Among symptomatic children with SMA Type 1 treated in the STR1VE-EU trial, including patients with more severe disease at baseline, the majority of children, 82%, achieved developmental motor milestones not observed in the natural history of SMA Type 1, including 16 children, or 49%, who sat without support for greater than or equal to30 seconds. The data will be presented at the European Academy for Neurology Virtual Congress 2021.

12:25 EDT NACCO Industries trading resumes

12:01 EDT NACCO Industries trading halted, news pending

12:00 EDT Nouveau Monde falls -17.3% - Nouveau Monde is down -17.3%, or -$1.57 to $7.48.

12:00 EDT Geo Group rises 8.5% - Geo Group is up 8.5%, or 61c to $7.81.

12:00 EDT CAI International rises 46.5% - CAI International is up 46.5%, or $17.74 to $55.90.

11:27 EDT Hutchmed announces NMPA approval of surufatinib for pNETs - Hutchmed, formerly Hutchison China MediTech, announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China, or "NMPA," for the treatment of advanced pancreatic neuroendocrine tumors, or "pNETs." This follows the approval of surufatinib in China in December 2020 for the treatment of advanced extra-pancreatic neuroendocrine tumors, or "epNETs." The company said it was "made aware through the website of the NMPA that surufatinib's approval for drug registration by the NMPA for the treatment of pNETs was completed and is now pending certification."

10:04 EDT Biophytis SA (ADS) trading resumes

10:01 EDT Accenture Federal Services wins $112M prime task order - Accenture Federal Services, a subsidiary of Accenture, has been awarded a $112M prime task order by the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency to protect Federal Civilian Executive Branch systems against cyberattacks. AFS will provide advanced cyber services for CISA to help FCEB agencies mitigate the effects of cyberattacks including ransomware, botnets, and malware campaigns, while enhancing real-time visibility into cyber threats.

10:00 EDT Ares Commercial falls -8.5% - Ares Commercial is down -8.5%, or -$1.39 to $14.92.

10:00 EDT Nouveau Monde falls -17.6% - Nouveau Monde is down -17.6%, or -$1.59 to $7.46.

10:00 EDT Centrais Electricas rises 10.0% - Centrais Electricas is up 10.0%, or 86c to $9.50.

09:54 EDT Biophytis SA (ADS) trading halted, volatility trading pause

09:47 EDT Ares Commercial falls -6.7% - Ares Commercial is down -6.7%, or -$1.10 to $15.21.

09:47 EDT Nouveau Monde falls -17.1% - Nouveau Monde is down -17.1%, or -$1.55 to $7.50.

09:47 EDT Centrais Electricas rises 9.8% - Centrais Electricas is up 9.8%, or 84c to $9.48.

09:37 EDT Bristol-Myers receives European Commission approval for Onureg - Bristol Myers announced that the European Commission has granted full Marketing Authorization for Onureg as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation. Onureg is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes. The centralized Marketing Authorization approves use of Onureg in all EU member states, as well as Norway, Iceland and Liechtenstein. Onureg is approved in the United States for the continued treatment of adult patients with AML who achieved first CR or CRi following intensive induction chemotherapy and who are not able to complete intensive curative therapy. In Canada, Onureg is approved as a maintenance therapy for adult patients with AML who achieved CR or CRi following induction therapy with or without consolidation treatment, and who are not eligible for HSCT. The EC approval of Onureg was based on results from the QUAZAR AML-001 study, a Phase 3, international, randomized, double-blind trial. Eligible patients were ages 55 years or older, had newly diagnosed AML, intermediate or poor cytogenetics, had achieved first CR or CRi following intensive induction chemotherapy with or without consolidation treatment, and were not candidates for HSCT at the time of screening.

09:19 EDT Ampio to join Russell 2000, Russell 3000 indexes - Ampio Pharmaceuticals announced that the company is expected to join the small cap Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of this year's reconstitution of the Russell stock indexes, effective after the U.S. stock market opens on Monday, June 28, accordingly to a preliminary list of additions posted on June 4.

09:18 EDT CAS Investment sends letter to At Home Group stockholders regarding sale - CAS Investment Partners, which beneficially owns approximately 17% of the outstanding common stock of At Home Group, sent the below letter to the company's stockholders. "... We are writing to you today regarding the proposed sale of At Home to funds advised by Hellman & Friedman LLC (collectively, "H&F"). Based on our thorough analysis of At Home's business and the transaction terms, we have concluded that H&F's original offer of $36 per share and its recently revised offer of $37 per share grossly undervalue the Company and deprive stockholders of meaningful value. We urge you to reject H&F's insufficient tender offer. Although we expect At Home's Board of Directors (the "Board") and H&F to dispute our analysis and tout the purported comprehensiveness of their transaction process, we urge you to see through this smokescreen. We believe you should instead focus on one question when considering whether or not to participate in the tender: Is $37 per share fair consideration for a business with clear momentum, a considerable growth runway and significant margin expansion opportunities?... If H&F wants to acquire At Home, we believe it should pay a reasonable premium that appropriately reflects the Company's path to enhanced value and the present consumer environment. It is disturbing that the Board's Special Committee is trying to usher through a fire sale just as At Home is gaining considerable momentum and the pandemic's economic overhang is subsiding. At Home, which can become the next great American retailer, has the ability to grow rapidly and produce tremendous value for stockholders in the public market... Given the substantial compensation and benefits Mr. Bird is set to receive under the proposed sale and his continuous dealings with H&F, we believe the sales process was flawed and riddled with conflict. We anticipate that At Home will try to deflect attention away from our concerns by highlighting its 40-day "go-shop" process, but the reality is that these processes have become an increasingly ineffective check on a bad deal. A 2020 analysis in the Harvard Law Review notes that "go-shops, in general, are no longer an effective tool for post-signing price discovery."4 The authors of the analysis "document several reasons for this change: the proliferation of first-bidder match rights, the shortening of go-shop windows, CEO conflicts of interest, investment banker effects, and collateral terms that have the effect of tightening the go-shop window."5 An after the fact "go shop" does not change the fact that this transaction was not the result of a full and fair sale process to maximize value for all At Home stockholders... We know we are not alone in opposing this insufficient, conflict-ridden deal. It has been encouraging to receive unsolicited feedback from many other stockholders who share our view about At Home's long-term prospects. As noted, we truly believe the Company can become the next great American retailer as the pandemic fades and the housing economy thrives. In the coming days and weeks, CAS will continue to share our analysis and views regarding this flawed sale. We are committed to continuing to demonstrate that it is in stockholders' best interest to reject the H&F tender. At Home's decision to pivot to a tender offer seems like recognition that the deal would have likely been voted down. We believe this only further proves how imperative it is that stockholders do not tender into this grossly undervalued price. We will not sit by as At Home gets taken private on terms that would benefit H&F and the Company's insiders far more than stockholders."

09:07 EDT Hoth Therapeutics extends license deal with U.S. Army Medical Research Command - In a regulatory 8-K filing filing, the company states: "On June 17, 2021, Hoth Therapeutics, Inc. entered into an amendment to the Non-Exclusive Commercial Evaluation License Agreement with the U.S. Army Medical Research and Development Command originally executed on December 22, 2020 pursuant to which the term of the License Agreement was extended such that it will terminate 12 months from the Effective Date."

09:04 EDT Natera says CMS grants ADLT status for Signatera MRD test - Natera announced that the Centers for Medicare & Medicaid Services has granted ADLT status for the Signatera molecular residual disease test. Obtaining ADLT status confirms that Signatera meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014. The initial ADLT rate established by CMS is $3,500 for each Signatera assay used in the recurrence monitoring setting. Signatera received Medicare coverage for use in stage II-III colorectal cancer in late 2020, while finalization of a draft local coverage determination for use in immunotherapy response monitoring is anticipated for release in late 2021.

08:45 EDT Bombardier delivers first Global 7500 aircraft in Indonesia - Bombardier announces the arrival of the first Global 7500 business jet in Indonesia. This aircraft was recently delivered to an undisclosed customer based in Jakarta. "Global aircraft are designed to deliver the ultimate in luxury, performance and smooth ride over long-distance flights, making them ideally suited to customers in the Asia-Pacific region who are looking to connect far-flung city pairs," said Nilesh Pattanayak, Regional Vice President, Sales, Asia Pacific, Bombardier. "The ultra-long-range Global 7500 aircraft opens up a world of possibilities for convenient and productive travel." Bombardier is significantly expanding its customer service footprint in the Asia-Pacific region with the creation of a state-of-the-art customer service centre at Essendon Fields Airport in Melbourne, Australia. The facility is targeted to be operational in 2022. Meanwhile, the ambitious expansion of Bombardier's Singapore Service Centre is ongoing. This site at the Seletar Aerospace Park will quadruple the operation's footprint, making it the largest OEM-owned business aviation maintenance facility in the region.

08:36 EDT Meten Edtechx: 247.8% increase in gross billings for junior ELT unit in May - Meten EdtechX announced that the gross billing and student enrollment of its junior ELT business in May 2021 increased by 247.8% and 163.9% respectively compared to the same period of last year and increased by 92.4% and 65.2% respectively compared to May 2019. In the first five months of 2021, the gross billing of the company's junior ELT business increased by 408.4% year over year and increased by 120.4% compared with the same period in 2019. These figures confirm that the company has returned to its pre-pandemic growth trajectory. The company is actively expanding its junior ELT business within its current network of 22 cities and has received positive market feedback. The gross billing from student renewals and referrals accounted for 57.7% of the total gross billing of the company's junior ELT business in May 2021, demonstrating that the company's services have been widely appreciated and recognized by students and their parents. Due to recent policy changes, the company will continue to develop the business of junior quality-oriented education

08:35 EDT GE to proceed with 1-for-8 reverse stock split on July 30 close - General Electric announced that it will proceed with the 1-for-8 reverse stock split previously approved by shareholders at the annual meeting of shareholders on May 4. GE plans to file an amendment to its certificate of incorporation to effectuate the reverse stock split after the close of trading on July 30, and GE common stock will begin trading on a split-adjusted basis on August 2. The move will reduce the number of outstanding shares of GE common stock from approximately 8.8B to approximately 1.1B.

08:34 EDT Luokung Technology unit wins contract for new traffic control network in China - Luokung Technology announced that its wholly owned subsidiary eMapgo Technologies, has entered into a contract to deliver a new generation traffic control network and smart highway demonstration project for the Changjiu Expressway in the Jiangxi Province of China. According to the terms of the contract, EMG will be responsible for the development and implementation of a 3D real-life highway digital management system for the new generation smart highway demonstration project for the Changjiu Expressway. A digital management system will provide real-time road information and intelligent operation management to support the latest smart transportation, such as lane navigation, autonomous driving, road coordination and vehicle-road collaboration, while increasing safety and decreasing congestion for improved road maintenance and management.

08:31 EDT Taseko Mines announces retirement of CEO, COO - Taseko Mines announced the voting results from its 2021 Annual General Meeting held yesterday. Additionally, the company announces the retirement of Russell Hallbauer, CEO, and John McManus, COO, effective June 30. Russ will remain a Director of the company, and Stuart McDonald, currently President, will also assume the role of CEO. Richard Tremblay will be promoted to Senior Vice President, Operations and Richard Weymark has been appointed Vice President, Engineering.

08:10 EDT Just Energy announces Texas legislation may help the company recover $100M - Just Energy Group announced that on June 16, Texas Governor Greg Abbott signed House Bill 4492, which provides a mechanism for recovery of certain costs incurred by various parties, including the Company, during the extreme weather event in Texas in February 2021 through certain securitization structures. HB 4492 addresses securitization of ancillary service charges above US $9,000/MWh during the Weather Event; reliability deployment price adders charged by the Electric Reliability Council of Texas during the Weather Event; and amounts owed to ERCOT due to defaults of competitive market participants, which were subsequently "short-paid" to market participants, including Just Energy. HB 4492 provides that ERCOT request that the Public Utility Commission of Texas establish financing mechanisms for the payment of the Costs incurred by load-serving entities, including Just Energy. Based on current information, if the Commission approves the financing provided for in HB 4492, Just Energy anticipates that it will apply to the Commission to recover approximately $100M of Costs. There is no assurance that the Company will be able to recover all of the Costs that it applies for under the Commissions order or orders.

08:05 EDT Cleveland BioLabs, Cytocom merger proxy statement declared effective by SEC - Cleveland BioLabs announced that its registration statement on SEC Form S-4 filed with U.S. Securities and Exchange Commission in connection with its previously announced merger with Cytocom was declared effective by the SEC.

08:02 EDT Exelixis CMO Gisela Schwab begins medical leave of absence - Exelixis announced that, effective immediately, Gisela Schwab, the company's president, product development and medical affairs and CMO, has begun a medical leave of absence. Schwab will remain available to advise Exelixis as needed during her leave.

07:58 EDT Orphazyme receives CRL from FDA following arimoclomol review - Orphazyme announced it has received a complete response letter, or CRL, from the FDA following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C, or NPC. The FDA issued the CRL based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale, or NPCCSS, and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data are needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA. A primary endpoint of the phase 2/3 clinical trial was progression in disease severity as measured by the 5-domain NPCCSS. This is a disease-specific measure of disease progression consisting of the five clinically most relevant domains to patients with NPC, caregivers and physicians.

07:40 EDT TG Therapeutics announces preclinical, clinical data evaluating TG-1701 - TG Therapeutics announced data from two presentations evaluating TG-1701, the company's investigational once-daily, oral BTK inhibitor, presented today during the 16th International Congress on Malignant Lymphoma. One presentation evaluated TG-1701 preclinically and the other included Phase 1 data evaluating TG-1701 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. Poster Presentation Title: Antitumoral activity of the novel BTK inhibitor TG-1701 is associated with disruption of Ikaros signaling and improvement of anti-CD20 therapy in B-cell non-Hodgkin lymphoma. In patient samples from a Phase 1 clinical trial of TG-1701, phosphoproteomic analysis differentiated early and late CLL responders to TG-1701 therapy. TG-1701 did not impair FcgammaR-driven ADCC and ADCP and cooperated with U2 in in vitro and in vivo models of BTKi-sensitive and BTKi-resistant B-NHL. Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib in Patients with B-cell Malignancies. 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. 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 (using doses of 100mg to 300 mg QD of resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma, diffuse large B-cell lymphoma and follicular lymphoma.

07:32 EDT Tilt Holdings reaches agreement with Massachusetts CCC - TILT Holdings announced it has reached an agreement with the Massachusetts Cannabis Control Commission, or CCC, resolving concerns of the CCC and clearing the path for provisional licensure for the retail sale of adult-use and medical cannabis in Massachusetts. With today's decision, TILT has fully resolved the dispute regarding certain agreements entered into by the original management team of TILT with other license applicants. In February, TILT terminated all remaining contractual relationships between the Company and prospective applicants. At yesterday's meeting of the CCC, the commissioners ratified a stipulated agreement resolving the related investigation pursuant to which TILT has agreed to make a $275,000 payment to the CCC Marijuana Regulation Fund. In light of the CCC's decisions, TILT is now positioned to complete the licensing process and increase its retail footprint in Massachusetts with the opening of two additional dispensaries in Cambridge and Brockton following final inspection and approval by the Commission. Both facilities are fully built out.

07:23 EDT ADC Therapeutics presents data on four Zynlonta clinical trials - ADC Therapeutics announced that posters on four Zynlonta clinical trials were presented at the 16th Annual International Conference on Malignant Lymphoma, or ICML. In LOTIS-2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed two established therapies, Zynlonta demonstrated continued substantial antitumor activity and an acceptable safety profile. Updated results were presented in a poster. As of the data cut-off date of March 1, all patients had completed treatment. Overall response rate, or ORR, was 48.3% and complete response rate, or CRR, was 24.8%. Median duration of response, or mDoR, of 13.4 months for the 70 responders. Median duration of response not reached for patients with a complete response. Median overall survival was 9.5 months. No new safety concerns were identified during the study and no increase in toxicity was observed in patients aged 65 years compared with patients less than 65 years. The most common grade 3 treatment-emergent adverse events. or TEAEs, were neutropenia, thrombocytopenia, increased gamma-glutamyltransferase and anemia. LOTIS-3, a Phase 1/2, two-part, open-label, single-arm clinical trial, is evaluating Zynlonta in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, or mantle cell lymphoma, or MCL. Updated Phase 1 results were presented in a poster. As of the data cut-off date of March 1, 30 patients with DLBCL and seven patients with MCL were included in the study. ORR in all patients was 62.2% and CRR was 35.1%. In non-GCB DLBCL patients, ORR was 66.7%. In GCB DLBCL patients, ORR was 16.7%. In MCL patients, ORR was 85.7%. Zynlonta in combination with ibrutinib had manageable toxicity, with the most common grade 3 TEAEs in 5% of patients being anemia, neutropenia, thrombocytopenia and fatigue. Pharmacokinetic profiles demonstrated sustained exposure and modest accumulation by Cycle 2

07:07 EDT Iveric bio to present GATHER2 enrollment data, GATHER1 analyses - Iveric bio announced that at the company's virtual symposium for investors and analysts, Arshad Khanani of Sierra Eye Associates and chairman of the GATHER2 Steering Committee, will discuss an accelerated enrollment timeline and patient retention, including injection fidelity, for GATHER2, the company's pivotal clinical trial of Zimura in development for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration (AMD). The Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis. The company also announced that GATHER2 is exceeding patient retention expectations. The company is targeting patient retention for the trial, as measured by injection fidelity rate through month 12, of greater than 90%. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients. The company also announced that Vas Sadda, of Doheny Eye Institute at UCLA, will present new post-hoc analyses from the GATHER1 clinical trial on progression of drusen and nascent GA, which are earlier forms of dry AMD, in patients treated with Zimura 2 mg as compared to patients in the sham group. The accompanying graphs illustrate the data that Sadda will discuss.

07:03 EDT Moderna reaffirms commitment to create jobs in Massachusetts - Moderna reaffirmed its commitment to job creation in Massachusetts. Over the last year, Moderna nearly doubled the size of its workforce, from approximately 830 employees as of March 31, 2020 to approximately 1,500 employees as of March 31. In the last year, Moderna created more than 650 new jobs at its manufacturing facility in Norwood, Massachusetts. The company continues to expand in Norwood and Cambridge. On June 15, Moderna was awarded a tax incentive from the Massachusetts Life Sciences Center, or MLSC, based on its commitment to hire 155 new full-time equivalent employees in 2021 and retaining that headcount through 2025. The MLSC Tax Incentive Program awards companies engaged in life science research and development, commercialization and manufacturing with the goal of creating new, long-term jobs in the state of Massachusetts.

07:00 EDT Palantir receives contract from FAA valued at up to $18.4M - Palantir Technologies announced it has been contracted by the Federal Aviation Administration to provide a data analytics tool that will help advance the agency's modernization objectives for aviation safety. Palantir Foundry will support the FAA's aircraft certification and continued operational safety activities, including the ongoing monitoring of the 737 MAX fleet's return to service. The one-year contract with two additional option years is valued at a maximum of $18.4M.

06:55 EDT Sykes Enterprises trading halted, news pending

06:48 EDT Ocwen to acquire RMS reverse mortgage servicing platform for $12.4M - Ocwen Financial announced that its wholly-owned subsidiary, PHH Mortgage Corporation, has entered into an agreement with Reverse Mortgage Solutions and its parent, Mortgage Assets Management, to acquire substantially all of the operations, assets and employees of the RMS reverse mortgage servicing platform. MAM is a subsidiary of investment funds managed by Waterfall Asset Management. The company will also acquire all of the outstanding equity interests in the RMS Real Estate Owned business, REO Management Solutions. Under the terms of the agreement, subservicing contracts for the reverse residential mortgages currently subserviced by RMS would be assigned to PHH. As of March 31, 2021, RMS serviced approximately 35,000 reverse mortgages, or approximately $7.8B in unpaid principal balance. As part of the transaction, PHH expects to assume the vast majority of the RMS reverse servicing and REO employees and PHH will become the subservicer under a five-year subservicing agreement for reverse mortgages owned by RMS and MAM. The aggregate purchase price is estimated to be approximately $12.4M and will be subject to certain post-closing adjustments. The transaction is expected to close in the third quarter, subject to appropriate regulatory approvals and other customary closing conditions.

06:09 EDT GeoPark co-founder O'Shaughnessy urges board to make changes - Gerald O'Shaughnessy, the co-founder, former Chairman and second largest shareholder of GeoPark, issued an open letter to the Board of Directors of GeoPark which stated in part: "Dear Members of the Board: I am writing you now because I am deeply concerned that GeoPark faces two significant barriers to enhancing shareholder value: (1) Jim Park's general resistance to full and independent evaluation of strategic alternatives and consistent lack of transparency have led to missed opportunities and call into serious question his performance as CEO and (2) the board has compounded these issues by failing to exert true independent and critical oversight of management. I believe action needs to be taken now to rectify this situation. Accordingly, I am formally requesting that you revise the slate that you are proposing for the upcoming annual meeting to re-include me as well as three additional independent candidates to bolster company oversight. I would not serve either as Chair or on any key committees where independence concerns would suggest my participation is inadvisable because of my prior role as Chair. I propose that the board should be constituted so that GeoPark keeps its status as a foreign private issuer and that a majority of its directors be considered independent under prevailing analyses. I believe that Ms. Escovar should remain Chair and that Ms. Suarez should be nominated as you have proposed. The directors who would step off would be discussed, and the number of directors could be increased, if necessary."

06:01 EDT Local Bounti to go public via merger with Leo Holdings III Corp. in $1.1B deal

05:24 EDT ArcelorMittal sells remaining Cleveland-Cliffs shares for $750M share buyback - ArcelorMittal North America, a wholly owned subsidiary of ArcelorMittal (MT), announced the conclusion of the sale of its remaining 38.2M common shares in Cleveland-Cliffs (CLF) following receipt of the shares on June 9. The value crystalized from this sale of Cleveland-Cliffs common shares will be returned to shareholders via a new $750M share buyback program of ArcelorMittal common shares. This new share buyback program will commence immediately and follows the previous buyback program which is now complete. The disposal of the remaining common shares in Cleveland Cliffs brings the total cash proceeds from the sale of ArcelorMittal USA to $1.9B so far, all of which will have been returned to ArcelorMittal shareholders via share buybacks.

05:15 EDT AWS to become cloud provider for Ferrari - Amazon Web Services, or AWS, an Amazon (AMZN) company, announced that it has entered into an agreement with Ferrari (RACE) to become their official cloud, machine learning, and AI provider. Together, the companies will accelerate the pace of innovation across the entire Ferrari organization, including their road cars department, GT Competitions, the Ferrari Challenge, and the Scuderia Ferrari Formula 1 team. In addition, Scuderia Ferrari will leverage AWS to launch a digital fan engagement platform, via its mobile app, to engage hundreds of millions of fans worldwide with exclusive, personalized content.

05:07 EDT Huize partners with Sunshine Insurance to launch Darwin Critical Care 2021 - Huize announced that it has partnered with Sunshine Insurance Group to launch Darwin Critical Care 2021, a critical illness insurance product designed for sub-optimal health group. Cunjun Ma, founder, chairman and CEO of Huize, commented, "This year marks the second year in a row for Huize to launch a product dedicated to customers with pre-existing medical conditions. Leveraging our years of experience in product development, advanced technology, and a massive amount of multi-dimensional user data, we are able to group sub-optimal health users at a reasonably large scale, deploy data-analytics to customize insurance underwriting requirements, and thereby empower our insurance carrier partner to implement risk-based pricing effectively."