Stockwinners Market Radar for June 12, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:04 EDT SPDR Gold Shares holdings rise to 1,136.22MT from 1,135.05MT - This is the 3rd consecutive increase and the highest level of holdings since April of 2013.

17:35 EDT Medtronic announces $337M product investment from Blackstone Life Science - Medtronic plc (MDT) and Blackstone (BX) announced that Medtronic intends to increase research and development funding in its Diabetes Group through an agreement to receive $337M of funding from funds managed by Blackstone Life Sciences including co-investors, aimed at advancing "new, innovative products especially designed to reduce the burden of diabetes management."

17:32 EDT S&P announces June quarterly rebalance effective 6/22 - S&P MidCap 400 constituents Tyler Technologies Inc. (TYL), Bio-Rad Laboratories Inc. (BIO) and Teledyne Technologies Inc. (TDY) will move to the S&P 500, replacing Harley- Davidson Inc. (HOG), Nordstrom Inc. (JWN) and Alliance Data Systems Corp. (ADS) all of which will move to the S&P MidCap 400. S&P SmallCap 600 constituents Strategic Education Inc. (STRA), Qualys Inc. (QLYS) and Glacier Bancorp Inc. (GBCI) will move to the S&P MidCap 400, replacing Bed Bath & Beyond Inc. (BBBY), Matador Resources Co. (MTDR) and Allscripts Healthcare Solutions Inc. (MDRX) all of which will move to the S&P SmallCap 600. Middleby Corp. (MIDD), Quidel Corp. (QDEL), Hexcel Inc. Inc. (KAR) and Univar Solutions Inc. (UNVR) will join the S&P MidCap 400. S&P MidCap 400 constituents NOW Inc. (DNOW), Cheesecake Factory Inc. (CAKE), and Resideo Technologies Inc. (REZI) will move to the S&P SmallCap 600. Dillard's Inc. (DDS) will be removed from the S&P MidCap 400 as it is no longer representative of the midcap market space. Tailored Brands Inc. (TLRD), CBL & Associates Properties Inc. (CBL), HighPoint Resources Corp. (HPR) and Tetra Technologies Inc. (TTI) will be removed from the S&P SmallCap 600 as they are no longer representative of the small-cap market space. BrightSphere Investment Group Inc. (BSIG) will join the S&P SmallCap 600.

17:28 EDT Lockheed Martin awarded maximum $375.49M Navy contract modification - Lockheed Martin was awarded a not-to-exceed $375.49M undefinitized contract modification to a previously awarded firm-fixed-price, cost-plus-fixed-fee contract. This modification provides non-recurring efforts to design and develop unique hardware and software for the multi-role helicopter MH-60R development program for the government of India. Work will be performed in Owego, New York and Stratford, Connecticut, and is expected to be complete by June 2025. Foreign Military Sales funds for $117.7M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:26 EDT Bio-Rad to replace Nordstrom in the S&P500 at open on 6/22

17:25 EDT Tyler Technologies to replace Harley-Davidson in the S&P500 at open on 6/22

17:04 EDT Pareteum Chief Commercial Officer Victor Bozzo steps down - In a regulatory 8-K filing, Parateum announced entering into a separation agreement with its Chief Commercial Officer Victor Bozzo effective as of June 9, 2020. .

16:49 EDT Corteva files motion challenging EPA registration of XtendiMax - Corteva filed a motion to intervene in the U.S. Court of Appeals for the Ninth Circuit case challenging the U.S. Environmental Protection Agency registration of the dicamba herbicide marketed as XtendiMax Herbicide with VaporGrip Technology. Corteva was not a party to the lawsuit, and until June 3, the case appeared to involve only the XtendiMax registration. The Ninth Circuit Court nevertheless vacated in its June 3 decision the EPA's registration of XtendiMax and Enginia herbicides, as well as Corteva's registration for DuPont FeXapan with VaporGrip Technology. Corteva is seeking to intervene to preserve our rights and to support the rights of customers to use the impacted dicamba weed control technologies. The company "believe dicamba is an effective weed management tool for farmers when used according to the label and seeks to preserve the role of the U.S. EPA to administer the Federal Insecticide, Fungicide & Rodenticide Act, including granting or cancelling crop protection product registrations, for the benefit of agriculture and society."

16:38 EDT Shake Shack board directors to be paid in equity through Q1 of 2021 - In a regulatory filing, Shake Shack said that "upon the recommendation of the Compensation Committee of the Board, approved an adjustment to how the company's directors are compensated for their service. Pursuant to the company's non-employee Director Compensation Policy, director compensation is paid 50% in cash and 50% in equity, with a one-year vesting period. For the annual service period starting with the second quarter of 2020 and continuing through the first quarter of 2021, directors will be compensated 100% in equity, with a one-year vesting period. This adjustment is intended to be temporary in nature as the company continues to manage the COVID-19 crisis."

16:22 EDT PTC Therapeutics announces data from SUNFISH, JEWELFISH trials - PTC Therapeutics announced two-year data from Part 1 of the SUNFISH trial in children and adults with type 2 or 3 spinal muscular atrophy, or SMA, and new preliminary 12-month data from JEWELFISH. The results of an exploratory efficacy analysis from SUNFISH showed risdiplam improved motor function after 24 months of treatment compared to natural history data. In addition, preliminary 12-month data from the JEWELFISH trial in people with SMA aged 6 months to 60 years, previously treated with other SMA therapies, showed that treatment with risdiplam led to rapid and sustained increases in SMN protein levels. No new safety signals were observed and the overall adverse event profile was consistent with that of treatment-naive patients. The exploratory efficacy analysis of Part 1 of the SUNFISH study assessed motor function, using the Motor Function Measure, or MFM, scale, which is used to evaluate fine and gross motor function in people with neurological disorders including SMA. It assesses different motor functions ranging from the use of hands and fingers to standing and walking. In a weighted analysis comparing the data with an external natural history comparator cohort, the MFM total change from baseline at Month 24 was greater in patients receiving risdiplam. These results are consistent with the results of the pivotal Part 2 of the trial at 12 months in non-ambulatory patients, which demonstrated that change from baseline in total MFM-32 score was significantly greater in people treated with risdiplam, compared to placebo. The most common adverse events in Part 1 of the SUNFISH study were fever, cough, vomiting, upper respiratory tract infections, cold and persistent sore throat. The most common serious adverse event that occurred in three of the 51 patients exposed to risdiplam was pneumonia. To date there have been no treatment-related safety findings leading to withdrawal. Enrollment for the JEWELFISH study, assessing safety and pharmacodynamics of risdiplam in previously treated patients with SMA, who are now receiving risdiplam, is complete. Among the patients who had completed 12 months of treatment with risdiplam, a rapid and sustained two-fold increase in median SMN protein levels versus baseline was observed. An early assessment of safety showed a consistent safety profile compared to treatment-naive patients.Of the 174 patients enrolled in the JEWELFISH study, 76 were previously treated with nusinersen and 14 with onasemnogene abeparvovec. The remaining patients had been treated in previous Roche SMA clinical trials. In the JEWELFISH study, the most common adverse events were upper respiratory tract infections, headache, fever, diarrhea, nasopharyngitis and nausea. To date there have been no drug-related safety findings leading to withdrawal and the overall adverse event profile has been similar to that observed in risdiplam trials of patients not previously treated with an SMA-targeting therapy.

16:17 EDT W. R. Berkley raises quarterly dividend to 12c per share - W. R. Berkley announced that its board has voted to increase the regular cash dividend to an annual rate of 48c per share, representing a 9% increase from the present rate. The first quarterly dividend at the new rate of 12c per share will be paid on June 30 to stockholders of record at the close of business on June 23.

16:04 EDT Concert Pharmaceuticals' CTP-543 ph.2 trial data saw 'positive findings' - The company states: "Concert Pharmaceutical released new data analyses from its Phase 2 dose-ranging clinical trial of its investigational agent CTP-543 for the treatment of moderate-to-severe alopecia areata. The data analyses released by Concert build on the previously-reported Phase 2 primary efficacy analysis which showed that administration of 8 mg twice-daily and 12 mg twice-daily doses of CTP-543 for 24 weeks produced a statistically significantly greater number of responders compared to placebo. In the new analyses, statistically significant results were reported for the 8 mg and 12 mg twice-daily doses at more stringent response thresholds, which may be more clinically meaningful to patients, and positive findings were reported for clinician and patient reported outcome measures of scalp hair loss."

15:51 EDT Eli Lilly's Ph2b data of lebrikizumab in dermatitis saw meaningful improvement - Eli Lilly and Dermira presented new data from the Phase 2b clinical trial of lebrikizumab in patients with moderate-to-severe atopic dermatitis. The company states that the "data from this study suggests that treatment with lebrikizumab provided rapid and clinically meaningful improvements in itch, sleep and overall measures of quality of life." Eli Lilly further states that "Lebrikizumab was generally well-tolerated with safety profile that was consistent with previous studies, including low frequency of conjunctivitis, herpes virus infections and injection site reactions."

15:08 EDT NJ reports May total gaming revenue down 65.4% to $95.9M - Based upon filings with the New Jersey Division of Gaming Enforcement, total gaming revenue for May was $95.9M, compared to $276.8M in May 2019, reflecting a 65.4% decrease. Due to COVID-19, Atlantic City Casinos closed at 8:00 p.m. on March 16, the state noted. Internet gaming win was $85.9M in May compared to $38.3M in the prior period, reflecting an increase of 124.1%. Sports wagering gross revenue was $9.9M for the month. Publicly traded companies in the casino gaming space include Boyd Gaming (BYD), Caesars (CZR), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN) and Wynn Resorts (WYNN). Online gambling names include Gan Limited (GAN), DraftKings (DKNG) and Scientific Games (SGMS).

14:26 EDT Qiagen believes Thermo Fisher offer is 'full, fair, attractive' - Qiagen (QGEN) continues to believe Thermo Fisher's (TMO) is "full, fair, attractive," a spokesman told Bloomberg in a phone interview. The comment comes after Glass Lewis's recommendation that Qiagen shareholders vote against the "Top Up" proposal under the Thermo Fisher deal.

14:06 EDT Aramark announces retail dining operator agreement with Purdue University - Purdue University and Aramark announced that they have entered into a retail dining operator agreement that "will enhance dining offerings for Purdue's West Lafayette campus and community." Aramark will operate 35 dining locations on the West Lafayette campus, including 11 locations in Purdue Memorial Union. Aramark will assume control of retail dining in early July. The retail dining operator agreement has a 10-year term with two five-year renewal options. As part of the partnership, Aramark will provide a portion of the funding to complete the renovation of the Purdue Memorial Union ground floor, which was approved by Purdue's Board of Trustees in April.

13:15 EDT Wrap Technologies announces order from sheriff's department in South Dakota - Wrap Technologies reported Sanborn County Sheriff's Department is the first agency in the state of South Dakota to purchase the BolaWrap remote restraint device. Mike Rothans, Chief Operating Officer of Wrap Technologies, said, "We are excited to see agencies in new states adopt the BolaWrap onto their duty belt. With states opening we are seeing increased sales and training activity and I believe other cities and counties will follow Sheriff Fridley's leadership in working toward a safer end to police encounters."

13:00 EDT Baker Hughes reports U.S. rig count down 5 to 279 rigs

12:58 EDT Digital Ally regains compliance with Nasdaq minimum bid price requirement - Digital Ally announced that on June 12, 2020 it received written notice from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC stating that the company regained compliance with the applicable Nasdaq minimum bid price continued listing requirement and the matter is now closed. The company had previously been notified by Nasdaq on April 22, 2020 that it was not in compliance with the minimum bid price requirement because its common stock failed to maintain a minimum bid price of at least $1.00 for 30 consecutive business days. In order to regain compliance with Nasdaq Listing Rule 5550(a)(2), the company was required to maintain a minimum closing bid price of at least $1.00 for at least 10 consecutive trading days, which was achieved on June 11, 2020. The company's closing price on June 11th was $4.15.

12:28 EDT GlycoMimetics Phase 3 RESET study data to be presented at Sickle Cell meeting - GlycoMimetics announced that a post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel , its wholly-owned development candidate, in acute vaso-occlusive crisis, or VOC, shows that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. This analysis and new biomarker data will be presented at the September meeting of the Foundation for Sickle Cell Disease Research, or FSCDR. In addition to the rivipansel poster, an abstract containing data on GlycoMimetics' more selective and highly potent E-selectin antagonist, GMI-1687, has been accepted for an oral presentation. The GMI-1687 abstract includes data from a preclinical model showing the drug candidate's potential as a subcutaneously administered treatment for VOC. FSCDR posted the abstracts online today for the meeting now scheduled for September 23-25, in Ft. Lauderdale, FL. The rivipansel abstract includes data from a supportive analysis of the Phase 3 RESET trial of 345 patients who were experiencing acute VOC requiring hospitalization for treatment. The analysis shows that patients treated with rivipansel early in their acute episode experienced a statistically significant improvement on the primary efficacy endpoint, time to readiness for discharge. This endpoint reflects achievement of multiple clinical criteria assessing healthcare utilization and a patient's medical improvement prior to leaving the hospital. Furthermore, patients treated with rivipansel showed a statistically significant reduction in soluble E-selectin, a biomarker indicating that the drug had the intended biological effect. The effect observed on soluble E-selectin in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute VOC. Data from the RESET trial additionally demonstrate a safety profile for rivipansel comparable to the placebo... The second abstract, accepted for oral presentation, discloses data from a preclinical model of GlycoMimetics E-selectin antagonist, GMI-1687, which is even more potent than rivipansel and is formulated for subcutaneous dosing."

12:00 EDT Blue Apron falls -6.6% - Blue Apron is down -6.6%, or -70c to $9.85.

12:00 EDT Perspecta rises 17.3% - Perspecta is up 17.3%, or $3.64 to $24.70.

12:00 EDT Bristow Group rises 205.8% - Bristow Group is up 205.8%, or $10.62 to $15.78.

11:04 EDT GameStop: Kurtis Wolf, Paul Evans elected to board - GameStop reported preliminary voting results from the 2020 Annual Meeting of Stockholders held Friday June 12, 2020. Based on the preliminary results, the ten directors that will serve as members of the Board of Directors until the next annual meeting of stockholders will include Hestia Capital Partners, LP's and Permit Capital Enterprise Fund, LP's nominees Kurtis Wolf and Paul Evans. Based on the preliminary results, the nominees elected to the Board were Lizabeth Dunn, Paul Evans, Raul J. Fernandez, Reginald Fils-Aime, George E. Sherman, William Simon, James Symancyk, Carrie W. Teffner, Kathy P. Vrabeck, and Kurtis Wolf. As previously announced, Ms. Vrabeck, formerly the Board's Lead Independent Director, will serve as Chair of the Board. Daniel A. DeMatteo, Gerald Szczepanski, Larry S. Zilavy and Steven R. Koonin retired from the Board and did not stand for re-election at the Meeting, reducing the Board to 10 members. "We welcome Mr. Wolf and Mr. Evans to the Board, and look forward to working together to deliver value to all GameStop stockholders. I would like to thank Jerome Davis and Thomas Kelly for their years of Board service. I would also like to thank Daniel DeMatteo for his years of service as Executive Chairman, former CEO and co-founder. Dan's passion for our business inspired us to grow from a small software retailer to the world's largest video game omni-channel retailer offering the best selection of new and pre-owned video gaming consoles, accessories and video game titles, in both physical and digital formats," said Kathy Vrabeck, Chair of the Board.

10:04 EDT Verrica announces results from two pooled analyses of Phase 3 CAMP trials - Verrica Pharmaceuticals announced the presentation of new pooled data from two analyses of the Phase 3 CAMP trials of VP-102, Verrica's lead product candidate for the treatment of molluscum contagiosum. These data are available in poster format online by the American Academy of Dermatology for the 2020 annual meeting, which was previously scheduled for March 20-24 in Denver, Colorado. A pre-specified exploratory analysis of pooled data demonstrated that, regardless of lesion count, all VP-102 quartiles had statistically significantly higher percentage of patients with complete clearance of all baseline and new lesions as compared to vehicle, and that complete clearance rates were similar across all VP-102 quartiles. In this analysis, patients treated with VP-102, across all lesion count quartiles, were similar in baseline characteristics and molluscum medical histories. Participants were segmented by baseline lesion count: Quartile 1, 1-7 lesions; Quartile 2, 8-14 lesions; Quartile 3, 15-28 lesions; and, Quartile 4, 29-184 lesions. Mean age of patients was: Quartile 1, 9.0 years; Quartile 2, 7.5 years; Quartile 3, 6.0 years; and, Quartile 4, 6.7 years. Mean time since clinical diagnosis was: Quartile 1, 134.3 days; Quartile 2, 116.8 days; Quartile 3, 121.0 days; and, Quartile 4, 118.2 days. At baseline, the percentage of patients presenting with a history of atopic dermatitis, or with active AD, included: Quartile 1, 8%; Quartile 2, 7%; Quartile 3, 16%; and, Quartile 4, 19%. Selected treatment-emergent adverse events at the application site were similar across quartiles with VP-102 treatment including vesicles, pain, scab, erythema, pruritus, discoloration, dryness, edema, erosion, and scarring. The second abstract is a post-hoc analysis in which VP-102-treated subjects were categorized by those who achieved complete lesion clearance and those who did not by the end of study visit, to compare demographics and outcomes between the groups, and identify characteristics potentially predictive of response to treatment with VP-102. The analysis demonstrated that in patients treated with VP-102, baseline demographics and medical histories were similar between the CC group and the NC group at EOS. Safety outcomes were similar in both groups, except for application site pain and pruritus. Baseline lesion count was not clinically different, and there was no difference in time since diagnosis between groups, age, gender, previous treatment, or atopic dermatitis history or status. These results demonstrated that any patient who fits the requirements of the study protocol and has similar characteristics could potentially achieve complete clearance of all baseline and new molluscum lesions after up to four treatments with VP-102.

10:00 EDT Nine Energy Service rises 29.2% - Nine Energy Service is up 29.2%, or 79c to $3.50.

10:00 EDT Bristow Group rises 233.1% - Bristow Group is up 233.1%, or $12.03 to $17.19.

09:47 EDT Direxion Financial Bear 3x falls -9.0% - Direxion Financial Bear 3x is down -9.0%, or -$1.72 to $17.43.

09:47 EDT ProShares Trust Ultra VIX Short Term Futures ETF falls -11.2% - ProShares Trust Ultra VIX Short Term Futures ETF is down -11.2%, or -$5.12 to $40.44.

09:47 EDT Hertz rises 61.5% - Hertz is up 61.5%, or $1.27 to $3.33.

09:46 EDT Zoom issues statement confirming China's request to suspend activist accounts - U.S. video conferencing firm Zoom issued a formal statement on its blog confirming that it received requests from China's government to interfere with certain accounts. The firm said, in part, in its most recent statement on the matter: "We hope that one day, governments who build barriers to disconnect their people from the world and each other will recognize that they are acting against their own interests...The reality is Zoom operates in more than 80 countries and continues to expand, which requires compliance with local laws even as Zoom seeks to promote the open exchange of ideas...Recent articles in the media about adverse actions we took toward Lee Cheuk-yan, Wang Dan, and Zhou Fengsuo have some calling into question our commitment to being a platform for an open exchange of ideas and conversations. To be clear, their accounts have been reinstated, and going forward, we will have a new process for handling similar situations. We will do better as we strive to make Zoom the most secure and trusted way to bring people together. In May and early June, we were notified by the Chinese government about four large, public June 4th commemoration meetings on Zoom that were being publicized on social media, including meeting details. The Chinese government informed us that this activity is illegal in China and demanded that Zoom terminate the meetings and host accounts." Reference Link

09:43 EDT Constellation Pharmaceuticals trading resumes

09:35 EDT Nabors Industries trading resumes

09:30 EDT Arrow Exploration remains 'committed' to the strategic alternatives process - ARROW Exploration announces an update to its proposed non-brokered private placement of 13,000,000 common shares of the Company at a price of CAD$0.025 per share for gross proceeds of C$325,000, as well as the proposed grant of options and strategic review. As previously announced by the Company on May 23rd, 2020, the proposed Private Placement will be subscribed for by certain consultants and insiders of the Company in an amount of C$100,000 each in the case of insiders and C$25,000 in the case of the consultant. The Company has agreed to provide loans equivalent to their total subscription amount to each of the subscribers pursuant to promissory notes secured by the shares issued in the Private Placement. The securities to be issued in connection with the Private Placement will be subject to a hold period of four months and one day from the closing of the Private Placement. The Private Placement is subject to certain conditions, including approval of the TSX Venture Exchange (the "TSXV"). The TSXV is continuing its review of the Private Placement and option grant and has yet to grant conditional approval for either transaction. The TSXV has requested that the Company clarify certain statements regarding the private placement made in the Company's press release of May 31st, 2020. Contrary to the statement in the Press Release, neither the Private Placement nor the option grant has been completed and the securities issued, and both transactions remain subject to the approval of the TSXV. Subject to the TSXV approving the proposed Private Placement and option grant, the Company intends to proceed with the transactions as it has agreed that, subject to regulatory approval, these transactions will form part of the compensation provided to placees for their services as executives or consultants of the Company. In the event the TSXV does not approve the Private Placement and the options, the Company intends to renegotiate with the placees to provide them with compensation in another form. The TSXV has also requested that the Company confirm that at the time the board of directors negotiated with the insiders and approved the proposed Private Placement and option grant, the Company was not in possession of any material undisclosed information and had yet to receive draft financial information or a draft reserves report. Consequently it is the Company's view that the proposed transactions were approved in compliance with the Company's Insider Trading Policy as well as the conditions attached to the TMX Bulletin dated April 8th, 2020 regarding Temporary Relief of the CAD$0.05 Minimum Pricing Requirement. Additionally, following the announcement of the transactions and the announcement of the Company's 2019 year-end financial results and reserves report, the Company's stock continued to trade at approximately CAD$0.03 for 4 consecutive trading days thereafter. On November 28th, 2019, Arrow announced it had initiated a strategic alternatives process to be overseen by a Special Committee of the Board of Directors. Subsequently, the Company engaged Stifel Nicolaus Canada Inc. as financial advisor to explore a comprehensive range of strategic and transaction alternatives, including a sale, merger or other business combination; a disposition of all or certain assets of the Company; recapitalization and refinancing opportunities; sourcing new financing and equity capital; and other alternatives to improve the Company's financial position and maximize value. Arrow and its financial advisor remain committed to the strategic alternatives process and intend to provide updates as determined to be appropriate by the Board of Directors.

09:19 EDT Novo Nordisk's semaglutide shows superior weight loss vs. placebo in trials - Novo Nordisk announced headline results from the final two phase 3a clinical trials investigating once-weekly subcutaneous semaglutide 2.4 mg for weight management. STEP 2 in adults with obesity and type 2 diabetes and STEP 3 as an adjunct to intensive behavioural therapy in adults with obesity. The STEP 2 trial met both primary endpoints. In all people randomised, a statistically significant greater weight loss of 9.6% was achieved at 68 weeks with sc semaglutide 2.4 mg, from a mean baseline bodyweight of 99.8 kg, compared to placebo and sc semaglutide 1.0 mg. 68.8% of those who received sc semaglutide 2.4 mg achieved a weight loss of 5% or more after 68 weeks, compared to 28.5% with placebo. The STEP 3 trial met both of its primary endpoints. In all people randomised, a statistically significantly greater weight loss of 16.0% was achieved with sc semaglutide 2.4 mg as an adjunct to IBT, from a mean baseline bodyweight of 105.8 kg, compared to a 5.7% weight loss with placebo plus IBT after the 68-week treatment period. 86.6% of those treated with sc semaglutide 2.4 mg achieved a weight loss of 5% or more after 68 weeks as an adjunct to IBT, compared to 47.6% with placebo plus IBT. "These results continue to build on the highly impressive weight loss reported previously in STEP 1 and 4. Altogether, the results indicate that semaglutide 2.4 mg will play a key role in improving the treatment of people with obesity," said Mads Krogsgaard Thomsen, executive VP and Chief Science Officer of Novo Nordisk. "We have now reported on all the four trials in the STEP programme and we look forward to sharing the results with regulatory authorities."

09:12 EDT Caterpillar reports retail machines sales down 23% in three months end May - Caterpillar reported in a regulatory filing that its total retail machines sales were down 23% on a three month rolling basis in May. For reference, retail sales of machines were down 22% in the period ending in April and down 17% in the period ending in March. The company reported world Resources Industries sales were down 21% in the May-end period, better than the April-end period decrease of 24%. Construction Industries world sales were down 23% in the May-end period, versus down 21% in the prior three-month period ending in April. Total Energy & Transportation Retail Sales were down 17% in the May-end period, and were down 19% in the April-end period.

09:09 EDT Playa Hotels & Resorts announces additional financing of $224M - Playa Hotels & Resorts announced that it has raised $204 million of additional debt financing, has sold $20 million of its ordinary shares at a price of $4.10 per share in a private transaction, and has entered into the Fourth Amendment to Amended & Restated Credit Agreement with its senior secured credit facility lenders. The Company has raised $204 million of additional debt financing from affiliates of Davidson Kempner Capital Management LP, consisting of the following: A $94 million credit facility maturing in April of 2024 with an effective interest rate of 9.25%, which we intend to immediately draw; and A $110 million property loan agreement secured by the Hyatt Ziva & Zilara Cap Cana and the Hilton Rose Hall maturing in July of 2025 with an effective interest rate of 9.25%, which is expected to be funded in June 2020 upon satisfaction of customary conditions precedent. The Company has also sold $20 million of its ordinary shares to affiliates of Davidson Kempner Capital Management LP at a price of $4.10 per share in a private transaction that was exempt from registration under the Securities Act of 1933. The Fourth Amendment amends the Company's senior secured credit facility to, among other things, substitute a minimum required liquidity test for the leveraged-based financial covenant from the third quarter of 2020 through, and including, the second quarter of 2021, modify the leveraged-based financial covenant for certain test dates after the Covenant Relief Period, and add certain restrictions on, among other things, the incurrence of additional debt and making of investments, dispositions and restricted payments during the Covenant Relief Period, as the case may be, all as more fully set forth in the Fourth Amendment. Proceeds from these transactions will be used for general corporate purposes.

09:07 EDT Electronic Arts announces expanded plans for FIFA 20 esports competitions - Electronic Arts and FIFA announced a larger FIFA 20 esports ecosystem, adding new competitions and returning football league tournaments, as well as online tournaments in place of the FIFA 20 Global Series including the FIFA eWorld Cup. These updates will build upon the FIFA Stay and Play Cup, which aired to millions in more than 100 countries, and growth in viewership across FIFA content from last year with 260% growth. The FIFA 20 Summer Cup Series is made up of six online regional tournaments featuring invited top players across Europe, Asia, South America, Oceania, North America and Middle East-Africa, all competing to be crowned one of six winners. The total prize pool created for the Summer Cup Series is $228,000, with the tournaments running from July 17 - August 9. Additionally, many of the world's football leagues, including Bundesliga, LaLiga, Ligue 1, MLS and more, are resuming FIFA 20 esports events under revised formats. Fans can also tune into the UEFA eChampions League which will transition to a special one-off online invitational event in mid-August. FIFA's member associations will also continue organizing domestic FIFA esports competition and online internationals to engage their national FIFA communities. Tournaments that will not proceed in the wake of current events include the FIFA 20 FUT Champions Cup Stage VI, FIFA eNations Cup, FIFA 20 Global Series Playoffs and the FIFA eWorld Cup. These tournaments require global, in-person events and could not be executed online. EA will still reward competitors $200,000 in prizes for those qualified to FUT Champions Cup Stage VI and another $700,000 based on FIFA 20 Global Series Rankings as of March 3.

09:04 EDT PHI Luxembourg Development launches Vietnam-related Luxembourg bank fund - PHI Luxembourg Development announced that it has successfully activated the first-ever Luxembourg bank fund for the Vietnamese economy, PHILUX Global Funds, a Reserved Alternative Investment Fund. PHILUX Global Funds plans to create a number of subfund compartments over a period of time for investments in real estate, renewable energy, agriculture, healthcare and education in Vietnam. Initially, the fund intends to focus on the development of the Free-Trade Zone in the Chu Lai Open Economic Zone in Quang Nam Province, which will house the Chu Lai Multiple Commodities Center and the Asia Diamond Exchange, the first-ever rough diamond exchange to be established in the Asian Hemisphere comparable to the Antwerp and Dubai exchanges.

09:02 EDT Blue Hat Interactive regains Nasdaq compliance - Blue Hat Interactive announced that, on June 11, the company received notification from The Nasdaq Stock Market stating that the company has regained compliance with Nasdaq Listing Rule 5550(a)(2), as the closing bid price of the company's ordinary shares closed at or above $1.00 per share for a minimum of 10 consecutive business days, and that Nasdaq considers the matter closed.

08:51 EDT Weyland's AtozGo expansion in residential Jakarta reaches 500 deliveries per day - Weyland Tech announced expansion of the AtozGo delivery service into residential Jakarta has now reached 500 deliveries per day being ordered by more than 2,000 registered residential users. The service has also attracted now more than 1,000 delivery people, up from 680 in March, by providing flexible hours and unlimited income potential. Many new merchants have also signed up for AtozGo, now totaling 21,000, providing a broader selection of options available to AtozGo customers. Previously available only to city office workers, in April AtozGo extended its service area and hours of operation to allow the Indonesian city's urbanites to use its mobile app to order food from local grocery and convenience stores. Residents can also order household services, including dry cleaning, shoe repair, maintenance, cleaning and water bottle delivery. After being in a COVID-19 lockdown since early March, over the next few weeks, workplaces, places of worship, shopping centers and recreational venues are expected to gradually reopen, as reported by the Straits Times. They will be required to follow certain health guidelines, including operating at 50 percent capacity and requiring individuals to maintain a distance of one meter. Powered by Weyland's m-Commerce technology and the AtozPay mobile payment platform, AtozGo supports these guidelines by allowing customers to easily order and pay for deliveries and services using AtozGo and their AtozPay e-Wallet. Many residents have already been using the AtozPay fintech solution to pay their phone, utility, rent and other personal bills. AtozPay transaction volume was virtually unaffected by COVID-19, with an annualized gross transaction volume on pace at more than $15 million over the last few months. Based on the momentum AtozGo was experiencing pre-pandemic, the company anticipates that as the city returns to normal over the next few weeks, deliveries will increase from around 15,000 overall to more than 20,000 deliveries per day, with the number of registered users to grow from more than 100,000 to more than 150,000.

08:47 EDT Sienna Senior Living appoints Nitin Jain as president, CEO - Sienna Senior Living announced the appointment of Nitin Jain as president and CEO of the Company, effective immediately. Mr. Jain has also been appointed to the Company's Board of Directors. Mr. Jain has served as CFO and CIO at Sienna since joining the Company in 2014 and played an instrumental role in executing all aspects of Sienna's strategy. Sienna also recently appointed former Sinai Health System CEO, Joseph Mapa, to provide additional healthcare expertise to the Board of Directors. Lois Cormack has advised the Board of Directors that, effective immediately, she is resigning as President and CEO and as a Board Director for personal reasons.

08:45 EDT Geron reports four imetelstat data presentations at EHA Congress - New Analyses of Data from IMbark Phase 2 Clinical Trial in Intermediate-2 or High-risk Myelofibrosis: IMbark was designed as a Phase 2 clinical trial to evaluate two dosing regimens of imetelstatin patients with Intermediate-2 or High-risk myelofibrosis who have relapsed after or are refractory to prior treatment with a janus kinase inhibitor. The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the proportion of patients who achieve a reduction of at least 35% in spleen volume as assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve a reduction of at least 50% in Total Symptom Score, at 24 weeks. Key secondary endpoints were overall survival and safety. Title: Telomerase Activity, Telomere Length and hTERT Expression Correlate with Clinical Outcomes in Higher-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor Treated with Imetelstat. The conclusions of the poster are as follows: Imetelstat achieved dose- and exposure-dependent reduction of telomerase activity and human reverse transcriptase expression level, demonstrating on-target mechanism of action. Achieving optimal pharmacodynamic effect in patients treated with imetelstat is correlated with longer OS, as well spleen and symptom response. Significant dose-dependent reduction in VAF of JAK2, CALR and MPL mutations were observed, indicating that imetelstat has disease-modifying activity by targeting the underlying MF malignant clones. Treatment with 9.4mg/kg of imetelstat improved clinical outcomes in patients with short telomeres or high hTERT expression level at baseline. The results are consistent with telomere biology in cancer cells and provide evidence for on-target mechanism of action of imetelstat through telomerase inhibition. This is the first clinical report to systematically evaluate the mechanism of action based PD effect of imetelstat, and its relationship to exposure and clinical benefits. Title: Imetelstat Treatment Results in Clinical Benefits, Including Improved Overall Survival, in Patients with Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitors: The overall conclusion of the poster is that triple negative patients who are relapsed/refractory to JAKi and treated with 9.4 mg/kg of imetelstat had better clinical outcomes and prolonged overall survival compared to non-TN patients, suggesting that imetelstat may improve the poor outcomes expected for TN patients. Additional highlights from the poster include: With 9.4 mg/kg of imetelstat treatment, clinical response rates were higher in TN vs non-TN pts: spleen response rate was 18.8% in TN vs 7.3% in non-TN; and symptom response was 50.0% in TN vs 24.4% in non-TN patients. Imetelstat treatment at 9.4 mg/kg resulted in significantly longer median OS of 35.9 months for TN patients compared to 24.6 months for non-TN patients. A majority of the TN patients enrolled on the study had grade three fibrosis. Higher rate of bone marrow fibrosis improvement was noted in the TN vs non-TN patients. TN patients enrolled on the study had short telomere length and high hTERT expression level at baseline, representing a suitable target population for imetelstat, a first-in-class telomerase inhibitor. Gitle: Favorable Overall Survival with Imetelstat Treatment Correlates with Other Clinical Benefits in Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor: The poster reports new analyses of data from all 107 patients in both arms of the IMbark Phase 2 clinical trial with a data cut-off date of February 19, 2020 and a median follow-up of 41.7 months. As of the data cut-off date, median OS was 28.1 months in the 9.4 mg/kg arm and 19.9 months in the 4.7 mg/kg arm. The overall conclusion of the poster was that imetelstat showed dose-related improvement in OS in patients who are R/R to JAKi. The survival benefit observed with imetelstat was supported by the trend of correlation with other clinical benefits. Additional highlights from the poster include: Among 57 patients across both treatment arms that had matching bone marrow samples, 20 patients had greater than or equal to1 degree of bone marrow fibrosis improvement while on study and had a significantly longer OS than those who had worsening bone marrow fibrosis. A similar trend was seen in 29 patients with stable vs. worsening fibrosis. Patients who achieved symptom and spleen response at week 24 showed a trend of longer OS compared to patients who did not achieve response. Transfusion dependency, response to last JAKi, higher baseline neutrophils, lower baseline hemoglobin and platelet values correlated with increased risk of death. The planned Phase 3 clinical trial in refractory MF is designed to be an open label 2:1 randomized, controlled trial with registration intent to evaluate imetelstat in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be refractory to a JAK inhibitor, an inclusion criterion that is planned to be defined as having an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an optimal dose of a JAK inhibitor for at least two months. The control arm is planned to be best available therapy , excluding JAK inhibitors. The primary efficacy endpoint for the trial is planned to be overall survival. Planned key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes. Under current assumptions, the Company expects to complete patient enrollment in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024. The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Both the planned interim and final analyses are event driven and could occur on different timelines than currently expected. On June 17, 2020, Geron will be hosting a webcasted event with authors from each respective data presentation from the EHA Annual Congress who will reprise the presentations from EHA. A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

08:44 EDT Trump retweets call for Microsoft ban from federal contracts - President Trump retweeted a call for Microsoft to be barred from federal government contracts and that "there should be consequences for not selling technology to police departments." Reference Link

08:36 EDT Datametrex receives final payment on shipping of COVID-19 test kit order - Datametrex AI announced that the Company has received the full and final payment from its purchaser and completed shipping the first purchase order of COVID-19 test kits for a mining company employees in multiple jurisdictions outside of Canada, as announced on May 15th 2020. The total gross sales amount is approximately C$500,000, excluding shipping. Under the terms of the PO, Datametrex sold to the purchaser an initial 10,000 units of the iONEBIO Inc. iLAMP Novel-CoV19 Detection Kit; 10,000 3 mL Universal Transport Medium Sterile Swabs with 16x100mm Skirted Tubes with Plastic Red Capture Caps, and 1 Real-Time PCR Detection System machine to analyze the samples. The iONEBIO test kits provide results within approximately 15 to 20 minutes. All of the items are shipped directly from manufacturers to the purchaser's mine operating sites. Security clearance backlogs continue to streamline as Governments align with the World Health Organization's remarks on the importance of testing. Governments have urged mining companies to implement testing and screening their workforce to properly fight the virus in order to avoid further closures.

08:34 EDT Eldorado Resorts announces reopening dates for five properties in FL, IN, CO, OH - Eldorado Resorts announced the planned resumption of operations at five properties in Florida, Indiana, Colorado and Ohio, pending receipt of final regulatory approvals. The company said in a release, "Eldorado plans to reopen Isle Casino Racing Pompano in Florida on Saturday, June 13, Tropicana Evansville in Indiana on Monday, June 15, Isle Casino Hotel Blackhawk and Lady Luck Casino Blackhawk in Colorado on Wednesday, June 17, and Eldorado Gaming Scioto Downs in Ohio on Friday, June 19. Upon these reopenings, 21 of Eldorado's 23 casino entertainment facilities will have reopened following the suspension of operations in March."

08:20 EDT E-Trade reports May DARTs up 244% y/y - E-Trade released its monthly activity report for May and also provided an update for June to-date trading activity. Daily average revenue trades, or DARTs, for May were a record 982,000, and derivative DARTs were a record 252,000. Trading volume has continued to increase in June, with DARTs of 1,195,000 and derivative DARTs of 277,000 through June 10, 2020. E-Trade has facilitated its five highest DARTs volume days of all time in June, achieving a record of 1,470,000 DARTs and 372,000 derivative DARTs on June 5.

08:16 EDT American Airlines expects to close on Treasury loan in June - In a regulatory filing, American Airlines said: "The company has applied for a secured loan in the amount of approximately $4.75B through the loan program under the CARES Act. Pursuant to this program, the loan is expected to be a five-year, senior secured obligation at a variable interest rate of LIBOR plus 3.50% and prepayable at any time without premium. It is the company's current intention to pledge its domestic AAdvantage Program assets as security for this loan. The most recent third-party appraisal has estimated the value of the AAdvantage program to be between $19.5B and $31.5B, a significant portion of which will be pledged as collateral to support the CARES Act loan. Based on this appraisal, the company believes there is sufficient collateral to support the CARES Act loan and potentially additional financings, subject to compliance with the ultimate terms and conditions of the CARES Act loan. Also in connection with this loan, AAG would issue to the U.S. Department of the Treasury additional warrants to purchase approximately 38.0 million shares of AAG common stock of the company, assuming a loan of $4.75B, at an exercise price of $12.51 per share. The loan program warrants will be issued in addition to, and have the same terms and conditions as, the approximately 13.7 million warrants expected to be issued under the Payroll Support Program upon receipt by the company of the full $5.8B of payroll assistance to be provided by the U.S. Treasury thereunder. Because these warrants provide for exercise on a "net exercise" basis, the ultimate dilutive impact of these warrants will be dependent on the market price of the company's common stock at the time the warrants are exercised. As of April 24, 2020, AAG had 422.9 million shares of common stock outstanding. The U.S. Treasury loan program continues to progress, and the company presently expects to close the loan in June 2020. However, the company has not yet entered into a definitive agreement related to this loan, and thus final terms and conditions and closing remain subject to ongoing negotiation, entry by the parties into definitive documentation and satisfaction of closing conditions. Beyond the value of the AAdvantage program, the company retains assets that could be used as collateral for additional secured debt."

08:14 EDT Bitauto enters definitive agreement for going-private transaction - Bitauto (BITA) announced that it has entered into an Agreement and Plan of Merger with Yiche Holding and Yiche Mergersub Limited, a wholly owned Subsidiary of Parent, pursuant to which the company will be acquired by an investor consortium led by Morespark Limited, an affiliate of Tencent Holdings (TCEHY) and Hammer Capital Opportunities Fund L.P. in an all-cash transaction that values the company's equity at approximately $1.1B. Pursuant to the Merger Agreement, at the effective time of the Merger, each ordinary share of the company issued and outstanding immediately prior to the Effective Time will be cancelled and cease to exist in exchange for the right to receive $16 in cash without interest, and each outstanding American depositary share of the company will be cancelled in exchange for the right to receive $16 in cash without interest, except for (a) certain Shares owned by affiliates of Tencent, an affiliate of JD.com (JD), and Bin Li, chairman of the board of directors of the company, which will be rolled over in the transaction , (b) Shares owned by Parent, Merger Sub, the company or any of their respective subsidiaries, (c) Shares held by the ADS depositary and reserved for issuance, settlement and allocation upon exercise or vesting of company's options and/or restricted share unit awards, and (d) Shares held by shareholders who have validly exercised and not effectively withdrawn or lost their rights to dissent from the merger pursuant to Section 238 of the Companies Law of the Cayman Islands. The Merger is currently expected to close in the second half of 2020 and is subject to customary closing conditions including the approval of the Merger Agreement by an affirmative vote of holders of Shares representing at least two-thirds of the voting power of the Shares present and voting in person or by proxy at a meeting of the company's shareholders. those dissenting shares in accordance with Section 238 of the Companies Law of the Cayman Islands.

08:13 EDT American Airlines sees June system capacity down 75% year-over-year - In a regulatory filing, American Airlines said: "In mid-March, the company first observed negative net bookings, where cancellations exceeded new bookings. To better align its capacity with lower expected demand, the company reduced its capacity through a combination of schedule reductions and close-in flight cancellations. This negative net booking trend persisted until late April. The company's flown system capacity was down approximately 75% year-over-year in April, and down approximately 80% year-over-year in May. The company's June system capacity is expected to be down approximately 75% year-over-year. As state and local shelter in place restrictions were relaxed, the company observed improved passenger demand, particularly in its domestic network. Since the first week of May, the company's net bookings have been consistently positive and have shown continued signs of improvement. Since the middle of May, the company has observed positive net bookings in each of the seven advanced purchase windows that it regularly monitors. These windows include tickets purchased between 1 to 6 days, 7 to 13 days, 14 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 150 days, and 151 to 331 days prior to departure. The company believes these trends are an indication of improving passenger demand although at levels significantly below those experienced in the same period in 2019. In response to the improving trends in demand, the company announced on June 4, 2020 that it is planning to fly 55% of its domestic schedule and nearly 20% of its international schedule in July 2020 compared to the same period last year. The company's July system-wide capacity amounts to approximately 40% of July 2019 flying."

08:08 EDT Takeda Pharmaceutical to present TOURMALINE-MM4, MM-6 study results - Takeda Pharmaceutical announced it will orally present the results of two studies at the 25th Congress of the European Hematology Association, or EHA. Presentations are available online starting June 12 and include positive results from TOURMALINE-MM4, a Phase 3, randomized clinical trial evaluating the effect of single-agent oral Ninlaro as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation. Takeda is also presenting key insights from the US MM-6 trial, which investigates the effectiveness and safety of an in-class transition to oral Ninlaro in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who have previously received a parenteral bortezomib-based triplet induction therapy. The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with Ninlaro resulting in a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation. This corresponds to a 34% reduction in risk of progression or death in patients treated with Ninlaro. The safety profile of Ninlaro was consistent with previously reported results of single-agent Ninlaro use and there were no new safety signals identified. The trial achieved its primary endpoint, with treatment with Ninlaro resulting in a statistically significant and clinically meaningful improvement in PFS in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation. Median PFS for patients in the Ninlaro arm was 17.4 months compared to 9.4 months in the placebo arm. This corresponds to a 34.1% reduction in risk of progression or death in patients treated with Ninlaro. The secondary endpoint of overall survival, or OS, is not yet mature and follow-up is ongoing. The benefits of Ninlaro maintenance were realized in the context of a well-tolerated safety profile and no adverse impact on patients' quality of life. The safety profile of Ninlaro is consistent with previously reported results of single-agent Ninlaro use and there were no new safety signals identified. The most common treatment emergent adverse events, or TEAEs, were nausea, vomiting, diarrhea, rash, peripheral neuropathy and pyrexia. Grade 3 TEAEs were experienced by 36.6% of patients receiving Ninlaro versus 23.2% receiving placebo. The rate of new primary malignancies was 5.2% versus 6.2% in the placebo arm. Discontinuation of treatment due to TEAEs was low, at 12.9% in the Ninlaro arm and 8% in the placebo arm. The rate of on-study deaths was 2.6% in the Ninlaro arm compared to 2.2% in the placebo arm. Updated data from US MM-6 will also be presented orally at EHA. The trial revealed the in-class transition from treatment with parenteral bortezomib to a Ninlaro-based treatment, taken by patients at home, allowed for prolonged proteasome inhibitor administration and resulted in an increase in overall response rate from 62% to 70% and an increase in complete response from 4% to 26%. These data suggest promising efficacy without impacting patients' quality of life. The safety profile of Ninlaro treatment in this setting is favorable with no unexpected safety signals identified in US MM-6.

08:07 EDT Cango regains compliance with NYSE continued listing standards - Cango announced that it received a letter from The New York Stock Exchange indicating that the company is now considered to be back in compliance in relation to the NYSE's quantitative continued listing standards.

08:06 EDT Bed Bath & Beyond donates $1M to NAACP empowerment programs - Bed Bath & Beyond announced a $1M product donation to the NAACP Empowerment Programs. The donation will provide essential items to the organization and its charity partners, supporting Black communities impacted by COVID-19 and recent unrest across the U.S. The company is making the donation as part of its recently launched Bringing Home Everywhere program, a $10M plan that is providing essential home products to communities hardest hit by the COVID-19 pandemic.

08:05 EDT Onconova presents genomic data from HMA-failure patients - Onconova Therapeutics announced updated aggregated baseline genomic data from HMA-failure patients screened for the INSPIRE trial were presented in an e-poster at the virtual 25th Annual EHA Congress. The on-demand presentation will be available on the EHA website as of Friday, June 12 at 8:30 a.m. CEST, and will be accessible until October 15, 2020. Abstract #EP829. "Mutations in RAS Pathway Genes Correlate with Type of Failure to Azacitidine: Genomic Analysis at Randomization onto the Inspire Trial."As an exploratory endpoint, bone marrow samples were collected at baseline, months 2, 4 and 6, and every 6 months thereafter, as well as at the end of treatment, for mutational analysis. Genomic DNA was extracted and deep sequencing of 295 genes will be performed on these samples following analysis of the primary endpoint. In total, 55 different mutations were identified at baseline, with the median number of mutations per patient at 3.

08:04 EDT CLPS signs partnership agreement with China-listed financial IT company - CLPS announced that it has signed a Memorandum of Cooperation with a Chinese company listed on one of the domestic Chinese stock exchanges. The Partner is an established financial IT company in China and one of China's leading financial asset risk management solution providers. As such, the Partner has maintained high market share in its sector for many years. Through the Memorandum, CLPS and its Partner have agreed to leverage each other's advantages and resources, including advanced technology research efforts, new product development and promotion, information technology and management talent training initiatives, domestic and overseas market business development, and financial IT project delivery. In addition, both parties will explore joint investment opportunities going forward.

08:03 EDT Catabasis Pharmaceuticals names Ben Harshbarger as General Counsel - Catabasis Pharmaceuticals announced that it has named Ben Harshbarger as Senior Vice President, General Counsel. Mr. Harshbarger most recently served as the Interim Chief Executive Officer and General Counsel at Novelion Therapeutics.

07:53 EDT FibroGen CEO Enrique Conterno buys almost $1M in company shares - FibroGen CEO Enrique Conterno disclosed in a filing that he had purchased 27,800 shares of company stock at an average price of $35.57 per share between June 10 and June 11. The total transaction value of the purchase was $988,882.

07:49 EDT Dr. Reddy's announces the launch of Colchicine Tablets in the U.S. - Dr. Reddy's announced the launch of Colchicine Tablets USP, a therapeutic equivalent generic version of Colcrys Tablets, 0.6 mg, approved by the FDA. The Colcrys brand and generic market had U.S. sales of approximately $491M MAT for the most recent twelve months ending in March according to IQVIA Health. Dr. Reddy's Colchicine is available in 0.6 mg tablets in bottle count sizes of 30s and 100s.

07:32 EDT FuelCell expects Torrington facility to remain closed through at least June 22 - The company said, "We continue to follow appropriate safety precautions, including continued work-from-home for those who can, and we currently anticipate the closure of our manufacturing facility in Torrington, CT to continue through at least June 22nd. We remain in contact with global team members, suppliers and customers to ensure timely sharing of information to help minimize any interruption in the execution of our business plan, and to help with the efficient restart of our manufacturing facility when appropriate."

07:21 EDT Esperion confirms NEXLETOL tablets to be included in ICER assessment - Esperion confirms it has received notice that the Institute of Clinical and Economic Review plans to assess new non-statin medicines for hypercholesterolemia in the U.S., including the clinical cost effectiveness and value of NEXLETOL. A report completion is targeted for February 2021. ICER generally only assesses medicines that are expected to have a meaningful impact in a therapeutic area. Esperion anticipates the assessment will find the same conclusions as the extensive pricing and value work already completed and the broad and high-quality managed care coverage already achieved for NEXLETOL. Driven by its mission of Lipid Management for Everybody, a core tenant of Esperion is to provide medicines that are both accessible and affordable to patients. With over 70% commercial and 40% Medicare Part D formulary coverage already achieved, NEXLETOL has demonstrated significant value to the health care system. The achieved formulary coverage is primarily preferred brand tiers, simplified and minimized documentation and the lowest possible patient out-of-pocket costs. Esperion is committed to providing oral, once-daily non-statin LDL-C-lowering treatment options that are affordable and accessible. Eligible patients with commercial drug insurance coverage may pay as little as $10 per fill, up to a 3-month supply. Esperion's mission is to remove or reduce cost as a burden for patients as they strive to achieve their long-term LDL-C goals. ICER had previously announced in July of last year that evaluating bempedoic acid was in their potential plans for 2020. The evaluation of ICER will be ongoing over the next several months and includes several steps in which the company and key stakeholders can provide information, comment and offer any relevant assistance.

07:15 EDT TG Therapeutics announces data presentations at EHA Annual Congress - TG Therapeutics announced data presentations at the 25th European Hematology Association annual congress including data from a Phase 1 study evaluating TG-1701, the Company's once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab in relapsed/refractory chronic lymphocytic leukemia and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma. Presentation Title: Safety and activity of the once daily selective bruton tyrosine kinase inhibitor TG-1701 in patients with chronic lymphocytic leukemia and lymphoma: This presentation includes interim data from a Phase 1 parallel dose-escalation study of TG-1701 monotherapy and TG-1701 in combination with U2 in 82 patients with relapsed/refractory B-cell malignancies. Sixty-nine patients were treated with single agent TG-1701, of which 25 patients were treated in the monotherapy dose escalation portion of the study and received TG-1701 at doses that ranged from 100mg to 400mg once daily, and 44 patients were treated with 200mg of TG-1701 in the monotherapy dose expansion cohort. An additional 13 patients were treated in the TG-1701 plus U2 dose escalation portion of the study. Safety and efficacy highlights include: TG-1701 monotherapy exhibited an encouraging preliminary safety profile across all dose levels evaluated with only 3% of patients having a dose reduction due to treatment-related adverse events, with no treatment discontinuations due to AEs in the monotherapy cohorts. In the monotherapy dose escalation cohort, TG-1701 produced partial responses at all dose levels evaluated in CLL, MCL, Waldenstrom's macroglobulinemia, and small lymphocytic lymphoma. In the monotherapy dose expansion cohort in which TG-1701 was administered at 200mg, 25 patients were evaluable for efficacy with a 92% overall response rate observed in CLL patients, a 33% ORR in MCL patients, and a 86% ORR in WM patients. The combination of TG-1701 plus U2 has been well tolerated and demonstrated encouraging clinical activity with a 77% ORR across all disease types, including complete responses in three patients; dose escalation continues. Presentation Title: Long term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL: This presentation includes updated long term data from a Phase 1/1b study of patients with relapsed or refractory CLL or MCL treated with umbralisib in combination with ibrutinib. Data from this trial were previously published in Lancet Haematology in December 2018. As of the updated data cutoff, 42 patients were evaluable for safety and efficacy. Safety and efficacy highlights include: With long term follow up median follow-up of 43.5 months, there were no cumulative or recurrent late onset toxicities observed. In relapsed/refractory CLL, the overall response rate was 95% including a 29% complete response rate, and the 4-year Progression-free Survival and Overall Survival were 78% and 90%, respectively In relapsed/refractory MCL, the ORR was 71% with a 24% CR rate, and median PFS and OS were 10.8 and 30.7 months, respectively.

07:10 EDT Karyopharm presents XPOVIO, eltanexor data EHA Annual Meeting - Karyopharm Therapeutics announced that eight posters relating to XPOVIO, the Company's first-in-class, oral Selective Inhibitor of Nuclear Export compound, and eltanexor, its next generation SINE compound, will be presented at the European Hematology Association 2020 Virtual Annual Meeting taking place June 11-21, 2020. The six selinexor abstracts include: overall survival data from the Phase 2b SADAL study evaluating selinexor in patients with relapsed or refractory diffuse large-B-cell lymphoma demonstrating a 9-month median overall survival in a patient population in which survival is expected to be less than6 months based on several historical controls, with the median overall survival not yet reached in the 29% of patients who had partial or complete responses on single agent selinexor; a post-hoc analysis from the SADAL study demonstrating clinically meaningful response rates in the subgroup of patients with primary refractory DLBCL and treated with at least two prior regimens; a post-hoc analysis from the SADAL study demonstrating durable response rates regardless of the number of prior lines of therapy or prior treatment with high dose chemotherapy with autologous stem cell transplant; an assessment of molecular markers that may predict response to selinexor in patients with DLBCL; data demonstrating the anti-myeloma effects of selinexor in combination with eukaryotic translation initiation factor 4E; and data demonstrating selinexor's potential to treat patients with acute myeloid leukemia harboring IDH2 pR172K mutations. The two eltanexor abstracts include: data demonstrating the efficacy of eltanexor in preclinical models of NPM1-mutated acute myeloid leukemia; and an assessment of molecular markers that may predict a response to eltanexor in patients with relapsed or refractory multiple myeloma.

07:08 EDT Imara presents interim results from Phase 2a study of IMR-687 - Imara presented interim results from its ongoing Phase 2a clinical trial of IMR-687 in adult patients with sickle cell disease at the 25th European Hematology Association Annual Congress. The data from this ongoing study demonstrated that IMR-687, an oral, once-a-day, potentially disease modifying treatment, was safe and well tolerated as a monotherapy and in combination with hydroxyurea. In the higher dose cohort, IMR-687 monotherapy showed a statistically significant increase in the number of F-cells, which are red blood cells containing fetal hemoglobin, as well as a dose-dependent increase in HbF levels in adult patients with SCD. This pre-specified protocol-driven interim analysis was triggered when at least 18 patients completed 24 weeks of dosing in the monotherapy cohort of the trial. All evaluable patient data at the time of the interim analysis were included in addition to those who had completed the 24 weeks of dosing in the monotherapy cohort, resulting in data from 37 patients in the monotherapy cohort and 20 patients from the combination cohort. Treatment with monotherapy IMR-687 was associated with statistically significant increases in F-cells in the 100 mg / 200 mg dose group compared to placebo after 24 weeks of dosing, with a relative increase in F-cell percentage of 18.1%, representing a mean increase from baseline through week 24 of approximately 155%. We also observed a mean increase in HbF percentage in the 100 mg / 200 mg dose group of 1.7% from baseline through week 24, representing a mean increase of approximately 38%. The increases in both F-cells and HbF were dose dependent in the monotherapy arm. The combination cohort was designed to be a low-dose short duration study and there was no observed reduction in HU pharmacokinetics when combined with IMR-687. From a safety standpoint, IMR-687 was well tolerated, with a higher incidence of reversible mild-to-moderate GI adverse events observed in the higher doses of monotherapy cohort. There was no hypotension or neutropenia observed in either the monotherapy or combination arms and fewer patients reported vaso-occlusive crises in the active treatment arms versus placebo or background HU. The EHA presentation, titled "IMR-687, A Highly Selective Phosphodiesterase 9 Inhibitor, Increases F-Cells and Fetal Hemoglobin in a Ph-2A Interim Analysis," is available for registered attendees of the virtual EHA annual congress through October. The presentation can also be found at the Investors section of Imara's website.

07:06 EDT Pipestone Energy 'continues to actively manage' production - The company said, "Pipestone Energy continues to actively manage its production in response to very high volatility in crude oil prices over the past few months. Due to very low Edmonton condensate pricing during May 2020, the seven wells on the recently tested 6-24 pad were shut-in for the month. Despite this, based on field estimates, the Company averaged ~14,700 boe/d in May from the North of the Wapiti River 15-14 and 3-1 pads as well as contribution from the legacy South of the Wapiti production. With oil prices improving over the past two weeks the Company is gradually bringing wells from the 6-24 pad back on-stream. The recently completed six well 6-30 pad is also now available for production, with installation of wellsite facilities recently completed for $0.5 million per well which is the lowest equipping and tie-in cost achieved to date at Pipestone. As previously disclosed, the 6-30 pad is a pacesetter on all-in realized DCE&T cost at $5.5 million."

07:05 EDT Pipestone Energy maintains $225M Reserve Based Loan - Pipestone Energy announced that it has successfully redetermined its Reserve Based Loan with its syndicate of banks, maintaining its credit capacity of $225 million. Pipestone Energy has closed on its RBL redetermination with its corporate banking syndicate, consisting of National Bank Financial Inc., Bank of Montreal, ATB Financial, and Canadian Western Bank. The Credit Facility's capacity has been maintained at $225 million, of which the Company was drawn approximately $184 million as of June 12th, 2020. The Company's previously announced $60 million capital program for 2020 is more than 95% complete, and with minimal capital expenditures forecast for the remainder of 2020, the Company expects to generate cash flow in excess of capital spending. As part of the amendment to its Credit Facility, the Company is restricted from spending more than $65 million of capital in 2020 without unanimous consent from its banking syndicate. This provision is a temporary amendment, which will terminate at the next redetermination, scheduled for November 2020.

07:04 EDT Party City reports Q1 brand comparable sales decreased 17.1% - Brand comparable sales through February 29th decreased 0.9%; an improvement relative to the fourth quarter of 2019 due to strong New Year's Eve and Super Bowl performance. Full first quarter brand comparable sales declined 17.1%.

07:03 EDT Plymouth Industrial REIT provides rent collection, operational update - Plymouth announced that to date the company has collected approximately 96% of its scheduled rent for April and approximately 92% of its scheduled rent for May. Payment trends for June are consistent with the timing and pace experienced in the April and May collection periods. Leasing activity has continued with a total of 258,000 square feet of new leases signed to date in Q2. Of this amount, 56,000 square feet was related to 2020 lease expirations and 202,000 square feet was related to leases that were scheduled to expire beginning in 2021. As of June 10, the company's cash balance was approximately $8.5M, excluding operating expense escrows of approximately $9.1M and it had approximately $17M of availability under the secured line of credit and the senior equity secured term loan, which reflects the partial paydown of outstanding borrowings on the line of credit since May 8. Excluding the company's senior equity secured term loan, Plymouth has no other material debt maturities until 2023. Jeff Witherell, chairman and CEO of Plymouth Industrial REIT, noted, "The positive trend in rent collections and leasing activity we noted through early May has continued to date in June. Our portfolio is performing well overall with occupancy in line with our expectations, rental rates consistent with past increases and no material concessions required as we continue to work closely with our tenants. The right-sizing of our dividend in line with our previous guidance provides us the flexibility to grow the company and take advantage of the strong fundamentals driving the demand for industrial space in our markets."

06:57 EDT Party City not providing FY20 guidance - During the remainder of 2020, the company plans to close approximately 21 stores, open 2 new stores, with the remaining 10 planned new store openings likely to shift into 2021. In 2020, the company plans to invest approximately $35M-$40M dollars in capital expenditures, with approximately one third invested in its retail segment, and the balance invested in its manufacturing and distribution capabilities. As a result of the continued disruption and uncertainty caused by the COVID-19 pandemic, the company is not providing any additional financial outlook information at this time for fiscal 2020.

06:34 EDT DPW Holdings says construction has resumed on luxury hotel in Tribeca - DPW Holdings announced that construction has resumed on the Tribeca Hotel at 456 Greenwich Street, New York, NY. The company is a limited partner in the Tribeca Hotel development project. On June 8, Governor Cuomo announced that construction can resume in New York City, including projects considered non-essential, lifting restrictions previously implemented due to the COVID-19 pandemic.

06:33 EDT Agios, Royalty Pharma announce $255M purchase agreement for IDHIFA royalty - Agios Pharmaceuticals (AGIO) and Royalty Pharma announced that Agios has sold its tiered, sales-based royalty rights on worldwide net sales of Bristol Myers Squibb's (BMY) IDHIFA, as well as its rights to receive up to $55M in outstanding regulatory milestone payments from Bristol Myers Squibb, to Royalty Pharma for $255M. Agios will continue to co-promote IDHIFA and receive reimbursement from Bristol Myers Squibb for this co-promotion under its 2010 collaboration agreement with Celgene, a wholly owned subsidiary of Bristol Myers Squibb. Agios also retains the right to receive a $25M payment upon achievement of a specified ex-U.S. commercial milestone event. IDHIFA is an oral, targeted therapy approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation.

06:26 EDT Aprea Therapeutics presents results from Phase Ib/II clinical trial of APR-246 - Aprea Therapeutics announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutant myelodysplastic syndromes and acute myeloid leukemia. The clinical trial is sponsored by the Groupe Francophone des Myelodysplasies. As of the April 1 data cutoff, the overall response rate in 28 evaluable MDS patients was 75%, with a 57% complete remission rate, by International Working Group criteria. With a median duration of follow-up of 9.7 months, the median overall survival for all enrolled patients was 12.1 months and in MDS patients was 12.1 months. For patients who remained on treatment for 3 or more cycles of treatment the median OS was higher at 13.7 months versus 2.8 months for patients who were on treatment for fewer than 3 cycles. Relative to baseline, mutant TP53 variant allele frequency was decreased in responding patients by 3 cycles of treatment, including 20 patients who achieved mutant TP53 negativity by next-generation sequencing. "The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities," said Thomas Cluzeau, M.D., co-lead investigator for the GFM trial. "We continue to observe ORR and CR rates in these patients that are substantially higher than the GFM's experience with azacitidine monotherapy. Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation."

06:23 EDT Apellis presents new pivotal data from Phase 3 PEGASUS study - Apellis Pharmaceuticals presented detailed results from the Phase 3 PEGASUS study, which in January showed superiority for pegcetacoplan over eculizumab in improving hemoglobin levels in adults with paroxysmal nocturnal hemoglobinuria, or PNH. Apellis said in a release, "New data from the pivotal study showed that pegcetacoplan's effect was seen consistently across the study population, both in patients who had low or no transfusion requirements (fewer than four transfusions in the 12 months before study entry) and high transfusion requirements (four or more transfusions). Pegcetacoplan also demonstrated a robust response across several key hematologic and clinical measures for PNH. The results were presented in a scientific oral presentation at the 25th Congress of the European Hematology Association. Pegcetacoplan met the study's primary endpoint for efficacy, demonstrating superiority to eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16, 53% higher than the eculizumab arm. In patients with low or no transfusion requirements, pegcetacoplan-treated patients had an adjusted mean hemoglobin increase of 2.97 g/dL vs. eculizumab-treated patients who had a mean change of -0.01 g/dL from the 8.9 g/dL baseline. In patients with high transfusion requirements, pegcetacoplan-treated patients had an adjusted mean hemoglobin increase of 2.11 g/dL vs. eculizumab-treated patients who had a mean change of -4.02 g/dL from the 8.5 g/dL baseline."

06:19 EDT Bluebird Bio announces new data from betibeglogene autotemcel study - Bluebird Bio announced that new data from ongoing Phase 3 studies of betibeglogene autotemcel show pediatric, adolescent and adult patients with a range of genotypes of transfusion-dependent ss-thalassemia, or TDT, achieve and maintain transfusion independence with hemoglobin, or Hb, levels that are near-normal. These data are being presented at the Virtual Edition of the 25th European Hematology Association, or EHA25. A total of 60 pediatric, adolescent and adult patients across genotypes of TDT have been treated with beti-cel in the Phase 1/2 Northstar and HGB-205 studies, and the Phase 3 Northstar-2 and Northstar-3 studies as of March 3. In studies of beti-cel, transfusion independence is defined as no longer needing red blood cell transfusions for at least 12 months while maintaining a weighted average Hb of at least 9 g/dL. ranged in age from four to 34 years, including eight pediatric and 15 adolescent/adult patients. Only 19 patients were evaluable for transfusion independence; four additional patients do not yet have sufficient follow-up to be assessed for transfusion independence. Eighty-nine percent of evaluable patients achieved transfusion independence, with median weighted average total Hb levels of 11.9 g/dL over a median of 19.4 months of follow-up to date. These 17 patients previously required a median of 17.5 transfusions per year. Improved iron levels, as measured by serum ferritin and hepcidin levels, were observed and trends toward improved iron management were seen. Over half of patients stopped chelation therapy, which is needed to reduce excess iron caused by chronic blood transfusions. Seven out of 23 patients began using phlebotomy for iron reduction. In exploratory analyses, biomarkers of ineffective erythropoiesis were evaluated in patients who achieved transfusion independence in HGB-207. The myeloid to erythroid ratio in bone marrow from patients who achieved transfusion independence increased from a median of 1:3 at baseline to 1:1.2 at Month 12. Improvement of the M:E ratio, the ratio of white blood cell and red blood cell precursors in the bone marrow, suggests an improvement in mature red blood cell production. Images illustrating the bone marrow cellularity at baseline, Month 12 and Month 24 are available in the EHA25 presentation. Additionally, biomarkers of erythropoiesis continue to demonstrate a trend toward normalization in patients who achieved transfusion independence, including improved levels over time of erythropoietin, a hormone involved in red blood cell production; reticulocytes, immature red blood cells; and soluble transferrin receptor, a protein measured to help evaluate iron status. The continued normalization of red blood cell production over time among some patients who achieved transfusion independence supports the disease-modifying potential of beti-cel in patients with TDT. As of March 3, 15 patients were treated and had a median follow-up of 14.4 months. Median age at enrollment was 15. Six of eight evaluable patients achieved transfusion independence, with median weighted average total Hb levels of 11.5 g/dL and continued to maintain transfusion independence for a median duration of 13.6 months as of the data cutoff. Eighty-five percent of patients with at least seven months of follow-up had not received a transfusion in more than seven months at time of data cutoff. These 11 patients previously required a median of 18.5 transfusions per year. In these patients, gene therapy-derived HbAT87Q supported total Hb levels ranging from 8.8-14.0 g/dL at last visit. Non-serious adverse events, or AEs, observed during the HGB-207 and HGB-212 trials that were considered related or possibly related to beti-cel were tachycardia, abdominal pain, pain in extremities, leukopenia, neutropenia and thrombocytopenia. One serious event of thrombocytopenia was considered possibly related to beti-cel. In HGB-207, serious events post-infusion in = two patients included three events of veno-occlusive liver disease and two events of thrombocytopenia. In HGB-212, serious events post-infusion in = two patients included two events of pyrexia. Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease. In both Phase 3 studies, there have been no deaths, no graft failure, no cases of vector-mediated replication competent lentivirus or clonal dominance, no leukemia and no lymphoma.

06:11 EDT Principia presents updated data of ongoing rilzabrutinib Phase 1/2 trial - Principia Biopharma announced positive data on durability of response from an ongoing Phase 1/2 trial of its investigational treatment, rilzabrutinib. Principia said in a release, "A total of 47 heavily pre-treated patients with immune thrombocytopenia, or ITP, have been enrolled with a median follow-up of 18 weeks. Data from this trial are being presented by David Kuter, M.D., director of Clinical Hematology at Massachusetts General Hospital and professor of Medicine at Harvard Medical School, at a virtual session of the European Hematology Association, or EHA. In this adaptive, open-label, dose finding Phase 1/2 trial, the primary endpoint was the proportion of patients able to achieve two or more consecutive platelet counts, separated by at least 5 days, of greater than or equal to 50,000/muL and an increase of platelet count of greater than or equal to20,000/muL from baseline, without use of rescue medication. Fifty percent of patients who started at 400 mg twice daily and had at least 12 weeks of treatment, achieved the primary endpoint. In the overall patient population, the primary endpoint was met by 43 percent of patients, irrespective of dose and duration of treatment. Among the patients who started on 400 mg twice daily, 53 percent achieved a clinically significant platelet count of greater than or equal to30,000/microL on day eight. Among the patients that achieved the primary endpoint, 79 percent had a platelet count greater than or equal to30,000/microL by day eight, and these patients had sustained responses greater than or equal to50,000/microL for 71 percent of the time. In addition, responders achieved platelet counts greater than or equal to20,000/microL above baseline 88 percent of the time. To date rilzabrutinib has been well-tolerated whether given as a monotherapy or with allowed concomitant ITP therapy, with no reported treatment related bleeding or thrombotic events. Related treatment emergent adverse events, or TEAEs, were reported in 21 patients and were all grade 1 or 2. These results are preliminary in nature and may change as patients progress in the trial and as additional patients may be enrolled. A complete analysis of this trial will be presented at a future medical conference."

06:10 EDT Bluebird Bio announces new data from Group C of HGB-206 study - Bluebird Bio announced that new data from its ongoing Phase 1/2 HGB-206 study of investigational LentiGlobin gene therapy for adult and adolescent patients with sickle cell disease, or SCD, show a near-complete reduction of serious vaso-occlusive crises, or VOCs, and acute chest syndrome, or ACS. These data are being presented at the Virtual Edition of the 25th European Hematology Association, or EHA25. As of March 3, a total of 37 patients have been treated with LentiGlobin for SCD to-date in the HGB-205 and HGB-206 clinical studies. The HGB-206 total includes: Group A, B and C. In Group C of HGB-206, 25 patients were treated with LentiGlobin for SCD and have up to 24.8 months of follow-up. Results from Group C are as of March 3 and include efficacy data for 16 patients who had at least a Month 6 visit, and safety data for 18 patients, which includes two patients who were at least six months post-treatment but results from a Month 6 visit are not available. In 16 patients with six or more months of follow-up, median levels of gene therapy-derived anti-sickling hemoglobin, HbAT87Q, were maintained with HbAT87Q contributing at least 40% of total hemoglobin. At last visit reported, total hemoglobin ranged from 9.6-16.2 g/dL and HbAT87Q levels ranged from 2.7-9.4 g/dL. At Month 6 the production of HbAT87Q was associated with a reduction in the proportion of HbS in total hemoglobin. Patients had a median of =60% HbS. All patients in Group C were able to stop regular blood transfusions and remain off transfusions at three months post-treatment. There was a 99.5% mean reduction in annualized rate of VOC and ACS among the 14 patients who had at least six months of follow-up and a history of VOCs or ACS, defined as four or more VOC or ACS events in the two years prior to treatment. These 14 patients had a median of eight events in the two years prior to treatment. There were no reports of serious VOCs or ACS at up to 24 months post-treatment in patients with at least six months of follow-up. As previously reported, one non-serious Grade 2 VOC was observed in a patient approximately 3.5 months post-treatment with LentiGlobin for SCD. In sickle cell disease, red blood cells become sickled and fragile, rupturing more easily than healthy red blood cells. The breakdown of red blood cells is hemolysis and this process occurs normally in the body. However, in sickle cell disease hemolysis happens too quickly due to the fragility of the red blood cells, which results in hemolytic anemia. Patients treated with LentiGlobin for SCD demonstrated improvement in key markers of hemolysis, which are indicators of the health of red blood cells. Lab results assessing these indicators were available for the majority of the 18 patients with 6 months of follow-up. The medians for reticulocyte counts (n=15), lactate dehydrogenase, or LDH, levels and total bilirubin improved compared to screening and stabilized by Month 6. In patients with Month 24 data these values approached the upper limit of normal by Month 24. These results suggest treatment with LentiGlobin for SCD is improving biological markers of sickle cell disease. Assays were developed by bluebird bio to enable the detection of HbAT87Q and HbS protein in individual red blood cells as well as to assess if HbAT87Q was pancellular, present throughout all of a patient's red blood cells. Samples from a subset of patients in Group C were assessed. In nine patients who had at least six months of follow-up, the average proportion of red blood cells positive for HbAT87Q was greater than 70%, and on average more than 85% of red blood cells contained HbAT87Q at 18 months post-treatment, suggesting near-complete pancellularity of HbAT87Q distribution. As of March 3, the safety data from all patients in HGB-206 are generally reflective of underlying SCD and the known side effects of hematopoietic stem cell collection and myeloablative conditioning. There were no serious adverse events related to LentiGlobin for SCD, and the non-serious, related adverse events, or AEs, were mild-to-moderate in intensity and self-limited. One patient with a history of frequent pre-treatment VOE, pulmonary and systemic hypertension, venous thrombosis, obesity, sleep apnea and asthma had complete resolution of VOEs following treatment, but suffered sudden death 20 months after treatment with LentiGlobin for SCD. The patient's autopsy revealed cardiac enlargement and fibrosis, and concluded the cause of death was cardiovascular, with contributions from SCD and asthma. The treating physician and an independent monitoring committee agreed this death was unlikely related to LentiGlobin for SCD gene therapy.

06:08 EDT Principia Biopharma reports 'positive' data from Phase 1/2 of rilzabrutinib - Principia Biopharma announced positive data on durability of response from an ongoing Phase 1/2 trial of its investigational treatment, rilzabrutinib. A total of 47 heavily pre-treated patients (median of six prior therapies) with immune thrombocytopenia have been enrolled with a median follow-up of 18 weeks. Data from this trial are being presented by David Kuter, M.D., director of Clinical Hematology at Massachusetts General Hospital and professor of Medicine at Harvard Medical School, at a virtual session of the European Hematology Association. "Rilzabrutinib treatment at 400 mg twice daily led to both a rapid response detectable at the first platelet measurement (day eight), and a durable response. These results are significant not only for the speed of onset and sustainability of response, but also for the heavily pretreated nature of the population in which these results were seen," said Dr. Kuter, the trial's Principal Investigator. "It is also important to note that rilzabrutinib continues to be well tolerated and achieved significant reliable responses across subgroups at all doses and treatment times."

06:03 EDT Hooker Furniture CEO sees Q2 'significantly better' than Q1 - "While we have limited visibility of how the economic and health crisis may fluctuate in the coming months, and still face headwinds of significant levels of unemployment, our business is improving, and we are in a better position than we expected just two months ago to be at this time," said CEO Toms. "We believe the company remains in exceptional financial condition with a strong balance sheet. We are grateful for the adaptability and resilience of our employees, and look forward to bringing our administrative and management team members back into the offices when the states say we can, and when we feel it is safe based on the status of COVID-19 in the communities around our corporate locations. We expect the second quarter to be significantly better than the first. Barring a second wave of infections, we expect business each quarter to improve as we go through the year. We're confident we will emerge from this crisis a stronger company."

05:59 EDT EU regulators to decide on Alstom, Bombardier deal by July 16 - EU antitrust regulators have set a July 16 deadline for a decision on whether to clear Alstom's (ALSMY) bid for Bombardier (BDRBF) rail division, according to a filing on the European Commission website.

05:47 EDT JinkoSolar appoints Ji Shao Guo as Chief Human Resources Officer - JinkoSolar announced that Ji Shao Guo has been appointed as Chief Human Resources Officer, effective immediately. Prior to joining the Company, Mr. Ji was the Vice President of Human Resources at Meicai.

05:44 EDT ADC Therapeutics says Lonca demonstrated ORR of 48.3%, CRR of 24.1% - ADC Therapeutics announced maturing data from LOTIS 2, a pivotal Phase 2 clinical trial of loncastuximab tesirine--Lonca, formerly ADCT-402--in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, including an overall response rate of 48.3%, a complete response rate of 24.1% and manageable toxicity. ADC said in a release, "The Company also announced interim results from LOTIS 3, a Phase 1/2 clinical trial of Lonca combined with ibrutinib, which highlight the potential of Lonca to advance into earlier lines of therapy in combination with other therapies. The data are being presented in an oral presentation and e-Poster at the virtual 25th Congress of the European Hematology Association (EHA25)." Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics said, "Our two presentations at EHA25 highlight Lonca's potential as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma. In LOTIS 2, Lonca demonstrated important anti-tumor activity and durability, as well as manageable toxicities, across a broad population of hard-to- treat, relapsed or refractory DLBCL patients, including patients with poor prognosis, those who never responded to prior therapy and those who received prior stem cell transplant." Chris Martin, CEO of ADC Therapeutics said, "We are pleased to be on track to file a Biologics License Application, or BLA, with the FDA for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020. If approved, we look forward to launching Lonca in mid-2021. We are also planning to initiate LOTIS 5, a post-marketing confirmatory clinical trial of Lonca in combination with rituximab, which we believe will support a supplemental BLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL."

05:27 EDT AstraZeneca says Calquence shows long-term efficacy, tolerability in two trials - Detailed results from both the Phase II ACE-CL-001 trial and the pivotal Phase III ASCEND trial showed the long-term efficacy and tolerability of Calquence in chronic lymphocytic leukaemia, reported AstraZeneca. The results will be presented during the Virtual Edition of the 25th European Hematology Association Annual Congress, June 11-14. Jose Baselga, Executive Vice President, Oncology R&D said: "These long-term data reaffirm that Calquence delivers a durable response with a favourable safety profile for chronic lymphocytic leukaemia patients. Patients with chronic lymphocytic leukaemia are typically 70 years or older with comorbidities and often require treatment over a long time, making the sustained safety and efficacy profile highly relevant to their quality of life."

05:16 EDT NXP Semiconductors, TSMC announce collaboration agreement - NXP Semiconductors (NXPI) and TSMC (TSM) announced a collaboration agreement to adopt TSMC's 5-nanometer, or 5nm, technology for NXP's next generation, high-performance automotive platform. The companies said in a release, "This collaboration combines NXP's automotive design expertise with TSMC's industry-leading 5nm technology to further drive the transformation of automobiles into powerful computing systems for the road. Building upon multiple successful 16nm designs, TSMC and NXP are expanding their collaboration to create a System-on-Chip (SoC) platform in 5nm to deliver the next generation of automotive processors. Using TSMC's 5nm process, NXP's offerings will address a wide variety of functions and workloads, such as connected cockpits, high-performance domain controllers, autonomous driving, advanced networking, hybrid propulsion control and integrated chassis management. TSMC's 5nm technology is currently the world's most advanced process in volume production. NXP will adopt N5P, an enhanced version of TSMC's 5nm technology, which provides about 20 percent faster speed or about 40 percent power reduction compared to the preceding 7nm generation, and is supported by the industry's most comprehensive design ecosystem. NXP and TSMC expect the delivery of first samples of 5nm devices to NXP's key customers in 2021."