Stockwinners Market Radar for June 03, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:19 EDT Keurig Dr Pepper jumps 7% to $37.29 after being added to S&P 500 index

17:55 EDT Insulet reports Omnipod 5 study results for children aged 2-5.9 years - Insulet presented new Omnipod 5 Automated Insulin Delivery System study results for very young children with type 1 diabetes. Omnipod 5, the first tubeless, wearable automated insulin delivery system in the U.S., significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years with type 1 diabetes over 12 months of use. This pivotal trial extension data was presented at the American Diabetes Association 82nd Scientific Sessions in New Orleans, Louisiana. In the original three-month pivotal trial, Omnipod 5 was shown to be safe and effective, significantly improving time in range and reducing HbA1c in 80 very young children with type 1 diabetes. Insulet previously presented these results at the ADA Virtual 81st Scientific Sessions in 2021. The pivotal trial participants were invited to continue using the Omnipod 5 System in an ongoing 12+ month extension phase, with 100% electing to participate. Results were analyzed after all participants had completed a total of 12 months of Omnipod 5 use. The extension phase results demonstrated that participants continued to experience significantly improved outcomes compared with baseline throughout 12 months of system use, including lower HbA1c and greater time in range, and there were no episodes of DKA or severe hypoglycemia. After 12 months of Omnipod 5 use, average HbA1c was 6.9%, compared with 7.4% at baseline and 6.9% at the end of the three-month pivotal trial. Similarly, percent time in range during months 10 - 12 of use was 67.6%, compared with 57.2% during standard therapy and 68.1% during the three-month pivotal trial. Percent time in hypoglycemia was reduced compared with standard therapy: the median was 1.9% during months 10-12 of use compared with 2.2% during standard therapy and 1.9% during the three-month pivotal trial.

17:44 EDT Ironwood to replace Greenhill & Co. in S&P 600 at open on 6/21

17:42 EDT Urban Outfitters to replace Tactile Systems in S&P 600 at open on 6/21

17:40 EDT Sotera Health to replace Urban Outfitters in S&P 400 at open on 6/21

17:39 EDT Trinity Industries to replace Endo in S&P 600 at open on 6/21

17:37 EDT Under Armour to replace Trinity Industries in S&P 400 at open on 6/21

17:35 EDT Keurig Dr Pepper to replace Under Armour in S&P 500 at open on 6/21

17:24 EDT Under Armour, IPG Photonics to be replaced in S&P 500

17:19 EDT Keurig Dr Pepper, VICI Properties, ON Semiconductor set to join S&P 500

17:01 EDT Bristol-Myers withdraws sBLA for Reblozyl - Bristol Myers Squibb announced that the company has withdrawn a supplemental biologics license application for Reblozyl for the treatment of anemia in adults with non-transfusion dependent beta thalassemia. The company could not appropriately address the U.S. FDA's questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial. "While we will not pursue this indication in the U.S., we're continuing to evaluate Reblozyl in a broad clinical development program to bring this important therapeutic option to more patients living with the burden of anemia," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb.

16:36 EDT Recon Technology receives Nasdaq bid requirement notice - Recon Technology announced that on June 1, 2022, it received a letter from The Nasdaq Stock Market LLC, notifying the company that it is currently not in compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2). It resulted from the fact that the closing bid price of the company's ordinary shares was below $1.00 per share for a period of 30 consecutive business days. This press release is issued pursuant to Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification. The notification has no immediate effect on the listing of the company's ordinary shares, which will continue to trade uninterrupted on Nasdaq under the ticker "RCON". Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the company has a compliance period of 180 calendar days, or until November 28, 2022, to regain compliance with Nasdaq's minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per share of the company's ordinary shares is at least $1.00 for a minimum of 10 consecutive business days, Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.

16:32 EDT Crestwood Equity to acquire Sendero Midstream for $600M - ECP has entered into a definitive agreement to sell Sendero to Crestwood Midstream Partners, an affiliate of Crestwood Equity for an enterprise value cash purchase price of $600M, plus/minus adjustments for working capital. Sendero is a gas gathering and processing business located in Eddy County, New Mexico, one of the most actively developed counties in the Permian Basin. Through ECP's ownership, Sendero has developed 350 MMcf/d of gas processing capacity and 140 miles of natural gas pipelines. The transaction, which is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions, is expected to close in July 2022.

16:29 EDT Darling Ingredients exec Long sells 25,000 common shares - In a regulatory filing, Darling Ingredients EVP and chief admin officer Jim Long disclosed the sale of 25,000 common shares of the company on June 1 at a price of $80.82 per share.

16:16 EDT Falcon Minerals announces stockholder approval of Desert Peak deal - Falcon Minerals announced the results for the proposals considered and voted upon by its stockholders at its special meeting of stockholders held on June 3, 2022. Falcon reported that all of the various proposals giving effect to the previously announced merger between Falcon and Desert Peak Minerals were approved by the requisite number of shares of Falcon common stock voted at the Special Meeting. In addition, Falcon reported that the Director Election Proposal was also approved by the requisite number of shares of Falcon common stock voted at the Special Meeting and, henceforth, William D. Anderson, Mark C. Henle and Adam M. Jenkins are hereby appointed to serve as Class II directors on Falcon's board of directors until the effective time of the Merger. A Current Report on Form 8-K disclosing the full voting results will be filed with the SEC on June 3, 2022.

16:05 EDT Freeline receives noncompliance notification from Nasdaq - Freeline disclosed the receipt of a notice from Nasdaq that the company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the company's American Depositary Shares on the Nasdaq Global Select Market, as set forth in Nasdaq Listing Rule 5450. Each Freeline ADS represents one ordinary share with a nominal value of GBP 0.00001. The notice indicated that, consistent with Nasdaq Listing Rule 5810, the company has 180 days, or until November 28 to regain compliance with the minimum bid price requirement by having the closing bid price of the company's ADSs meet or exceed $1.00 per ADS for at least ten consecutive business days.

16:01 EDT Arcellx reports 'positive' clinical data from Phase 1 CART-ddBCMA study - Arcellx announced new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with relapsed or refractory multiple myeloma. The clinical results are being presented during an oral presentation at the 2022 American Society of Clinical Oncology Annual Meeting. Evaluable for efficacy and safety analysis were 31 patients, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level, the second dose level, and a dose expansion cohort at the recommended Phase 2 dose of 100 million CAR+T cells. All patients enrolled in the study have poor prognostic factors with 21 of 31 patients penta-refractory, 12 of 31 extramedullary disease, and all 31 patients having had at least three prior treatments. The interim CART-ddBCMA clinical results demonstrate deep and durable responses in patients with poor prognostic factors. Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "The demand for clinically meaningful and safe CAR-T therapies outweighs what's currently available to multiple myeloma patients. It is encouraging to see these data continue to demonstrate deep responses and provide a benefit to patients. I look forward to enrolling patients in the Phase 2 pivotal study." "We're excited by these long-term results, particularly given the challenging patient demographics, and believe these promising results reflect the potential for our lead program, CART-ddBCMA, to be a best-in-class treatment for patients with multiple myeloma," said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. "We believe there's a significant unmet need for cell therapies and we're committed to providing physicians with a safe and effective treatment option for multiple myeloma patients. We're honored to have our data presented at ASCO by Dr. Frigault and look forward to beginning enrollment in our Phase 2 pivotal study by the end of this year as the next step in the path towards regulatory approval."

15:47 EDT Steel Dynamics senior VP Graham sells 12,000 common shares - In a regulatory filing, Steel Dynamics senior VP Christopher Graham disclosed the sale of 12,000 common shares of the company on June 3 at a price of $83.20 per share.

15:14 EDT Seagen says trial data show Adcetris, AVE-PC combo was well tolerated - Seagen announced results from a presentation by the Children's Oncology Group of a phase 3 trial evaluating ADCETRIS in children and young adults with high-risk, previously untreated classical Hodgkin lymphoma. The trial showed ADCETRIS in combination with standard of care dose-intensive chemotherapy AVE-PC achieved superior event-free survival compared to the current standard of care for the pediatric dose-intensive regimen of ABVE-PC, as part of the multi-modality treatment. The findings were presented by COG in an oral session at the 59th American Society of Clinical Oncology Annual Meeting in Chicago on Friday, June 3, 2022, 1-4 p.m. CT. In the study, 600 pediatric and young adult patients were randomized to either the experimental brentuximab vedotin plus AVE-PC arm or the standard chemotherapy ABVE-PC arm. Results from the BV-AVE-PC arm showed a clinically meaningful and statistically significant 59% reduction in the risk of disease progression or relapse, second malignancy or death. At median follow-up of 42.1 months, 3-year EFS rate in the BV-AVE-PC arm was 92.1% compared to 82.5% in the control arm. ADCETRIS in combination with AVE-PC was well tolerated with a manageable safety profile in pediatric patients. Grade 3+ adverse events recorded, including febrile neutropenia, were comparable across both arms and consistent with the known dose-intensive chemotherapy regimen. Grade 2+ peripheral neuropathy rates were similar across both arms. No deaths occurred during treatment.

14:22 EDT Immutep announces new data from 1st line NSCLC patients in TACTI-002 trial - Immutep (IMMP) announces new data from 1st line NSCLC patients of the Phase II TACTI-002 trial evaluating Immutep's lead product candidate, eftilagimod alpha, or "efti," in combination with Merck's (MRK) anti-PD-1 therapy KEYTRUDA in 114 patients. The data was presented in an Oral Presentation at the American Society of Clinical Oncology, or ASCO, 2022 Annual Meeting. Immutep CSO and CMO, Dr Frederic Triebel, said: "Our ORR by local read of 38.6% in 1st line NSCLC patients is comparing favourably to historical results from anti-PD-1 monotherapies where response rates in PD-L1 all-comer trials are typically around 20%. We are particularly pleased to see encouraging responses across all PD-L1 status groups, showing that efti may kick start an anti-tumour immune response even in patients with no or low PD-L1 expression. In addition, the combination of efti plus pembrolizumab has a safety profile consistent with that observed in previously reported studies for pembrolizumab monotherapy. We continue to believe that efti, with its unique mechanism of action, may ultimately provide a very meaningful benefit to diverse sets of cancer patients including those with more limited treatment options." Immutep CEO Marc Voigt added: "We are delighted that patient outcomes are improved with the combination of efti plus pembrolizumab across different patient groups. The data is encouraging for patients, as there is an unmet medical need particularly for those with NSCLC with no or low PD-L1 expression. We enlarged this part of the study in order to see if the strong earlier results in a smaller group of patients are holding true in more than a hundred patients. By biotech standards, we consider this to be a large patient population for a Phase II trial. For Immutep, these highly favourable results are of strategic importance, as they support late stage development for an attractive and very large adressible market."

13:01 EDT Baker Hughes reports U.S. rig count unchanged at 727 rigs - Baker Hughes reports that the U.S. rig count is unchanged from last week at 727 with oil rigs unchanged at 574, gas rigs unchanged at 151 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 271 rigs from last year's count of 456 with oil rigs up 215, gas rigs up 54 and miscellaneous rigs up 2. The U.S. Offshore Rig Count is unchanged at 16, up 3 year-over-year. The Canada Rig Count is up 14 from last week to 117, with oil rigs up 17 to 72, gas rigs down 3 to 45. The Canada Rig Count is up 40 rigs from last year's count of 77, with oil rigs up 29, gas rigs up 11.

12:46 EDT Novavax down 26% after FDA notes myocarditis events in vaccine review docs - Shares of Novavax have continued lower throughout the trading day after the FDA posted briefing documents this morning for its Vaccines and Related Biological Products Advisory Committee Meeting scheduled for June 7 to discuss the company's COVID-19 vaccine application. In the documents prepared in advance of an expert panel being convened, the FDA staff stated: "Myocarditis events were identified across the clinical development program, including four events of myocarditis (and one additional event that in FDA's assessment is clinically consistent with myocarditis) within the 20-day window post vaccination. There were no myocarditis cases in the placebo arm within 0-20 days post vaccination. These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines. Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine. However, interpretation of these passive surveillance data is not straightforward, and further evaluation is needed to inform the risk of myocarditis and pericarditis associated with this vaccine, and their outcomes, as additional data emerge over time." In afternoon trading, Novavax shares have fallen $14.59, or 26%, to $41.38. Reference Link

12:30 EDT Microsoft detects, disables Iran-linked attack activity in Israel - Microsoft said in a blog post yesterday that it successfully detected and disabled attack activity abusing OneDrive by a previously undocumented Lebanon-based activity group Microsoft Threat Intelligence Center tracks as POLONIUM. The associated indicators and tactics were used by the OneDrive team to improve detection of attack activity and disable offending actor accounts. To further address this abuse, Microsoft has suspended more than 20 malicious OneDrive applications created by POLONIUM actors, notified affected organizations, and deployed a series of security intelligence updates that will quarantine tools developed by POLONIUM operators. Our goal with this blog is to help deter future activity by exposing and sharing the POLONIUM tactics with the community at large. MSTIC assesses with high confidence that POLONIUM represents an operational group based in Lebanon. We also assess with moderate confidence that the observed activity was coordinated with other actors affiliated with Iran's Ministry of Intelligence and Security, based primarily on victim overlap and commonality of tools and techniques. Such collaboration or direction from Tehran would align with a string of revelations since late 2020 that the Government of Iran is using third parties to carry out cyber operations on their behalf, likely to enhance Iran's plausible deniability. Reference Link

12:09 EDT Nextech AR Solutions to spin out ARitize Maps - Nextech AR Solutions, its wholly-owned subsidiary ARWAY Ltd., and PC 1 Corp. announced that they have entered into a binding letter agreement which outlines the general terms and conditions of a proposed transaction pursuant to which PC 1, a capital pool company listed on the TSX Venture Exchange, will enter into a business combination pursuant to which it shall acquire the assets of ARWAY. The principal asset of ARWAY is an application currently called ARitize Maps, a No-Code Web Based end to end Metaverse Creator Platform. The Agreement was negotiated at arm's length and is effective as of June 1, 2022. PC 1 has not commenced commercial operations and has no assets other than cash. The Transaction, when completed, will constitute PC 1's "Qualifying Transaction", as defined in TSXV policies. Evan Gappelberg, CEO of Nextech commented, "We are now and have always been focused on increasing shareholder value, and through the spin out of the ARitize Maps application through one of our newly commercialized business units, I believe we are immediately creating shareholder value. The spin out will result in ARitize Maps being the principal asset of a stand-alone public company, in which Nextech will continue to be a significant shareholder... In addition to distributing a portion of the shares of the listed issuer resulting from the Transaction to existing Nextech shareholders, a private placement of a minimum of $1,500,000 will be completed into ARWAY or a special purpose financing vehicle as a condition of the Transaction, resulting in zero dilution to the holdings of Nextech shareholders in Nextech."

12:00 EDT Carvana falls -10.3% - Carvana is down -10.3%, or -$3.09 to $26.99.

12:00 EDT Invitae falls -14.4% - Invitae is down -14.4%, or -51c to $3.05.

12:00 EDT Global Cord Blood rises 14.1% - Global Cord Blood is up 14.1%, or 41c to $3.28.

11:32 EDT Marriott suspends all operations in Russia due to new restrictions - Marriott International said in a statement: "The conflict in Ukraine, now stretching into the fourth month of fighting and displacement, has had grave humanitarian, socioeconomic and global impacts. Throughout this challenging period, Marriott has kept the safety and wellbeing of our associates and guests top of mind. Since the start of the war, we have remained in regular contact with our teams on the ground as we continued to evaluate our ability to operate in this changing legal and geopolitical landscape. On March 10, we shared our decision to close our corporate office in Moscow and pause the opening of upcoming hotels and all future hotel development and investment in Russia. We have come to the view that newly announced US, UK and EU restrictions will make it impossible for Marriott to continue to operate or franchise hotels in the Russian market. We have therefore made the decision to suspend all Marriott International operations in Russia. The process to suspend operations in a market where Marriott has operated for 25 years is complex." Reference Link

10:19 EDT Dropbox up 4% following report about takeover interest - Shares of Dropbox are up 91c, or 4%, to $22.40 after The Deal.com said the company was approached last month about a potential takeover.

10:00 EDT Invitae falls -11.5% - Invitae is down -11.5%, or -41c to $3.15.

10:00 EDT Revlon falls -12.3% - Revlon is down -12.3%, or -53c to $3.79.

10:00 EDT Quanex rises 8.9% - Quanex is up 8.9%, or $1.84 to $22.58.

09:49 EDT Kyndryl says indemnity obligation potentially owed to IBM 'indeterminate' - In a regulatory filing, Kyndryl Holdings (KD) noted that the company has previously disclosed that, in July 2017, BMC Software sued International Business Machines Corporation (IBM) in the U.S. District Court for the Southern District of Texas in a dispute involving various aspects of IBM's business. "BMC alleged IBM's removal, at the client's request, of BMC software from one of its client's operating environments constituted breach of contract, fraud and trade secret misappropriation. The company is not directly named as a party to this matter, but has previously included disclosure about the matter in its filings with the Securities and Exchange Commission because the matter raises allegations about IBM's managed infrastructure business, which IBM contributed to the company in connection with IBM's spin-off of the company. On May 30, 2022, the trial court issued an opinion dismissing several of BMC's claims and awarding BMC $717 million in direct damages and $717 million in punitive damages, plus interest. This judgment is against IBM. IBM has publicly stated that it plans to appeal the judgment because it believes that the judgment is contrary to the facts and the law, and intends to seek a complete reversal on appeal. The company also understands that IBM plans to seek a stay of any final judgment entered by the court while the appeal is pending. IBM may seek an indemnity from the company in connection with the matter. Until there is a final and conclusive judgment in the case after appeals and proceedings are concluded, until the amount of any applicable insurance is determined, and until a definitive assessment of Kyndryl's indemnity obligations (if any) occurs, which in the aggregate will likely take several years, the amount of any indemnity obligation that the company may owe to IBM is indeterminate," Kyndryl stated.

09:47 EDT Invitae falls -6.9% - Invitae is down -6.9%, or -24c to $3.31.

09:47 EDT Asana falls -12.3% - Asana is down -12.3%, or -$2.97 to $21.14.

09:47 EDT Quanex rises 9.9% - Quanex is up 9.9%, or $2.06 to $22.80.

09:42 EDT Janssen says Imbruvica combo reduced lymphoma death by 25% in study - Johnson & Johnson's Janssen Pharmaceutical announced primary results from the Phase 3 SHINE study, which it says demonstrated that the combination of once-daily oral Imbruvica plus bendamustine-rituximab and rituximab maintenance reduced the risk of disease progression or death by 25% compared to patients who received placebo plus BR and rituximab maintenance in patients aged 65 years or older with newly diagnosed mantle cell lymphoma. The Phase 3 SHINE study, sponsored by Janssen Biotech, in collaboration with Pharmacyclics, an AbbVie (ABBV) Company, enrolled 523 patients aged 65 years or older with newly diagnosed mantle cell lymphoma. With a median follow-up of 84.7 months, the Imbruvica plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median progression-free survival, the company said. This is a 50% improvement as compared to patients treated with BR and rituximab maintenance.

09:33 EDT Sarissa to seek Amarin board seats, says shares 'significantly undervalued' - Sarissa Capital Management, which owns 6.05% of Amarin or 24M shares, disclosed that it has had discussions with the company and other interested parties about ways to maximize the value of its assets. More recently, Sarissa discussed with the Amarin "the disappointing first quarter results." Sarissa believes that the meaningful decrease in share price following the earnings announcement reflects the company's "insufficient adjustment to changing market conditions for its key drug Vascepa and investor concerns about the ability of leadership as currently constituted to navigate the Issuer during this critical time." Sarissa believes "that the expertise and experience of its principals would be extremely beneficial" to Amarin and intends to seek representation on its board of directors" It also believes the shares continue to be "significantly undervalued."

09:28 EDT Wildpack Beverage COO Chuck Zadlo resigns - Wildpack Beverage announced that Chuck Zadlo, COO, has resigned from the Company effective June 2, 2022. Wildpack will not seek to fill the position, but rather reporting will be streamlined directly from key working operational personnel through to the CEO.

09:22 EDT Zealand Pharma completes registration of capital increase - Further to the company announcements no. 3/2022, Zealand Pharma announces that it has today, as part of completion of a directed issue and private placement, registered with the Danish Business Authority, the capital increase of DKK 2,892,368, divided into 2,892,368 ordinary shares. Following the registration of the New Shares with the Danish Business Authority, Zealand's share capital amounts to DKK 46,526,510 divided into 46,526,510 shares with a nominal value of DKK 1 each. The New Shares rank pari passu with Zealand's existing shares and carry the same dividend and other rights. Each New Share carries one vote at Zealand's general meetings. Zealand only has one class of shares. The New Shares are expected to be admitted to trading on Nasdaq Copenhagen on 7 June 2022 in Zealand's permanent ISIN code DK0060257814. The amendments to Zealand's articles of association required by the capital increase have been registered today with the Danish Business Authority. Danske Bank A/S and Nordea Danmark, Filial af Nordea Bank Abp, Finland are acting as joint global coordinators. Danske Bank A/S is acting as settlement agent for the Private Placement. Plesner is acting as legal counsel to Zealand in the Private Placement.

09:05 EDT Scilex announces preemptive repurchase of $41.4M of senior secured notes - Scilex announced that on June 3, 2022, it pre-emptively paid off and eliminated $41.4 million of the principal amount of its senior secured notes. In connection with this payoff, the holders of the Notes agreed that Scilex can repurchase the remaining principal amount of the Notes at any time on or before September 30, 2022 for $41.4 million and the holders of the Notes will forgive and discharge $28.0 million of the aggregate principal amount of the Notes. "As we prepare to complete our previously announced merger with Vickers Vantage Corp. I and begin our registration and pre-commercialization plans of our recently successfully completed SP-102 Phase 3 clinical trial program, this pre-emptive repurchase of part of the Notes is another important accomplishment of our company goals. It gives us the ability to attract new capital at competitive terms, preserve cash that would have been spent on royalty payments under the Notes, as well as being able to avoid the effects of negative debt leverage. We believe these advantages will be of significant benefit to Scilex and our stockholders as we continue to execute on our business plan," said Jaisim Shah, CEO of Scilex.

09:04 EDT Kintara Therapeutics granted 180-day extension to regain Nasdaq compliance - Kintara Therapeutics announced that the company received written notification from the Listing Qualification Department of The Nasdaq Stock Market granting the company's request for a 180-day extension to regain compliance with Nasdaq's minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The company now has until November 28, 2022 to meet the requirement. Nasdaq's extension notice has no immediate effect on the continued listing status of the company's common stock on The Nasdaq Capital Market LLC under the symbol "KTRA". If at any time during the additional 180-day extension, the bid price of the company's common stock closes at, or above, $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff will provide the company with a written confirmation of compliance and the matter will be closed. The company was first notified by Nasdaq of its failure to maintain a minimum bid price of $1.00 per share for 30 consecutive trading days under Nasdaq Listing Rule 5550(a)(2) on December 3, and was given until June 1, 2022 to regain compliance.

09:04 EDT Tomi announces inclusion on EPA's List Q of disinfectants - TOMI Environmental Solutions has been included on the Environmental Protection Agency, EPA, list of "Disinfectants for Emerging Viral Pathogens, EVPs,: List Q" for the use of its BIT solution to help fight the spread of rare or novel viruses such as Monkeypox virus, SARS-CoV-2 and its variants that causes COVID-19. TOMI was notified of EPA's inclusion on June 2, 2022. TOMI's inclusion on the EVP list positions its SteraMist products as effective tools to provide disinfection protection against emerging viruses. Dr. Halden Shane, Chief Executive Officer, commented, "We are very pleased to have our BIT solution recognized by EPA as an effective and environmentally friendly disinfectant for use against emerging viral pathogens including Monkeypox virus, SARS-CoV-2 virus and its variants. SteraMist has been and continues to be a leading solution for the disinfection and decontamination of numerous different viruses, and TOMI's inclusion on List Q is yet another testament to the reliability and effectiveness of our product."

09:01 EDT MSC Industrial acquires Engman-Taylor, terms not disclosed - MSC Industrial announced that it has acquired Engman-Taylor, a Menomonee Falls, Wisc.-based distributor of metalworking tools and supplies. Under the agreement, Engman-Taylor will continue to do business under its current name after becoming an MSC company. The company's president and owner, Rick Star, will continue to lead the approximately 90-associate business. The acquisition is expected to be roughly neutral to MSC's fiscal 2022 earnings and slightly accretive to fiscal 2023 earnings.

08:49 EDT Ormat Technologies appoints Michal Marom, Karin Corfee to board - Ormat Technologies announced the election at its annual meeting of stockholders, held on June 2, 2022, of Michal Marom and Karin Corfee to the Company's Board of Directors, effective immediately. Ms. Marom will also serve as the Chair of the Audit Committee and a member of the Compensation Committee. Ms. Marom and Ms. Corfee will replace the departing Board members Dan Falk and Albertus Bruggink, respectively. With these new additions, one third of Ormat's Board of Directors will be represented by women. Ms. Marom joins Ormat's Board of Directors having served in numerous senior executive leadership roles. Ms. Marom currently serves on the Board of Directors and the audit and compensation committees of several publicly traded companies in the U.S. and Israel. Ms. Corfee currently serves as Vice President, Professional & Advisory Services at Kevala LLC, a power grid analytics company, a position she has held since October 2021.

08:47 EDT Canacol Energy says gas sales averaged 189 MMscfpd for May - Canacol Energy is pleased to provide the following information concerning its May 2022 natural gas sales and the results of the Alboka 1 exploration well, along with near term drilling plans. Gas sales averaged 189 MMscfpd for May 2022: Realized contractual natural gas sales were approximately 189 million standard cubic feet per day for May 2022. Alboka 1 exploration well tests 33 MMscfpd: The Corporation completed the drilling of the Alboka 1 exploration well located on the VIM-5 Block 100% working interest and operated by CNE OIL & GAS S.A.S. Alboka 1 was spud on May 5, 2022 and reached a total depth of 10,155 feet measured depth on May 18, 2022. The well encountered multiple gas filled sandstones between 7,778 and 9,078 feet true vertical depth within the primary Cienaga de Oro sandstone reservoir target with average porosity of 22 percent. The well was flowed for a total of 24 hours with an average production rate of 6 MMscfpd during the first 22 hour flow period, 23 MMscfpd production rate during the following 2 hour flow and a final rate of 33 MMscfpd. The well is currently shut in for a pressure build up. The Corporation is commencing the laying of a flow line to tie the well into permanent production. Forward Drilling Program - Cornamusa 1 exploration well and Toronja 3 development well: The Petro Polar drilling rig is preparing to spud the Cornamusa 1 exploration well located on the Corporations 100% working interest VIM 21 E&P Contract. Cornamusa 1 is targeting gas bearing sands within the CDO sandstone reservoir. The Cornamusa 1 exploration well should take approximately 4 weeks to drill, test, and complete. The Pioneer drilling rig is being mobilized to drill the Toronja 3 development well located on its 100% working interest VIM 21 E&P contract. Toronja 3 is targeting gas bearing sandstone reservoirs within the Porquero Formation which are productive in the offsetting Toronja 1 and 2 wells. The Corporation anticipates spudding the well in mid June 2022, which is planned to take 3 weeks to drill, complete and tie in to permanent production.

08:37 EDT Veracyte announcing publication of Decipher Prostate genomic classifier data - Veracyte announced the publication of data reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy, or RP. The findings, from an ancillary study of the prospective open-label, multicenter, randomized phase 3 SAKK 09/10 trial conducted at 28 centers in Belgium, Germany, and Switzerland, appear in Annals of Oncology. It is estimated that more than 40% of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen, or PSA. For men who experience a rising PSA, determining the optimal timing to initiate salvage radiotherapy, or SRT, and whether to add androgen deprivation therapy, or ADT, to SRT is challenging. This decision is important in part because the side effects of ADT when given concurrently with SRT are often difficult for patients to manage and are associated with long-term cardiovascular impact of hormone therapy.

08:35 EDT Legend Biotech announces FDA clearance of LB1908 IND application - Legend Biotech announced that the FDA has cleared its investigational new drug, or IND, application to evaluate LB1908 in a Phase 1 clinical trial in the United States. LB1908 is an investigational, autologous chimeric antigen receptor T-cell, or CAR-T, therapy selectively targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with relapsed or refractory gastric, esophageal or pancreatic cancers. Claudin18.2 is a tight junction protein commonly expressed in patients with these cancer subtypes. The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy. Study will have dose escalation and dose expansion phases. Patients enrolled in the study must sufficiently express Claudin 18.2. A Phase 1 investigator-initiated trial evaluating LB1908 for advanced gastric cancers is also ongoing in China.

08:33 EDT Alkaline Water CEO Richard Wright resigns, Frank Lazaran succeeds - Alkaline Water announced that Frank Lazaran, a current director of the company and a 40-year veteran of the retail food industry, has been appointed as the CEO of the company. Lazaran was most recently the chairman, CEO and president of Marsh Supermarkets and, prior to Marsh served as the CEO, president and director of Winn-Dixie Stores, which was a publicly traded company and one of the largest supermarket chains in the Southeast. Richard Wright has resigned from his positions of CEO, president, and a director of the company effective immediately.

08:32 EDT Summit Therapeutics reschedules Annual Shareholders' Meeting - Summit Therapeutics invites shareholders and other interested parties to attend the Company's Annual Shareholders' Meeting, which will now be held virtually on Thursday, June 16, 2022, at 1:00 pm Eastern Time, one day later than previously planned.

08:21 EDT DarioHealth reports three new research studies at ADA - DarioHealth announced three new research studies presented at the American Diabetes Association's 82nd Scientific Sessions being held June 3rd to 7th, 2022 in New Orleans, Louisiana. The studies demonstrated significant improvement in glucose control and reductions in blood pressure for users managing diabetes and hypertension and improvement in clinical measures for users with diabetes, stress and depression. The third study demonstrates that the Dario solution has similar positive impact on diabetes across ethnicities.

08:16 EDT Stevia Corp to launch line of dietary supplement, herbal extract products - Stevia announced that it has published a letter to shareholders from the Company's Chairman and President Kenneth Maciora. The letter read in part, "Over the past few months, I have reviewed a long list of business opportunities. Over the course of multiple conversations, I have reviewed these opportunities with my fellow director Dr. Jerry Smartt Jr. Dr. Smartt is a board-certified practicing neurologist in Indiana with an impeccable reputation as a medical doctor and as a person. As I previously mentioned in our first shareholder letter, I requested Dr. Smartt's continued presence on our board of directors because of his impeccable reputation and intellect in the healthcare field. I have also traveled multiple times in the middle of a pandemic to conduct due diligence on multiple opportunities. The question I continued to ask after reviewing each opportunity was, "Is it right for shareholders?". Some opportunities required a reverse split which resulted in a resounding no. Others were promising but also required significant money raises which would result in significant dilution to our current shareholders and as a result, we also passed on those opportunities. On behalf of our entire company and all our valued shareholders, it is with great pleasure that I announce that we have chosen to launch our own branded, select line of dietary supplement and herbal extract products with the first product to be marketed for men's prostate health by the summer of 2022. As some of you may know, the rules regarding the marketing of dietary supplements are clear and concise. Under no circumstance can a product be marketed with unsubstantiated claims. That means that most dietary supplements are marketed with mandatory language on the label which includes these two mandatory sentences: "This statement has not been evaluated by the Food and Drug Administration" and "This product is not intended to diagnose, treat, cure, or prevent any disease." Even with all the strict rules and marketing guidelines which are strictly monitored by the United States Food and Drug Administration, the worldwide market for dietary supplements was in excess of $150 billion USD in 2021. So the question is, how does a company that is small with limited resources now compete in a dietary supplement/herbal extracts marketplace that typically requires multi-million-dollar marketing budgets to realistically compete and build sales in a highly competitive marketplace? The plan is based on 5 key points which will guide our company going forward. Carefully choose products by gauging current patient acceptance and reviews of certain dietary supplements and herbal extracts that are achieving that population's desired effect. Patent our formulas to create our own proprietary brand because intellectual property is the key strategic advantage in the dietary supplements and herbal extracts market. Form an advisory panel consisting of medical and scientific experts to recommend dietary and herbal supplements with favorable patient acceptance rates to guide the rollout of these products. Initiate a limited regional rollout to gauge customer reviews before national rollout to conservatively manage corporate spending. The key to our marketing plan will be to use customer generated reviews of our products which will be wholly distinctive and separate from any statements our company makes about our own products. We have identified the key ingredients in our first product which will be marketed to men over 50 for prostate health. Over the next few days, we expect to be able to file a provisional patent for our proprietary formula. We will update shareholders as soon as the provisional patent is filed and as soon as the United States Patent and Trademark Office acknowledges receipt of our filing. Most importantly, we are not abandoning our former business. To this end, we fully intend to launch our own branded organic stevia line. One of the business trips I had taken was for the sole purpose of sourcing out a quality organic stevia product and we have identified such a product. Although we don't believe the organic stevia product will amount to the same sales as our supplement for men's prostate health, we believe there is a void in the marketplace for a quality organic stevia product and we fully intend to tackle that endeavor and to fill that void. However, it is important that we clearly communicate that our product for men's prostate health has many times the revenue potential of an organic stevia product."

08:10 EDT Ionis says Biogen's VALOR study showed clinical benefit in SOD1-ALS patients - Ionis Pharmaceuticals (IONS) reported that partner Biogen (BIIB) announced results from the Phase 3 VALOR study and its open-label extension of tofersen, an investigational antisense medicine being evaluated for people with superoxide dismutase 1, or SOD1, amyotrophic lateral sclerosis, or ALS. The data show that earlier initiation of tofersen, compared to delayed initiation, slowed declines in clinical function, respiratory function, muscle strength and quality of life. At the time of the analysis, because the majority of participants survived without permanent ventilation, the median time to death or PV could not be estimated. However, early survival data suggest a lower risk of death or PV with earlier initiation of tofersen. These results are based on new integrated data from the VALOR pivotal study and its OLE study, Ionis stated. "As previously reported in October 2021, VALOR, a six-month Phase 3 randomized study, did not meet the primary endpoint of change from baseline to week 28 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. However, trends of reduced disease progression across multiple secondary and exploratory endpoints were observed. The new 12-month data further build on the results previously observed in the initial readout," Ionis stated. The results were presented at the European Network to Cure ALS, or ENCALS, meeting in Edinburgh, Scotland. "We are very pleased with these new 12-month data, which show that tofersen slowed disease progression and lowered neurofilament levels. Together, these results offer compelling evidence of tofersen's potential to provide meaningful clinical benefit to people living with SOD1-ALS," said C. Frank Bennett, Ph.D., executive vice president, chief scientific officer and franchise leader for neurological programs at Ionis.

08:09 EDT MiMedx reminds shareholders to preregister for Annual Meeting - MiMedx Group reminded shareholders to pre-register for the upcoming 2022 Annual Meeting of Shareholders, by no later than 9:00 a.m. Eastern Time on Monday, June 6, 2022. In order to attend and submit questions at the virtual meeting, all MIMEDX shareholders of record must pre-register by the deadline of 9:00 a.m. Eastern Time on June 6, 2022. Instructions on how to pre-register can be found within the Company's 2022 definitive proxy statement or online at www.votemimedx.com. MIMEDX will host its 2022 Annual Meeting of Shareholders on Tuesday, June 7, 2022, at 9:00 a.m. Eastern Time.

08:08 EDT Vaxart reports preliminary preclinical data on two COVID-19 vaccine candidates - Vaxart reported positive preliminary preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike protein for Wuhan or S protein for Omicron protected hamsters when challenged with the Omicron BA.1 variant. The data reported are from a study in which the S-only Wuhan and Omicron vaccine candidates were compared in a hamster challenge model. Animals were immunized mucosally on days zero and 28 and challenged on day 56 with an Omicron variant of SARS-CoV-2; Both vaccines produced antibody responses to the S protein of Omicron, with the Omicron candidate slightly better at making serum IgG antibodies to the matched protein; Weight loss, lung viral titers, and viral shedding were reduced in animals receiving either vaccine candidate compared to unvaccinated animals.

08:07 EDT Bionano Genomics announces presentation featuring applications of OGM - Bionano Genomics announced that researchers from University Health Network in Toronto, Columbia University Medical Center, and Children's Hospital of Eastern Ontario will deliver a two-hour presentation on technologies and applications of OGM for genetic research at the Canadian College of Medical Geneticists General Meeting 2022. The CCMG conference will be held virtually this year and runs from June 6-10, 2022.

08:06 EDT Novocure, Zai Lab announce EF-31 phase 2 pilot study met primary endpoint - Novocure (NVCR) and Zai Lab (ZLAB) announced that the EF-31 phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields, or TTFields, together with standard-of-care as a first-line treatment in patients with gastric adenocarcinoma, met its primary endpoint of objective response rate with supportive signals across secondary endpoints. TTFields therapy was well tolerated, with no increase in the systemic toxicity of the XELOX chemotherapy regimen or the combination regimen, and no high-grade skin toxicities were reported. Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival has not yet been reached with a one-year survival rate of 72%.

08:04 EDT Zai Lab, Novocure report EF-31 Phase 2 pilot study meets primary endpoint - Zai Lab (ZLAB) and Novocure (NVCR) announced that the EF-31 phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields together with standard-of-care as a first-line treatment in patients with gastric adenocarcinoma, met its primary endpoint of objective response rate with supportive signals across secondary endpoints. TTFields therapy was well tolerated, with no increase in the systemic toxicity of the XELOX chemotherapy regimen or the combination regimen, and no high-grade skin toxicities were reported. Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival has not yet been reached with a one-year survival rate of 72%. The EF-31 clinical study, which is a prospective, single arm, phase 2 pilot study conducted in China, included 26 patients with unresectable, locally advanced or metastatic gastroesophageal junction or gastric adenocarcinoma who were previously untreated with systemic therapy. Patients received continuous treatment with TTFields together with the XELOX chemotherapy regimen. Trastuzumab was allowed for HER2-positive patients.

08:02 EDT Society Pass announces it has acquired Gorilla Networks - Society Pass announced that it acquired Singapore-based Gorilla Networks, a Web3-enabled mobile virtual network operator, MVNO. With the rebound of the travel market throughout Southeast Asia in 2Q/3Q 2022, Gorilla expects to dramatically increase its customer base by marketing to the region's business and leisure travellers with its user-friendly technology platform. It plans to expand its MVNO services offering to Vietnam, Thailand, and Malaysia over the next 12 months. Dennis Nguyen, Society Pass Founder, Chairman and Chief Executive Officer, explained, "We are excited to make our first acquisition in Singapore, and welcome Gorilla into our SoPa family. Gorilla's technology platform aligns well with our acquisition strategy as we incorporate Gorilla's blockchain and Web3 capabilities into the SoPa ecosystem and enable the new meta-economy for all our portfolio companies. From our Leflair lifestyle e-commerce platform to our Pushkart/Handycart F&B delivery services, as we roll out the Society Pass loyalty platform in the coming months, we leverage Gorilla's technology to drive customer retention for merchants and create innovative revenue models for our ecosystem."

07:58 EDT Spirit Airlines announces Glass Lewis recommendation for Frontier Group merger - Spirit Airlines (SAVE) announced that independent proxy advisory firm Glass Lewis has recommended that Spirit stockholders vote for the proposed merger with Frontier Group (ULCC), parent company of Frontier Airlines. "We are pleased that Glass Lewis supports our Board's unanimous recommendation to vote FOR the merger with Frontier," said Ted Christie, president and CEO of Spirit. "In its favorable recommendation, Glass Lewis acknowledges the value of the stock consideration in our Frontier merger agreement, which enables Spirit stockholders to participate in the upside of the combined company, as well as post-pandemic recovery in the airline industry. Glass Lewis shares our Board's view that the Frontier transaction has an easier path to close and provides third party validation that JetBlue may have ulterior motives behind its offer."

07:34 EDT Noranda Income Fund reaches agreement on terms for 2022/2023 contractual period - Noranda Income Fund announced that it has reached an agreement with Glencore Canada on the terms under which zinc concentrate will be purchased and zinc metal will be sold for the period of May 1, 2022, to April 30, 2023. For the 2022/2023 contractual period, the Fund's purchases of primary zinc concentrates will be made 60% at a fixed treatment charge and 40% at a variable treatment charge that will fluctuate in line with market movements, among other conditions. The Fund and Glencore Canada agreed upon a fixed premium price on zinc metal sales for the same May 1 to April 30 contractual period. Detailed terms are not disclosed as they are considered commercially sensitive and confidential. As per the agreements in place, Glencore Canada, as principal, supplies the Fund with all of its zinc concentrate requirements, and purchases all of the Fund's zinc metal for the five-year period ending April 30, 2025. The terms for each contractual period are to be agreed upon annually in-line with prevailing market conditions and in consultation with the Independent Trustees' independent industry consultants. Given the high level of market volatility, the Fund has not provided an illustrative Adjusted EBITDA range applying these terms as it has historically. The Fund does not expect to realize the full impact of these terms until all inventory purchased prior to May 1, 2022 has been processed. This is expected to occur in the third quarter of 2022.

07:32 EDT TG Therapeutics announces data presentations from ULTIMATE I, II Phase 3 trials - TG Therapeutics announced data presentations, including one oral and two poster presentations, highlighting data from exploratory and pooled analyses from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis, presented at the Consortium of Multiple Sclerosis Centers annual meeting. Michael Weiss, Chairman and CEO of TG Therapeutics stated, "We are pleased to have presented three data sets at the CMSC conference yesterday. We believe these data further support the previously reported positive Phase 3 results from the ULTIMATE I and II studies." Mr. Weiss continued, "We continue to be encouraged by the feedback received at this week's conference, which reinforces our confidence in the commercial potential of ublituximab, if approved."

07:16 EDT Lifeist's CannMart Labs provides update on proprietary cannabis product offering - Lifeist Wellness provided updates with respect to its wholly owned subsidiary CannMart Labs. Commercializing proprietary 2.0 branded cannabis products is a key part of Labs' strategy to drive higher margin growth. In recent months Labs has made solid progress commercializing its award-winning Roilty brand, with expanded capacity, increased distribution and sell-through, and development efforts toward an expanded portfolio of product formats. The Roilty proprietary brand is now available in six Canadian provinces, Alberta, Saskatchewan, Manitoba, Yukon, Nunavut, and Northwest Territories, four of which are being fed products produced at Labs' facility in Etobicoke, Ontario. Labs has been successfully producing live resin since fall 2021, and having seen solid traction for co-manufactured shatter, has more recently begun commercial scale runs of Labs-produced shatter, opening up another category of Labs-produced product. Labs is currently on track for the Labs-produced shatter to be in market by fiscal Q3 2022. In total, there are now 10 Roilty SKUs in the market. Roilty vapes are performing particularly well, as are Roilty live resin products such as Priest Punch, Kings Kush and Lemon Haze. To meet increasing demand, Labs continues to add capacity month over month processing fresh frozen and dried biomass through its extraction units. Labs has received approval from Health Canada to begin construction at its facility for future storage and distribution of certain controlled substances including psilocybin, psilocin, ketamine, LSD, DMT and MDMA, as part of its application for a Controlled Drugs and Substances Dealer's License. While making progress in the application process with this construction approval, in the immediate term Labs will not commence construction at the facility as it instead allocates its capital and resources towards further advancing its product pipeline, promising a nearer-term path to profitability and value creation than psychedelics currently would. The Company intends to issue an aggregate of 4,375,000 common shares, without a hold period, as payment of the sixth tranche of the remaining base purchase price to the vendors under the share purchase agreement for the acquisition of Labs. The issuance is considered to be a shares for debt transaction under the policies of the TSX Venture Exchange and remains subject to TSX-V approval.

07:14 EDT Microbix Biosystems presents on test validation methods at AACC - Microbix Biosystems announces it is presenting about the utility of its Quality Assessment Products to monitor the end-to-end diagnostic process, including the impact of "preanalytical" sample-handling variables on test accuracy, at the 2022 "Preanalytical Phase Conference" of the American Association of Clinical Chemistry taking place in Alexandria, Virginia from June 3-4, 2022. Microbix is attending this AACC conference to present about these important aspects of infectious disease testing, alongside leaders in the global medical diagnostics industry. Microbix will also be conducting business development activities in relation to its expanding portfolio of QAPs, which includes Health Canada, U.S. FDA, EU "CE mark," or TGA in-vitro-diagnostic regulated SKUs and research-use-only designated SKUs across both liquid-vial and Copan FLOQSwab formats. Its poster presentation is titled "Simulated Swab Specimens for Whole Workflow Quality Control of SARS-CoV-2 Molecular Diagnostic Testing." The poster details methods of using Microbix's REDx FLOQ SARS-CoV-2 Swab Positive Control QAPs to assess the influence on patient-samples of hold-period durations of up to five days, high temperatures of 35-40 degrees C, or a freeze-thaw cycle, relative to more optimal conditions. The study examined the effects of such conditions on the detectability of Microbix's positive QAPs at full-strength and in 1:100 diluted form relative to strong-positive and weak-positive clinical specimens, using two different viral transport mediums and two different Health Canada approved assays. The results establish that the effects of sample storage and handling conditions can be accurately modeled using QAPs as proxies for clinical patient-samples. These Microbix products and methods can be used to validate processes for new-generation testing practices, such as at-home sample-collection, for a wide range of disease screening and diagnostic purposes, including COVID-19 and high-risk HPV infection, among others. The study was conducted in collaboration with FH Health Laboratory of Toronto, Ontario, whose support in sourcing clinical specimens, testing, and tabulation is gratefully acknowledged.

07:12 EDT Enthusiast Gaming announces postponement of annual general meeting - Enthusiast Gaming announces that it has received approval from the Toronto Stock Exchange to hold its 2022 annual meeting on or before August 30, 2022, in order to allow sufficient time for the Company to review and respond to the dissident shareholder's proposals and to provide proper information to all shareholders in advance of the meeting. The board of directors of the Company has resolved to postpone the annual meeting of shareholders to July 19, 2022, with an updated record date of June 10, 2022, and will file an amended notice of meeting and record date on its SEDAR profile in due course. Shareholders are not required to take any action at this time. Shareholders will receive detailed information about how to vote and the matters presented at the meeting in a management information circular to be sent to shareholders in advance of the meeting.

07:11 EDT Aurinia Pharmaceuticals presents data from Lupkynis trial - Aurinia Pharmaceuticals presented data demonstrating the efficacy of Lupkynis for the treatment of people with lupus nephritis, or LN, a serious complication of systemic lupus erythematosus, or SLE, in achieving the proteinuria treatment targets recommended by the European Alliance of Associations for Rheumatology, or EULAR and the European Renal Association, or ERA. The pooled analysis from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies assessed the efficacy of voclosporin, in addition to mycophenolate mofetil, or MMF, and low-dose steroids, to reduce urine protein creatinine ratio, or UPCR, to achieve the following EULAR/ERA treatment targets updated in 2019: 25% reduction in UPCR by three months, 50% reduction in UPCR by six months, UPCR 0.7 mg/mg by 12 months, as well as steroid dose of 7.5 mg/day at 12 months. The breakdown of the reductions in UPCR at month three, six, and 12 is as follows: At three months, 78.4% of patients in the voclosporin group and 62.4% of patients in the control group achieved 25% reduction in UPCR. At six months, 66% of patients in the voclosporin group and 47% of patients in the control group achieved 50% reduction in UPCR. At 12 months, 52.6% of patients in the voclosporin group and 33.1% of patients in the control group achieved UPCR of 0.7 mg/mg. At 12 months, 89.6% of the voclosporin group and 82.8% of the control group achieved the recommended steroid dose of 0.75 mg/day according to the protocol-defined steroid taper. In addition, the proportion of patients meeting UPCR of 0.7 and steroid dose of 7.5 mg/day was 44.4% in the voclosporin group and 27.1% in the control group.

07:09 EDT Aurora Cannabis repurchases $20M of convertible senior notes - Aurora Cannabis announced that it has repurchased an aggregate of approximately $20M principal amount of its convertible senior notes at a total cost, including accrued interest, of $19.2M in cash. The purpose of the transaction, which represents a repurchase of a portion of the Notes at a 5.25% discount to par value, was to reduce the company's debt and annual cash interest costs. Annual cash interest savings from the repurchases of Notes made from Q3 2022 onwards now total $7.5M. Aurora's balance sheet is among the strongest in the industry with approximately $455M in cash inclusive of the transaction announced today, and the company reiterates its expectation of achieving a positive Adjusted EBITDA run rate by the first half of fiscal 2023.

07:08 EDT Aravive appoints Rudy Howard as Chief Financial Officer - Aravive (ARAV) announced the appointment of Rudy Howard as Chief Financial Officer, CFO, effective today. Vinay Shah has stepped down as CFO for personal reasons but will remain with the Company as an advisor to ensure a smooth transition. Prior to joining Aravive, Howard served as the Chief Financial Officer of vTv Therapeutics (VTVT).

07:06 EDT Optinose announces departure of CFO Goldan, Janis to succeed - Optinose announced that Keith Goldan, Chief Financial Officer, will leave Optinose to accept a CFO opportunity at another public company. Goldan will continue to serve as Chief Financial Officer until his departure on June 10, 2022. Michele Janis, Vice President of Finance, who joined Optinose in 2011, has served as a member of the Company's leadership team since joining Optinose and will now serve as the Company's Acting Chief Financial Officer. Anthony Krick, Vice President, Controller, will assume the newly created role of Vice President and Chief Accounting Officer and be responsible for financial reporting and managing the day to-day activities of the finance & accounting team. Jonathan Neely, Vice President, Investor Relations & Business Development will lead investor communications.

07:06 EDT Amylyx announces FDA extension of review timeline for AMX0035 NDA - Amylyx announced that the FDA has extended the review timeline of the New Drug Application, or NDA, for AMX0035 for the treatment of amyotrophic lateral sclerosis, or ALS. The updated Prescription Drug User Fee Act, or PDUFA, goal date is September 29. The FDA extended the PDUFA date to allow more time to review additional analyses of data from the Company's clinical studies. The submission of this information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA goal date.

07:04 EDT Immunocore enters trial collaboration with Sanofi for SAR444245 with KIMMTRAK - Immunocore (IMCR) announced it has entered into a clinical trial collaboration and supply agreement with Sanofi (SNY). Under the agreement, Sanofi will evaluate its precisely PEGylated, engineered version of IL-2, SAR444245, in combination with KIMMTRAK, Immunocore's novel bispecific protein targeting gp100, in HLA-A*02:01 positive patients with advanced unresectable or metastatic skin cancers as part of Sanofi's ongoing Phase 1/2 study. Under the terms of the agreement, Sanofi will be responsible for clinical development and will assume all costs associated with the study, other than expenses related to the manufacturing and supply of KIMMTRAK for which Immunocore is responsible. John Reed, MD, PhD, Executive Vice President and Global Head of R&D of Sanofi, said: "While we are actively studying SAR444245 as monotherapy and in combination with anti-PD-1 class checkpoint inhibitors and with approved immuno-competent monoclonal antibodies, the collaboration with Immunocore represents Sanofi's first exploration of combining SAR444245 with a T cell engager. We are therefore very eager to explore this high potential combination in our ongoing multi-arm Phase 1/2 clinical study."

07:03 EDT ALX Oncology to initiate new clinical study of Evorpacept for UC in Q4 - ALX Oncology Holdings announced clinical program updates for its lead program, evorpacept, a next generation CD47 blocker. Introducing ASPEN-07, a Phase 1 Trial of Evorpacept for the Treatment of Patients with Urothelial Carcinoma. ALX Oncology will initiate a new clinical study, ASPEN-07, to investigate evorpacept in combination with an antibody-drug conjugate, PADCEV for the treatment of patients with urothelial carcinoma in the fourth quarter of 2022. Enfortumab vedotin-ejfv is an ADC directed to Nectin-4, a protein located on the surface of cells that is highly expressed in UC. In April 2022, ALX Oncology successfully completed a pre-IND consultation with the U.S. Food and Drug Administration for a Phase 1 study of evorpacept in combination with enfortumab vedotin-ejfv in patients with previously treated locally advanced or metastatic UC. The IND application for ASPEN-07 was submitted to the FDA in May 2022. "We continue to pursue strategies to expand the potential value of evorpacept as a cornerstone therapy for the treatment of patients with cancer," said Jaume Pons, Ph.D., Founder, President and CEO of ALX Oncology. "ASPEN-07 further expands our solid tumor investigations and will be the first combination study of evorpacept with an ADC. The addition of evorpacept is expected to enhance the antibody-dependent cellular phagocytosis mediated by enfortumab vedotin-ejfv to improve efficacy in patients with UC without increasing toxicity. Our currently enrolling randomized Phase 2 studies remain a key priority for us in order to maintain ALX Oncology's leadership position in solid tumors in the CD47 space."

07:02 EDT West Fraser Timber announces preliminary results of substantial issuer bid - West Fraser Timber announced the preliminary results of its substantial issuer bid, or SIB, pursuant to which West Fraser offered to purchase for cancellation up to $1.25B of its common shares. In accordance with the terms and subject to the conditions of the SIB and based on the preliminary calculations of Computershare Investor Services, as depositary for the SIB, West Fraser expects to take up and pay for approximately 11.898M shares at a price of approximately $95 per share, representing an aggregate purchase price of approximately $1.13B. West Fraser currently expects that all shareholders who made auction tenders and purchase price tenders will have 100% of their successfully tendered Shares purchased by West Fraser at the purchase price.

07:00 EDT Bristol-Myers to acquire Turning Point Therapeutics for $76.00 per share

06:58 EDT Alaska Air sees FY22 capacity 'below low end of prior guide' - In an 8-K filing last night, the company stated: "The public health and economic crises resulting from the outbreak of COVID-19 have dramatically impacted demand for air travel and driven significant change to our business operation and performance. From the beginning of these crises, the recovery path has been volatile and difficult to predict. If circumstances no longer support the plans we have established, our expectation for these metrics could change. Since our last update, operational performance has improved, with system-wide completion rates at 96% in April and 98% in May. We remain committed to operational excellence as we prepare to step capacity back to 2019 levels and return to a single mainline fleet, with our A320 aircraft targeted for retirement no later than early 2023. Given our focus on operational reliability and accelerated fleet transition, we now expect full year 2022 capacity to be below the low end of our previous guide of flat to down 3% versus 2019. The following reflects our latest expectation for second quarter financial and operational results. We continue to experience sustained strong demand for air travel throughout our network. As a result, expected total revenue compared to 2019 has increased by 6.5 points at the midpoint, as load factors have increased, and passenger yields remain at double-digit percentages above 2019 levels. Stronger revenue is offsetting increases in oil prices. Our economic fuel cost per gallon includes expected hedge benefit of approximately $0.45 per gallon. There are no changes to our unit cost expectations. As a result of these updates, we continue to expect to deliver double digit pretax margin in the second quarter."

06:44 EDT Vasta Platform announces investment in Educbank - Vasta Platform announces the execution of a minority investment agreement by its wholly-owned subsidiary, Somos Sistemas de Ensino S.A., which establishes the terms and conditions for the issuance and the payment of new shares on Educbank Gestao de Pagamentos Educacionais S.A. According to the agreement, the investment will be made in installments over a two-year period, upon subscription of new Educbank shares, according to the growth of students served by Educbank and other conditions. The closing of the transaction is subject to certain conditions precedent, including the approval by the Brazilian antitrust authority. Educbank is the first financial ecosystem dedicated to K-12 schools, intended to expand access to quality education in Brazil, through services' management and financial support to educational institutions by providing payment guaranty to school tuitions. This investment will enable Vasta to capture great value potential in the following years, by tapping the K-12 tuitions payment means, which total payment volume is estimated at R$70B per year. Educbank's services complement Vasta's digital services platform, which provides access to data, management tools and now working capital management, releasing time for school partners to focus on delivering education.

06:34 EDT MarketAxess reports May total trading ADV of $34.8B, up 45% - Consisting of credit ADV of $12B, up 16%, and rates ADV of $22.8B, up 66%.

06:01 EDT Biodesix announces research agreement with top U.S. cancer center - Biodesix announced that it intends to develop a new novel minimal residual disease test as a part of a master sponsored research agreement with Memorial Sloan Kettering Cancer Center. In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR platform, the Bio-Rad QX600 ddPCR System.

05:11 EDT JetBlue issues statement on Frontier-Spirit amended merger ageement - JetBlue (JBLU) issued the following statement regarding the amended Frontier (ULCC) and Spirit (SAVE) merger agreement: "The Spirit Board of Directors' conflicts continue to guide their every move. Today's announcement demonstrates why, in their shareholders' best interest, they should negotiate with us in good faith - which, yet again, they have failed to do. Spirit's Board only went back to Frontier under pressure, when it became increasingly clear their shareholders would decisively reject the Spirit Board's flawed process and Frontier's inferior transaction. The addition of a reverse termination fee in the face of a likely defeat is simply an acknowledgement that the regulatory profiles and timelines of both deals are indeed similar. Spirit had already admitted that its own prior unreasonably optimistic projections of receiving approval this year were in fact not accurate. Experts agree both transactions will receive the same level of scrutiny. JetBlue will review and assess the revised terms of the amended merger agreement once it has been made available. We believe we have put forward a clearly superior offer and remain prepared to negotiate in good faith a consensual transaction at $33, subject to receiving necessary diligence. We urge Spirit shareholders to continue to let the Spirit Board know they want an open, fair process, providing us a level playing field and full access to the same information available to Frontier. There is still time for the Spirit Board to do the right thing for their shareholders."

05:08 EDT Walmart to build new fulfillment center in McCordsville - Walmart announced plans to build four new high-tech fulfillment centers, one of which will be located in McCordsville, Indiana, 20 miles northeast of Indianapolis. The new 2.2M square-foot facility will be located at 5259 W 500 N and is set to open spring 2023, bringing more than 1,000 new jobs to Hancock County. The fulfillment center will implement automation technology that provides customers and Walmart+ members in Indiana, Illinois, Kentucky and Ohio with access to next- or two-day shipping on millions of items. The fulfillment center will be hiring full-time positions, including new tech-focused jobs like control technicians, quality audit analysts and flow managers.

05:04 EDT Innate Pharma, AstraZeneca announce IPH5201 clinical trial in lung cancer - Innate Pharma (IPHA) announced that IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca (AZN), will advance into a Phase 2 clinical trial in lung cancer. Innate will receive a $5M milestone payment from AstraZeneca and will be responsible for conducting the study. AstraZeneca and Innate will share study costs and AstraZeneca will supply clinical trial drugs.