Stockwinners Market Radar for May 28, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:09 EDT G Squared Ascend I receives expected NYSE notice on delayed 10-Q - G Squared Ascend I Inc. announced that on May 25, 2021, the company received a notice from the New York Stock Exchange indicating that the company is not in compliance with Section 802.01E of the NYSE Listed Company Manual because the company has not timely filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 with the U.S. Securities and Exchange Commission. The Notice has no immediate effect on the listing of the company's stock on the NYSE, and indicated that the company has six months to file its Form 10-Q to regain compliance.

18:01 EDT Ibere Pharmaceuticals receives expected NYSE notice - Ibere Pharmaceuticals announced that it received a notice on May 25, 2021 from the New York Stock Exchange indicating that the company is not in compliance with Section 802.01E of the NYSE Listed Company Manual as a result of its failure to timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2021 with the Securities and Exchange Commission. The notice has no immediate effect on the listing of the company's stock on the NYSE.

17:57 EDT Prologis director Kennard sells 10,000 common shares - In a regulatory filing, Prologis director Lydia Kennard disclosed the sale of 10,000 common shares of the company on May 27 at a price of $118 per share.

17:33 EDT Social Capital Hedosophia Holdings Corp. IV receives expected NYSE notice - On April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the U.S. Securities and Exchange Commission together issued a statement regarding the accounting and reporting considerations for warrants issued by special purpose acquisition companies entitled "Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies. As previously disclosed, given the scope of the process for determining the appropriate accounting treatment of its outstanding warrants in accordance with the SEC Staff Statement and Accounting Standards Codification 815-40, Derivatives and Hedging: Contracts in an Entities Own Equity, Social Capital Hedosophia Holdings Corp. IV was unable to complete and file its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2021 by the required due date without unreasonable effort and expense.

17:31 EDT HumanCo Acquisition to restate 2020 financial statements - HumanCo Acquisition Corp. announced that it has determined to restate its 2020 financial statements in light of the U.S. Securities and Exchange Commission's recently issued "Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies. This Staff Statement issued on April 12, 2021 informed market participants that warrants issued by SPACs and former SPACs may need to be reclassified as liabilities with non-cash fair value adjustments recorded in earnings at each reporting period. The company had previously classified its issued warrants as equity. The company currently expects that the reclassification of the warrants will have no impact on its historical liquidity, cash flows or revenues. The company is working diligently with its auditors in order to finalize and to file a second amendment to its Annual Report on Form 10-K/A for the year ended December 31, 2020 reflecting the reclassification of the warrants for the Non-Reliance Period as soon as practicable. The adjustments to the financial statement items for the Non-Reliance Period will be set forth through disclosures in the financial statements included in the Form 10-K/A.

17:12 EDT Huntington Ingalls awarded $302.6M U. S. Navy contract - Huntington Ingalls is awarded a $302.6M hybrid cost-plus-award-fee, cost-plus-fixed-fee with a special performance incentive, and cost-only-type contract for planning yard support for LPD 17 amphibious transport dock ships, LHD 1/LHA 6 amphibious assault ships, LSD 41/49 dock landing ships and LCC 19 amphibious command ship.

17:06 EDT Tekkorp Digital Acquisition receives Nasdaq notice related to delayed filing - Tekkorp Digital Acquisition Corp. received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC. On April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the U.S. Securities and Exchange Commission together issued a statement regarding the accounting and reporting considerations for warrants issued by special purpose acquisition companies entitled "Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies. As previously disclosed, given the scope of the process for determining the appropriate accounting treatment of its outstanding warrants in accordance with the SEC Staff Statement and Accounting Standards Codification 815-40, Derivatives and Hedging: Contracts in an Entities Own Equity, the Company was unable to complete and file its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2021 by the required due date without unreasonable effort and expense.

17:03 EDT Social Leverage Acquisition Corp I receives expected NYSE notice - On April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the U.S. Securities and Exchange Commission together issued a statement regarding the accounting and reporting considerations for warrants issued by special purpose acquisition companies entitled "Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies. As previously disclosed, given the scope of the process for determining the appropriate accounting treatment of its outstanding warrants in accordance with the SEC Staff Statement and Accounting Standards Codification 815-40, Derivatives and Hedging: Contracts in an Entities Own Equity, Social Leverage Acquisition Corp I was unable to complete and file its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2021 by the required due date without unreasonable effort and expense.

17:00 EDT Natera responds to Guardant Health lawsuit - Natera (NTRA) announced it has been sued by Guardant Health (GH), in an attempt to stop Natera from exposing Guardant Reveal's true test performance and the differences between tumor-informed and tumor-naive molecular residual disease tests. Natera has filed a claim against Guardant in the U.S. District Court for the Western District of Texas, (Docket No.6:21-cv-00540), alleging that Guardant used false and misleading claims to deceive physicians about the performance capabilities of its MRD test, in violation of the Lanham Act. Guardant's MRD test performance claims are incomplete or unsupported by clinical evidence, and can be misinterpreted by physicians and patients. "Natera's complaint alleges that Guardant has engaged in: Misleading promotions of 91% sensitivity in the surveillance setting, even though this analysis excluded 7 false negatives without clinical justification (24% of all recurrence events). The test specificity was also not evaluated in this setting, since longitudinal and surveillance samples were not analyzed from the patients who remained relapse-free. It is inappropriate to claim test sensitivity without evaluating specificity in the same population. The only valid sensitivity claim for Guardant's MRD test uses serial longitudinal samples, and is 69%1 compared to Signatera's 88-93%2-4 sensitivity. Misleading promotions, including emails to physicians and a presentation at the recent JP Morgan Healthcare Conference, that inappropriately pair a claim of 91% sensitivity with a mismatched claim of 100% specificity. It is highly deceptive to pair sensitivity from one analysis with specificity from a different analysis. It is also inappropriate for Guardant to claim 100% specificity without clarifying that this analysis excluded 2 false positive cases where a full year of clinical follow-up information was not collected, despite having time to do so. This commercial promotion significantly misrepresents the study's findings and puts patients at risk. Misleading promotions of its test for use in Stage II-III CRC, using performance claims derived from a study that does not match the intended use population. 19% of the patients included in the Guardant study had Stage IV disease. Patients in the study had an overall recurrence rate of greater than 35% which does not match the Stage II-III intended use population.1 No breakdown of performance was provided for patients with Stage II-III CRC. Furthermore, many patients in the study received neoadjuvant therapy, which makes them less eligible for adjuvant therapy. In addition, test performance was not reported from the post surgical timepoint, which is the time point needed for adjuvant chemotherapy decision making. Misleading promotions of industry-leading performance, even though Guardant declined to report several unfavorable metrics from its study that are critical for evaluating differences between MRD testing methods. For example, its pre-surgical detection rate was only 47% in patients who did not receive neoadjuvant therapy, compared to the tumor-informed Signatera test with reported pre-surgical detection rates of 89-94%.2-4 In addition, Reveal's diagnostic lead time to detect recurrence was ~4 months vs. 8.7 months2 for Signatera, which is a 2x difference. Natera is committed to free and open dialogue about data that directly impacts clinical decision making and patients' safety. We look forward to working with the medical and academic community to advance the science of MRD testing, in a transparent manner."

16:45 EDT Wejo to go public through business combination with Virtuoso Acquisition - Wejo Limited, a connected vehicle data company, and Virtuoso Acquisition (VOSO), a special purpose acquisition company, announced that they have entered into a definitive agreement for a business combination. Upon completion of the transaction, the combined company will operate under the Wejo name. Richard Barlow, CEO and Founder of Wejo, said, "The team at Virtuoso champions our vision to transform connected vehicle data into data for good, and we are proud to establish the market standard for collecting and aggregating that data. Insights developed by our data will make mobility safer, smarter, and more sustainable. Driven by our marketplace solutions for customers and SaaS solutions for OEM and Tier 1 partners, we expect rapid growth in revenues over the next several years." Pursuant to the transaction, Virtuoso will combine with Wejo at an enterprise value of $800 million, which implies an estimated $1.1B pro forma equity value. Wejo's existing shareholders are rolling 100% of their existing equity into the combined company and will own approximately 64% of the issued and outstanding shares immediately following closing of the business combination, assuming no redemptions by Virtuoso's public stockholders. The transaction is expected to deliver approximately $330M of gross proceeds, composed of Virtuoso's $230M cash held in trust, assuming no redemptions by Virtuoso's public stockholders, and a fully committed $100M PIPE priced at $10.00 per share with participation from lead strategic investors including Palantir Technologies Inc. (PLTR) and General Motors (GM). Additional strategic investors have expressed interest in participating in the PIPE for up to an incremental $25M within the next 30 days and are in continuing negotiations with the parties. Cash proceeds from the transaction will fully fund Wejo's five-year plan and position the company to execute on all of its strategic objectives, including acceleration of OEM onboarding, continued rollout of new offerings and services for connected vehicle customers and further expansion into new geographies and in-demand marketplaces. The company will be well capitalized with an estimated $300M cash at closing and $32M of debt. The board of directors of Virtuoso and the board of directors of Wejo have each unanimously approved the proposed transaction, which is expected to close during the second half of 2021, subject to Virtuoso shareholder approval and customary closing conditions.

16:36 EDT Waldencast Acquisition receives Nasdaq notice related to delayed 10-Q filing - Waldencast Acquisition Corp. received on May 28, 2021 a notice from The Nasdaq Stock Market LLC indicating that, as a result of not having timely filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, the company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required periodic financial reports with the Securities and Exchange Commission.

16:34 EDT Lazydays receives Nasdaq notice on late filing of Form 10-Q - Lazydays Holdings announced that it has received a notice from The Nasdaq Stock Market on May 25, 2021 notifying the company that, because of its failure to timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2021 with the Securities and Exchange Commission, the company is no longer in compliance with the periodic filing requirements for continued listing set forth in Nasdaq Listing Rule 5250(c)(1).

16:33 EDT Apollo Strategic Growth Capital receives NYSE notice of non-compliance - Apollo Strategic Growth Capital announced that it received a notice from the New York Stock Exchange indicating that the company is not in compliance with Section 802.01E of the NYSE Listed Company Manual as a result of its failure to timely file its Quarterly Report on Form 10-Q for the period ended March 31 with the U.S. SEC. The NYSE informed the company that, under NYSE rules, the company will have six months from May 25 to file the Q1 2021 Form 10-Q with the SEC. The company can regain compliance with the NYSE listing standards at any time prior to that date by filing its Q1 2021 Form 10-Q.

16:31 EDT Liminal BioSciences to stop plans to move fezagepras into Phase II study - Liminal BioSciences announced that based on interim pharmacokinetic results from the ongoing fezagepras multiple ascending dose study, the company has decided to stop its plans to move fezagepras into a Phase II clinical study in Idiopathic Pulmonary Fibrosis and a phase Ia/IIb study in Hypertriglyceridemia, as it evaluates the impact of the PK data profile observed in the on-going study. The company is continuing to evaluate the interim PK results. Once the MAD study is complete, the company expects that a full analysis of the complete PK data set from the phase 1 study will help determine the choice of any other potential indication(s) for further development of fezagepras. No dose-limiting adverse events or other potential safety signals have been observed in the MAD study to date.

16:06 EDT Adobe recommends stockholders reject Tutanota's 'mini-tender' offer - Adobe announced that it recently became aware of an unsolicited "mini-tender" offer by Tutanota LLC to purchase up to one million shares of Adobe's common stock, representing significantly less than one percent of Adobe's common stock outstanding. The offer price of $565 per share is conditioned on, among other things, the closing price per share of Adobe's common stock exceeding $565 per share on the last trading day before the offer expires. This means that unless Tutanota waives this condition, Adobe stockholders who tender their shares in the offer will receive a below-market price. Adobe cautions stockholders that Tutanota can extend the offer for successive periods of 45 to 180 days, in which case payment would be delayed beyond the scheduled expiration date of Friday, June 4, 2021. There is no guarantee the conditions of the offer will be satisfied. Adobe recommends that stockholders do not tender their shares in response to Tutanota's offer because the offer is at a price below a conditional market price for Adobe's common stock and subject to numerous additional conditions. Stockholders who have already tendered their shares may withdraw them at any time prior to 5:00 p.m., Eastern Time, on Friday, June 4, 2021, in accordance with the offering documents. Adobe does not endorse Tutanota's unsolicited mini-tender offer and is not associated in any way with Tutanota, its mini-tender offer, or its mini-tender offer documents.

16:03 EDT East Resources Acquisition receives Nasdaq notice of non-compliance - East Resources Acquisition Company announced that, on May 26, it received a notice from the Listing Qualifications Department of The Nasdaq Stock Market stating that the company is not in compliance with Nasdaq Listing Rule 5250(c)(1) because the company failed to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31 with the SEC. The Notice has no immediate effect on the listing or trading of the company's securities on the Nasdaq.

16:02 EDT Viveon Health Acquisition receives noncompliance notice from NYSE - Viveon Health Acquisition Corp. announced that on May 25, 2021, as a result of its inability to timely file with the Securities and Exchange Commission its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2021, it received a notice from the New York Stock Exchange stating that the company is not in compliance with the NYSE American's continued listing requirements under the timely filing criteria established in the NYSE American LLC Company Guide. Under the Section 1007 of the NYSE American LLC Company Guide, the company could be granted up to 12 months to cure the late filer deficiency. The initial six month period to regain compliance is automatic and the additional six months is only granted upon request by the company and approval by the NYSE. The NYSE notice has no immediate effect on the listing or trading of the company's securities on the NYSE American.

15:13 EDT Surgery Partners announces new strategic partnership with UCI Health - Surgery Partners and UCI Health have announced a new strategic partnership that they said "marks an expansion of community access to outpatient surgical facilities for nearly 4 million residents throughout Orange County, western Riverside County and southern California." Eric Evans, Surgery Partners CEO, said, "We are excited about our joint venture with UCI Health, a renowned academic health system, and the opportunity it provides to further deliver on our mission to enhance patient quality of life through partnership."

14:05 EDT FCA US recalling 446,643 U.S.-market vehicles over wheel stud issue - Stellantis announced that FCA US is voluntarily recalling an estimated 446,643 U.S.-market vehicles to correct their service and owner's manuals, and inspect and replace their wheel studs, as needed. Affected are certain model-year 2012-2021 Ram 3500 heavy-duty pickups, and 4500 and 5500 cab-chassis vehicles. "Routine customer data analysis led to an FCA US investigation that discovered certain service and owner's manuals contain incorrect lug-nut torque instructions. Accordingly, the corresponding vehicles may have had their lug nuts over-torqued, a condition that could conceivably compromise studs and lead to wheel separation. There is no component defect and torque applied during vehicle assembly is within specification, so the recall condition may only be present in vehicles that have been subject to wheel-removal as part of a service or upfit procedure. The company is unaware of any related injuries or accidents," Stellantis said.

13:33 EDT Ali Group confirms $23 per share proposal to acquire Welbilt - In response to media reports, Ali Holding S.r.l., which identifies itself as "one of the largest and most diversified global leaders in the foodservice equipment industry," confirmed that on May 25, 2021, it submitted to the board of directors of Welbilt (WBT) a proposal under which Ali Group would acquire all of the outstanding shares of Welbilt common stock for $23.00 per share in cash. This proposal represents a premium of 47.2% to the Welbilt share price as of April 20, 2021, the last trading day prior to The Middleby Corporation's (MIDD) announcement of its pending all-stock transaction with Welbilt, and a premium of approximately 13.9% to the implied value of the Middleby transaction as of May 24, 2021, the last trading day prior to Ali Group submitting its proposal to Welbilt. Ali Group issued the following statement: "Ali Group has a 60-year history in the foodservice equipment sector and has long-admired Welbilt. Our $23 per share proposal delivers significant cash premium value to Welbilt shareholders and is superior in every respect to Welbilt's pending all-stock transaction with Middleby. In addition to superior value, our proposal offers greater certainty of closing for Welbilt and its shareholders. We and our advisors look forward to engaging with Welbilt and its advisors to quickly negotiate and finalize a definitive agreement." Ali Group is "highly confident" its proposed transaction will obtain all necessary regulatory approvals "in a timely manner without the uncertainty created by the antitrust provisions contained in the Middleby transaction," the company added.

13:18 EDT Guardant Health receives FDA approval for Guardant360 CDx test - Guardant Health (GH) announces that the U.S. FDA has approved the Guardant360 CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer who harbor the KRAS G12C mutation and may benefit from LUMAKRAS, an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen (AMGN). The Guardant360 CDx FDA approval was based on clinical validation data from the CodeBreaK 100 trial evaluating sotorasib in patients with locally advanced or metastatic NSCLC. Patients identified with the KRAS G12C mutation using the Guardant360 CDx demonstrated an objective response rate consistent with those identified using traditional tissue-based biomarker testing.

13:07 EDT Gracell Biotechnologies Inc (ADS) trading halted, volatility trading pause

12:51 EDT Amgen confirms FDA approval of targeted lung cancer pill Lumakras - Amgen announced that the Food and Drug Administration has approved Lumakras for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy. The orally administered once-daily cancer treatment will cost $17,900 per month.

12:35 EDT FDA approves Amgen's targeted therapy for lung cancer Lumakras - The Food and Drug Administration said it approved Amgen's (AMGN) Lumakras as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers, the agency said in a statement. Along with Lumakras, the FDA also approved the Qiagen (QGEN) therascreen KRAS RGQ PCR kit and the Guardant360 CDx, approval granted to Guardant Health (GH), as companion diagnostics for Lumakras.

12:12 EDT Conn's to open new HomePlus showroom in Ocala, Florida - Conn's announced an expansion into the Ocala, Florida market, opening a new Conn's HomePlus showroom this May. The store is located in the Boyd Market Center at 2800 SW 24th Ave. "We are excited for the continued expansion of our Florida footprint, as we open our seventh store within the state in less than a year," said Norm Miller, Conn's HomePlus Chairman and CEO. "The new showroom in Ocala showcases our continued commitment to being a key player in the growing economy and we look forward to joining the community and helping our newest customers to Make It Happen."

12:00 EDT Caleres falls -13.7% - Caleres is down -13.7%, or -$3.73 to $23.55.

12:00 EDT Veeva rises 11.3% - Veeva is up 11.3%, or $29.80 to $294.44.

12:00 EDT Welbilt rises 21.9% - Welbilt is up 21.9%, or $4.36 to $24.28.

11:46 EDT ISS recommends Extended Stay America investors vote against proposed sale - Tarsadia Capital, LLC together with its affiliates, associates and funds it manages, announced that independent proxy advisory firm Institutional Shareholder Services has recommended that Extended Stay America (STAY) shareholders VOTE AGAINST the proposed sale of the company to Blackstone Real Estate Partners (BX) and Starwood Capital Group at the Special Meeting scheduled for June 8, 2021. In making its recommendation, ISS agrees with Tarsadia's core argument that the sale comes at the wrong time, the wrong price and after the wrong process, saying "Given the potential upside from the sector-wide recovery and company-specific catalysts, the current deal terms do not appear to offer a sufficiently compelling value relative to the standalone scenario."

11:02 EDT Capcom's 'Monster Hunter: Rise' has shipped over 7M copies worldwide - Capcom (CCOEY) announced yesterday via Twitter that "Monster Hunter: Rise," the latest in its "Monster Hunter" franchise, has now shipped over 7M copies worldwide since its March 26, 2021 launch. The game is currently available on Nintendo Switch (NTDOY), with a PC port set for release in 2022. Reference Link

10:43 EDT Northern Star Acquisition stockholders approve proposed merger with BARK - Northern Star Acquisition announced that Northern Star's stockholders voted to approve its proposed merger with Barkbox at its Annual Meeting of Stockholders held on May 28, 2021. The merger is scheduled to close on June 1, 2021 and the common stock and warrants of the combined company, which will be renamed "The Original BARK Company", are set to commence trading on the New York Stock Exchange on June 2, 2021 under the new ticker symbols, "BARK" and "BARK WS", respectively.

10:05 EDT Zymergen acquires Lodo Therapeutics, terms not disclosed - Accelerator Life Science Partners announced that its portfolio company, Lodo Therapeutics Corporation, has been acquired by Zymergen (ZY) for an undisclosed amount. The transaction is the third exit from ALSP's investment fund, Accelerator Life Science Partners I, in the last year. Lodo Therapeutics discovered and developed novel therapeutics to address undruggable targets by applying its proprietary platform to tap the vast collections of undiscovered molecules encoded in environmental microbial DNA. ALSP invested in Lodo as part of the Company's $17M Series A financing. ALSP managed the Company business, research, and development operations for more than four years. In 2018 ALSP helped Lodo to establish a multi-target collaboration with Genentech worth up to $969M. ALSP also recruited serial entrepreneur Dale Pfost, Ph.D., as the Company's Chairman and CEO, and helped to fill key executive leadership positions as the Company graduated from ALSP's operations.

10:00 EDT Lannett falls -14.1% - Lannett is down -14.1%, or -69c to $4.25.

10:00 EDT Veeva rises 11.7% - Veeva is up 11.7%, or $30.90 to $295.55.

10:00 EDT AMC Entertainment rises 22.9% - AMC Entertainment is up 22.9%, or $6.08 to $32.60.

09:51 EDT TRxADE Group changes name to TRxADE Health - TRxADE Group announced that the company will be changing its name to TRxADE HEALTH, Inc., effective Tuesday, June 1, 2021, to reflect its new mission and strategic direction of the business. The name change does not affect the rights of the company's stockholders, creditors, customers or suppliers. The company's common stock will continue to trade on the NASDAQ Capital Market under the current trading symbol "MEDS". The dompany's current stockholders will not need to exchange their current stock certificates as the stock certificates reflecting the Company's prior corporate name will continue to be valid. The name change is expected to be effective on The Nasdaq Capital Market on Tuesday, June 1, 2021.

09:48 EDT Freeline Therapeutics Holdings Plc (ADS) trading resumes

09:47 EDT U.S. Silica falls -7.4% - U.S. Silica is down -7.4%, or -91c to $11.47.

09:47 EDT Express rises 12.7% - Express is up 12.7%, or 61c to $5.42.

09:47 EDT AMC Entertainment rises 33.7% - AMC Entertainment is up 33.7%, or $8.94 to $35.46.

09:34 EDT Finch Therapeutics Group Inc trading halted, volatility trading pause

09:25 EDT Dassault Aviation announces Croatia selects the Rafale for Air Force - Croatia has selected the Rafale for its Air Force, following an international call for tenders as part of its Multi Role Fighter Aircraft program. The contract between the French and Croatian authorities will cover the acquisition of 12 Rafale previously in service with the French Air Force, as well as fleet support and training.

09:08 EDT Calliditas Therapeutics submits MAA for Nefecon to European Medicines Agency - Calliditas Therapeutics announced that the company submitted a Marketing Authorisation Application to the European Medicines Agency for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy. The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed a renal protective effect by way of stabilization of eGFR at 9 months. The submission also includes clinical data from the Phase 2 NEFIGAN trial, which met the same primary and secondary endpoint as the NefIgArd study. The NefIgArd trial also showed that Nefecon was generally well-tolerated, with a safety profile in keeping with the Phase 2b results. Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN. If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying

09:04 EDT Humanigen submits application to FDA for EUA for lenzilumab in COVID-19 - Humanigen announced that the company submitted an application to the Food and Drug Administration requesting Emergency Use Authorization, or EUA, for lenzilumab for the treatment of patients hospitalized with COVID-19. This EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation, or SWOV, in newly hospitalized COVID-19 patients. Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir and resulted in a 3-fold improvement in the likelihood of SWOV in patients with a CRP less than150 mg/L and less than 85 years of age. In these patients, a 2.2-fold improvement in the likelihood of survival was observed with lenzilumab. No serious adverse events were attributed to lenzilumab and the overall safety profile was comparable to placebo.

09:03 EDT Churchill Downs signs HRM agreement with Aristocrat Gaming - Churchill Downs announced an agreement that will bring Aristocrat Gaming to their historical racing machine facilities. Aristocrat's HRM games will appear across CDI's HRM facilities in Kentucky, including Derby City Gaming in Louisville; Oak Grove Racing, Gaming & Hotel in Oak Grove; Newport Racing & Gaming in Newport; and Turfway Park Racing & Gaming in Florence when it opens in 2022. Players at CDI's HRM facilities will have the opportunity to enjoy Aristocrat brands including Buffalo, Wild Lepre'Coins and others exclusively on the MarsX family of cabinets.

09:02 EDT BetMGM partnering with NYRA Bets on horse race wagering - BetMGM announced a partnership with NYRA Bets, the official online wagering platform of the New York Racing Association and a leading provider of horse racing content in the United States. NYRA Bets will become BetMGM's first horse racing partner, allowing customers to watch and wager on premier Thoroughbred, Harness, and Quarter Horse races at more than 200 tracks around the world.

08:55 EDT Omeros announces preliminary results from COVID-19 patients given narsoplimab - Omeros announced preliminary results from the second cohort of critically ill COVID-19 patients treated with narsoplimab in Bergamo, Italy. These patients were part of the "second surge" of COVID-19 in Italy. The patients were treated under compassionate use at ASST Papa Giovanni XXIII Hospital between October 2020 and April 2021. Baseline characteristics of the 10 study patients: median age 65 years; 90% were men; all had comorbidities/risk factors for poor outcome; acute respiratory distress syndrome severity at time of intubation or ICU admission, 80% severe, 20% moderate; and all had failed other therapies. 90% of participants were intubated at initiation of narsoplimab treatment and narsoplimab was administered intravenously twice weekly. The median doses administered was 6. 80% of participants recovered, survived and were discharged. There were 2 deaths, one a 76-year-old man from complications of pre-existing cardiomyopathy who received 3 doses of narsoplimab and the other a 68-year-old man from multi-organ failure, narsoplimab dosing was initiated after 13 days of intubation. Narsoplimab is being evaluated in the I-SPY COVID-19 Trial, an adaptive platform clinical trial enrolling critically ill COVID-19 patients. The trial is sponsored by Quantum Leap Healthcare Collaborative and is funded in part by the United States government through the Biomedical Advanced Research and Development Authority. Narsoplimab is the only complement inhibitor in the I-SPY trial. The Biologics License Application for narsoplimab in HSCT-TMA is under Priority Review by FDA. The drug also is in Phase 3 clinical trials for IgA nephropathy and atypical hemolytic uremic syndrome.

08:33 EDT Alamos Gold board member Ronald Smith to retire - Alamos Gold reported a summary of the voting results of its Annual General Meeting of Shareholders. The Company is also announcing the retirement of Ronald Smith from the Board of Directors.

08:18 EDT Hartree completes purchase of controlling interest in Sprague Resources - Sprague Resources LP and Hartree Partners, LP announced that affiliates of Hartree have closed the purchase of the general partner interest, the incentive distribution rights and all of the common units representing limited partner interests that a subsidiary of Axel Johnson had held in Sprague. The aggregate purchase price paid by Hartree to Axel Johnson was $290M, consisting of approximately $265M attributable to the purchase of 16,058,484 Common Units, and approximately $25M attributable to the general partner interest and incentive distribution rights.

08:16 EDT Sprague Resources announces sale of interest in general partner - Sprague Resources announced that Sprague HP Holdings, LLC, acquired from Sprague Resources Holdings 100% of the limited liability company interests of Sprague Resources GP. the general partner of Sprague; all of Sprague Holding's common units; and, all of the Partnership's Incentive Distribution Rights. The Buyer and its affiliates now collectively hold approximately 74.5% of the Partnership's outstanding common units.

08:12 EDT Taoping releases server products to enhance digital business growth - Taoping Iannounced the release for sale of two new high-performance digital server models, GY3070Pro and GY2060S. Operating with Taoping's smart cloud management platform, the new server products can be applied to cloud computing, big data, and other cloud services to facilitate the digital transformation and upgrading of enterprises.

08:10 EDT LifeMD announces dismissal of all shareholder suits against company - LifeMD announced that all shareholder suits filed against the company have been voluntarily dismissed. The two cases - Owens v. LifeMD and Cho v. LifeMD - were both filed in the U.S. District Court for the Southern District of New York last month. "We are pleased that these meritless class-action suits have been withdrawn. We remain laser-focused on using technology to make healthcare more accessible and affordable for people from all walks of life," said Justin Schreiber, LifeMD's Chairman and CEO. "We pursue our mission with transparency and integrity - always putting our patients first - and we're very proud of that." The Owens and Cho plaintiffs' law firms filed the notices of voluntary dismissal on May 18 and 19, respectively, court records show.

08:07 EDT Foresight Autonomous chosen by European car manufacturer for joint POC project - Foresight Autonomous announced the signing of a joint proof of concept project with an American subsidiary of a leading European passenger car manufacturer. The project is meant to test Foresight's stereoscopic technology abilities to enhance the vehicle manufacturer's existing active safety features without requiring additional sensors and infrastructure. Following successful completion of the project and satisfactory outcome, the vehicle manufacturer may consider integrating Foresight's solutions into its vehicle safety applications. The project, which is based on a predefined technological statement of work, consists of two phases: a feasibility testing phase followed by a simulation and real-life testing phase. Total expected consideration for the POC is up to $120,000.

08:05 EDT 180 Life Sciences appoints Russell Ray, Teresa DeLuca to board - 180 Life Sciences announced that it has appointed Russell Ray, MBA and Teresa DeLuca MD, MBA to its Board of Directors effective June 15, 2021. Most recently, Mr. Ray was a Partner and Senior Advisor to HLM Venture Partners, a health care focused venture capital firm that invests in health care services, health care information technology and medical technology companies. DeLuca's most recent role was at Columbia University as Managing Director, NY Life Science Venture Fund which includes leading the consortium of the 12 private/public institutions.

08:03 EDT Cocrystal Pharma announces passing of chairman, CEO Gary Wilcox - Cocrystal Pharma announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

08:02 EDT OrthoPediatrics launches RESPONSE Neuromuscular Scoliosis System - OrthoPediatrics announced the launch of its RESPONSE Neuromuscular Scoliosis System. This will be the 36th surgical system the Company has launched. The system received FDA 510(k) clearance in 2020, and the Company has been preparing for a full-scale domestic launch this summer. RESPONSE Neuromuscular represents the latest addition to the RESPONSE Scoliosis platform, which is designed to treat pediatric patients. This new system is dedicated for the treatment of neuromuscular scoliosis and was developed in conjunction with pediatric orthopedic surgeons to address the distinct challenges in treating a unique patient population. Building on the base of the Company's RESPONSE Spine System, RESPONSE NM features a complete set of implants and instruments with innovative attributes that simplify insertion and specific options to address extreme hyperlordosis and sacral/pelvic fixation. The RESPONSE NM system also works in conjunction with other products in the OrthoPediatrics Scoliosis franchise, including the BandLoc Sublaminar banding system, and FIREFLY 3D printed pedicle screw guides. OrthoPediatrics is the exclusive distributor for Mighty Oak Medical's FIREFLY technology in children's hospitals across the United States.

08:00 EDT Eton Pharmaceuticals trading halted, news pending

07:49 EDT Lionsgate says tracking at high-end of historical subscriber target range - In a conference call yesterday, the company stated: "With our acceleration and content spend this upcoming fiscal year, we're forecasting even better net ads domestically and internationally in FY22, than in FY21. While some of our peers are seeing the slowdown as we lapped the pandemics impact on streaming, our highly targeted original strategy enables us to project a year-over-year net add improvements that accelerates in the second quarter of a year with a back loaded programming schedule. And then reassessing our historical target of 50M to 60M subscribers by FY25, we are now tracking at the high end of the range. Approximately 80% of those 60M subscribers will be streaming subs."

07:38 EDT Medicenna Therapeutics expects cash to fund operations through late 2022 - Medicenna had cash, cash equivalents, and marketable securities of $40.4M at March 31, 2021. These funds provide the Company with sufficient capital to execute its current planned expenditures through late 2022 based on its current plans and projections.

07:35 EDT Titan Medical receives $10M license fee under Medtronic development agreement - Titan Medical (TMDI) announced today that it has completed the second technical milestone under the development and license agreement with Medtronic (MDT), and received a $10M payment for licensing the developed technologies to Medtronic. The development and license agreement provides for the development of robotic-assisted surgical technologies for use by both Titan and Medtronic in their respective businesses. Titan retains world-wide rights to commercialize the developed technologies for use with its own Enos robotic single access surgical system. On October 26, 2020, Titan announced achievement of the first technical milestone and the completion of a non-technical financial milestone pursuant to the development agreement, with the satisfactory raising of U.S. $18M of capital. Under the development and license agreement, Titan would receive an additional payment of approximately U.S. $11M upon completing the third technical milestone, representing the fourth and final milestone.

07:31 EDT Verrica announces extension of FDA review period for VP-102 NDA - Verrica Pharmaceuticals announced that the U.S. Food and Drug Administration has extended the review period for the New Drug Application for VP-102 for the treatment of molluscum contagiosum. The Prescription Drug User Fee Act goal date has been extended by three months to September 23, 2021. The FDA extended the PDUFA goal date to allow the Agency to have additional time to review information submitted by Verrica, including its training program and distribution model, in response to comments from the agency regarding the Company's human factors study. On May 26, 2021, the FDA informed Verrica that the information submitted has been designated a major amendment, which allows FDA to take an additional three months to review the submitted information.

07:09 EDT Bitfarms mines 1,000th bitcoin with hydroelectricity - Bitfarms provides a bitcoin production update. Year-to-date, Bitfarms has mined and deposited in custody 1,006 bitcoin, currently valued at approximately $39M, or approximately 5.5% of the Company's market capitalization as of the close of trading yesterday, May 27, 2021. Bitfarms achieved this milestone a full 9 days ahead of the schedule reported on April 16, 2021. The company said, "Based on public information of other publicly traded cryptocurrency mining companies, Bitfarms has mined and accumulated one of the largest reported amount of bitcoin from mining activities in North America, year-to-date; and has done so with 100% hydroelectricity. Since starting its Bitcoin Inventory Pilot Program in early January, Bitfarms has quickly climbed the ranks of publicly traded companies with Bitcoin on their balance sheet and has now earned the 13th spot for publicly traded companies on bitcointreasuries.org." With approximately 1% of the Bitcoin network, Bitfarms is currently mining and adding approximately 7.8 bitcoins a day to inventory at a cost of approximately $9,500 per bitcoin as of May 27, 2021.

07:05 EDT Bowlero Corp to acquire Bowl America, terms not disclosed - Bowlero Corp announced it has entered into a definitive merger agreement with Bowl America under which Bowlero Corp will acquire Bowl America. Upon completion of the transaction, Bowlero Corp, the owner and operator of over 300 bowling center locations in North America, will acquire Bowl America's 17 bowling centers in Florida, Virginia and Maryland. The acquisition is subject to stockholder approval and other customary closing conditions.

07:02 EDT Lithium Americas, Ganfeng Lithium commence expansion planning - Lithium Americas Corp. (LAC) is pleased to provide an update on the Cauchari-Olaroz lithium project in partnership with Ganfeng Lithium Co., Ltd (GNENF) in Jujuy province, Argentina. The Cauchari-Olaroz Partners have approved the commencement of development planning for a second stage expansion of at least an additional 20,000 tonnes per annum of lithium carbonate equivalent production capacity from Cauchari-Olaroz. The Cauchari-Olaroz Stage 2 expansion is targeting the following development parameters: Production capacity of at least 20,000 tpa LCE to commence in 2025. Construction commencing in H2 2022, following the commissioning and start-up of the initial 40,000 tpa operation. Infrastructure additions to support long-term expansions beyond Stage 2. The Cauchari-Olaroz Partners expect to provide further details of the Stage 2 expansion plan by Q4 2021, followed by an updated feasibility study in 2022. Construction on the initial 40,000 tpa Stage 1 operation remains on track for first production in mid-2022. There are currently over 1,000 workers on site, following the completion of additional camp capacity to ensure compliance with strict COVID-19 health and safety protocols. No positive cases of COVID-19 have been reported at site in eight months. In Q2 2021, senior members of Ganfeng Lithium's commissioning and construction team arrived in Argentina to assist the project through to start-up. Ganfeng Lithium's team brings recent experience constructing and commissioning lithium carbonate plants in China. All major equipment and the majority of bulk materials have been delivered to site, reducing risk of supply chain delays. The evaporation ponds are well advanced with sufficient brine inventory to support production ramp up. Mechanical construction of the lime plant is completed and the piping work to connect the lime line is more than 95% complete.

07:00 EDT Palantir awarded $111M contract by USSOCOM - Palantir Technologies announced it had been selected by the United States Special Operations Command to continue its work as their enterprise data management and AI-enabled mission command platform as part of the Mission Command System/Common Operational Picture program. The contract is valued at a total of $111M, inclusive of options, with $52.5M executed upon award. The total contract includes a base year and one option year.

06:51 EDT Caleres CEO says Q1 results driven by Famous Footwear business - "Caleres had a strong start to the year, maintaining its solid upward momentum in the first quarter of 2021, driven in large part by an outstanding performance in our Famous Footwear business, where we achieved record quarterly earnings and delivered record first quarter sales levels," said Diane Sullivan, Chairman and CEO. "Notably, Famous Footwear's quarterly sales increased 13 percent over the first quarter of 2019, benefitting from strong demand for the category, increased consumer confidence and improving in-store traffic trends. Famous continues to leverage its enhanced omni-channel capabilities and capitalize on its direct-to-consumer model, as evidenced by a 13.2 percent increase in new rewards members - compared to the first quarter 2019 - and still-strong ecommerce sales levels." "We remain positive about our outlook and expect continued strength at Famous Footwear to be combined with an improving performance in our Brand Portfolio as we progress through the year," said Sullivan. We are particularly enthusiastic about the recent strong performances from our Vionic, Sam Edelman, Blowfish Malibu and Ryka brands, and are increasingly optimistic about our ability to drive margin growth and return to 2019 earnings levels for the segment in the year's second half." "Looking ahead, we plan to lean into the robust momentum at Famous Footwear and our enhanced direct-to-consumer capabilities; ensure alignment of supply and demand; and - as always - maintain our balanced approach to capital allocation. In short, we are excited about our strategy for continued value creation and believe we are exceptionally well positioned to capitalize on the accelerated recovery in the marketplace and to chase and capture market share opportunities as they develop throughout the year."

06:46 EDT Genetic Technologies trading halted, news pending

06:34 EDT Hibbett Sports reports Q1 gross margin 41.4% of net sales - Gross margin was 41.4% of net sales for the 13-week period ended May 1, 2021, compared with 27.5% of net sales for the 13-week period ended May 2, 2020. The approximate 1,390 basis point increase was driven by higher sell through, a low promotional environment, a mix shift away from e-commerce sales which carry a lower margin due to incremental fulfillment costs, leverage of store occupancy expenses, and a decline in non-cash lower of cost or net realizable value reserve charges. In the prior year, incremental inventory valuation charges were recorded as a result of uncertainty brought about by the pandemic. Excluding adjustments to our non-cash inventory valuation reserves last year, the current year gross margin of 41.4% is comparable to the non-GAAP gross margin of 29.4% in the prior year.

06:31 EDT Zhongchao launches business line on tumor, rare disease patient management - Zhongchao announced the launch of the patient management service focusing on the professional field of tumor and rare disease operated through its subsidiary Shanghai Zhongxin Medical Technology. Zhongchao has been closely following up on the new study and research of tumor and rare disease both in China and worldwide. Based on the statistics provided by World Health Organization's International Agency for Research on Cancer, there were approximately 19.29 million new cancer cases and 10 million cancer deaths globally in 2020. China had approximately 4.57 million new cancer cases in 2020, accounting for approximately 23.7% of the total cancer cases around the world. China's National Health Commission indicated that there are approximately 20 million patients with rare disease in China. Medical treatment markets for both cancer and rare diseases have been expanding along with the increasing number of patients. The company said, "The Company has realized that, in addition to drug development and more advanced medical treatment options, patients' active engagements in the treatment is also critical to lead to better overall treatment outcomes such as higher chemotherapy completion rate, lower rehospitalization risk and longer survival time. Many multinational pharmaceutical companies have also realized such significance by conducting strategic investments in not only drug developments but also patient management projects. With our MDMOOC online platform which provides information, education, and training services for healthcare professionals and Sunshine Health Forums which provides healthcare knowledge for the public, the Company could provide technical supports for Zhongxin's patient management services to assist patients with tumor or rare disease. Zhongxin plans to build a comprehensive patient management system with integrated data insights into existing clinical workflows."

06:11 EDT High Tide receives approval for Nasdaq listing - High Tide announced that the Company's application to list its common shares on the Nasdaq Capital Market has been approved. The Company's Shares are expected to begin trading on Nasdaq under the ticker symbol "HITI" on June 2nd, 2021. High Tide will also retain its listing on the TSX Venture Exchange under the symbol "HITI". The ticker used for High Tide's Shares traded on the OTC Markets quotation system under the current symbol "HITID" will seamlessly transfer to the new ticker symbol "HITI" on the first day of trading on Nasdaq.

06:10 EDT AstraZeneca's Tagrisso approved in E.U. for NSCLC treatment - The company states: "AstraZeneca's Tagrisso has been approved in the European Union for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer, or NSCLC, after complete tumour resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 mutations. The approval by the European Commission was based on positive results from the ADAURA Phase III trial in which Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The trial also showed a statistically significant and clinically meaningful improvement in DFS for Tagrisso in the overall trial population, a key secondary endpoint. While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease. Historically, nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, have experienced disease recurrence within five years. About a fifth of the world's lung cancer patients are in the EU and among those with NSCLC, approximately 15% have tumours with an EGFR mutation."Reference Link

06:02 EDT Lucira Health appoints Kevin Collins as CRO - Lucira Health (LHDX) announced Kevin Collins has joined the company as chief revenue officer with global revenue responsibility. Most recently, he was Vice President of International Commercial Operations at Outset Medical (OM).

05:35 EDT LyondellBasell boosts quarterly dividend by 7.6% to $1.13 per share - LyondellBasell announced that its board has declared a quarterly dividend of $1.13 per share, representing a 7.6% increase over the company's Q1 dividend. The dividend will be paid June 14, to shareholders of record June 7, with an ex-dividend date of June 4. "Over the past three years, LyondellBasell's strategic investments have increased our earnings power at all points in the cycle. The stronger dividend reflects confidence in our ability to consistently provide leading returns for LyondellBasell shareholders," said Bob Patel, CEO of LyondellBasell. "With this dividend increase, we are on track to post our eleventh consecutive year of annual dividend growth in 2021."

05:29 EDT Guardant Health files lawsuit against Natera for 'unlawful trade practices' - Guardant Health (GH) said it filed a lawsuit against Natera (NTRA) for "false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health's new oncology test, Guardant Reveal." Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from "continuing to make these false or misleading statements and requiring Natera to take corrective actions." The complaint alleges that Natera is "misleading healthcare providers about the performance of the Guardant Reveal test by suggesting the test is inaccurate and/or insensitive, and inferior to Signatera."