Stockwinners Market Radar for September 15, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
IONS | Hot Stocks18:30 EDT Ionis treatment of Pelizaeus-Merzbacher disease granted FDA orphan designation - According to a post on the FDA's website, Ionis Pharmaceuticals' treatment of Pelizaeus-Merzbacher disease was granted orphan designation. Reference Link
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TMUS | Hot Stocks17:24 EDT T-Mobile CAO Bazzano sells 3,953 common shares - In a regulatory filing, T-Mobile US chief accounting officer Dara Bazzano disclosed the sale of 3,953 common shares of the company on September 13 at a price of $141.36 per share.
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LMT | Hot Stocks17:17 EDT Lockheed Martin awarded $104.7M Army contract modification - Lockheed Martin was awarded a $104.7M modification to a contract for Long-Range Hypersonic Weapon ground support equipment. Work will be performed in Huntsville, Alabama, with an estimated completion date of February 28, 2028. FY23 missile procurement, Army funds; and FY23 research, development, test and evaluation, Army funds in the amount of $104.7M, were obligated at the time of the award. Army Contracting Command is the contracting authority.
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LMT | Hot Stocks17:15 EDT Lockheed Martin awarded $100M Navy contract modification - Lockheed Martin was awarded a not-to-exceed $100M cost-plus-fixed-fee modification to a previously awarded contract. This modification exercises an option to procure software licenses, prototypes, digital twins, and associated test hardware required to support F-35 Block Four early capability development for the Air Force, Navy, Marine Corps, and non-Department of Defense, or DOD, participants. Work is expected to be completed in March 2026. FY23 research, development, test and evaluation funds in the amount of $3.69M; FY23 research, development, test and evaluation funds in the amount of $3.69M and non-DOD participant funds in the amount of $1.62M will be obligated at the time of award, none of which will expire at the end of the current fiscal year. Naval Air Systems Command is the contracting activity.
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BHIL | Hot Stocks17:13 EDT Benson Hill receives NYSE notice of non-compliance - Benson Hill announced that on Sept. 13, 2023, it received a notice from the New York Stock Exchange notifying the company that it is not in compliance with the NYSE's continued listing standards because as of Sept. 12, 2023, the average closing price of the company's common stock, was less than $1.00 per share over a consecutive 30 trading-day period. The Notice does not result in the immediate delisting of the company's common stock from the NYSE.
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LMT | Hot Stocks17:13 EDT Lockheed Martin awarded $196.54M Navy contract - Lockheed Martin was awarded a $196.54M cost-plus-incentive-fee, cost reimbursable contract. This contract provides for the upgrade of the verification and validation systems being utilized in the U.S. Reprogramming Laboratory; and the Norway Italy Reprogramming Laboratory, in support of aligning with the upgraded Block Two and Five capabilities, as well as automating and accelerating the verification and validation process for mission data files for the F-35 Joint Strike Fighter program. Work is expected to be completed in June 2028. FY23 research, development, test, and evaluation funds in the amount of $8.45M; FY23 research, development, test, and evaluation funds in the amount of $8.45M and non-U.S. Department of Defense participant funds in the amount of $96.32M, will be obligated at the time of award, none of which will expire at the end of the current fiscal year. This contract was not competitively procured pursuant to Federal Acquisition Regulation 6.302-1. The Naval Air Systems Command is the contracting activity.
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GD | Hot Stocks17:10 EDT General Dynamics awarded $517.25M Navy delivery order - General Dynamics was awarded a not-to-exceed $517.25M firm-fixed-price, undefinitized delivery order against a previously issued basic ordering agreement, to provide unique parts and specialized material, including initial spares, for Virginia-class submarines. Work is expected to be completed by September 2028. FY23 working capital funds in the amount of $496.32M; and FY23 other procurement funds in the amount of $20.92M, will be obligated at time of award, of which $496.33M will expire at the end of the current fiscal year. This order was not competitively procured in accordance with 10 U.S. Code 3204(a)(1), only one responsible source and no other supplies or services will satisfy agency requirements. Naval Sea Systems Command is the contracting activity.
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VHAQ | Hot Stocks16:58 EDT Viveon Health Acquisition receives audit opinion with going concern - Viveon Health Acquisition Corp. announced that, as previously disclosed in its annual report on Form 10-K for the fiscal year ended December 31, 2022, which was filed on August 24, 2023 with the U.S. SEC, the audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the company's ability to continue as a going concern.
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RBT | Hot Stocks16:31 EDT Rubicon Technologies announces 1-for-8 reverse stock split - Rubicon Technologies announced that the company's board of directors approved a reverse stock split of Rubicon's Class A common stock, par value $0.0001 per share, at a ratio of 1-for-8. The Reverse Stock Split is expected to become effective immediately after the close of trading on the New York Stock Exchange on September 26, 2023, and Rubicon's Common Stock is expected to begin trading on the NYSE on a split-adjusted basis at the opening of trading on September 27, 2023, under the existing ticker symbol "RBT", new CUSIP number 78112J208, and new ISIN number US78112J2087. Rubicon's publicly traded warrants will continue to be traded on the NYSE under the existing ticker symbol "RBT.WS" and existing CUSIP and ISIN numbers. The Reverse Stock Split was approved by Rubicon's stockholders at the company's 2023 Annual Meeting of Stockholders, held on June 8, 2023, with the final ratio to be determined by the Board. The company will file an amendment to its Certificate of Incorporation to implement the Reverse Stock Split as of the Effective Time. The primary goal of the Reverse Stock Split is to increase the per share market price of the Common Stock to regain compliance with the minimum $1.00 average closing price requirement for continued listing on the NYSE.
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FPH | Hot Stocks16:11 EDT Five Point Holdings names Kim Tobler as CFO - Five Point Holdings announced the appointment of Kim Tobler as CFO, Treasurer and Vice President of the company, effective immediately. Tobler is an experienced executive with over 35 years of experience in tax, financial reporting, and corporate finance, primarily in the real estate sector. He has served as the company's Vice President - Treasury and Tax since 2016. Prior to that, he was a tax partner at Ernst & Young LLP from 2008 to 2016 and previously from 1995 to 2003.
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GSK | Hot Stocks16:07 EDT GSK says FDA approves Ojjaara for treatment of myelofibrosis - GSK announced that the US Food and Drug Administration has approved Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, in adults with anaemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 inhibitor. To date, it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that addresses the key manifestations of the disease, namely anaemia, constitutional symptoms, and splenomegaly. Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: "The vast majority of myelofibrosis patients eventually develop anaemia, causing them to discontinue treatments and require transfusions. Given this high unmet need, we are proud to add Ojjaara to our oncology portfolio and address a significant medical need in the community. We look forward to helping improve outcomes in this difficult-to-treat blood cancer."
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ARIZ | Hot Stocks16:06 EDT Arisz Acquisition extends deadline to complete combination to October 22 - Arisz Acquisition Corp. announced that Arisz Investments LLC, the company's initial public offering sponsor, has timely deposited into the company's trust account, an aggregate of $120,000, in order to extend the period of time the company has to complete a business combination for an additional one month period, from September 22, 2023 to October 22, 2023. The Extension is the fifth of up to nine one-month extensions permitted under the May 12, 2023 amendment to the Amended and Restated Certificate of Incorporation of Arisz Acquisition Corp. The Extension provides Arisz with additional time to complete its proposed business combination with Finfront Holding Company.
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POL | Hot Stocks16:06 EDT Polished announces NYSE American notification of continued listing deficiency - Polished.com announced that it had received a deficiency letter from the NYSE American LLC stating that the company is not in compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide. The Letter stated that because the company's common stock had been trading for a low price per share for a substantial period of time, the company was not in compliance with Section 1003(f)(v) of the Company Guide. The NYSE American staff determined that the company's continued listing is predicated on it effecting a reverse stock split of its common stock or otherwise demonstrating sustained price improvement within a reasonable period of time, which the staff determined to be until March 13, 2024. The company intends to regain compliance with the NYSE American's continued listing standards by undertaking a measure or measures that are in the best interests of the company and its stockholders.
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OCCI | Hot Stocks16:01 EDT OFS Credit estimates NAV $8.08-$8.18 as of August 31 - "Management's unaudited estimate of the range of our NAV per share of our common stock as of August 31, 2023 is between $8.08 and $8.18. This estimate is not a comprehensive statement of our financial condition or results for the month ended August 31, 2023. This estimate did not undergo the Company's typical quarter-end financial closing procedures. We advise you that current estimates of our NAV per share may differ materially from future NAV estimates or determinations, including the determination for the period ending October 31, 2023, which will be reported in our Annual Report on Form N-CSR."
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HWBK | Hot Stocks15:40 EDT Hawthorn Bank names John Bowers as new Chief Strategy Officer - Hawthorn Bank, the wholly owned subsidiary of Hawthorn Bancshares, has named John Bowers as its new Chief Strategy Officer. "Bowers will be responsible for formalizing and leading the development of the organization's strategic planning processes and translating the strategy across functions and business units," the bank stated.
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SATL | Hot Stocks14:06 EDT Satellogic, Skyloom sign agreement for multipath optical comms data transmission - Skyloom Global announced that it has signed an agreement with Satellogic, a player in submeter Earth Observation data and satellite technology. The agreement details plans to integrate Skyloom's Optical Communications Terminal onto Satellogic satellites. Utilizing Skyloom's OCT, Satellogic will test new methods of high-resolution EO data delivery through both SkyCompass-1, the geostationary-based lasercom network infrastructure Skyloom developed with its partner, Space Compass, and direct downlink to a gateway within view of the low altitude image area, significantly decreasing latency. As a first step in its commissioning, the Satellogic spacecraft will conduct a low earth orbit-to-ground link by handshaking with Skyloom's optical ground station in Broomfield, Colorado. The Satellogic-Skyloom agreement follows a feasibility study on the ability of Satellogic's Mark-V platform to establish lasercom links.
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BKR | Hot Stocks13:03 EDT Baker Hughes reports U.S. rig count up 9 to 641 rigs - Baker Hughes reports that the U.S. rig count is up 9 from last week to 641 with oil rigs up 2 to 515, gas rigs up 8 to 121 and miscellaneous rigs down 1 to 5. The U.S. Rig Count is down 122 rigs from last year's count of 763 with oil rigs down 84, gas rigs down 41 and miscellaneous up 3. The U.S. Offshore Rig Count is unchanged at 19, up 4 year-over-year. The Canada Rig Count is up 8 from last week to 190, with oil rigs up 6 to 119 gas rigs up 2 to 71. Canada Rig Count is down 21 from last year's count of 211, with oil rigs down 27, and gas rigs up 6.
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BKR | Hot Stocks13:02 EDT Baker Hughes reports U.S. rig count up 9 to 641 rigs
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AYRO | Hot Stocks12:38 EDT Ayro announces 1-for-8 reverse stock split - Ayro announced that it intends to effect a reverse stock split of its common stock at a ratio of one post-split share for every every pre-split shares. The reverse stock split will become effective at 4:00 p.m. New York time on Friday, September 15. Ayro's common stock will continue to be traded on the Nasdaq under the symbol AYRO and will begin trading on a split-adjusted basis when the market opens on Monday, September 18.
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MSFT SONY | Hot Stocks12:33 EDT Bethesda says 'Ghostwire: Tokyo' surpasses 6M players - Microsoft's (MSFT) Bethesda said that over 6M players have played "Ghostwire: Tokyo," which launched for PlayStation 5 (SONY) in 2022 and Xbox Series X/S this year. Reference Link
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GM... | Hot Stocks12:22 EDT Biden says record automaker profits haven't been shared fairly with workers - President Joe Biden made the comment when speaking about the UAW strike at Ford (F), General Motors (GM) and Stellantis (STLA) plants in a press conference.
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LNN | Hot Stocks12:01 EDT Lindsay falls -8.4% - Lindsay is down -8.4%, or -$10.71 to $117.12.
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KMPR | Hot Stocks12:00 EDT Kemper falls -9.9% - Kemper is down -9.9%, or -$5.06 to $45.97.
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PLNT | Hot Stocks12:00 EDT Planet Fitness falls -12.8% - Planet Fitness is down -12.8%, or -$7.65 to $52.15.
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OWL | Hot Stocks12:00 EDT Blue Owl Capital rises 6.0% - Blue Owl Capital is up 6.0%, or 72c to $12.74.
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PHIN | Hot Stocks12:00 EDT Phinia rises 6.2% - Phinia is up 6.2%, or $1.69 to $28.97.
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SOXS | Hot Stocks12:00 EDT Direxion Daily Semiconductor Bear 3X Shares rises 7.0% - Direxion Daily Semiconductor Bear 3X Shares is up 7.0%, or 70c to $10.80.
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LEN LEN.B | Hot Stocks11:31 EDT Lennar focused on production over margins
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LEN LEN.B | Hot Stocks11:31 EDT Lennar: Demand for affordable homes is strong
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LEN LEN.B | Hot Stocks11:28 EDT Lennar: Starting 2024 with 10% initial growth expectation
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LEN LEN.B | Hot Stocks11:20 EDT Lennar: Land, supply shortages to constrain homebuilding
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LEN LEN.B | Hot Stocks11:11 EDT Lennar believes housing market has 'leveled'
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LEN LEN.B | Hot Stocks11:09 EDT Lennar: Consumers have adjusted to 'higher for longer' interest rates
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LEN LEN.B | Hot Stocks11:08 EDT Lennar: Macro environment remains 'constructive' - Comments taken from Q3 earnings conference call.
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EA... | Hot Stocks10:47 EDT EA's 'Madden NFL 24' best-selling game in U.S. in August, says Circana - Circana analyst Mat Piscatella said that Electronic Arts' (EA) "Madden NFL 24" was the best-selling game of August in the U.S., instantly becoming the 6th best-selling game of 2023 YTD. This is the 24th consecutive year in which a "Madden NFL" franchise release was the best-selling title of its launch month. Launch month dollar sales of "Madden NFL 24" software, excluding digital add-on spending, grew by a double-digit percentage when compared to "Madden NFL 23" a year ago. Bandai Namco's (NCBDY) "Armored Core VI: Fires of Rubicon" was the 2nd best-selling game of August and ranked as the 20th best-selling game of 2023 year-to-date after one month in market. Other top selling premium games for the month of August in the U.S. were Embracer's (THQQF) "Remnant II," Activision Blizzard's (ATVI) "Call of Duty: Modern Warfare 2" and "Diablo IV," Warner Bros. Discovery's (WBD) "Hogwarts Legacy," Nintendo's (NTDOY) "The Legend of Zelda: Tears of the Kingdom," Sony's (SONY) "MLB The Show 23," and Microsoft's (MSFT) "Minecraft." Reference Link
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SONY... | Hot Stocks10:44 EDT U.S. video game consumer spending grew 3% y/y in August, says Circana - Circana analyst Mat Piscatella said that August 2023 U.S. consumer spending on video game content, hardware and accessories grew 3% vs YA, to $4.2B. Growth across both content and accessories spending offset a double-digit percentage decline in hardware. Year-to-date U.S. consumer spending across video game products was 2% higher than a year ago, at $34.9B. Spending on video game content in August grew 4% vs YA, to $3.7B. On console and PC platforms, growth in digital premium downloads offset declines across physical SW and digital add-ons. Non-mobile subscription spending fell 4%, while Sensor Tower reported mobile growth of 2.5%. Video game hardware spending fell 13% when compared to a year ago, to $328M. PlayStation 5 (SONY) dollar sales fell by a single-digit percentage in the month when compared to a year ago, while both Switch (NTDOY) and Xbox Series (MSFT) declined by a double-digit percentage. PlayStation 5 was the best-selling hardware platform in both unit and dollar sales during August 2023, with Xbox Series ranking 2nd across both measures. PlayStation 5 continued to lead the 2023 hardware market across both units and dollars. Year-to-date hardware spending was 13% higher when compared to the same period in 2022, at $3.2B. Accessories spending in Aug grew by 12% vs YA, to $159M. 7 of the top 8 best-selling accessories of August in dollar sales were PlayStation DualSense gamepads, with PlayStation VR2 ranking as the only non-DualSense gamepad appearing among the top 8. Other publicly traded companies in the video game space include Electronic Arts (EA), Activision Blizzard (ATVI), Take-Two (TTWO), Tencent (TCEHY), Roblox (RBLX), Ubisoft (UBSFY), Capcom (CCOEY), Square Enix (SQNXF), and GameStop (GME). Reference Link
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AZN DSNKY | Hot Stocks10:04 EDT AstraZeneca says Enhertu recommended for approval in EU by CHMP - AstraZeneca (AZN) and Daiichi Sankyo's (DSNKY) Enhertu has been recommended for approval in the European Union as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer, or NSCLC, whose tumors have an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy, the companies announced.
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U | Hot Stocks10:03 EDT Unity off highs after BofA upgrade as game publishers turn off ads - The stock, after rallying at the open, is up 22c to $35.94 in morning trading.
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IZEA | Hot Stocks10:01 EDT Izea secures low-seven-figure content production contract - IZEA Worldwide announced that it has secured a low-seven-figure content production contract with a leading EdTech company, a recurring customer. IZEA's network of creators will produce custom content to increase brand exposure and website traffic for the client. The program will run through end of year.
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JDST | Hot Stocks10:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -6.1% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -6.1%, or -43c to $6.72.
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LNN | Hot Stocks10:00 EDT Lindsay falls -6.3% - Lindsay is down -6.3%, or -$8.03 to $119.80.
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PLNT | Hot Stocks10:00 EDT Planet Fitness falls -13.3% - Planet Fitness is down -13.3%, or -$7.96 to $51.84.
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AGQ | Hot Stocks10:00 EDT ProShares Ultra Silver rises 5.9% - ProShares Ultra Silver is up 5.9%, or $1.51 to $27.27.
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JNUG | Hot Stocks10:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs rises 6.0% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is up 6.0%, or $1.82 to $32.09.
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OWL | Hot Stocks10:00 EDT Blue Owl Capital rises 6.2% - Blue Owl Capital is up 6.2%, or 74c to $12.76.
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U | Hot Stocks09:49 EDT Mobile game studios to turn off Unity Ads monetization across projects - On Friday, a collective of mobile game studios issued an open letter to protest the pricing changes Unity announced on September 12. The letter says in part: "Unity has been an instrumental force in this industry. In many ways, it has inspired us to create new immersive worlds and empowered a plethora of dynamic and independent developers to bring their visions to life. We've played our part in this journey, moving the industry forward and creating specialists that use Unity as the primary game engine for their projects... That's why the September 12 announcement hits us hard. Effective January 1, 2024, Unity plans to introduce installation-dependent fees, a decision that jeopardizes small and large game developers alike, made without any industry consultation. To claim, as Unity has, that this new 'Runtime Fee' will impact only 10% of the industry is not just misleading, it's patently false. We strongly oppose this move, which disregards the unique challenges and complexities of our industry... As a course of immediate action, our collective of game development companies is forced to turn off all IronSource and Unity Ads monetization across our projects until these changes are reconsidered. We urge others who share this stance to do the same. The rules have changed, and the stakes are simply too high. The Runtime Fee is an unacceptable shift in our partnership with Unity that needs to be immediately canceled." The letter was signed by Azur Games, Voodoo, Homa, Century Games, SayGames, CrazyLabs, Original Games, Ducky, Burny Games, Inspired Square, Geisha Tokyo, tatsumaki games, New Story, Playgendary, Supercent, KAYAC, and TapNation. Reference Link
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WE | Hot Stocks09:47 EDT WeWork falls -4.9% - WeWork is down -4.9%, or -22c to $4.32.
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SCX | Hot Stocks09:47 EDT L.S. Starrett Co falls -4.6% - L.S. Starrett Co is down -4.6%, or -48c to $10.03.
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PLNT | Hot Stocks09:47 EDT Planet Fitness falls -8.2% - Planet Fitness is down -8.2%, or -$4.92 to $54.88.
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FPH | Hot Stocks09:47 EDT Five Point Holdings rises 5.2% - Five Point Holdings is up 5.2%, or 16c to $3.23.
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PAGS | Hot Stocks09:47 EDT PagSeguro Digital rises 5.3% - PagSeguro Digital is up 5.3%, or 48c to $9.62.
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MJ | Hot Stocks09:47 EDT ETFMG Alternative Harvest ETF rises 6.6% - ETFMG Alternative Harvest ETF is up 6.6%, or 29c to $4.69.
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WU | Hot Stocks09:40 EDT Western Union fund distributes $40M to victims in U.S. and abroad, DOJ reports - The Justice Department announced that the Western Union Remission Fund began a distribution of approximately $40M in funds forfeited to the United States from the Western Union Company to approximately 25,000 victims located in the United States and abroad. These victims stand to recover the full amount of their losses. "This is the first distribution in the second phase of the Western Union Remission distributions. The first phase of distributions paid more than $365M to over 148,000 victims, all of whom received full compensation for their losses. The Justice Department anticipates authorizing more distributions for victims in the coming months," the DOJ stated. Reference Link
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EPOW GPHOF | Hot Stocks09:32 EDT Sunrise announces Graphic One was awarded $37.5M from U.S. government - Sunrise New Energy (EPOW) announced that Graphite One Inc. (GPHOF) was awarded $37.5 million from US government. In August 2023, Sunrise and Graphite One conducted multiple rounds of communication about the draft Consulting Agreement and Supply Agreement, in which Graphite One wishes to engage Sunrise to provide consulting services relating to the development of the G1 Facility due to that Sunrise's principals and technical personnel have knowledge, skill, know-how and expertise in R&D and manufacturing process such that the finished products may be sold as active anode materials into the supply chain for lithium-ion batteries. The two parties have reached a preliminary consensus on these cooperation agreements and are revising on the details. It is expected that these documents will be signed within next month. "I am extremely proud of the work of our entire team." said Sunrise's Chairman, Mr. Haiping Hu."The cooperation with Graphite One shows the recognition of Sunrise's leading technology in global lithium battery anode materials industry. We are pleased to explore the potential opportunity to participate in the North America's fast growing graphite materials market. "
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AEHL | Hot Stocks09:32 EDT Antelope Enterprise Holdings announces one-for-ten reverse stock split - Antelope Enterprise Holdings announced that its Board of Directors has set the date of September 18, 2023 to be the effective date for the company's one-for-ten reverse stock split of its issued and outstanding ordinary shares. The company's Class A ordinary shares will begin trading on the NASDAQ Stock Market on a split-adjusted basis when the market opens on September 18, 2023. The CUSIP number for the company's Class A ordinary shares will be changed to G041JN122.
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BMRN | Hot Stocks09:30 EDT BioMarin receives positive CHMP opinion in Europe to expand use of VOXZOGO - BioMarin Pharmaceutical announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization to expand the indication for VOXZOGO for injection to treat children with achondroplasia aged 4 months and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing. A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in the fourth quarter of 2023. VOXZOGO is currently approved in Europe in children with achondroplasia who are 2 years of age and older with open growth plates. The U.S. FDA has also set a PDUFA Target Action Date of Oct. 21, 2023, for the company's Supplemental New Drug Application for VOXZOGO to expand treatment in the United States to include children with achondroplasia under the age of 5 years. VOXZOGO is currently approved in the U.S. in children with achondroplasia who are 5 years of age and older with open growth plates.
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WTO JZXN | Hot Stocks09:30 EDT UTime announces strategic partnership with subsidiary of Jiuzi Holdings - United Time Technology, an entity controlled via contractual agreement by UTime, signed a strategic partnership agreement on September 12, 2023 to design, assemble and supply up to 10,000 new smart EV chargers to Shenzhen Jiuzi XinNeng Holding Group Co, an indirect subsidiary of Jiuzi Holdings (NASDAQ: JZXN) from 2024 to 2027. The parties aim to deploy the chargers to provide more convenient and efficient charging solutions for electric vehicle users in third and fourth-tier cities in China. This cooperation is expected to leverage the advantages of both parties in technology, service and marketing to inject new impetus into the sustainable development of the electric vehicle industry chain and create greater value for investors, partners and customers. This cooperation marks an important step for WTO in the field of smart EV charger production. CEO Hengcong Qiu commented, "WTO has been committed to create a more intelligent and convenient charging ecosystem for users. This strategic cooperation agreement does not only showcase the company's core technology capabilities, but is also extremely important for WTO's business development and future growth."
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NNDM | Hot Stocks09:27 EDT Nano Dimension appoints Nissan-Cohen as Chairman of the board - Nano Dimension announced that its Board of Directors has appointed Dr. Yoav Nissan-Cohen as Chairman of the Board, effective immediately. Yoav Stern will continue as the Company's Chief Executive Officer and Director. In addition, Col. Channa Caspi announced that she will be stepping down from the Board due to personal medical circumstances, effective immediately. Following the departure of Col. Caspi, the Board will be reduced from nine to eight directors. Dr. Nissan-Cohen joined Nano's Board of Directors in December 2022.
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MMV | Hot Stocks09:22 EDT MultiMetaVerse to acquire Taomee for RMB 543M plus variable consideration - MultiMetaVerse Holdings announced that it has, through its subsidiary in China, entered into an agreement to acquire 100% equity in Shanghai Shengran Information Technology Co., Ltd. and associated interests pertaining to all of its consolidated VIEs. MMV expects to complete this transaction by the end of this year. The acquisition will be a major milestone for MMV in expanding its portfolio and will significantly enhance its financial performance including its revenue and cash flow. Founded in 2007, Taomee is one of China's leading entertainment and media companies for the younger generations, with established and popular original brands including "Mole's World", "Seer" and "Flower Angel". The total purchase price is comprised of a fixed consideration of RMB 543M, plus a variable consideration based on certain adjustments but in no event lower than RMB 17M, all to be paid in cash. The purchase price will be financed through a combination of share issues and bank loans. During the year ended December 31, 2022, Taomee recorded a total unaudited revenue of $33.6M and adjusted unaudited EBITDA of $13.1M. During the last twelve months ended June 30, 2023, Taomee recorded a total unaudited revenue of $42.6M and adjusted unaudited EBITDA of $17.1M.
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F | Hot Stocks09:20 EDT Ford says UAW's counterproposal 'showed little movement' - Ford issued the following update on UAW negotiations: "At 8 p.m. [last] evening at Solidarity House in Detroit, the United Auto Workers presented its first substantive counterproposal to Ford a few hours from the expiration of the current four-year collective bargain agreement. On the key economic issues that matter most to our UAW-represented employees, Ford has submitted four proposals to the UAW since Aug. 29. The last offer Ford submitted was historically generous, with large wage increases, cost of living adjustments, more paid time off, additional retirement contributions and more. Unfortunately, the UAW's counterproposal tonight showed little movement from the union's initial demands submitted Aug. 3. If implemented, the proposal would more than double Ford's current UAW-related labor costs, which are already significantly higher than the labor costs of Tesla, Toyota and other foreign-owned automakers in the United States that utilize non-union-represented labor. The union made clear that unless we agreed to its unsustainable terms, it plans a work stoppage at 11:59 p.m. eastern. Ford has bargained in good faith in an effort to avoid a strike, which could have wide-ranging consequences for our business and the economy. It also impacts the very 57,000 UAW-Ford workers we are trying to reward with this contract. Our hourly employees would take home nearly 60% less on average with UAW strike pay than they would from working. And without vehicles in production, the profit-sharing checks that UAW workers could expect to receive early next year will also be decimated by a significant strike. Ford remains absolutely committed to reaching an agreement that rewards our employees and protects Ford's ability to invest in the future as we move through industry-wide transformation." Reference Link
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MRK | Hot Stocks09:17 EDT Merck announces CHMP opinion recommending approval of Keytruda - Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer, or NSCLC, who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
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SCNI | Hot Stocks09:06 EDT Scinai Immunotherapeutics sells 1.15M ADSs at $1.16 in registered direct offer - Scinai Immunotherapeutics announced that it has entered into a definitive agreement for the purchase and sale of 1,146,552 of the company's American Depositary Shares, each ADS representing 400 ordinary shares, at a purchase price of yesterday's closing price of $1.16 per ADS, in a registered direct offering. In addition, in a concurrent private placement, the company will issue unregistered warrants to purchase up to 1,146,552 ADSs representing ordinary shares. The warrants will have an exercise price of $1.16 per ADS and will be immediately exercisable upon issuance for a period of five and one-half years. The closing of the offering is expected to occur on or about September 19, 2023, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the company from the offering are expected to be approximately $1.33M, before deducting the placement agent's fees and other offering expenses payable by the company. The company intends to use the net proceeds from the offering for general working capital, research and development, and general corporate purposes.
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SMFL | Hot Stocks09:03 EDT Smart for Life appoints Crockett to advisory board - Smart for Life announced that it has appointed Alicia Crockett to the Company's advisory board.
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JZXN WTO | Hot Stocks09:03 EDT Jiuzi Holdings announces strategic partnership agreement with United Time - Jiuzi (JZXN) provided updates on its business operations. Shenzhen Jiuzi XinNeng Holding Groupa subsidiary of the Company entered into a strategic partnership agreement with United Time Technology Co, an entity controlled via contractual arrangement by UTime (WTO) on September 12, 2023, pursuant to which Jiuzi may procure up to 10,000 smart electric vehicle chargers and the parties shall cooperate to install them in third and fourth tier cities in China by 2027. The strategic partnership agreement serves as a binding framework pursuant to which United Time shall supply and service the EV chargers upon Jiuzi's request according to the terms of the purchase agreement and Jiuzi shall identify the location for the EV chargers. The parties agreed to collaborate on the promotion and marketing of the EV chargers. The parties have also agreed on the forms of the purchase agreement although the per unit purchase price will be negotiated at the time of the purchase. The parties expect to deploy the stations in third and fourth-tier cities, providing convenient, fast, efficient and cost-effective charging solutions for electric vehicle users in such regions. According to the Company's strategic business plan, it plans to procure up to 1,000 new smart EV chargers from United Time in 2024. Assuming a per unit price of RMB 50,000, Jiuzi is expected to invest up to US$7 Millio to procure and operate all 1,000 EV chargers. Assuming the operating results during such period is satisfactory and the Company is able to secure financing at satisfactory terms, the Company plans to deploy an additional 9,000 smart EV chargers in China's third and fourth-tier cities through the fourth quarter of 2027 for approximately US$61 Million assuming the average per unit purchase price is RMB50,000. According to the Company's projections, the annual revenue is estimated to reach approximately $10.9Millionif all 1,000 smart EV chargers are installed and fully operational.
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VRTX | Hot Stocks08:54 EDT Vertex announces CHMP recommendation for Kaftrio label extension - Vertex Pharmaceuticals announced that the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, adopted am opinion for the label extension of Kaftrio in a combination regimen with ivacaftor, for the treatment of children with cystic fibrosis, or CF, ages two through five years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene.
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SCHW | Hot Stocks08:50 EDT Charles Schwab reports total client assets of $8.09T at August end - Charles Schwab released its monthly activity report. Core net new assets brought to the company excluding Ameritrade brokerage originated clients equaled $28.1B for the month, bringing year-to-date Schwab originated core asset gathering up to $219.9B. Total core net new assets across all clients totaled $4.9B in August and $202.5B on a year-to-date basis. Total client assets were $8.09T as of month-end August, up 14% from August 2022 and down 2% compared to July. Average interest-earning assets were $449.5B in August, down 23% from August 2022 and down 4% compared to July.
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PLNT | Hot Stocks08:47 EDT Planet Fitness names Craig Benson as interim CEO, effective immediately - Planet Fitness announced that Craig Benson, a member of the company's Board of Directors, has been appointed Interim CEO, effective immediately. Benson's appointment follows the decision by the Board to transition to new leadership, resulting in Chris Rondeau's departure as the company's CEO. Rondeau will continue to serve as a member of the company's Board of Directors and will be nominated for re-election at the company's 2024 Annual Meeting. Rondeau will continue to serve the company in an advisory role as contemplated under his existing agreements with the company to help ensure a smooth transition. In connection with this transition, the Board is engaging a leading executive search firm to assist in a comprehensive search process to identify a permanent CEO, with both internal and external candidates being considered. The management change is not the result of any material or unexpected financial events. Benson has served on the Planet Fitness Board of Directors since July 2017. He currently serves as the CEO at Soft Draw Investments, LLC.
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CAAP | Hot Stocks08:34 EDT Corporacion America Airport reports August traffic increased 18.7% - Corporacion America Airport reported a 18.7% year-on-year, or YoY, increase in passenger traffic in August, reaching 98.7% of August 2019 levels.
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YS | Hot Stocks08:31 EDT YS Biopharma granted new patent covering PIKA YS-HBV-002 - YS Biopharma announced that the United States Patent and Trademark Office has issued it a patent covering the company's PIKA YS-HBV-002, an immunotherapeutic vaccine designed to treat patients suffering from chronic hepatitis B virus infection. YS Biopharma expects to submit an Investigational New Drug application and commence the clinical development of PIKA YS-HBV-002 as a novel immunotherapy for the treatment of chronic HBV infection in 2024.
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TU | Hot Stocks08:07 EDT Telus to offer new iPhone 15 lineup - Telus will offer iPhone 15 and iPhone 15 Plus, iPhone 15 Pro and iPhone 15 Pro Max, the advanced new Apple Watch Series 9, and the Apple Watch Ultra 2. James Rooke, Vice-president of Connectivity Products & Brands, TELUS said, "Through our award-winning 5G network, we're proud to offer Canadians the best value, the fastest speeds, and industry-leading performance they can rely on. "
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RCI | Hot Stocks08:07 EDT Rogers Communications to offer new iPhone 15 lineup - Rogers will offer iPhone 15 and iPhone 15 Plus, iPhone 15 Pro and iPhone 15 Pro Max, the advanced new Apple Watch Series 9, and the Apple Watch Ultra 2. "Rogers is excited to offer our customers the new iPhone 15 lineup on Canada's largest and most reliable 5G network, so our customers can take full advantage of the lightweight titanium design, powerful camera, and A17 Pro chip," said Phil Hartling, President, Wireless.
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FA | Hot Stocks08:03 EDT First Advantage extends existing share repurchase authorization through 2024 - First Advantage announced that its Board of Directors has approved a one-year extension of its share repurchase authorization, extending the existing $200 million authorization through December 31, 2024. "The extension of our share repurchase program reflects our confidence in the trajectory of our business as we continue to execute against our strategic priorities," said Scott Staples, First Advantage's Chief Executive Officer. "We continue to generate strong cash flow and maintain a healthy balance sheet. We remain committed to returning value to our shareholders through a disciplined and balanced capital allocation approach, which includes organic investments in our technology, strategic M&A, share repurchases, and our recent one-time special dividend."
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ASND | Hot Stocks08:03 EDT Ascendis Pharma launches SKYTROFA in Germany - Ascendis Pharma announced the launch in Germany of SKYTROFA, its growth hormone approved in the European Union for the once-weekly treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient endogenous growth hormone secretion. "SKYTROFA is designed to deliver unmodified somatropin, the same growth hormone used in daily pediatric GHD treatments for more than 30 years, and we are pleased now to make it available in Germany," said Camilla Harder Hartvig, Executive Vice President and Global Chief Commercial Officer at Ascendis Pharma. "This first European Union launch of SKYTROFA begins acceleration of its commercialization beyond the U.S. as we work to expand our leadership to new geographies."
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NRBO | Hot Stocks08:02 EDT NeuroBo Pharmaceuticals doses first patient in Phase 2a DA-1241 trial - NeuroBo Pharmaceuticals announced dosing of the first patient in its two-part, Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist, for the treatment of nonalcoholic steatohepatitis, at The Pinnacle Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of Principal Investigator, Dr. David Ramirez.
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PLRX VIR | Hot Stocks08:02 EDT Pliant Therapeutics appoints Kuo as Chief Development Officer - Pliant Therapeutics (PLRX) announced the appointment of Minnie Kuo as Chief Development Officer. Kuo will oversee all aspects of the Company's nonclinical and clinical development activities. Prior to joining Pliant, Kuo held roles of increasing responsibilities at Vir Biotechnology (VIR), most recently serving as Senior Vice President of Translational and Clinical Development Operations.
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CNXC | Hot Stocks08:01 EDT Concentrix provides update on pending combination with Webhelp - Concentrix announced that it has obtained all required regulatory approvals for its pending combination with Webhelp and expects to close the transaction on or about September 25, 2023. The closing of the transaction remains subject to customary closing conditions. "Upon the close, the combination with Webhelp will create a leading provider of customer experience solutions globally with broad capabilities across CX digital services and technology delivered at scale," said Chris Caldwell, President and CEO of Concentrix. "Our combined clients will benefit from the strategic value of our integrated service offerings, providing a strong platform for growth and value creation for clients, staff, and shareholders."
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ENSV | Hot Stocks08:01 EDT Enservco names Lade as SVP, Chief of Staff - Enservco announced the appointment of executive Mike Lade as senior vice president, SVP, and chief of staff. Lade is the former president and CFO of Rapid Hot, an oilfield services company recently acquired by Enservco.
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NKLA | Hot Stocks07:56 EDT Nikola expands dealer network into Canada - Nikola announced an expansion of its dealer network into Canada for its Class 8 truck sales and service coverage with the addition of ITD Industries Inc., an industry leading commercial trailer manufacturer and technology business headquartered in Toronto, ON. ITD is a North American leader in transportation equipment manufacturing, boasting more than two decades of experience, more than 20,000 trailers built and a growing network of customers from across Canada and the U.S. ITD's diversified products set industry standards for quality, innovation and customer experience. ITD will be promoting Nikola's zero-emission trucks across its national sales channels and is a qualified dealer under the Federal government's iMHZEV program. ITD will be holding a launch event for industry and other interested stakeholders in the Fall of 2023 to share more about its partnership with Nikola.
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ETRGF TLRY | Hot Stocks07:46 EDT Entourage Health announces amendment to key supply agreement - Entourage Health (ETRGF) announced it has entered into an amended supply agreement with HEXO Corp. The amendments, amongst other things, extend the initial term of the agreement, securing Entourage's ongoing access to high-quality bulk cannabis biomass for its product portfolio. The prices of all products supplied under the Supply Agreement are fixed but subject to limited and periodical adjustments depending on prevailing production costs. The amended terms follow HEXO's acquisition by Tilray Brands (TLRY). "We take pride in the exceptional quality of our cannabis products," remarked George Scorsis, CEO and Chair. "Our partnership with HEXO has consistently delivered impressive results. Moving ahead with Tilray, a highly respected company, we share a common goal - to develop a partnership deeply rooted in our promise to ensure our products continue to meet and exceed the highest standard of quality and satisfaction for our patients and consumers. We are excited to work together towards this shared objective with Tilray."
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TRP | Hot Stocks07:35 EDT TC Energy completes Bruce Power's major component replacement unit 6 - TC Energy announces the successful commercial operation of Unit 6 - marking a major milestone in Bruce Power's Major Component Replacement program. This week, the nuclear power unit fully returned to service, surpassing a significant milestone in Ontario's largest clean-energy initiative and one of Canada's largest infrastructure projects. "We are proud that this work was completed safely, on budget and ahead of schedule. It demonstrates our shared commitment to project execution," said Francois Poirier, TC Energy's President and Chief Executive Officer. "Thank you to Bruce Power employees and the people supporting the Life-Extension Program. This vital asset is back online generating reliable, safe, low-cost and carbon-free electricity for Ontarians."
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SVM | Hot Stocks07:31 EDT Silvercorp Metals announces 8.49M share repurchase program - Silvercorp Metals announced a normal course issuer bid to acquire up to 8,487,191 common shares of the company, representing approximately 4.8% of the 176,816,488 common shares issued and outstanding as of September 5, 2023. The repurchase program will run from September 19, 2023 to September 18, 2024. The company is taking this action to provide it with enhanced flexibility should market conditions result in Silvercorp's shares being undervalued relative to the value of its mining operations and corporate assets comprised of cash and cash equivalents and short-term investments of $200.6M, in addition to investments in associates and other companies having a total market value of $71.7M, both as at June 30, 2023.
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HARP | Hot Stocks07:29 EDT Harpoon Therapeutics announces first patients with SCLC dosed in HPN328 trial - Harpoon Therapeutics announced dosing of the first patients with small cell lung cancer, SCLC, in an ongoing Phase 1/2 trial of HPN328, a DLL3 targeting TriTAC, in combination with atezolizumab. Harpoon previously entered a Master Clinical Supply Agreement with F. Hoffmann-La Roche for the supply of atezolizumab. "Dosing the first patients in these combination cohorts for HPN328 with atezolizumab in patients with SCLC marks a significant milestone for this clinical program," said Luke Walker, M.D., Chief Medical Officer for Harpoon Therapeutics. "Building on the strength of our Phase 1 data, we remain committed to realizing the full potential of HPN328 as an important treatment option for patients with SCLC and other neuroendocrine tumors across early and late lines of therapy."
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NRXP | Hot Stocks07:12 EDT NRx Pharmaceuticals signs data sharing agreement for ketamine treatment - NRx Pharmaceuticals announced that it has signed a data sharing agreement with the study leadership of a randomized, placebo-controlled trial of 156 patients hospitalized for Acute Suicidality and Depression in 7 French Government Hospitals. This trial, conducted under International Good Clinical Practices and Helsinki standards demonstrated a statistically-significant reduction in suicidal ideation and depression among patients randomized to intravenous racemic ketamine, compared to those randomized to placebo. The trial reached its primary endpoint for all patients and demonstrated the largest effect among the subgroup with bipolar depression. The top line data from this trial were published in the British Medical Journal and additional data reports are planned. The efficacy demonstrated confirms earlier, smaller trials conducted in the United States and elsewhere. As disclosed previously, NRx met with the FDA in January 2023 at which time the FDA requested randomized, placebo-controlled data in support of intravenous ketamine for acute suicidality in the inpatient setting. Such trials are extraordinarily complex to organize and generally require Government support. In this case, NRx approached the Fondation FundaMental, led by Marion Leboyer, who served on the NRx Scientific Advisory Board and facilitated establishing the current Data Sharing Agreement. Under this agreement, NRx has translated the clinical study report, which will be submitted to FDA and is converting the electronic, patient level data files to a form suitable for FDA review. NRx plans to meet with FDA in the coming months to discuss a regulatory path for the use of ketamine to treat patients with Bipolar Depression and Acute Suicidal Ideation and Behavior.
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VISL | Hot Stocks07:02 EDT Vislink acquires majority assets of Broadcast Microwave Services - Vislink Technologies has acquired the majority assets of Broadcast Microwave Services, a provider of wireless microwave equipment for video and data transmission. "BMS is a well-established international player in the AVDS space," said Vislink CEO Mickey Miller. "By adding its assets to Vislink, we are consolidating the market and extending our position as the leading worldwide provider of AVDS products. We look forward to driving new sales to a larger customer base with an increased focus on the growing public safety market. Our strong balance sheet allows us to meet the needs of current BMS customers, while our industry-leading technology provides us with an attractive opportunity to up-sell and cross-sell our solutions. With the addition of BMS assets, we are even better positioned to scale our business in the growing MilGov sector."
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KMPR | Hot Stocks06:56 EDT Kemper names Bradley Camden as interim CFO - Kemper announced the appointment of Bradley Camden, its Senior Vice President and Treasurer, as Interim CFO, effective immediately. Camden will report to Joseph Lacher, Jr., Kemper's President, CEO and Chairman, and replaces James McKinney, who will serve as a senior advisor to the company to support a smooth transition. Kemper is initiating a formal search process as part of the selection of a permanent CFO.
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GIB | Hot Stocks06:36 EDT CGI Inc. announces C$380M partnership with Alimentation Couche-Tard - CGI announced a 10-year, C$380M strategic partnership with Alimentation Couche-Tard to deliver managed IT services. As part of the 10-year agreement, CGI will deliver a range of IT services and infrastructure support for mission-critical business functions, such as store manager experience, business process automation and innovation, and data access and visibility. CGI will leverage its proven end-to-end digital processes, governance and frameworks to deliver enhanced operational efficiency and optimize costs.
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F... | Hot Stocks06:31 EDT UAW starts strike at Ford, GM, and Stellantis plants - The United Auto Workers union announced overnight that thousands of its members at Ford (F), General Motors (GM) and Stellantis (STLA) walked out, "marking the beginning of the Stand Up Strike." UAW members at GM Wentzville Assembly, Local 2250 in Region 4, at Stellantis Toledo Assembly Complex, Local 12 in Region 2B, and at Ford Michigan Assembly Plant - Final Assembly and Paint, Local 900 in Region 1A are on strike. "This fight is our generation's defining moment. Not just at the Big Three, but across the entire working class," the UAW said in a statement. Shares of Ford and General Motors are down around 2% in pre-market trading while Stellantis is up slightly. Reference Link
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F... | Hot Stocks06:30 EDT UAW starts strike at Ford, GM, and Stellantis plants - The United Auto Workers union announced overnight that thousands of its members at Ford (F), General Motors (GM) and Stellantis (STLA) walked out, "marking the beginning of the Stand Up Strike." UAW members at GM Wentzville Assembly, Local 2250 in Region 4, at Stellantis Toledo Assembly Complex, Local 12 in Region 2B, and at Ford Michigan Assembly Plant - Final Assembly and Paint, Local 900 in Region 1A are on strike. "This fight is our generation's defining moment. Not just at the Big Three, but across the entire working class," the UAW said in a statement. Shares of Ford and General Motors are down around 2% in pre-marker trading while Stellantis is up slightly. Reference Link
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NVS | Hot Stocks06:12 EDT Novartis shareholders approve proposed 100% spinoff of Sandoz - At an Extraordinary General Meeting, Novartis shareholders approved the proposed 100% spin-off of Sandoz, the Generics and Biosimilars business of Novartis. Shareholders also approved an ordinary capital decrease of the share capital of Novartis AG in the amount of the share capital of Sandoz. This is to achieve tax neutrality of the spin-off for Swiss withholding tax purposes and for income tax purposes for Swiss domiciled shareholders holding the shares as private assets. This decision follows the announcement in August 2022 that Novartis intended to separate the Sandoz business to create an independent company by way of a 100% Spin-off. Novartis is confident that the Spin-off is in the best interests of shareholders, creating a European champion and a global leader in Generics and Biosimilars, and a more focused Novartis. The spin-off is planned to occur on or around October 4, 2023. The spin-off will be implemented through the distribution of a dividend-in-kind of Sandoz shares to Novartis shareholders, and of Sandoz American Depositary Receipts, or ADRs, to Novartis ADR holders. Novartis shareholders and Novartis ADR holders will receive: 1 Sandoz Share for every 5 Novartis Shares; 1 Sandoz ADR for every 5 Novartis ADRs. The spin-off is expected to be tax neutral for Swiss tax and US federal income tax purposes. The proposed 100% Spin-off of Sandoz is planned to occur on or around October 4, 2023. The Novartis Shareholder Information Brochure includes an indicative timeline of the next steps for the proposed Sandoz Spin-off. Sandoz is planned to be listed on the SIX Swiss Exchange, with an American Depositary Receipt, or ADR, program in the U.S. The ADRs will not be listed on a US national securities exchange. In addition to Novartis shareholder approval, completion of the proposed Sandoz Spin-off is subject to satisfaction of certain conditions, including receipt of the necessary approvals for the listing of the Sandoz shares, no event outside of the control of Novartis preventing the spin-off and no material adverse change. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed, the company stated.
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PTCT | Hot Stocks06:09 EDT PTC Therapeutics reports CHMP opinion against Translarna marketing authorization - PTC Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy, or nmDMD. The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination per EMA guidelines. Translarna will remain on the market and available to patients with nmDMD until the re-examination process is completed. Based on CHMP procedural guidance, the opinion following the re-examination process would be expected to occur in January 2024, with EC ratification of the opinion within the following 67 days. "We are surprised and extremely disappointed by the CHMP decision, given the well-established and favorable safety and efficacy profile of Translarna," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "Of course, this decision is most devastating for the hundreds of boys and young men in Europe with nonsense mutation DMD, for whom no other approved therapies are available. We will be submitting a request for re-examination to the CHMP to reverse this opinion, as we have done previously in the regulatory history of Translarna in Europe."
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MNSO | Hot Stocks05:31 EDT Miniso reports new $200M share repurchase program - Miniso announced that, following the expiration of the share repurchase program the company adopted in September 2022, the board of directors of the company authorized and approved a new share repurchase program on September 15, under which the company may repurchase up to $200M in value of its outstanding ordinary shares and/or American depositary shares representing its ordinary shares over a period of 12 months starting from the date on which the program was approved. The company expects to fund repurchases under the program from surplus cash on its balance sheet.
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UBER | Hot Stocks05:08 EDT Uber, Deliverect enter global partnership - Deliverect and Uber announced a new global partnership to help restaurants better manage and grow their delivery operations. With Deliverect Dispatch, restaurants can scale their orders by offering fast and white-label delivery powered by Uber Direct as a preferred partner.
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ARGX | Hot Stocks05:06 EDT Argenx announces CHMP recommendation for EC approval of SC efgartigimod - Argenx announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended EC approval of the SC injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis, or gMG, who are anti acetylcholine receptor, or AChR, antibody positive. SC efgartigimod is formulated with Halozyme's Enhanze drug delivery technology to facilitate subcutaneous delivery of biologics.
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PLTK | Hot Stocks05:04 EDT Playtika to acquire Innplay Labs for up to $300M - Playtika announced it has entered into a definitive agreement to acquire Innplay Labs, a mobile gaming studio based in Israel. This deal will have an upfront consideration of $80M with a maximum consideration of $300M. The proposed acquisition is subject to the satisfaction of customary closing conditions.
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