Stockwinners Market Radar for September 07, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:57 EDT Dell Technologies jumps 6% to $108.33 after being added to S&P 500

17:39 EDT S&P announces changes to S&P 400, 600 indexes for quarterly rebalance - American Airline Group (AAL) will replace TEGNA (TGNA) in the S&P MidCap 400, and TEGNA will replace Designer Brands (DBI) in the S&P SmallCap 600. Etsy (ETSY) will replace Haverty Furniture Companies (HVT) in the S&P SmallCap 600. Bio-Rad Laboratories (BIO) will replace Erie Indemnity (ERIE) in the S&P MidCap 400. CNH Industrial NV (CNH), Western Alliance Bancorp (WAL), Parsons Corp. (PSN), Hamilton Lane (HLNE), Viper Energy (VNOM) and S&P SmallCap 600 constituent Fabrinet (FN) will replace MP Materials (MP), Progyny (PGNY), Adient (ADNT), Wolfspeed (WOLF), Helen of Troy (HELE) and Ziff Davis (ZD) in the S&P MidCap 400 respectively. MP Materials, Progyny, Adient, Wolfspeed, Helen of Troy, and Ziff Davis will replace Calavo Growers (CVGW), Enhabit (EHAB), Mercer International (MERC), Compass Minerals International (CMP), 3D Systems (DDD), and Fabrinet in the S&P SmallCap 600 respectively. Zurn Elkay Water Solutions (ZWS), Clear Secure (YOU), TG Therapeutics (TGTX), Inspire Medical Systems (INSP), CSW Industrials (CSWI), ADMA Biologics (ADMA), and Impinj (PI) will replace Community Healthcare Trust (CHCT), Varex Imaging (VREX), Dine Brands Global (DIN), Nu Skin Enterprises (NUS), AMC Networks (AMCX), Olympic Steel (ZEUS) and B. Riley Financial (RILY) in the S&P SmallCap 600, respectively. S&P Dow Jones Indices will make the above changes to the S&P MidCap 400 and S&P SmallCap 600 indices effective prior to the open of trading on Monday, September 23, to coincide with the quarterly rebalance.

17:19 EDT Palantir, Dell Technologies, Erie Indemnity to be added to S&P 500

16:54 EDT Casella Waste sees $9M charge in September quarter due to landfill closure - In a regulatory filing, Casella Waste disclosed that on August 15, the Massachusetts Department of Environmental Protection issued a letter to Casella Waste Systems notifying the company that it has completed its technical review of the company's landfill closure completion application on behalf of the company's subsidiary, Southbridge Recycling & Disposal Park, relative to the Subtitle D landfill in the Town of Southbridge. MADEP determined that the application is technically complete and by that letter it issued the final closure permit to the company. Pursuant to the terms of the Permit, the company is required to meet certain general permit conditions and certain specific permit conditions, including environmental monitoring, third party inspections, inspection of the final cover, leachate sampling, post-closure monitoring, and other post-closure requirements. The company expects to record a charge of approximately $9M in the three months ended September 30 to revise the accrued post-closure liability for the Southbridge Landfill to reflect the estimated cost of satisfying the expanded conditions as currently specified in the Permit. The company expects to exclude this charge in its calculation of Adjusted EBITDA and Adjusted Net Income consistent with its historical treatment of expenses related to the closure of the Southbridge Landfill. In the event that the conditions are modified, the company could be required to take additional charges.

16:03 EDT Dril-Quip, Innovex complete merger - Dril-Quip (DRQ) announced it has completed its previously announced merger with Innovex Downhole Solutions, a designer and manufacturer of products to support global upstream onshore and offshore activities. This combined company has assumed the Innovex International (INVX) name and will begin trading on the New York Stock Exchange on September 9, under the ticker symbol "INVX." In connection with the close of the transaction, Dril-Quip's common stock ceased trading on the New York Stock Exchange under the ticker symbol "DRQ" as of the close of trading on September 6.

14:48 EDT U.S. Steel files trade cases on imports of corrosion-resistant steel - U. S. Steel, along with the United Steelworkers union, or "USW," and Wheeling-Nippon, has filed antidumping and countervailing duty petitions with the United States Department of Commerce and the United States International Trade Commission on imports of corrosion-resistant steel, or "CORE," from Australia, Brazil, Canada, Mexico, Netherlands, South Africa, Taiwan, Turkey, United Arab Emirates, and Vietnam. Duane Holloway, Senior Vice President, General Counsel and Chief Ethics & Compliance Officer of U. S. Steel, commented, "As we have for decades, U. S. Steel continues to lead the domestic industry in the fight against unfair trade on behalf of our workers, families, communities, and customers we serve. These new trade cases-the largest filed by U. S. Steel in nearly a decade-will address low-priced and subsidized CORE imports that continue to pour into the U.S. market. These cases aim to restore a level playing field and support our investments in Big River Steel's new dual coating line and second mini-mill in Arkansas, as well as U. S. Steel's CORE facilities across the country."

13:56 EDT Shopify allying with Roblox as platform's first commerce integration partner - Shopify (SHOP) is announcing a new alliance with Roblox (RBLX) as the platform's first commerce integration partner. Shopify stated: "This partnership brings together two companies on a mission of furthering entrepreneurship and making commerce everywhere a reality-even in immersive spaces. Soon, we will pilot Shopify's world-class Checkout into Roblox, with a larger launch in early 2025. This means developers, creators, and brands who are on Shopify can sell physical items directly within their Roblox games without ever leaving the Roblox platform. Through this integration, creators and brands will be able to engage with a global audience of nearly 80 million daily active Roblox users (as of Q2 2024) and potential customers. It also gives Roblox creators a brand new avenue to entrepreneurship. Commerce happens everywhere-from physical stores, to online, to immersive spaces. One of the most relevant places for digitally-savvy Gen Z consumers in the world right now is Roblox, where millions of creators pursue entrepreneurship through immersive content creation. Now, we're unlocking a new channel for their ventures. This is another example of how Shopify is shaping the future of immersive commerce and shopping. When entrepreneurs have more spaces to connect with fans, they have more opportunities to succeed. That is what we power at Shopify. See you soon on Roblox." Reference Link

13:34 EDT Roblox says to achieve 10% of gaming content revenue at 300M DAUs

13:33 EDT Roblox partnering with Shopify to sell physical goods from 'creators' - At its developers conference, Roblox said starting early next year, creators can sell physical merchandise directly from their experience.

13:00 EDT Baker Hughes reports U.S. rig count down 1 to 582 rigs

12:00 EDT Direxion Daily Semiconductor Bull 3X Shares falls -12.8% - Direxion Daily Semiconductor Bull 3X Shares is down -12.8%, or -$3.82 to $25.93.

12:00 EDT Samsara rises 15.5% - Samsara is up 15.5%, or $6.02 to $44.77.

12:00 EDT Argan rises 24.4% - Argan is up 24.4%, or $17.43 to $88.81.

10:42 EDT Alibaba to offer U.S. credit card for businesses with Mastercard - Alibaba.com (BABA) announced yesterday a partnership with Mastercard (MA) and Cardless to offer a co-branded credit card "designed to reward businesses for cross-border and domestic sourcing purchases through Alibaba.com." The Alibaba.com Business Edge Credit Card will be the company's first co-branded U.S. credit card. "This new credit card will enable Alibaba.com buyers in the U.S. to earn rewards on all of their purchases in the form of cashback, or special financing terms. The waitlist for the Alibaba.com Business Edge Credit Card is live as of Thursday, September 5, 2024, and the credit cards will be available for application later this year," the company said in a statement.

10:21 EDT Invitation Homes says 'well positioned' to deliver outsized AFFO growth - Says renewal lease rate growth for July August of 4.4% vs. 5.6% in 2Q24, with new lease rate growth of 1.9% vs. 3.6% in 2Q24, and blended lease rate growth of 3.7% vs. 5% in 2Q24. Says fundamentals for SFR housing expected to remain favorable. Despite recent temporary supply pressures, expects a decade-long shortfall in single-family construction likely to persist for foreseeable future. Expects portfolio to be more resilient as new supply comes online. Comments taken from investor presentation slides.

10:00 EDT Quanex rises 18.3% - Quanex is up 18.3%, or $4.56 to $29.42.

10:00 EDT a.k.a. Brands falls -7.5% - a.k.a. Brands is down -7.5%, or -$1.67 to $20.49.

10:00 EDT Genesco falls -14.2% - Genesco is down -14.2%, or -$4.19 to $25.31.

09:47 EDT Bloom Energy falls -7.1% - Bloom Energy is down -7.1%, or -79c to $10.24.

09:47 EDT Bowlero rises 16.7% - Bowlero is up 16.7%, or $1.80 to $12.59.

09:47 EDT Argan rises 27.7% - Argan is up 27.7%, or $19.80 to $91.18.

09:43 EDT Safety Shot announces Notice of Allowance of for a U.S. patent - Safety Shot has announced the Notice of Allowance of for a U.S. patent that covers its newest clinically-backed formula. "This latest patent marks a significant milestone in Safety Shot's quest to lead a brand-new category that the company has created to solve alcohol related problems," stated Safety Shot COO and co-owner of the patent, David Sandler. "The patent locks up our IP and further separates us from the pack as the only the group that has been able prove that Safety's Shot revolutionary formula can dramatically reduce blood alcohol and reduce the build-up toxins associated with alcohol consumption rapidly. This patent helps solidify Safety Shot as the uncontested world leader in making people feel better faster," continued Sandler, who co-invented the Safety Shot wellness product.

09:36 EDT Molecular Partners AG (ADR) trading halted, volatility trading pause

09:11 EDT Power Solutions enters credit agreement, shareholder loan agreement - Power Solutions International closed on its new uncommitted senior secured revolving credit agreement with Standard Chartered Bank and two other lenders. The Credit Agreement allows the Company to borrow up to $120 million at a lower interest rate than previously available and expires on August 30, 2025. As part of the closing of the Credit Agreement, the Company made an initial draw in the amount of $100 million. The Company utilized the amount drawn under the Credit Agreement to repay the outstanding balance of approximately $40 million under the Company's credit agreement, dated March 22, 2024, by and among the Company and Standard Chartered; and to repay the total outstanding balance of approximately $60 million under the $30M Second Amended and Restated Shareholder's Loan Agreement, dated as of March 22, 2024 between PSI and its majority shareholder, Weichai America, and the $25M Third Amended and Restated Shareholder's Loan Agreement, dated as of May 20, 2024 between PSI and Weichai, the $50M Second Amended and Restated Shareholder's Loan Agreement, dated as of November 29, 2023 between PSI and Weichai. The Credit Agreement is subject to customary events of default and covenants, including minimum consolidated EBITDA and Consolidated Interest Coverage Ratio covenants for the fourth quarter of 2024 and the first and second quarters of 2025. Borrowings under the Credit Agreement will incur interest at the applicable Secured Overnight Financing Rate plus 2.00% per annum. The obligations under the Credit Agreement are unconditionally guaranteed, on a joint and several basis, by certain wholly-owned, existing and subsequently acquired or formed direct and indirect domestic subsidiaries of the Company, subject to customary exceptions. The obligations under the Credit Agreement are secured by substantially all assets of the Company and the Company's wholly-owned subsidiaries. In connection with the Credit Agreement, on August 30, 2024, the Company also entered into a new shareholder's loan agreement with Weichai, which allows the Company to borrow up to $105 million and expires August 31, 2025. The payment of the borrowings under the Shareholder's Loan Agreement is subordinated in all respects to the Credit Agreement with Standard Chartered except that the Company is allowed to make a single payment of $10 million to Weichai. As of September 4, 2024, the outstanding principal balance under the Shareholder's Loan Agreement is $35 million. The Shareholder's Loan Agreement is subject to customary events of default and covenants. Borrowings under the Shareholder's Loan Agreement will incur interest at the applicable "SOFR" plus 4.05% per annum.

09:04 EDT Afya announces MEC decision on medical seats reconsideration - Afya announced that following the conclusion of an administrative procedure, the Ministry of Education, or MEC, has granted the request for reconsideration submitted by Universidade do Grande Rio Professor Jose de Souza Herdy. Per the e-MEC portal, Unigranrio reestablished 10 medical seats in the city of Rio de Janeiro, reaching 318 medical seats across both Unigranrio campuses, contributing to Afya's 3,593 total approved medical seats. This seat reconsideration highlights our dedication to excellence in medical education and establishes us as a leading medical education group in Brazil.

09:03 EDT Tegna, Dallas Mavericks announce new multi-year broadcast rights agreement - The Dallas Mavericks announced a new multi-year broadcast rights agreement with Tegna to bring all Mavericks games not exclusively televised nationally to approximately 10M people in Texas, for free over-the-air, nearly tripling the current number of households the Mavericks can reach across the state. Starting with the Mavs vs. Suns game on October 26, Tegna station KMPX Dallas-Ft. Worth will broadcast all games not exclusively televised nationally - 70 or more in the first season - for free over-the-air, with 15 or more games simulcast on WFAA Dallas-Ft. Worth. The games will also be broadcast on Tegna stations in Waco, Tyler, Midland-Odessa, Abilene and San Angelo.

09:01 EDT Brilliant Earth announces expansion of international shopping capabilities - Brilliant Earth Group announced that the Company has expanded its international shopping capabilities to better serve new and existing customers across the globe. "We are pleased to enhance our capabilities to serve our international customers in a new way," said Beth Gerstein, CEO and Co-Founder at Brilliant Earth. "We've served customers in over 50 countries worldwide, which speaks to our growing, global brand presence. We look forward to bringing our elevated, seamless digital shopping experience to both new and existing customers seeking the premium, trend-leading products for which we are known."

08:50 EDT Core Scientific announces 30-day extension of option to contract - Core Scientific announced a 30-day extension of CoreWeave's remaining option to contract 118 megawatts of infrastructure for high-performance computing. Both Core Scientific and CoreWeave agreed to the 30-day option extension to accommodate design, supply chain and construction timeline development activities. CoreWeave has contracted a total of 382 megawatts of infrastructure to support HPC hosting operations at multiple Core Scientific data centers.

08:42 EDT DLocal appoints Menendez as Chief Operating Officer - dLocal announces the appointment of Carlos Menendez as Chief Operating Officer, effective immediately. Jacobo Singer, who currently serves as COO and Co-President, will continue to serve in both roles during a transition period until December 15, 2024, at which time he will step down from both roles. During this transition period, Carlos and Jacobo will work closely to ensure a smooth handover of responsibilities. Following the transition period, Jacobo will continue to serve as a member of our Board of Directors.

08:35 EDT Zevra Therapeutics presents data for arimoclomol, OLPRUVA at SSIEM 2024 - Zevra Therapeutics announced the presentation of five posters at the Society for the Study of Inborn Errors of Metabolism 2024 Annual Symposium. Four posters focused on data from multiple studies showing the efficacy and safety of arimoclomol as a treatment for people living with Niemann-Pick disease type C, and one poster highlighted data from pharmacokinetic modeling studies of OLPRUVA, a therapy for the long-term management of certain adult and pediatric patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinic acid synthetase. The data for arimoclomol presented at SSIEM is summarized below: Title: Efficacy Results from a 12-month Double-blind Randomized Trial of Arimoclomol for Treatment of Niemann Pick Disease Type C - presenting an improved 4-Domain NPC Clinical Severity Scale: Summary: The treatment effect of arimoclomol was evaluated in a 12-month, double-blind, placebo-controlled clinical trial using the original 5-domain Niemann pick type C clinical severity scale and the modified 4-domain Niemann Pick type C clinical severity scale. A statistically significant treatment effect was shown using the modified 4DNPCCSS and the prespecified 5DNPCCSS primary endpoint in the 12-month clinical trial, representing a clinically meaningful reduction in disease progression with arimoclomol treatment compared to placebo. Title: Long-term Efficacy and Safety Evaluation of Arimoclomol Treatment in Patients with Niemann Pick Type C - Data from 48 Months Open Label Trial: Summary: The long-term safety and efficacy of arimoclomol in the 12-month double-blind, and 48-month open-label extension portion of the clinical trial were presented using the 4-Domain Niemann Pick Type C Clinical Severity scale which evaluates ambulation, speech, swallowing and fine motor skills. For those patients transitioning from placebo to arimoclomol at the start of the open-label extension period, the mean annual rate of disease progression reduced from an annual rate of change of 1.9 points during the double-blind phase, to a rate of 0.3 in the first 12 months of treatment, remained numerically smaller for the rest of the trial, and was comparable between the double-blind phase of the trial and the open-label extension phase of the trial. Additionally, arimoclomol was well tolerated with no new safety signals observed. Title: Arimoclomol for the Treatment of NPC in a Real-World Setting: Long-term Outcomes from an Expanded Access Program in the USA. Summary: The long-term safety and efficacy of arimoclomol in a real-world setting were evaluated in a total of 56 adult and pediatric patients in the U.S. arimoclomol expanded access program trial. Data presented included over 3 years of U.S. EAP clinical outcomes and demonstrated that adult and pediatric patients treated with arimoclomol, including those with and without miglustat as a component of their routine clinical care, experienced relatively stable disease as measured by the 5DNPCCSS and 4DNPCCSS and show that arimoclomol was well tolerated. Title: Arimoclomol safety profile in the treatment of NPC in a Real-World setting: Long-term data from an Expanded Access program in the USA: Summary:Safety data from 94 adult and pediatric participants in the arimoclomol US EAP were presented. Safety outcomes reported from exposure periods spanning as much as 46 months of treatment, demonstrated a safety profile consistent with the published clinical trial experience of arimoclomol in NPC. The data for OLPRUVA presented at SSIEM is summarized below: Summary:Pharmacokinetic modeling evaluating whether sodium phenylbutyrate could be safely and effectively administered while fasting showed greater absorption and bioavailability with increased drug exposure in fasted administration of NaPBA compared to fed administration of NaPBA and glycerol phenylbutyrate in both adult and child virtual patients, which is predicted to increase efficacy in proportion to increased drug exposure, theoretically allowing for a 30% dose decrease compared to fed conditions.

08:06 EDT Lixiang Education CFO Ye resigned, appoints Yang as new CFO - Lixiang Education announced that Luoyuan Ye resigned as the Chief Financial Officer, CFO, of the Company with effect from August 31, 2024 and will remain as the consultant to the Company. Zhifu Yang was appointed as the CFO with effect from September 2, 2024.

08:04 EDT LiveOne launches price increases for Plus, Premium membership plans - LiveOne announced a price adjustment, effective immediately, for its Plus and Premium membership plans. This change affects all new subscribers to LiveOne Plus on an annual basis and all new monthly subscribers to LiveOne Premium. As of today, LiveOne boasts over 4 million ad-supported and paid members, positioning the company to leverage the growth of the music streaming market which is expected to increase from $35 billion to over $100 billion by 2030. LiveOne Plus annual price increased to $39.99, a $4 per subscriber increase; LiveOne Premium monthly price increased to $10.99, a $1 per subscriber increase; Price adjustments will support future product innovation and enhanced content experiences

08:03 EDT Vivid Seats' Game Center debuts 'Leagues' for NFL Season - Vivid Seats announced new feature upgrades to Game Center, the brand's in-app free-to-play product. Fans will now be able to win free National Football League tickets each week and easily earn ticket credits in new ways this season, while competing against friends and family with Game Centers' "Leagues" in the Vivid Seats app. In Vivid Seats' Game Center, live event fans can play free daily games to score points towards ticket credits and enter drawings for free tickets. The addition of "Leagues" provides a new exciting group play option for sports fans, allowing the most competitive fans to create leaderboards, inviting an unlimited number of friends and family to play in pools for "Pick It" or "Trivia" while comparing and sharing scores.

08:02 EDT Texas Capital shares strategic business update - Texas Capital Bancshares announced a series of actions that materially progresses the firm towards realization of the performance targets outlined in its strategic plan, communicated on September 1, 2021. "Three years after announcing our strategic plan, we are pleased with the tremendous progress made building a balance sheet and a business model worthy of serving the best clients in our markets," said Rob C. Holmes. "Actions announced today represent another deliberate step in translating observed strategic success into targeted financial performance associated with long-term value creation. We remain focused on delivering exceptional results for clients and shareholders by leveraging our differentiated platform." Following the multi-year coverage and capability build in its corporate banking healthcare vertical, Texas Capital has entered into an agreement to acquire a portfolio of approximately $400 million in committed exposure to companies in the healthcare sector. Many of the companies in the portfolio are supported by sector-focused sponsors with notable track records of value creation and with whom Texas Capital has significant institutional knowledge. The firm expects these clients to benefit from an extensive solutions-focused platform, with revenue cycle management, healthcare asset-based lending and other sector-specific products integrated with differentiated cash management, commercial banking and investment banking capabilities. The transaction is expected to close this month, subject to customary closing conditions. In addition to deliberate investments to expand the portfolio and enhance client-facing services, in August of 2024 the firm continued its multi-year process of effectively rationalizing its legacy balance sheet, selling approximately $1.24 billion of available-for-sale securities with an average book yield of 1.23%, purchased prior to 2021. Cash proceeds from the sale were used to purchase $1.06 billion of securities at a yield of 5.26%, which is expected to contribute an incremental $35 to $40 million in net interest income on an annualized basis based on the federal funds futures curve. The $139 million after tax loss generated by the repositioning, which had no impact on GAAP equity or on Texas Capital's industry leading tangible common equity to tangible assets ratio, is expected to result in a net loss for the third quarter of 2024 before notably improving forward profitability metrics in the fourth quarter of 2024 and subsequent reporting periods. The firm continues to leverage proven capabilities to deliver tech-enabled process improvements that enhance client journeys, reduce risk and deliver structural efficiencies. Action taken in the quarter is expected to reduce anticipated 2025 non-interest expense by approximately $30 million, keeping total non-interest expense nearly flat from adjusted full year 2024. This reduction in non-interest expense is the direct result of material investments made over the previous three years that continue to realign the expense base to support near-term financial performance while also enabling sustained investment to drive long-term strategic objectives.

07:57 EDT SciSparc announces publication of international patent application - SciSparc announced that as part of its ongoing collaboration with Clearmind Medicine, an international patent application under the Patent Cooperation Treaty has been published for the innovative combination of 3,4-Methylenedioxymethamphetamine with N-Acylethanolamines. As part of their collaboration, SciSparc and Clearmind are researching innovative combination therapies that combine psychedelic molecules with the N-Acylethanolamines family, including Palmitoylethanolamide. To date, thirteen patents related to this collaboration have been filed by Clearmind with the U.S. Patent and Trademark Office, as well as in several other global jurisdictions.

07:46 EDT Faraday Future secures $30M in financing - Faraday Future announced that it has secured $30M in financing commitments from investors in the Middle East, the United States, and Asia. The participation from a Middle East investor, Master Investment, an investment firm of Sheikh Abdulla Al Qassimi from Ras Al Khaimah, the UAE represents a milestone. The new financing commitment includes a previously funded $7.5M and $22.5M of new investment in the form of convertible notes and warrants to acquire additional shares of the company's common stock. The conversion price for the convertible notes and exercise price for the Warrants, are $5.24 and $6.29 per share, respectively, subject to adjustment as set forth therein. The shares of common stock underlying the convertible notes and warrants issued in the financing are currently unregistered, subject to trading restrictions, and not immediately tradable. The financing is subject to customary closing conditions. With FF's entry into the Middle East, it now operates a "third pole" geographic strategy expanding its reach beyond the U.S. and China.

07:39 EDT Voss discloses Intermex stake, discussed take private transaction - Voss Capital disclosed a 5.6% stake in Intermex, which represents over 1.83M shares. The filing with the SEC allows for activism. Voss said it has engaged, and intends to continue to engage, in communications with the Intermex's board and management regarding ways to maximize shareholder value, including, but not limited to, a sale of the company in a take private transaction. Shares of Intermex shares in premarket trading are up 5c to $17.75.

07:33 EDT Tradeweb Markets reports total trading volume for August of $50.9T - Tradeweb Markets reported record total trading volume for the month of August of $50.9T. Average daily volume for the month was a record $2.21T, an increase of 53.9% year-over-year. Excluding the impact of the ICD acquisition, which closed on August 1, total ADV for the month of August was up 35.7% YoY.

07:33 EDT Y-mAbs Therapeutics announces new data on naxitamab, GD2-SADA - Y-mAbs Therapeutics announced new clinical and preclinical data from studies evaluating naxitamab and GD2-SADA, respectively, in neuroblastoma. The results are summarized in poster presentations scheduled to be presented September 6 - 7, 2024, at the American Academy of Cancer Research, AACR, Special Conference in the Advances in Pediatric Cancer Research in Toronto, Canada. Naxitamab maintains disease control in patients with refractory/relapsed high-risk neuroblastoma: Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor achieved a disease control rate of 63%. High-affinity binding of GD2-SADA to Tb-DOTA: The study demonstrated tight binding interactions between GD2-SADA and DOTA-chelated terbium, a metal in the same lanthanide family as lutetium with multiple medical isotopes of potential benefit in diagnosis and therapy. The results have informed ongoing PK/PD modeling and the initial dosing in Trial 1001

07:10 EDT Milestone partner announces Phase 3 study of etripamil met primary endpoint - Milestone Pharmaceuticals announced its licensing partner, Ji Xing Pharmaceuticals, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycardia, PSVT. The trial design closely matched the RAPID Phase 3 Study of etripamil in PSVT conducted by Milestone in North America and Europe. The 500-patient Phase 3 trial met its primary endpoint, with a Kaplan Meier analysis shows a statistically significantly greater proportion of patients who self-administered etripamil converted from PSVT to sinus rhythm within 30 minutes compared to placebo. Statistically significant results were also shown for the secondary efficacy endpoints for percent of patients' PSVT converted to sinus rhythm by 10, 15, 45, and 60 minutes after self-administration of study drug.

07:09 EDT Aya Gold & Silver announces update on expansion at Zgounder - Aya Gold & Silver provided an update on construction progress at its Zgounder Silver Mine in the Kingdom of Morocco. The expansion project was 98% complete as at August 30, fully funded, and on budget. The Corporation's engineering, procurement, and construction partner, Duro Felguera, encountered issues during commissioning of the hydraulic unit of the ball mill. As a result of these issues, DF recently advised Aya that a rework of the hydraulic unit piping is required. This does not impact the integrity of the ball mill, the hydraulic unit or other equipment. Commissioning of other subsystems is proceeding steadily, and the crushing circuit is now operational. As a result of the necessary rework, DF has requested and obtained from Aya a two-month extension for hot commissioning and ramp-up of the Zgounder expanded plant. All other critical areas of the Zgounder expansion project are progressing to plan or are in commissioning: Commissioning of other areas of the plant continues to progress: ore has been crushed throughout the entire crushing circuit and sent to the silo. Work has begun on the underground ramp from the 1,925m to 1,900m levels and will continue to lower levels. The entire mining site is now powered with renewable energy from the newly built 60kV power line. The new underground mobile workshop is in use. The primary underground ventilation is working on all levels. The on-surface cemented backfill mixing station and piping on all sublevels are mechanically complete and will shortly be commissioned. All four underground electrical substations have been deployed. The water dams and other water storage infrastructures are operational. The new tailings dam is in use. Water is being recovered from the tailing dam. The base camp is complete. The new assay laboratory is near-complete with commissioning planned end of September 2024. Given the delay in hot-commissioning and ramp-up of the Zgounder expanded plant, the Corporation's 2024 production guidance is under review. Aya expects to revisit its production guidance based on construction progress and operational results by latest November 14, 2024, when it will publish its third-quarter 2024 financial results.

07:07 EDT Beasley Broadcast launches exchange ofer, new notes offer, tender offer - Beasley Broadcast Group announced that its wholly owned subsidiary, Beasley Mezzanine Holdings, has commenced an exchange offer pursuant to which holders may exchange their outstanding 8.625% Senior Secured Notes due 2026 into: newly issued 9.200% Senior Secured Notes due August 1, 2028 at an exchange ratio of 95.0% of the aggregate principal amount of the Existing Notes tendered for exchange; a pro rata share of 3,588,495 shares of Class A common stock of the Company, based upon pro rata ownership of the Exchange Notes issued by the Issuer, pursuant to the terms and conditions described in the Exchange Offer Memorandum and Consent Solicitation Statement, dated September 5, 2024 and a consent fee of $5.00, in each case per $1,000 principal amount of Existing Notes tendered. A holder of approximately 73% of the Existing Notes has entered into a transaction support agreement to support the Exchange Offer, subject to certain customary conditions, including a minimum participation condition requiring 100% of Existing Noteholders to participate in the Exchange Offer or Tender Offer/ Caroline Beasley, Chief Executive Officer of Beasley Media Group, said, "We are very pleased with the announcement of both the launch of this transaction and the support of a holder of approximately 73% of our outstanding indebtedness. We believe this transaction, when consummated, will provide meaningful long-term improvements to our balance sheet and provide value to debt holders and equity holders alike. This transaction is the product of several months of negotiations and represents a significant initial step forward in our long-term plan to reduce leverage and position the Company for future success."

07:05 EDT AxoGen completes submission of BLA to U.S. FDA for Avance Nerve Graft - Axogen announced that it has completed the rolling submission process for its Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for Avance Nerve Graft. The Company anticipates the FDA will notify the company regarding whether the submission is accepted for review and confirm the procedural review timeline within approximately the next 60 days. Avance Nerve Graft previously received Regenerative Medicine Advanced Therapy designation from the FDA. The RMAT designation, under the 21st Century Cures Act, aims to streamline the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions. The Company has requested priority review status for this BLA which, if granted, could reduce the review timeline from the standard 10-month to a priority 6-month review timeline from the date the submission is accepted by FDA. Based on this process, we believe we are on track for FDA determination of approvability between April and September of next year.

07:05 EDT Nasdaq announces new structure for Financial Crime Management Technology - Nasdaq announced a new leadership structure including leadership appointment for its Financial Crime Management Technology business, designed to support the business' strong momentum and continuing its growth trajectory. Effective today, Brendan Brothers, EVP, Head of Financial Crime Management Technology, and Verafin Co-Founder will step back from his current executive responsibilities and will transition into a senior strategic advisory role until at least December 31, 2024. Coinciding with Brothers' transition to an advisory role, Nasdaq will implement a new leadership structure for Financial Crime Management Technology with the establishment of an Executive Chair position. Stephanie Champion, current SVP and Head of Sales, will succeed Brothers as EVP and Head of Nasdaq Verafin, responsible for overseeing the business. Jeremy Skule, EVP and Nasdaq Chief Strategy Officer will take on an additional responsibility as Executive Chair of Financial Crime Management Technology. In this expanded role, Skule will support the development of Nasdaq Verafin's strategic roadmap, including its global business expansion, as well as provide guidance to the Nasdaq Verafin leadership team and continue to advance its integration and cross-sell objectives.

07:03 EDT Nasdaq reaffirms 2024 expectations, medium-term growth outlook - Nasdaq reaffirms its medium-term growth outlook for all divisions, sub-divisions, and AxiomSL and Calypso combined. Nasdaq also reaffirms all 2024 expectations shared in its second quarter 2024 earnings call and expects the Regulatory Technology sub-division to grow within its medium-term revenue growth outlook range for full-year 2024. Nasdaq will provide additional details in the accompanying presentation and publicly announced conference call on this topic.

07:02 EDT Zepp Health plans to implement ADS ratio change - Zepp Health announced that it will change the ratio of its American depositary shares to its Class A ordinary shares from one ADS representing four Class A ordinary shares to one ADS representing sixteen Class A ordinary shares. For the company's ADS holders, the change in the ADS Ratio will have the same effect as a one-for-four reverse ADS split. A post-effective amendment to the ADS Registration Statement on Form F-6 will be filed with the SEC to reflect the change in the ADS Ratio. The company anticipates that the change in the ADS Ratio will be effective on or about September 16, subject to the effectiveness of the post-effective amendment to the ADS Registration Statement on Form F-6 on or before that date.

06:55 EDT Wabash to explore all options in response to St. Louis circuit court verdict - Wabash announced it is evaluating all available legal options in response to the verdict by a St. Louis jury in Williams et al. v. Wabash. The case concerns a 2019 motor vehicle accident in which a passenger vehicle traveling at a high speed struck the back of a nearly stopped 2004 Wabash trailer. "While this was a tragic accident, we respectfully disagree with the jury's verdict and firmly believe it is not supported by the facts or the law," said Wabash's General Counsel and Chief Administrative Officer Kristin Glazner. "No rear impact guard or trailer safety technology has ever existed that would have made a difference here." The accident occurred nearly two decades after the trailer involved was manufactured by Wabash in compliance with all existing regulatory standards. Additionally, despite precedent to the contrary, the jury was prevented from hearing critical evidence in the case, including that the driver's blood alcohol level was over the legal limit at the time of the accident. The fact that neither the driver nor his passenger was wearing a seatbelt was also kept from the jury, even though plaintiffs argued both would have survived a 55-mile-per-hour collision had the vehicle not broken through the trailer's rear impact guard. Wabash stands firmly behind the quality and safety of all its products, and this ruling will not prevent the company from continuing to provide its customers with products that contribute to safer roads.

06:33 EDT KalVista presents sebetralstat data at Bradykinin Symposium 2024 - KalVista Pharmaceuticals announced that it presented additional analyses of the efficacy and safety of sebetralstat from phase 2 and phase 3 double-blind, placebo-controlled crossover clinical trials as well as interim data from KONFIDENT-S, a phase 3 open-label extension trial, and real-world patient data at the Bradykinin Symposium 2024 taking place in Berlin, Germany, on September 5-6. Sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adult and pediatric patients aged 12 years and older. "Delay or denial in the treatment of HAE attacks is often related to the administration of the currently approved injectable on-demand treatments which commonly result in injection-site reactions or pain. The data presented today highlight that oral sebetralstat may remove these challenges and has a safety profile no different than placebo," said Emel Aygoren-Pursun, MD, specialist in internal medicine at the Division of Oncology, Hematology and Hemostaseology at the Department for Children and Adolescents of the University Hospital Frankfurt, and a leading investigator for the phase 2, phase 3 KONFIDENT and KONFIDENT-S trials. "Sebetralstat also resulted in rapid symptom relief in the clinical trials. If approved, sebetralstat might become a major advance for people living with HAE by addressing critical gaps in the current standard of care for on-demand treatment of attacks." "We are encouraged by the observation of exceptional consistency of both safety and efficacy across the entire clinical program for sebetralstat for the on-demand treatment of HAE," said Paul Audhya, MD, MBA, Chief Medical Officer of KalVista Pharmaceuticals. "These data reinforce the potential for sebetralstat to transform the management of HAE."

06:21 EDT GSK announces Phase III trial of Nucala met primary endpoint - GSK announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala, a monoclonal antibody that targets interleukin-5, IL-5, in adults with chronic obstructive pulmonary disease, COPD. The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema, who were receiving optimized inhaled maintenance therapy. Participants were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count. MATINEE met its primary endpoint with the addition of Nucala to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks. The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing.

05:33 EDT Faraday Future receives noncompliance notification from Nasdaq - Faraday Future announced that it received written notice from Nasdaq stating that the company regained compliance with the bid price requirement in Nasdaq Listing Rule 5550 and the periodic filing requirement in Listing Rule 5250. The company is now in compliance with all Nasdaq continued listing criteria. As part of the compliance confirmation and in application of Listing Rule 5815, the company will be subject to a mandatory panel monitor for a period of one year from the date of the letter from Nasdaq dated September 4. If, during that time, the company falls out of compliance, Nasdaq will issue a non-compliance letter, and the company will be required to request a new hearing on the matter.

05:21 EDT BioCryst presents first interim real-word evidence from APeX-N trial - BioCryst announced the presentation of six posters, including the first interim real-word evidence from the APeX-N trial, and new data highlighting the value of shared decision making, or SDM, between healthcare providers, or HCPs, and their hereditary angioedema, or HAE, patients to provide optimal patient outcomes. APeX-N is a European multi-center observational study assessing the safety, effectiveness and quality of life of berotralstat 150 mg in routine clinical use. This interim analysis included 56 patients from the United Kingdom, France, Germany and Sweden. Non-serious gastrointestinal adverse events were reported in 12.5 percent of patients. Seven percent of patients discontinued treatment. One patient had a severe HAE attack but continued treatment. This study, conducted in Germany, explored the dynamics between HCPs and patients in HAE management, identifying barriers to SDM and strategies to improve it. Ten HCPs participated in 60-minute interviews and simulated patient consultations. Eight HAE patients participated in 30-minute interviews. Participants then convened in structured focus groups to discuss their findings. The participants identified a need for enhanced HCP awareness of patient perspectives, more comprehensive HCP-patient conversations and improved education about HAE treatment management.

05:11 EDT Qudian announces change of auditor - Qudian announced the appointment of BDO China Shu Lun Pan Certified Public Accountants as the company's independent registered public accounting firm, effective on September 6. BDO succeeds Ernst & Young Hua Ming, which previously was the independent auditor providing audit services to the company. The change of the company's independent auditor was made after careful consideration and was approved by the audit committee and the board of directors of the company. The company said the decision to change auditor was not as a result of any disagreement between the company and EY on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures.