Stockwinners Market Radar for September 27, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EDT Sonnet Biotherapeutics Holdings Inc trading halted, news pending

19:50 EDT ChinaNet Online trading halted, news pending

18:49 EDT Berkshire Hathaway sells 11.7M Bank of America shares for $460.7M - In a regulatory filing, Berkshire Hathaway (BRK.A) disclosed that its sold about 11.7M shares of Bank of America (BAC) stock valued at $460.7M over the period of September 25 to September 27.

17:35 EDT Pure Storage exec sells $1.26M in common stock - In a regulatory filing, Pure Storage disclosed that its Chief Accounting Officer Mona Chu sold 25K shares of common stock on September 25th in a total transaction size of $1.26M.

17:31 EDT Wesco director Raymund sells 5,819 common shares - In a regulatory filing, Wesco director Steven Raymund disclosed the sale of 5,819 common shares of the company on September 26 at a price of $171.563 per share.

17:22 EDT HP Enterprise CEO Neri sells 83,334 common shares - In a regulatory filing, HP Enterprise president and CEO Antonio Neri disclosed the sale of 83,334 common shares of the company on September 25 at a price of $19.7248 per share.

17:05 EDT Daxor to resubmit 510(k) application for blood volume analyzer platform - Daxor announces a strategic update to its regulatory approach for its novel diagnostic blood volume analyzer platform. Following productive discussions with the U.S. FDA, the company has decided to withdraw its current dual 510(k)/CLIA-waiver application and resubmit a focused 510(k) application. This decision comes after considerable progress in addressing key regulatory considerations and aims to expedite the approval process, potentially bringing this innovative technology to patients sooner. Daxor plans to pursue a separate CLIA-waiver application subsequently, allowing for a more targeted approach to each regulatory pathway. The company expects to submit the new 510(k) application in the coming quarter and will provide updates on its progress in the regulatory process, as appropriate.

16:46 EDT American Rebel announces 1-for-9 reverse stock split - American Rebel announced that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-9, to be effective as of 12:00 a.m. Eastern Time on October 2, 2024. The company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of The Nasdaq Capital Market on Wednesday, October 2, 2024. Following the reverse stock split, the common stock will continue to trade on Nasdaq under the symbol "AREB" with the new CUSIP number, 02919L505. The reverse stock split is intended for the company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on Nasdaq.

16:34 EDT Ensysce Biosciences receives Nasdaq notice - Ensysce Biosciences has received notice from the listing qualifications department staff of The Nasdaq Stock Market stating that the Company has not regained compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company's common stock has remained below $1.00 per share through the initial 180-day compliance period ended September 23, 2024. The Company is not eligible for a second 180-day period because it does not comply with the minimum stockholders' equity requirement for initial listing on The Nasdaq Capital Market. The Nasdaq Hearings Panel will consider this matter in rendering a determination regarding the Company's continued listing on The Nasdaq Capital Market at an upcoming hearing which will also consider the Company's non-compliance with the $2.5 million stockholders' equity requirement set forth in Nasdaq Listing Rule 5550(b)(1).

16:33 EDT Johnson & Johnson reports results from Phase 3 CARTITUDE-4 study - Johnson & Johnson announced long-term results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI significantly extended overall survival in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, reducing the risk of death by 45% versus standard therapies of pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone. With these data, CARVYKTI is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line.

16:32 EDT Poseida Therapeutics reports data from Phase 1 trial of P-BCMA-ALLO1 - Poseida Therapeutics announced new interim clinical data from its ongoing Phase 1 trial of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma. Data demonstrated a 91% overall response rate and compelling safety results in the 23 heavily pretreated patients in Arm C, an optimized lymphodepletion arm. The new clinical data were presented today in an oral session at the 21st International Myeloma Society Annual Meeting in Rio de Janeiro. "The compelling and differentiated results from the optimized lymphodepletion arms of the ongoing Phase 1 trial of P-BCMA-ALLO1 showed deep responses and a high response rate in patients with heavily pre-treated relapsed or refractory multiple myeloma, regardless of prior exposure to B-cell maturation antigen-targeting therapy. The high overall response rate of 91% is remarkable because most study participants in my center had rapidly proliferative refractory disease, in contrast with those treated in the pivotal clinical trials of FDA-approved autologous CAR-T therapies. Such patients treated in the current trial of P-BCMA ALLO1 would not have qualified for standard of care autologous CAR T therapy," said Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine, Malignant Hematology & Stem Cell Transplantation at Vanderbilt University Medical Center in Nashville, Tenn., and trial investigator. "All patients in the Phase 1 trial have been treated quickly once enrolled, with no waiting for manufacturing, with no need for apheresis or bridging therapy, demonstrating key advantages of allogeneic CAR-T cell therapy."

16:15 EDT SES AI receives continued listing notice from NYSE - SES AI Corporation announced that, on September 26, 2024, it had received a notice from the New York Stock Exchange that it is not in compliance with Section 802.01C of the NYSE Listed Company Manual because the average closing price of its Class A common stock was less than $1.00 per share over a period of 30 consecutive trading days, which is the minimum average closing price required to maintain continued listing on the NYSE. SES AI will respond to the NYSE within 10 business days of receipt of the notice regarding its intent to cure the deficiency and return to compliance with the NYSE continued listing requirements. The Company can regain compliance at any time within the six-month period following receipt of the NYSE notice if on the last trading day of any calendar month during the cure period the Company's Class A common stock has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month.

16:02 EDT flyExclusive names Brad Garner as CFO, Matt Lesmeister as COO - flyExclusive announced a number of key leadership appointments, adding additional experience to the company's executive leadership. Brad Garner joins flyExclusive as CFO, Matt Lesmeister will become COO, and Mike Guina will transition to Chief Commercial Officer, effective immediately. Garner joins flyExclusive from Hale Partnership Capital Management, a multi-strategy investment partnership with a focus on public equity, private equity and real estate, where he served as Chief Financial and Compliance Officer since 2015.

15:11 EDT FDA grants traditional approval to selpercatinib for MTC with RET mutation - The Food and Drug Administration announced it has granted traditional approval to selpercatinib, or Retevmo, from Eli Lilly, for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer, or MTC, with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. On May 29, 2024, the FDA granted accelerated approval for this indication to pediatric patients 2 years of age and older. Reference Link

14:24 EDT BOEM postpones Oregon offshore wind energy auction - The Bureau of Ocean Energy Management announced that it is delaying the offshore wind energy auction planned for potential lease areas offshore Oregon due to insufficient bidder interest at this time. On Aug. 29, 2024, the Department of the Interior announced the Final Sale Notice (FSN) for offshore wind leasing on the Outer Continental Shelf offshore Oregon following engagement through the Oregon Intergovernmental Renewable Energy Task Force, including coordination with the State of Oregon on advancing opportunities for leasing that would precede a multi-year process for site assessments and subsequent review of any specific project plans if submitted. The FSN set an auction date for Oct. 15, 2024, and included two lease areas offshore Oregon and identified the five companies qualified to participate in the sale. Following issuance of the FSN, BOEM received bidding interest from one of the five qualified companies. In determining a future opportunity for a potential lease sale, BOEM will continue to collaborate with representatives from federal, state and local agencies and Tribal governments, to coordinate on potential leasing and support ongoing stakeholder engagement processes on broader offshore wind considerations, such as the state-led development of a strategic roadmap for offshore wind. Shares of GE Vernova, which is a major player in offshore wind energy, are up fractionally in afternoon trading. Reference Link

13:17 EDT CN announces Unifor filed Notice of Dispute - CN announced that Unifor has filed a Notice of Dispute three days after the beginning of negotiations. "The Union represents 3,300 Mechanical, Clerical, and Intermodal employees in Canada across three collective agreements. The current collective agreements expire on December 31, 2024. While CN is disappointed that Unifor is filing the Notice so early in the process, the Company is committed to reaching negotiated agreements with the Union that are good for employees, customers, and the economy," CN stated.

13:01 EDT Baker Hughes reports U.S. rig count down 1 to 587 rigs - Baker Hughes reports that the U.S. rig count is down 1 from last week to 587 with oil rigs down 4 to 484, gas rigs up 3 to 99 and miscellaneous rigs unchanged at 4. The U.S. Rig Count is down 36 rigs from last year's count of 623 with oil rigs down 18, gas rigs down 17 and miscellaneous rigs down 1. The U.S. Offshore Rig Count is down 1 to 19, down 1 year-over-year. The Canada Rig Count is up 7 from last week to 218, with oil rigs up 8 to 152, gas rigs down 1 to 65 and miscellaneous rigs unchanged at 1. The Canada Rig Count is up 27 from last year's count of 191, with oil rigs up 37, gas rigs down 11 and miscellaneous rigs up 1.

12:15 EDT AbbVie submits BLA for Teliso-V in NSCLC with c-Met protein overexpression - AbbVie announced submission of a Biologics License Application to the U.S. Food and Drug Administration for accelerated approval of telisotuzumab vedotin in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer with c-Met protein overexpression. "Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology." In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA. The BLA submission is supported by data from Phase 2 LUMINOSITY trial, an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations. Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress and topline data from this trial were shared in 2023. Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.

12:00 EDT Zeekr rises 15.2% - Zeekr is up 15.2%, or $2.79 to $21.12.

12:00 EDT IonQ rises 17.4% - IonQ is up 17.4%, or $1.40 to $9.46.

12:00 EDT MeridianLink falls -7.2% - MeridianLink is down -7.2%, or -$1.66 to $21.26.

11:22 EDT Onconetix rallies after Altos Venture reports 32.5% stake - Onconetix is moving higher after Altos Venture last night disclosed a 32.5% in the company, which represents over 2.69M shares. The filing with the SEC allows for activism. Onconetix in late morning trading is up 54%, or $1.80, to $5.16.

11:03 EDT Cytokinetics presents additional data from SEQUOIA-HCM - Cytokinetics announced that additional data from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy, were presented at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania. A new analysis from SEQUOIA-HCM showed that treatment with aficamten was associated with beneficial changes in five indices reflecting structural, electrophysiologic and biomarker changes in patients from SEQUOIA-HCM. This analysis was performed in patients treated with aficamten and compared to placebo, at 24 weeks as follows: Improvement in maximal wall thickness by greater than or equal to1.5 mm (n = 282; 47.9% vs 30.7%; p=0.003); Improvement in left atrial volume index category in those with mild, moderate, or severe enlargement at baseline (n = 185; 46.8% vs. 18.7%; pless than0.001); Resolution of ECG changes consistent with left ventricular hypertrophy (n = 282; 19.0% vs. 4.3%; pless than0.001); Normalization of hyperdynamic left ventricular ejection fraction into the normal range (n = 282; 35.2% vs 20.7%; pless than0.007); Reduction in NT-proBNP by greater than or equal to 50% from baseline (n = 282; 81.7% vs. 7.1%; pless than0.001). Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (pless than0.001, NNT = 2.2). "This new analysis evaluated clinical data from SEQUOIA-HCM through the lens of remodeling to characterize the impact of treatment with aficamten in patients with obstructive HCM in terms of structural and functional changes. The results demonstrated favorable remodeling across multiple domains, including cardiac structure and function, electrophysiology and biochemistry," said Stephen Heitner, M.D., Vice President, Head of Clinical Research. "We are encouraged by these findings, and we look forward to further expanding our understanding of the long-term clinical outcomes of treatment with aficamten through our continued conduct of FOREST-HCM, the open-label extension clinical study."

10:27 EDT Sandvik divests engineer-to-order business of DWFritz Automation - At the Capital Markets Day 2023, Sandvik communicated the intention to increase the focus on software solutions and enabling hardware in the Sandvik Manufacturing Solutions offering. Furthermore, Sandvik communicated a revised additive manufacturing strategy to focus mainly on metal powders. As a consequence of these changes in strategic direction, the engineer-to-order business of DWFritz Automation has been divested and the decision to seek an exit of the minority stake in BEAMIT has been made during the quarter. Charges totaling approximately SEK 390M will be accounted for in the third quarter and reported as items affecting comparability. Out of the total charges, approximately SEK 250M relates to a capital loss, including transactional costs, from the divestment of DWFritz, and about SEK 140M relates to a write-down of the stake in BEAMIT. Sandvik has divested the engineer-to-order business of DWFritz to the U.S.-based private equity firm Balmoral Funds. Sandvik acquired DWFritz in 2021, with the intention to grow the ZeroTouch business of DWFritz. The ZeroTouch platform is a unique inspection gauging equipment enabling near-line and in-line metrology and is an important part of the closed loop strategy. Since the acquisition, Sandvik has developed and started to commercialize ZeroTouch, which will not be part of the divestment but remain a part of Sandvik. Additionally, Sandvik has decided to seek an exit of its minority stake in the Italian additive manufacturing service provider BEAMIT. The decision to seek an exit is in line with Sandvik's revised additive manufacturing strategy to focus mainly on metal powders. DWFritz and the BEAMIT holding have both been reported within business area Sandvik Manufacturing and Machining Solutions.

10:16 EDT Honeywell boosts annual dividend to $4.52 from $4.32 per share - Honeywell said it has approved an increase in the company's regular annual cash dividend from $4.32 to $4.52 per share. The increase will be effective starting with the Q4 dividend of $1.13 per share, which was declared today, and is payable on December 6, out of surplus to holders of record at the close of business on November 15. "By further aligning our portfolio with the three compelling megatrends - automation, the future of aviation, and the energy transition - we continue accelerating progress against our disciplined commitment to deploy at least $25 billion toward dividends, acquisitions, capital expenditures and share buybacks through 2025," said Vimal Kapur, CEO of Honeywell. "This marks the 15th time in 14 consecutive years that we are increasing our dividend as we remain focused on delivering value for our shareholders.'

10:00 EDT ReposiTrak falls -5.6% - ReposiTrak is down -5.6%, or -$1.11 to $18.76.

10:00 EDT MeridianLink falls -7.8% - MeridianLink is down -7.8%, or -$1.78 to $21.14.

10:00 EDT AMTD Digital rises 10.4% - AMTD Digital is up 10.4%, or 34c to $3.63.

09:48 EDT Studio City falls -5.2% - Studio City is down -5.2%, or -39c to $7.12.

09:47 EDT Vail Resorts falls -6.4% - Vail Resorts is down -6.4%, or -$12.11 to $175.84.

09:47 EDT IonQ rises 9.4% - IonQ is up 9.4%, or 76c to $8.82.

09:37 EDT Regeneron, Sanofi announce Dupixent approved in U.S. for COPD patients - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease, or COPD, and an eosinophilic phenotype. "Dupixent is the first biologic medicine approved in the U.S. to treat these patients," the companies stated. "This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the U.S. who can sometimes struggle just to breathe during their everyday lives. Dupixent has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory related diseases such as asthma and atopic dermatitis. This latest approval represents an important next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in Phase 3 trials," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent.

09:30 EDT Qifu Technology says short seller report is 'without merit' - Qifu Technology issues the following preliminary responses to the key claims made in a report by Grizzly Research, a short seller, on September 26, 2024. The company said, "The Company believes that the Report is without merit and contains inaccurate information, flawed analyses, misleading conclusions and interpretations regarding information relating to the Company. Specifically: The SAMR Financial Data Used in the Report is Completely Wrong...Rebuttal of Unsubstantiated Media Reports about the Company's Regional Headquarters...Rebuttal of Unsubstantiated Financial Manipulation Claim and Relationship between Shanghai Qibutianxia and the Company...Rebuttal of Unsubstantiated Claim about Delinquency Rates and Provisions...Non-Risk-Bearing Loans are Irrelevant to Leverage Ratio...Rebuttal of Unsubstantiated Claim About Loan Annual Interest Rates...The Company emphasizes its continued and unwavering commitment to maintaining high standards of corporate governance and internal control, as well as transparent and timely disclosure in compliance with applicable rules and regulations. To protect the interests of the Company and its shareholders, the Company will vigorously defend itself against false and baseless claims made by short seller reports. The Company's board of directors, including the audit committee, is reviewing the allegations and considering the appropriate course of action to protect the interests of all shareholders. The Company will make additional disclosures in due course consistent with the requirements of applicable rules and regulations of the U.S. Securities and Exchange Commission, The Nasdaq Stock Market, and The Stock Exchange of Hong Kong Limited."

09:18 EDT Acadia allocating $100M in additional technology investments - Acadia Healthcare said it is "committed to doing everything in its power to ensure that all patients in Acadia's care receive the support and compassionate treatment they deserve." The company is expanding its organizational structure "with new roles critical to providing safe, quality care," allocating approximately $100M in additional technology investments "that enhance patient and staff safety as well as care coordination, such as electronic medical records systems, a wearable remote patient monitoring system," incorporating new field-based training programs for frontline caregivers, and standardizing clinical protocols and oversight. "These actions are already starting to deliver positive results. For example, more patients have expressed feelings of safety, hope and healing when rating their care in our facilities; our patient experience scores have meaningfully increased in just one year; and across our 161 CTC Opioid Treatment Programs, we scored greater than99% against all 13 dimensions of quality as measured by CARF, a leading accreditation body for behavioral health facilities," Acadia added.

09:14 EDT Acadia says media reports 'completely inconsistent' with protocols - Acadia Healthcare said in a statement, "During the last several weeks, media has reported on patients who have shared troubling experiences at Acadia's facilities. As reported, these experiences are completely inconsistent with Acadia's policies and protocols. Furthermore, reporting on these issues has not reflected the many clinical considerations that inform the appropriate care for a person facing a mental health crisis, including whether and for how long they should receive direct care in a facility. These are complex medical decisions, and all decisions on patient care, including whether treatment is necessary and for how long, are made by licensed physicians, and in accordance with stringent state, federal and other regulations. At Acadia, decisions on patient care are not business decisions - they are medical ones - and these decisions are not in any way related to or influenced by insurance coverage or a patient's ability to pay. In fact, in 2023 alone, Acadia provided millions of dollars in care for which the Company was not reimbursed by insurance companies, Medicaid or Medicare, but that Acadia felt was critical to ensuring the best outcomes for patients."

09:07 EDT Gryphon Digital Mining CFO Sim Salzman to continue in role - Gryphon Digital Mining announced that Sim Salzman will continue in his role as CFO. Sim's decision to remain with Gryphon follows the company's recent efforts to bolster its management team and board, which included appointing Steve Gutterman as CEO and Jimmy Vaipoulos as Chairman.Sim Salzman has served as Gryphon's CFO since the closing of the business combination with Akerna Corp. and joined Legacy Gryphon's management team as the CFO on June 19, 2023

09:03 EDT Allied Gaming & Entertainment responds to filing by Ourgame International - Allied Gaming & Entertainment acknowledges a recent filing by Ourgame International Holdings Limited, one of AGAE's shareholders, which also references a legal letter that Ourgame sent to AGAE's Board of Directors. In the filing and letter, Ourgame expressed opposition to certain actions recently taken by AGAE's Board of Directors and management, citing concerns over the impact on their interests as a shareholder. The Company respects and values the opinions of all its shareholders and remains committed to engaging with them in an open and constructive manner. While AGAE is actively responding to the requests in the letter, it firmly disagrees with Ourgame's characterization of the Board's recent decisions.

09:02 EDT Alumis announces 28-week data from OLE period of Phase 2 STRIDE trial - Alumis announced 28-week data from the open-label extension period of its Phase 2 STRIDE clinical trial of ESK-001. These data were presented during a late-breaking oral session at the 2024 European Academy of Dermatology & Venereology Congress held September 25-29 in Amsterdam, Netherlands. ESK-001 is a highly selective allosteric oral tyrosine kinase 2 inhibitor currently being evaluated in the Phase 3 ONWARD clinical program for the treatment of moderate-to-severe plaque psoriasis. The interim 28-week OLE data showed dose-dependent sustained increases in Psoriasis Area and Severity Score endpoint responses observed over time, with the majority of patients achieving PASI 75, the primary endpoint, at the highest dose of 40 mg twice daily. ESK-001 continued to show a favorable safety profile in the OLE. Treatment emergent adverse event frequency and severity were similar across study arms, with the majority being mild-to-moderate and self-limited. In both the Phase 2 STRIDE clinical trial and the ongoing OLE, the most common TEAEs were upper respiratory tract infections, nasopharyngitis, and headaches. Alumis presented three additional abstracts this week at EADV. An oral presentation highlighting biomarker data from the Phase 2 STRIDE clinical trial and an e-poster summarizing exploratory exposure response analyses from ESK-001 clinical trials present evidence indicating the 40 mg twice daily dose, which achieves maximal target inhibition according to blood and skin biopsy biomarkers, leads to the highest response rates. These findings support use of the 40 mg twice daily dose in the ongoing Phase 3 clinical program. Also, an e-poster described data that associated positive efficacy and safety outcomes in the Phase 2 STRIDE clinical trial and OLE with significant improvements in patients reported quality of life and psoriasis-associated pruritus with clear, dose-dependent improvement observed.

08:51 EDT Foresight Autonomous signs multi-phase collaboration agreement with BuilderX - Foresight Autonomous announced the signing of multi-phase collaboration agreement with BuilderX. BuilderX's products enable real-time remote operation and monitoring of heavy machinery through remote controlled consoles, utilizing multiple cameras mounted on the heavy machinery. The collaboration agreement follows the completion of a proof-of concept project reported by the Company on July 10, 2024. The project aimed to address key challenges in diverse industrial operations, including the presence of hazardous chemicals and gases that can be toxic, severe dust conditions that pose significant health risks to human operators, and poor visibility conditions caused by intensive dust, glare, or insufficient lighting that can impair operator vision and increase the risk of accidents. BuilderX presented Foresight's technology to its customers, receiving positive feedback regarding its potential for integration into industrial and heavy machinery applications. The parties will cooperate to develop and commercialize advanced 3D perception solutions for construction machinery and equipment, based on Foresight's stereoscopic technology, using mainly visible-light cameras, to be integrated into BuilderX remote-controlled consoles. In the longer term, the parties will collaborate to integrate Foresight's perception capabilities, utilizing both visible-light and thermal cameras, into BuilderX's autonomous heavy machinery equipment. This integration is expected to potentially enhance full autonomous driving capabilities in harsh industrial environmental conditions.

08:40 EDT Hyliion's KARNO linear generator qualifies under California's RPS - Hyliion Holdings announced that its innovative KARNO linear generator is now an eligible technology under California's Renewables Portfolio Standard, RPS, following the passage of Assembly Bill 1921 by Governor Newsom. This inclusion allows the KARNO technology to play a pivotal role in delivering low-emission energy solutions, using renewable fuels such as landfill gas, biogas, hydrogen, and others to meet California's climate goals.

08:39 EDT Acadia Healthcare issues statement regarding government investigation - Acadia Healthcare Company issued the following statement with respect to a government investigation separately disclosed by the Company. Acadia is cooperating fully with the authorities regarding this matter. "Ensuring we provide the highest quality of care is personal for me and the number one priority for my colleagues across the Company," said Acadia Chief Executive Officer Chris Hunter. "We take seriously our patient care and compliance responsibilities and understand how critical it is to provide these services with excellence and compassion. We're committed to taking action on incidents that fall short of our rigorous standards and are making investments necessary to establish Acadia as the leading behavioral healthcare provider for high-acuity and complex needs patients."

08:38 EDT Acadia received voluntary request for information, grand jury subpoena - In a regulatory filing, Acadia Healthcare disclosed that on September 24, the company received a voluntary request for information from the United States Attorney's Office for the Southern District of New York as well as a grand jury subpoena from the United States District Court for the Western District of Missouri related to its admissions, length of stay and billing practices. "In addition, Lakeland Hospital Acquisition, LLC, a subsidiary of Acadia, also received a grand jury subpoena from W.D.Mo. on the same day regarding similar subject matter. Acadia anticipates receiving similar document requests from the U.S. Securities and Exchange Commission and may receive additional document requests from other governmental agencies. Acadia is fully cooperating with authorities and, at this time, cannot speculate on whether the outcome of these investigations will have any impact on its business or operations," the company stated in the filing with the SEC. Reference Link

08:36 EDT Aquestive Therapeutics spotlights epinephrine delivery pipeline at Investor Day - Aquestive Therapeutics hosted a virtual investor day highlighting the Company's pipeline inclusive of Anaphyl Sublingual Film and AQST-108 Topical Gel, both product candidates emerging from the Company's Adrenaverse epinephrine prodrug platform. The event included presentations by members of the Aquestive management team and by distinguished key opinion leader J. David Farrar, PhD, Associate Professor, Immunology/Molecular Biology, UT Southwestern Medical Center. "Our pipeline is progressing, and we are excited about the next chapter for growth. We recently submitted our pre-NDA meeting request to the FDA for Anaphylm and are on track to report topline data from our oral allergy challenge study in the coming weeks," remarked Daniel Barber, CEO. "This is an exciting time for the Company and for our stakeholders, most importantly the patients we seek to help. As our next step for the Adrenaverse platform, we will focus on developing AQST-108 for the treatment Alopecia areata, based on our candidate's differentiated therapeutic profile and significant unmet need in this indication." Aquestive outlined that it has completed enrollment in its remaining supportive study for Anaphylm, the oral allergy syndrome challenge study, which is expected to be completed in the fourth quarter of 2024 following the completion of dosing. The Company remains on track to hold the pre-New Drug Application meeting with the U.S. Food and Drug Administration in the fourth quarter of 2024 as it has recently submitted a meeting request letter to the FDA. Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026. The Company completed its first human clinical study for AQST-108. The two-part study was designed to assess the safety and local tolerability of AQST-108. Part 1 was designed as a single ascending dose escalation study to assess the safety and pharmacokinetics of five different dose levels. The 1.0% dose of AQST-108 was chosen based on the highest dose found with no appreciable transdermal absorption in order to move into the Part 2 study of the development program. In Part 2, three formulations based on excipient variations were evaluated in twelve healthy subjects. In Parts 1 and 2, no serious adverse events or topical adverse events were observed. In Part 2, the calculated percentage of AQST-108 observed in the skin remained consistent across all studied formulations and zero post dose AQST-108 concentrations in plasma were observed. Aquestive unveiled in the event its plan to develop AQST-108 for the treatment of Alopecia areata, which impacts as many as 6.7 million people in United States. AQST-108, a topically delivered adrenergic agonist prodrug, has the potential to support immune privilege in the hair follicle. The Company outlined the design of its planned Phase 2 study to assess the safety and efficacy of AQST-108 in mild to moderate Alopecia areata patients. The Company expects to hold a pre-Investigational New Drug meeting with the FDA in the first quarter of 2025 and to commence the Phase 2 study in the second half of 2025, pending alignment with the FDA.

08:32 EDT Omnicom unit acquires LeapPoint, terms not disclosed - Omnicom announced its precision marketing division, Omnicom Precision Marketing Group, acquired LeapPoint, a digital advisory firm focused on helping organizations improve the orchestration and performance of their entire marketing lifecycle. The move is part of OPMG's strategic efforts to offer the industry's most comprehensive end-to-end content solution, empowering marketers to accelerate workflows and deliver personalized experiences to their customers at speed and scale.

08:31 EDT Coherent announces sale of UK manufacturing facility following strategic review - Coherent announced the sale of its manufacturing facility in Newton Aycliffe, County Durham, UK. The sale is part of the company's ongoing efforts to streamline operations and optimize its global footprint. "Divesting the Newton Aycliffe plant is part of our effort to optimize our portfolio and streamline our operations, which allows us to focus our investment and capital on the areas of greatest long-term growth and profitability for the company," said Jim Anderson, CEO. The 310,000 square feet plant, located in Aycliffe Business Park, was acquired by the former II VI Incorporated in 2017. Macquarie Semiconductor and Technology, a unit within Macquarie Group's Commodities and Global Markets division, served as transaction consultant to Coherent; Taylor Wessing served as legal advisors to Coherent.

08:22 EDT Aditxt announces 1-for-40 reverse stock split - Aditxt announced that it will effect a 1-for-40 reverse split of its common stock. Commencing with the opening of trading on the Nasdaq Capital Market on October 2, 2024, the Company's common stock will trade on a post-split basis under the same symbol ADTX. The reverse stock split was approved by the Company's stockholders at the annual meeting held on August 7, 2024, with the final ratio determined by the Company's board of directors.

08:16 EDT Blink Charging surpasses 100,000 charger milestone - Blink Charging has surpassed 100,000 chargers sold, deployed, or contracted globally. "We're proud to reach this significant accomplishment through dedicated pursuit of our mission to advance the energy transition through Blink's innovative charging solutions," said Brendan Jones, Blink's President and CEO. "By prioritizing, listening to, and understanding our customers' needs and expectations, we have learned to strategically tailor charger placement and installation, so that the right charger is in the right place at the right time for every EV driver."

08:12 EDT Expanse Studios announces participation in SBC Summit Lisbon 2024 - Expanse Studios announced participation in the SBC Summit Lisbon 2024, held from September 24-26 at the Feira Internacional de Lisboa. The event, which saw a record-breaking attendance of 25,000 industry professionals, served as a launchpad for Expanse Studios' latest innovations, catalyzing discussions with over 20 potential partners. "Our presence at SBC Summit Lisbon 2024 has been nothing short of extraordinary," said Damjan Stamenkovic, CEO of Expanse Studios. "The unprecedented scale of this year's event in Lisbon provided an ideal backdrop for us to showcase our cutting-edge games and engage with key industry players. We're thrilled to report that our booth was a hub of activity, with more than 20 operators expressing keen interest in our offerings and engaging in promising talks about potential collaborations." Expanse Studios exhibited in Hall 2, where the company introduced two game-changing titles that captivated attendees: "Beach Penalties" - Expanse Studios' first game specifically designed and launched for the social casino category, marking a significant milestone in the company's strategic expansion into the rapidly growing social gaming market. While Expanse's extensive portfolio has always been adaptable for social casino platforms, "Beach Penalties" represents the studio's first title tailored from the ground up for this segment. "Super Heli" - A high-octane crash game dubbed "the diamond of crash games" by the public, that generated incredible buzz among operators and players alike. Both titles garnered substantial attention, reflecting the industry's growing appetite for innovative gaming content that pushes boundaries and engages players in new ways. The level of interest shown by operators at the event underscores Expanse Studios' growing influence in the iGaming sector. With the number of talks and pending agreements, the company is optimistic about the prospects these discussions present for future growth and market expansion.

08:10 EDT Savara announces EAP for molgramostim for patients with aPAP - Savara announced the Savara Early Access Program, a molgramostim Expanded Access Program, EAP, for patients with Autoimmune Pulmonary Alveolar Proteinosis, aPAP. The program enables physicians to request molgramostim for eligible aPAP patients in select geographies where the product is not commercially available and in compliance with local regulatory requirements. "Expanded access is granted to investigational products that address a serious condition for which there are no comparable therapies available," said Matt Pauls, Chair and CEO of Savara. "Given the high unmet need in aPAP, and positive results demonstrated in the Phase 3 IMPALA-2 clinical trial, we felt it was critically important to establish the Savara Early Access Program to allow eligible aPAP patients pre-approval access to molgramostim. This program reflects our ongoing commitment to the global aPAP community and the goal of potentially delivering an effective therapy for patients with this rare lung disease as quickly as possible."

08:08 EDT EQV Ventures announces separate trading of Class A shares, warrants - EQV Ventures Acquisition announced that, effective immediately, holders of the units sold in the Company's initial public offering may elect to separately trade the Class A ordinary shares and warrants included in the units. The Class A ordinary shares and warrants that are separated will trade on the New York Stock Exchange under the symbols "EQV" and "EQVW," respectively. Those units not separated will continue to trade on NYSE under the symbol "EQVU." Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company's transfer agent, to separate the units into Class A ordinary shares and warrants.

08:07 EDT Lexicon to present Phase 3 trial design for sotagliflozin in HCM - Lexicon Pharmaceuticals will unveil study design details of SONATA-HCM, the company's Phase 3 clinical trial of sotagliflozin as a potential new treatment for adults with hypertrophic cardiomyopathy, at the virtual Hypertrophic Cardiomyopathy Medical Society 2024 Scientific Sessions. Lexicon plans to conduct the multinational study at 130 sites in 20 countries and enroll adults aged 18 years or older diagnosed with symptomatic HCM, either obstructive or non-obstructive. Initial study sites have been activated and patient randomization is underway. Details for the presentation on "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy" is as follows: HCMS - a moderated poster presentation, Friday, September 27, 2:00-2:30p.m. ET, presented by Carolyn Y. Ho, M.D., Cardiology, Brigham and Women's Hospital, Boston, MA

08:05 EDT Lifetime Brands signs agreement to expand offerings in Mikasa Hospitality - Lifetime Brands has signed an agreement to expand its product offerings within its Mikasa Hospitality division to distribute and market the Royal Leerdam and ONIS brands. Both brands are part of the renowned European glass producer Leerdam Crisal Glass, which boasts a rich heritage rooted in the historic glassmaking cities of Leerdam and Marinha Grande. Lifetime continues to validate its growth strategy with execution through investment in the high growth business line of Commercial Food Services, evident in the new agreement in glassware. With the addition of these brands Lifetime expects to grow its share of the $2 billion addressable market in commercial food services. Importantly, the new product offerings are expected to begin shipping in 2024 and we believe the agreement with Royal Leerdam and ONIS will generate additional revenue in Commercial Food Services for Lifetime's Mikasa Hospitality division.

08:04 EDT KB Home announces grand opening of West Magnolia - KB Home announced the grand opening of West Magnolia, a new community of two-story homes in desirable Marysville, Washington. West Magnolia offers personalized, new homes in the Seattle area with family friendly community amenities and close to outdoor recreation, priced from the $670,000s.

08:04 EDT KB Home announces the grand opening of Red Bend - KB Home announced the grand opening of Red Bend, a new community in a prime southwest Las Vegas location. Red Bend offers personalized, spacious, new homes close to family friendly parks and resorts, priced from the $480,000s.

07:39 EDT Mira Pharmaceuticals presents preclinical data for Ketamir-2 - MIRA Pharmaceuticals announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA. The presentation, entitled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models. Neuropathic pain, caused by nerve damage or dysfunction, remains a major challenge in pain management due to the limited efficacy and significant side effects of current therapies. Ketamir-2 a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 given orally, demonstrated superior efficacy compared to ketamine, achieving 100% reversal of pain responses, representing a full normalization of the response. These findings underscore Ketamir-2's potential as a breakthrough therapy for neuropathic pain, providing more consistent pain relief with reduced risk of adverse effects. MIRA is advancing the development of Ketamir-2 through ongoing preclinical studies and is preparing to publish its findings in peer-reviewed journals. The company remains on track to submit an Investigational New Drug application to the U.S. FDA by December 2024, with plans to demonstrate an efficacy signal in humans as early as 2025. To achieve this, MIRA has designed strategic Phase I/II studies aimed at showcasing Ketamir-2's clinical effectiveness in treating neuropathic pain and potentially other neurological conditions. This approach underscores the company's commitment to accelerating the pathway to clinical success, delivering early and impactful data that will drive timely decision-making and help expedite patient access to innovative treatments.

07:34 EDT Beyond Air terminates loan, security agreements with Avenue Capital - Beyond Air has terminated the loan and security agreements with Avenue Capital and entered into an $11.5 million loan agreement with an insider-led investor group. Beyond Air and Avenue Capital have reached an agreement to extinguish the Avenue Capital senior secured term loan for a one-time payment of $17.85 million. This agreement eliminates the debt and interest payments that would have been made to Avenue Capital from October 1, 2024 through June 30, 2026 of $12.0 million. In addition, Avenue Capital is investing $3.35 million in Beyond Air through the private placement equity offering also announced today. The Company entered into a $11.5 million royalty funding agreement led by certain Beyond Air board members based on net sales of LungFit PH. This debt will carry a payment-in-kind interest rate of 15% until July 2026. Payments for interest and principal will commence in July 2026 and be determined based on an 8% royalty rate on sales of LungFit PH. Payments will continue until principal and accrued interest are paid off. Since July 1, 2024, Beyond Air has increased the number of hospital contracts by 60%, including a contract with the U.S. Naval Hospital Guam, made possible through the Company's collaboration with TrillaMed. The Company believes the retirement of the Avenue debt the royalty based loan and concurrent equity financing will provide sufficient cash runway to support its operations through June 2026. The Company is withdrawing its previous revenue guidance for fiscal year 2025.

07:24 EDT Jeffs' Brands' Fort Products selected by Amazon UK as key account - Jeffs' Brands announced that its subsidiary, Fort Products, has been classified as a Key Account, granting eligibility for the Amazon Top Seller Program. This accomplishment, announced on September 23, 2024, emphasizes Fort Products' solid performance and growth potential within Amazon's marketplace.

07:06 EDT Tonix issued U.S. patent covering subcutaneous delivery of Zembrace SymTouch - Tonix Pharmaceuticals announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,097,183 to the Company on September 24, 2024. The patent, entitled "Pharmaceutical Composition for Treating Migraine", claims use of a pre-filled autoinjector comprising a composition of Zembrace SymTouch for treating migraines via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to provide protection into 2036.

07:03 EDT Regeneron, Sanofi announce Dupixent approval in China for patients with COPD - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the National Medical Products Administration in China has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist, or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has been approved in more than 30 countries worldwide, including the 27 countries in the European Union The approval is based on results from the landmark BOREAS and NOTUS Phase 3 trials, which evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with raised blood eosinophils. All patients were on background maximal standard-of-care inhaled therapy. Dupixent significantly reduced COPD exacerbations by 30% and 34% compared to placebo in the BOREAS and NOTUS trials respectively. Dupixent significantly and rapidly improved lung function compared to placebo, with improvements sustained at 52 weeks. Improvements in health-related quality of life compared to placebo were also observed, as assessed by the St. George's Respiratory Questionnaire. Data from both trials were published in separate manuscripts in The New England Journal of Medicine. Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Additional adverse reactions of injection site bruising, injection site induration, injection site rash and injection site dermatitis were reported in the COPD trials. Adverse events more commonly observed with Dupixent compared to placebo in either COPD trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis.

06:33 EDT Hyzon Motors regains compliance with Nasdaq listing standards - Hyzon received notification from the Nasdaq Hearings Department on September 26, 2024 that the Company has regained compliance with all applicable Nasdaq Capital Markets listing requirements and has fully cured its prior bid price deficiencies.

06:31 EDT Ault Disruptive Technologies to redeem shares, will not pursue combination - Ault Disruptive Technologies, a publicly-traded special purpose acquisition company, announced that its board of directors has determined to redeem all of its outstanding shares of common stock because the company will not consummate an initial business combination within the time period required by its Amended and Restated Certificate of Incorporation. The estimated per-share redemption price for the public shares will be approximately $11.18. The last day that the company's securities will trade on the New York Stock Exchange American is expected to be October 10, 2024. Effective as of the close of business on October 11, 2024, the public shares will be deemed cancelled and will represent only the right to receive the Redemption Amount.

06:02 EDT Ideaya Biosciences announces inducement grants under Nasdaq listing rule - IDEAYA Biosciences announced that, on September 26, 2024, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 140,000 shares of the Company's common stock to a newly hired employee. The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan as an inducement material to such individual entering into employment with IDEAYA in accordance with Nasdaq Listing Rule 5635(c)(4).The stock options have an exercise price of $30.50 per share, which is equal to the closing price of IDEAYA's common stock on The Nasdaq Global Select Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter. Vesting of the stock options is subject to such employee's continued service to IDEAYA on each vesting date.

05:57 EDT Bristol Myers announces FDA approval of COBENFY - Bristol Myers Squibb announced that the U.S. FDA has approved COBENFY, an oral medication for the treatment of schizophrenia in adults. COBENFY represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.

05:42 EDT Oracle reveals 29% stake in Ampere with option to own - Oracle this week revealed a 29% stake in server CPU design startup Ampere and said it can exercise future investments options that would give it control of the chipmaker. In a regulatory filing, Oracle said in addition to equity in the startup, it invested $600M in the fiscal year ended May 31 in convertible debt issued by Ampere after $400M in such debt in fiscal 2023. The debt matures in June 2026 and if exercised with options through January 2027 to acquire additional equity, Oracle would "obtain control of Ampere and consolidate its results with our results of operations." In addition, Oracle announced that Ampere founder and CEO Renee James won't run for reelection as a director at the company's annual meeting on November 14. Vishal Sikka, founder and CEO of Vianai Systems, also is leaving the board, which reduces the size of the board to 13 members from 15. Bloomberg previously reported that Ampere has been working with a financial advisor over the past few months regarding a potential sale and that it was open to talks with a larger industry player on a potential transaction.