Core Insights - Actinium Pharmaceuticals is advancing its clinical programs for Actimab-A, Iomab-ACT, and Iomab-B, with significant regulatory updates and financial results reported for Q3 2024 [1][2][6] Regulatory and Development Updates - Actinium has aligned with the FDA on a seamless Phase 2/3 trial for Actimab-A combined with CLAG-M for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3] - Actimab-A has been selected for the National Cancer Institute's myeloMATCH precision medicine program targeting AML and myelodysplastic syndromes [1][4] - The FDA has cleared two IND applications for Iomab-ACT, including a commercial CAR-T trial and a sickle cell transplant trial, with proof-of-concept data expected in 2025 [1][4] - Actinium is seeking a U.S. strategic partner for Iomab-B to conduct a Phase 3 trial based on FDA guidance [1][5] Financial Performance - As of September 30, 2024, Actinium reported cash and cash equivalents of approximately $78.6 million, expected to fund operations into 2027 [1][6] - Research and development expenses decreased to $9.8 million in Q3 2024 from $11.6 million in Q3 2023, primarily due to lower CMC expenses [7] - General and administrative expenses increased slightly to $2.8 million in Q3 2024, attributed to higher non-cash stock compensation [8] - The net loss for Q3 2024 was $11.6 million, a decrease from $13.3 million in Q3 2023, due to lower R&D expenses [11]

Core Insights - Lipocine Inc. announced the publication of a Phase 2 trial manuscript for LPCN 1148, which shows promise in treating sarcopenia and hepatic encephalopathy in male patients with cirrhosis [1][2][5] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing therapeutics through effective oral delivery, with a proprietary technology platform [1][12] - The company has multiple drug candidates in development, including LPCN 1148, which targets liver cirrhosis and its complications [12][13] Clinical Trial Details - The Phase 2 trial (LPCN 1148-21-001) was conducted in two stages: a double-blind, placebo-controlled stage followed by a single-arm open-label extension [2] - The trial specifically evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation [2] Key Findings - At 24 weeks, LPCN 1148 therapy significantly improved sarcopenia compared to placebo, and participants experienced fewer episodes of overt hepatic encephalopathy [3] - Additional benefits included improvements in muscle quality, hemoglobin levels, and patient-reported symptoms [3] Industry Context - Cirrhosis is a severe liver disease with limited treatment options, affecting over 382,000 patients in the US, many of whom are awaiting liver transplants [6][7] - Overt hepatic encephalopathy is a common and debilitating complication of liver disease, with a high recurrence rate and significant impact on patient quality of life [8][9][10]

Core Insights - TruGolf Holdings, Inc. reported a strong third quarter in 2024 with sales reaching $6,236,795, marking an 82% increase compared to the same quarter in 2023. The company achieved an EBITDA of $1.1 million despite having no franchising revenues recognized [1][2]. Financial Performance - The gross margin for Q3 2024 was 69%, up from 55% in Q3 2023. Year-to-date gross margin stood at 66%, slightly down from 67% in the same period last year [3]. - Operating income for Q3 2024 was $872,000, a significant improvement of 137% compared to an operating loss of $2.3 million in Q3 2023. Year-to-date operating loss decreased by 87% to $856,000 from $6.8 million in the same period last year [3]. - Year-to-date 2024 free cash flow was $3.1 million, compared to a negative $6.1 million in the same period of 2023 [3]. Growth Initiatives - The company has launched a franchise concept with 120 franchise locations committed across the United States, which is expected to enhance user engagement with the sport and support technology sales growth [2]. - TruGolf has revised its full-year revenue target for 2024, expecting total revenue growth of 9%-13% compared to 2023 levels, with EBITDA for the second half of 2024 estimated between $1.1 million to $1.5 million [2]. Cash and Assets - As of September 30, 2024, TruGolf's current assets totaled $14,417,544, an increase from $12,656,606 at the end of 2023. Cash and cash equivalents were reported at $7,452,185, up from $3,297,564 [6][7]. - Total assets increased to $17,039,690 from $15,769,560 at the end of 2023 [7]. Liabilities - Total current liabilities rose to $16,153,607 from $10,668,339 at the end of 2023, indicating an increase in obligations [8][9]. - The company reported a stockholders' deficit of $10,226,583 as of September 30, 2024, compared to $3,917,728 at the end of 2023 [11].

Mori Arkin's appointment as interim CEO as of January 1, 2025 approved by shareholdersPhase 3 clinical trial of SGT-610 for Gorlin Syndrome is ongoing with over 40 clinical sites activatedSGT-210 proof-of-concept study in patients suffering from Darier disease is ongoing NESS ZIONA, Israel, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase-3 clinical trial of SGT-610 (patidegi ...

DICK'S Sporting Goods, Inc. (DKS) is benefiting from its growth efforts, including merchandising initiatives and store-related endeavors. The company has been making smart moves to enrich customer experience. DKS is putting emphasis on the omnichannel experience to drive solid athlete engagement.Buoyed by such strengths, shares of this sporting goods dealer have gained 71.2% compared with the industry’s 10.1% growth in a year.Growth Efforts to Benefit DICK'S SportingDICK’S Sporting’s store-related endeavors ...

Key Business Highlights - The Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease is expected to begin in Q1-2025, with initial data read-out anticipated around mid-2025 [1][4]. - A new Scientific Advisory Board (SAB) for Obesity, Metabolic & Inflammatory Disease was formed in October 2024 to support the development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications [1][6]. - Two proof-of-concept studies for IC 100 in diet-induced obesity (DIO) mouse models are planned, with at least one study expected to begin in Q4-2024 [1][7]. - An Investigational New Drug (IND) submission for IC 100 is planned for Q2-2025, followed by a Phase 1 clinical trial in healthy overweight subjects at risk for metabolic complications, with safety data expected in H2-2025 [1][5]. Financial Results - For the quarter ended September 30, 2024, the company reported net losses of approximately $2.4 million, an improvement of about $0.5 million or 17.3% compared to a net loss of approximately $2.9 million for the same period in 2023 [7][8]. - Research and development expenses were approximately $0.4 million for the three months ended September 30, 2024, a decrease of about $0.2 million or 35.3% from the same period in 2023 [9]. - General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2024, a decrease of about $0.4 million or 17.7% compared to the same period in 2023 [10]. Cash Position and Funding Needs - As of September 30, 2024, the company had approximately $0.1 million in cash, which is expected to be sufficient for month-to-month operating expenses, but additional financing will be needed to support ongoing operations and clinical activities [8]. - The company plans to seek funding through public or private equity, debt financings, government grants, collaborations, or outstanding warrant exercises [8]. Company Overview - ZyVersa Therapeutics, Inc. is a clinical-stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with high unmet medical needs [2][11]. - The company is positioned in the emerging inflammasome space with its lead compounds, Inflammasome ASC Inhibitor IC 100 for obesity and its associated metabolic complications, and Cholesterol Efflux Mediator™ VAR 200 for focal segmental glomerulosclerosis (FSGS) [11]. - The total accessible market for these therapeutic areas is estimated to exceed $100 billion [11].

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UKCash, cash equivalents, other financial assets and marketable securities of $193.8 million DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric ...

New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients with poor prognoses. Our innovative decentralized cell therapy manufacturing platform delivers fresh, fit cells within a median vein-to-vein time of seven days, with potentially encouraging patient outcomes. Three abstracts, including one oral presentation for GLPG5101 in relapsed/refractory non-Hodgkin lymphoma, and a company showcase, will spotlight our cutting-edge ...

SAN ANTONIO, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Rackspace Technology® (NASDAQ: RXT), a leading hybrid, multicloud, and AI technology services company, announced today that it will work with Amazon Web Services (AWS), an Amazon.com, Inc. company, as part of the company’s new Generative AI Partner Innovation Alliance. The Generative AI Partner Innovation Alliance will help scale and expand the reach of the AWS Generative AI Innovation Center (GenAIIC) - a program that helps AWS customers successfully build and ...

FISHKILL, N.Y., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Toll Brothers, Inc. (NYSE:TOL), the nation's leading builder of luxury homes, today announced that Van Wyck Mews, an exceptional new home community in Fishkill, New York, has released its final condominiums for sale in the community. This final building of 20 luxury condos in this established community offers quick move-in homes with Designer Appointed Features that will be move-in ready in spring 2025. Pricing for these final homes starts in the mid-$400,00 ...