SPRING Trial Data Presented at BSG Live'25 Confirms the Clinical Potential of Nebokitug as a First-in-Class Novel Treatment for PSC and Supports Advancement to Phase 3 Treatment with Nebokitug Is Well-Tolerated and Associated with Substantial Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of PSC Disease Progression TEL AVIV, Israel and GLASGOW, United Kingdom, June 30, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology c ...

SALT LAKE CITY, June 30, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today provided a regulatory update following a Type C meeting with the U.S. Food and Drug Administration (FDA), and announced two additional meetings scheduled with the FDA in the 3rd quarter of 2025. In th ...

Core Insights - Artelo Biosciences, Inc. has announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5), which shows promising safety and pharmacokinetic profiles [1][4][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions including cancer and pain [1][8] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet needs in multiple diseases and conditions [8] Product Development - ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation, targeting chronic pain management [4][5] - The Phase 1 Single Ascending Dose (SAD) study enrolled 49 healthy volunteers to assess the safety, tolerability, and pharmacokinetics of ART26.12 [2][5] Market Opportunity - The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030, driven by increasing prevalence of conditions such as neuropathic pain and arthritis [5] - There is a significant gap in innovation for non-opioid therapies in the pain management market, which ART26.12 aims to fill with its unique mechanism of action [5] Safety and Efficacy Findings - All adverse events reported in the study were mild, transient, and self-resolving, with no drug-related adverse events observed [7] - The pharmacokinetic profile showed dose-dependent, linear absorption, indicating a predictable response to the drug [7] - A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy [7] Future Development Plans - A Multiple Ascending Dose study is expected to commence in the fourth quarter of this year to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [5]

--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) --No other concerns stated, including pre-clinical, clinical, or safety data --The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL --The Company plans to immediately request a Type A ...

Core Viewpoint - Nektar Therapeutics' stock surged nearly 157% following positive Phase 2b trial results for Rezpeg, an experimental treatment for atopic dermatitis, with analysts projecting further price increases based on market potential [1][2]. Group 1: Clinical Trial Results - Rezpeg achieved statistically significant results in a Phase 2b trial involving 393 patients, meeting both primary and secondary endpoints [4]. - The primary endpoint was the average percentage change in the Eczema Area and Severity Index (EASI) compared to placebo, with Rezpeg demonstrating a 30% average reduction in EASI scores [5]. - Up to 46% of patients experienced a dramatic decrease of at least 75% in their severity scores, a key secondary measure [5]. - Rezpeg has received Fast Track designation from the FDA, indicating its potential to address unmet medical needs [6]. Group 2: Market Potential - The eczema market is substantial, affecting an estimated 9.8 million adults and children in the U.S., representing approximately 2.8% of the total population [9]. - The market for atopic dermatitis therapies is rapidly growing, driven by high demand for effective treatments [10]. - Analysts have set price targets for Nektar's stock at $100 and $120, with a consensus price target of around $76, implying a potential upside of 212% to 349% [1][8]. Group 3: Competitive Landscape - Rezpeg faces competition from Dupixent, which has shown superior efficacy in initial measures, achieving a 50% average severity improvement compared to Rezpeg's 30% [12]. - Nektar believes Rezpeg can address underlying immune imbalances and may treat patients who do not respond to Dupixent, creating a niche market [13]. - The company plans to report 52-week results on Rezpeg in Q1 2026, which could enhance its competitive positioning against Dupixent [14].

Core Viewpoint - The departure of top-level management at Iovance Therapeutics has raised investor concerns, leading to a nearly 15% decline in the company's stock value during the week [1]. Management Changes - CFO Jean-Marc Bellemin resigned from his position, effective July 10, following a regulatory filing on June 13 [2][4]. - The resignation is occurring during a challenging period for the company, which is facing legal issues and a commercial setback for its flagship drug, Amtagvi [4]. Legal and Commercial Challenges - Iovance is currently under investigation by multiple law firms, which suggests that the company's legal troubles may be contributing to its management instability [2][4]. - The company has experienced a significant reduction in its product-revenue guidance for the year, despite some top-line growth attributed to Amtagvi, a melanoma drug [5]. Investment Outlook - While Iovance is facing significant challenges, Amtagvi still holds potential, indicating that the company may be worth monitoring for investors willing to take on higher risks [6].

Core Viewpoint - Amgen is competing in the rapidly growing obesity drug market, which is projected to reach $100 billion by 2030, with its drug MariTide being a key focus in this race [1]. Company Overview - Amgen is developing MariTide, a GIPR/GLP-1 receptor agonist, designed for convenient monthly dosing via an autoinjector, distinguishing it from competitors' weekly injection options [2]. - In phase II studies, MariTide demonstrated an average weight loss of approximately 20% over 52 weeks in obese or overweight individuals without type II diabetes, although this was at the lower end of investor expectations [3]. - Amgen has initiated two phase III studies for MariTide as part of its MARITIME program, with additional studies planned for 2025 targeting various cardiovascular conditions [4]. Competitive Landscape - The obesity drug market is becoming increasingly competitive, with companies like Viking Therapeutics developing their own candidates, such as VK2735, which is being evaluated in late-stage studies [6]. - Other major pharmaceutical companies, including Roche, Merck, and AbbVie, are also entering the obesity space, potentially challenging the market positions of Novo Nordisk and Eli Lilly [7]. Financial Performance - Amgen's stock has increased by 8.9% year-to-date, outperforming the industry average decline of 0.7% [8]. - The company's shares are currently trading at a price/earnings ratio of 13.26, which is lower than the industry average of 14.87 and below its five-year mean of 13.77 [10]. - Earnings estimates for 2025 and 2026 have seen upward revisions, with the consensus for 2025 rising from $20.57 to $20.82 per share and for 2026 from $21.13 to $21.29 per share [11].

Core Insights - Biogen announced new data reinforcing the clinical impact of nusinersen for spinal muscular atrophy (SMA), highlighting findings from the DEVOTE trial and NURTURE trial presented at a recent conference [1][6][8] - The higher dose regimen of nusinersen is under review in multiple global markets, featuring a rapid loading and higher maintenance dosing schedule [1][5] DEVOTE Trial Findings - Part C of the DEVOTE trial demonstrated potential clinical benefits of a higher dose of nusinersen in previously treated patients (n=38) aged 4 to 65, with a median treatment duration of approximately 3.9 years [3][4] - Improvements were observed in motor function across various assessments, with non-ambulatory participants showing an average improvement of +2.5 on the Hammersmith Functional Motor Scale – Expanded (HFMSE) [4][5] NURTURE Study Outcomes - Final data from the NURTURE study indicated that all 25 participants remained alive, with no need for permanent ventilation, and 92% achieved independent walking ability [6][7][8] - Participants with elevated neurofilament light chain (NfL) levels at baseline showed significant reductions in NfL after starting nusinersen, suggesting its potential as a biomarker for treatment response [9] Safety Profile - The safety profile of the higher dose regimen aligns with the known safety profile of the 12 mg SPINRAZA, with most adverse events reported as mild to moderate [5][9] - In the DEVOTE study, 37 out of 40 participants reported adverse events, with serious adverse events occurring in 15% of participants, none related to the treatment [5]

Core Insights - Neurocrine Biosciences announced significant reductions in cognitive and motor-related burdens in adults with Huntington's disease chorea treated with INGREZZA (valbenazine) capsules, based on new patient-reported post-hoc data from the KINECT-HD study [1][4] Group 1: Study Findings - The KINECT-HD study is the first clinical trial to show measurable changes in cognitive and motor disease burden with a vesicular monoamine transporter 2 inhibitor in Huntington's disease patients [1][2] - In the 12-week Phase 3 KINECT-HD clinical trial, INGREZZA showed a significant reduction in chorea severity, with a placebo-adjusted mean reduction in the Total Maximal Chorea (TMC) score of 3.2 units (p<0.0001) [11] - Patient-reported analyses indicated greater reductions in cognitive and motor-related disease burden for INGREZZA compared to placebo across various domains, including memory loss and mobility limitations [3][4] Group 2: Cognitive and Motor-Related Improvements - Statistically significant improvements were observed in cognition-related items, such as memory loss (-0.9 for INGREZZA vs -0.2 for placebo) and decision-making abilities (-1.0 for INGREZZA vs -0.3 for placebo) [3] - For motor-related items, INGREZZA demonstrated larger reductions in scores compared to placebo, including abnormal movements (-1.5 for INGREZZA vs -0.8 for placebo) and impaired coordination (-1.0 for INGREZZA vs -0.4 for placebo) [3][5] Group 3: Background on Huntington's Disease - Huntington's disease is a hereditary progressive neurodegenerative disorder affecting approximately 41,000 adults in the U.S., characterized by motor, cognitive, and psychiatric symptoms [7] - Chorea, a common symptom of Huntington's disease, involves irregular and unpredictable movements that can interfere with motor coordination and daily activities [7] Group 4: About INGREZZA - INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating chorea associated with Huntington's disease and tardive dyskinesia [14][15] - The drug is designed for once-daily administration without the need for titration, making it convenient for patients [16]

Year-end 2024 Business Update NASDAQ: ATOS www.atossatherapeutics.com Disclaimer • This presentation may contain certain forward-looking statements related to or Atossa Therapeutics, Inc. (the "Company") that involve risks and uncertainties. • Actual results and events may differ significantly from results and events discussed in forward-looking statements. • Factors that might cause or contribute to such differences include, but are not limited to, those discussed in "Risk Factors" in the Company's Annual ...