Industry veteran with proven track record in neurorehabilitation and fundraising to lead next phase of growth; Co-founder Brian Harris transitions to Chief Scientific OfficerPORTLAND, Maine, July 7, 2025 /PRNewswire/ -- MedRhythms, Inc., a company pioneering the development of next-generation neurotherapeutics to improve walking, mobility and related functional outcomes, and creator of the world's first prescription music platform, announced the appointment of Larry Jasinski as Chief Executive Officer, effe ...

Tovecimig Clinical Trial Results (COMPANION-002 Study) - The COMPANION-002 study is a Phase 2/3 registrational-intent study in patients with BTC who have received one prior line of therapy[9] - In the Intent-to-Treat population, the Overall Response Rate (ORR) for Tovecimig + Paclitaxel was 17.1% (19 out of 111 patients) compared to 5.3% (3 out of 57 patients) for Paclitaxel alone, with a two-sided p-value of 0.031[12] - The Complete Response (CR) rate in the Tovecimig + Paclitaxel arm was 0.9% (1 out of 111 patients), while the Partial Response (PR) rate was 16.2% (18 out of 111 patients)[12] - Stable Disease (SD) was observed in 44.1% of patients (49 out of 111) in the Tovecimig + Paclitaxel arm compared to 33.3% (19 out of 57) in the Paclitaxel arm[12] - Progressive Disease (PD) was observed in 16.2% of patients (18 out of 111) in the Tovecimig + Paclitaxel arm compared to 42.1% (24 out of 57) in the Paclitaxel arm[12] Tovecimig Development and Potential - Tovecimig is a bispecific antibody targeting DLL4 and VEGF-A, designed to disrupt tumor vessel formation and angiogenesis[6, 7] - The company anticipates top-line Phase 2/3 data for PFS, OS, and DoR in Q4 2025[25] - Tovecimig has the potential to become a standard of care in 2L BTC, with PFS, OS and DoR data expected in Q4 2025[18] Market and Unmet Needs - There are significant unmet needs in current treatments for BTC, with approximately 85% of 2L patients having limited treatment options[19, 20] - Incidence of BTC is significant, with an estimated ~23,000 cases annually[22] - Projected ~100,000 incidence of liver and intrahepatic bile duct cancer by 2040[23]

Vancouver, Canada, July 03, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a propri ...

Summary of Atai Life Sciences (ATAI) Update / Briefing July 01, 2025 Company Overview - **Company**: Atai Life Sciences - **Focus**: Development of psychedelic therapies for mental health, specifically targeting treatment-resistant depression with the drug BPL-three Key Industry Insights - **Market Context**: Treatment-resistant depression is a significant public health issue, affecting millions globally and is the second leading cause of disability worldwide [12][12] - **Competitor Analysis**: SPRAVATO, a leading treatment in this space, achieved blockbuster status with approximately $930 million in sales in the U.S. in the previous year [47][47] Core Findings from Phase 2B Trial of BPL-three - **Trial Success**: The Phase 2b trial of BPL-three exceeded expectations, meeting both primary and secondary endpoints, demonstrating rapid and durable antidepressant effects [6][6][10][10] - **Efficacy**: - Significant reductions in MADRS scores were observed with both 8 mg and 12 mg doses compared to the active comparator (0.3 mg) [7][7] - The drug showed a robust effect lasting at least two months post-administration [42][42] - Approximately one-third of subjects were responders by day eight, maintaining this response through day 57 [27][27] - **Safety Profile**: - The drug was well tolerated, with 99% of adverse events being mild or moderate, and no serious drug-related adverse events reported [8][8][32][32] - No suicide-related safety signals were detected, which is critical given the population studied [36][36] Dosing and Administration Insights - **Dosing Strategy**: The 8 mg dose was identified as potentially optimal, showing comparable efficacy to the 12 mg dose with fewer side effects [25][25][30][30] - **Administration Time**: The treatment requires a short in-clinic time of approximately two hours, allowing for rapid discharge post-treatment, which aligns with the interventional psychiatry model [10][10][34][34] Future Development Plans - **Phase 3 Readiness**: The company is preparing to advance BPL-three into Phase 3 trials, with an end-of-phase 2 meeting with the FDA anticipated in Q3 2025 [45][45] - **Redosing Strategy**: Future studies will explore a potential redosing paradigm, likely within a two to three-month window, which would significantly improve treatment convenience compared to SPRAVATO [68][68] Competitive Advantages - **Unique Positioning**: Atai Life Sciences is positioned uniquely with BPL-three and VLS-one, both designed for a two-hour treatment paradigm, contrasting with competitors requiring multiple doses over extended periods [51][51][52][52] - **Commercial Scalability**: The single administration model with a two-hour follow-up is expected to enhance commercial scalability and patient convenience [51][51] Upcoming Milestones - **Data Releases**: Additional data from ongoing studies, including an open-label extension study, are expected in the near future, which will further inform the efficacy and safety profile of BPL-three [44][44] - **Regulatory Engagement**: The company plans to engage with regulatory bodies regarding potential breakthrough designations and the national review voucher program for expedited approval processes [117][117] Conclusion - **Overall Assessment**: The Phase 2b trial results for BPL-three indicate a promising new treatment option for patients with treatment-resistant depression, with a favorable safety profile and significant efficacy, setting the stage for further development and potential market entry [62][62]

Core Insights - The United Kingdom telehealth market was valued at USD 21.56 Billion in 2024 and is projected to grow at a CAGR of 12.10%, reaching USD 67.56 Billion by 2034, driven by increased internet access and smartphone penetration [2][10] - Strong policy support from the NHS and the UK government is facilitating the adoption of telehealth services, ensuring funding and integration within public healthcare frameworks [2] Market Growth Drivers - The UK government announced an investment of up to EUR 600 million (USD 764 million) for a centralized Health Data Research Service, aimed at enhancing data access for researchers and accelerating clinical trials, which is expected to significantly boost telehealth market growth [4] - Rising demand for remote inpatient care and AI-driven solutions, such as Teladoc's AI-powered Virtual Sitter, are enhancing patient safety and care efficiency, contributing to market value growth [5] - User-centric telehealth platforms, like Doctorsa's global telehealth platform, are addressing increasing wait times for GP appointments and improving patient satisfaction, thereby driving market development [5] Market Trends - AI-powered tools for women's health, such as Moody's mental health tool, are expanding the telehealth market by providing personalized care solutions [8] - Investment in virtual wards, exemplified by West Suffolk NHS Foundation Trust's tender for remote patient monitoring services, is expected to enhance clinical outcomes and operational efficiency [8] - Digital therapeutics are gaining traction, offering validated software-based interventions for chronic conditions, supported by NHS initiatives [8] Market Segmentation - The services segment is anticipated to lead the market due to its role in enabling seamless virtual care delivery, particularly in managing chronic diseases and elderly care [8] - England is expected to dominate the market, supported by a robust NHS digital infrastructure and a high urban population, while Scotland, Wales, and Northern Ireland are progressing at varying rates [8] Key Players - Major companies in the UK telehealth market include Doctor Care Anywhere, Teladoc Health, Livi, Babylon Health, Medicspot, Push Doctor, eConsult Health, Cisco Systems Inc., and Codal [7][19]

Clinical Assets & Pipeline - Bosakitug (ATI-045) is a uniquely potent monoclonal antibody targeting TSLP, currently in a two-arm placebo-controlled Phase 2 trial initiated in Q2 2025 [6] - ATI-052, a bispecific antibody targeting both TSLP and IL-4R, has initiated a Phase 1a/1b SAD/MAD program in Q2 2025 [6] - ATI-2138, a potent and selective oral inhibitor of ITK/JAK3, expects top-line results from a Phase 2a OL trial in July 2025 [6] - The company is conducting discovery/preclinical evaluation for novel ITK inhibitors and BsAbs, with new INDs expected to start in 2026 [6] - Aclaris expects Phase 2a top-line results for ATI-2138 in Atopic Dermatitis in July 2025 [8, 11] Financial Position - Aclaris has a strong balance sheet and is expected to fund operations through the first half of 2028 [6] - The company anticipates opportunities for additional non-dilutive financing and development partners [6] - As of Q1 2025, Aclaris has $1905 million in cash, cash equivalents, and marketable securities [86] Bosakitug (ATI-045) Data - Bosakitug is reported to be >60x more potent than Tezepelumab in hPBMC CCL17 Inhibition [17] - Phase 2a trial data showed that 94% of patients achieved EASI 75 at Week 26 [37] - Phase 2a trial data showed that 65% of patients achieved EASI 90 at Week 26 [37] - Phase 2a trial data showed that 24% of patients achieved EASI 100 at Week 26 [37] - Phase 2a trial data showed that 88% of patients achieved IGA 0/1 at Week 26 [37] ATI-052 Data - ATI-052 is reported to be 3-5x more potent than the combination of Tezepelumab + Dupilumab on CCL17 release [54]

Hundreds of kids in Australia to be tested for disease after childcare rape charge https://t.co/fZNfkkJZ8k ...

Summary of Arcturus Therapeutics KOL Presentation on ARCT-810 Phase II Interim Data for OTC Deficiency Company Overview - **Company**: Arcturus Therapeutics - **Headquarters**: San Diego - **Focus**: mRNA medicines, specifically targeting rare liver diseases like ornithine transcarbamylase (OTC) deficiency [5][6] Industry Context - **Industry**: Biotechnology, specifically in the development of mRNA therapeutics for rare diseases - **Condition**: OTC deficiency is the most common urea cycle disorder with significant unmet medical needs [6][7] Key Points from the Presentation 1. **ARCT-810 Overview**: - ARCT-810 is an mRNA therapeutic designed to replace dysfunctional OTC enzymes, improving urea cycle activity, detoxifying ammonia, and potentially eliminating the need for liver transplants [6][7][8] - It utilizes Arcturus' proprietary lunar delivery platform for effective delivery to hepatocytes [7] 2. **Regulatory Designations**: - ARCT-810 has received multiple designations: orphan drug designation, orphan medicinal product designation, fast track designation, and rare pediatric disease designation [8] 3. **Phase II Study Design**: - Two Phase II studies were conducted: one in the US and one in Europe, focusing on safety, tolerability, and biomarker assessments [11][12] - The US study enrolled patients with more severe disease, while the European study included patients with stable disease [12] 4. **Biomarker Results**: - **Plasma Glutamine**: - In the European study, mean glutamine levels decreased from high to normal during treatment and began to rise again after four weeks post-treatment [13][14] - In the US study, glutamine levels normalized after three doses and remained normal for approximately twenty days [14] - **Ureagenesis Function**: - The new N15 assay showed significant increases in relative ureagenesis function (RUF) post-treatment, with a mean increase of 14.7% [16][17] - Two subjects achieved RUF levels above 50%, indicating clinically meaningful improvements [17] - **Ammonia Levels**: - Ammonia levels remained stable and within normal ranges after treatment, supporting the favorable glutamine and ureagenesis data [18] 5. **Safety Profile**: - The safety database included 40 participants, indicating that ARCT-810 was generally safe and well-tolerated [19] - No serious infusion-related reactions were reported, and adverse events were manageable [19][20] 6. **Next Steps**: - Arcturus plans to complete the ongoing Phase II US study and engage with regulatory agencies for a multi-biomarker driven pivotal trial [68][69] Additional Insights - **Clinical Implications**: - The KOLs emphasized the importance of normalizing diet and reducing the need for ammonia scavengers as key success metrics for OTC therapies [78][80] - mRNA therapies are viewed as a potential alternative to liver transplants, especially for severe cases [100][101] - **Comparison with Other Therapies**: - ARCT-810 is positioned as a more effective solution compared to existing ammonia scavengers, which do not restore urea cycle function [87][88] Conclusion - The interim data for ARCT-810 demonstrates promising results in reducing glutamine levels and improving urea cycle function, with a favorable safety profile. The company is poised to advance its clinical development and regulatory strategy to address the significant unmet needs in OTC deficiency treatment [67][68]

Key Takeaways TECH struck a deal with USP to distribute mAb and AAV standards, alongside its Maurice analytics platform. TECH aims to ease analytical challenges in mAb and gene therapy development through this partnership. TECH's tools enable efficient, integrated analysis of complex biologics from development to product release.Bio-Techne Corp. (TECH) has recently entered into a distribution agreement with the U.S. Pharmacopeia (“USP”) to sell USP monoclonal antibody (mAb) and recombinant adeno-associate ...

Vancouver, Canada, June 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AU ...