NEW YORK, Aug. 27, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers.  The class action, filed in the United States District Court Northern District of California, and docketed under 25-cv-06923, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Unicycive securities between March 29, 2024 and June ...

Core Viewpoint - Lexaria Bioscience Corp. will participate in the 27th Annual H.C. Wainwright Global Investment Conference from September 8th to September 10th, 2025, highlighting its innovative drug delivery technology, DehydraTECH [1][3]. Company Overview - Lexaria Bioscience Corp. is a global innovator in drug delivery platforms, focusing on improving the way drugs enter the bloodstream through oral delivery [1][3]. - The company operates a licensed in-house research laboratory and holds a strong intellectual property portfolio with 50 patents granted and additional patents pending worldwide [3]. Technology Highlights - DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform that enhances bio-absorption, reduces side effects, and improves drug delivery across the blood-brain barrier [3].

Summary of BioXcel Therapeutics (BTAI) Conference Call - August 27, 2025 Company Overview - **Company**: BioXcel Therapeutics - **Focus**: Development of BXCL501 for the treatment of agitation associated with bipolar disorders and schizophrenia in home settings Key Points Industry Context - **Agitation in Bipolar Disorders and Schizophrenia**: - A significant unmet medical need exists as there are currently no FDA-approved therapies for treating agitation in home settings [5][8] - Most agitation episodes occur at home, leading to emergency room visits and hospitalizations [5] Clinical Trial Results - **SERENITY at Home Phase III Trial**: - The trial evaluated the 120 microgram dose of BXCL501, which was well tolerated and met its primary objective [4][6] - An estimated 57 million to 77 million agitation episodes occur annually in the U.S. [6] - The trial involved 2,628 agitation events with over 2,400 treated episodes, with patients self-administering the drug successfully [10][19] - No drug-related serious adverse events were reported, and the adverse event profile was consistent with the approved label [14][19] Efficacy and Safety - **Efficacy**: - Patients experienced consistent benefits with repeat dosing throughout the study [19] - The incidence of somnolence, the most common adverse event, was 22% and did not increase with repeated dosing [15][16] - The study showed no evidence of tachyphylaxis, indicating sustained efficacy over time [70] Regulatory and Commercial Strategy - **sNDA Submission**: - The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for label expansion to include home use [7][20] - The FDA has provided alignment on the protocol for the sNDA submission [36][68] Market Opportunity - **Commercialization Strategy**: - The company is developing a multi-pronged commercialization strategy, potentially including partnerships and self-commercialization [39][54] - Initial estimates suggest a need for 50 to 70 sales representatives to effectively launch the drug in the U.S. market [81] Future Development - **Potential for Other Indications**: - There is a significant opportunity to explore BXCL501 for treating agitation in Alzheimer's patients, with an estimated 100 million episodes annually [43][46] - A second confirmatory Phase III trial for Alzheimer's agitation is planned, expanding the patient population to include various care settings [44][47] Financial Considerations - **Funding and Financial Strategy**: - The positive trial data opens multiple financial options for the company, including strategic partnerships and potential royalty deals [53][54] - The company is evaluating its cash position and operational expenditures to ensure sufficient runway for upcoming initiatives [52] Additional Insights - **Patient Self-Management**: - The drug allows patients to self-manage their agitation episodes, which is crucial for maintaining home stability and caregiver relationships [64][66] - **Real-World Application**: - The drug's ease of use and tolerability may encourage its adoption in real-world settings, addressing the needs of patients experiencing agitation [80] Conclusion - The results from the SERENITY at Home trial represent a significant milestone for BioXcel Therapeutics, paving the way for potential FDA approval and commercialization of BXCL501 for home use in managing agitation associated with bipolar disorders and schizophrenia. The company is well-positioned to address a large unmet need in the market while exploring future indications for the drug.

Core Insights - The article highlights a landmark meeting co-sponsored by LIXTE Biotechnology Holdings, focusing on the activation of oncogenic signaling as a novel cancer treatment strategy [1][2] - LIXTE's lead compound, LB-100, was presented as a first-in-class PP2A inhibitor that activates oncogenic signaling, leading to cancer cell toxicity [2][4] Group 1: Conference Highlights - The conference introduced a paradigm shift in cancer therapy, advocating for the activation of oncogenic pathways rather than solely inhibiting them [3] - LB-100 exemplifies this approach by inhibiting PP2A, which removes a cellular "off switch," resulting in uncontrolled signaling that drives cancer cells to self-destruction [4] - Presentations at the conference reinforced the recognition of PP2A inhibition as a new therapeutic frontier, supporting LB-100's role as a platform therapy [5] Group 2: Company Positioning - By co-sponsoring the meeting, LIXTE positioned itself as a global thought leader in innovative cancer therapies, demonstrating its commitment to advancing cancer research [6] - LIXTE is focused on developing therapies targeting the PP2A pathway, with LB-100 showing strong preclinical results and early-stage clinical tolerability [7] - The company is currently advancing a proof-of-concept trial in Ovarian Clear Cell Carcinoma, indicating its active role in clinical development [7]

SEATTLE, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or “Nautilus”), a company pioneering a single-molecule protein analysis platform, today announced the company will be participating in the following investor conferences. Morgan Stanley 23rd Annual Global Healthcare Conference in New York, NYManagement is scheduled to participate in a fireside chat on Monday, September 8h at 10:50 a.m. Pacific Time / 1:50 p.m. Eastern Time. Q3 Investor Summit Group Virtual ConferenceManag ...

SOUTH SAN FRANCISCO, Calif., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that management will participate in the following upcoming investor conferences in September: Cantor Global Healthcare Conference 2025 Presentation on Wednesday, September 3, 2025, at 11:30 a.m. ET 2025 Wells Fargo Healthcare ConferenceFireside chat on Friday, September 5, 2025, at 8:45 a ...

Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with I ...

Company Overview - Minovia Therapeutics Ltd. is a clinical-stage biotechnology company focused on developing therapies for mitochondrial diseases and age-related decline [1][5] - The company is working on its main drug product, MNV-201, which is currently being tested for Pearson Syndrome and Myelodysplastic Syndrome [5] Recent Developments - Minovia has been awarded a $350,000 grant from Countdown for a Cure to develop novel mitochondrial blood-based biomarkers [1][2] - The grant will fund clinical operations for blood sample collection from approximately 30 patients with primary mitochondrial diseases and 140 samples from healthy controls [2] Research and Development - The company aims to develop blood-based functional mitochondrial biomarkers to identify patients who may benefit from its proprietary mitochondrial augmentation technology (MAT) [2] - A clinical trial has been initiated at Sheba Medical Center to collect blood samples for analysis and to determine a "MitoScore" for each sample [2] Market Need - Mitochondrial dysfunction is associated with rare genetic mitochondrial diseases and chronic age-related diseases, with a significant unmet need for effective treatments [3] - Currently, there are no approved therapies for mitochondrial dysfunction, nor functional tests to diagnose and quantify it [3] Business Combination - Minovia has entered into a definitive business combination agreement with Launch One Acquisition Corp., a publicly traded special purpose acquisition company [4] - The transaction is expected to close in late 2025, after which the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol [4]

LAUSANNE, Switzerland, Aug. 27, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that Ameet Mallik, Chief Executive Officer, will participate in a fireside chat at the Cantor Global Healthcare Conference 2025 on Wednesday, September 3, 2025, at 9:10 a.m. ET.A webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ...

Core Insights - Skye Bioscience, Inc. will host a virtual KOL event on September 4, 2025, to discuss the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, a first-in-class peripheral CB1 antibody for obesity [1][2] - The event aims to provide clarity on what constitutes success in the proof-of-concept study, focusing on safety, tolerability, and new preclinical insights related to nimacimab [2][7] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][8] - The company is conducting a Phase 2a clinical trial for nimacimab, which is designed to inhibit peripheral CB1 and is also assessing its combination with a GLP-1R agonist [8] KOL Event Highlights - The event will feature discussions with leading obesity experts, including Skye's CEO, Punit Dhillon, who will address the significance of safety and tolerability benchmarks in the obesity treatment landscape [2][7] - Key opinion leaders participating include Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves, who bring extensive experience in metabolic health and obesity research [3][4][6] Research Focus - The event will cover the mechanism and potential role of peripheral CB1 inhibition as a differentiated anti-obesity therapeutic pathway [7] - Newly generated preclinical data with nimacimab will be highlighted, contributing to the understanding of its potential advancement into Phase 2b development [2][7]