Core Insights - Certara, Inc. has launched TFL Studio, a cloud-native module of its Phoenix Cloud solution, which enables the creation of Tables, Figures, and Listings (TFLs) 50% faster, enhancing collaboration among pharmacokinetic (PK) and pharmacodynamic (PD) scientists [1][3][4] Group 1: Product Features and Benefits - TFL Studio allows scientists to create high-quality TFLs in a user-friendly, no-code environment, significantly reducing the technical complexities involved in data handling and formatting [3][5] - The module integrates with Integral™, Certara's data repository, providing a unified source for PK/PD data, models, and visualizations [3] - A complementary module, AI PK Reports, will be released soon, utilizing GenAI to expedite the generation of draft PK reports from TFLs, reducing the time from days to minutes [3] Group 2: Market Position and Strategy - The introduction of TFL Studio is a strategic move to enhance drug discovery and development processes by leveraging AI and cloud technology, addressing inefficiencies in traditional TFL workflows [2][3] - Certara serves over 2,400 clients, including biopharmaceutical companies and regulatory agencies across 70 countries, indicating a strong market presence and demand for its innovative solutions [5]

Core Insights - BioXcel Therapeutics has completed the database lock for its SERENITY At-Home pivotal Phase 3 safety trial, with topline results expected in August 2025 [2][3] - The trial aims to evaluate the safety of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting, addressing a significant unmet medical need [3][5] Company Overview - BioXcel Therapeutics is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [2][15] - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology [15] Trial Details - The SERENITY At-Home trial is a double-blind, placebo-controlled study involving 200 patients with a history of agitation episodes while on stable treatment for bipolar disorder or schizophrenia [6][8] - Patients self-administered a 120 mcg dose of BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout [6][8] Collaboration and Oversight - BioXcel partnered with Worldwide Clinical Trials (WCT) to conduct the SERENITY At-Home trial, implementing robust oversight controls to ensure patient safety [4] - Independent industry experts were engaged for additional oversight of high enrolling sites to ensure compliance with Good Clinical Practice (GCP) [4] Product Information - BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine, currently under investigation for treating agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting [7] - BXCL501 has received Fast Track Designation from the FDA for the acute treatment of agitation associated with bipolar disorders and schizophrenia [5][9] Patient Enrollment and Data Collection - The trial enrolled over 200 patients across 22 sites nationwide, with no single site contributing more than 11% of the total patient population [8] - Data from more than 2,600 agitation episodes was collected during the trial [8]

Core Insights - Psyence BioMed is advancing its mission to develop safe and effective psychedelic therapies for mental health challenges, with significant progress in clinical development, regulatory compliance, and strategic partnerships [2][11][14] Clinical Development - The company is executing a clinical trial in partnership with Southern Star Research, aiming to expand patient access and accelerate enrollment [3] - A Steering Committee has been established to guide the development of a study on psilocybin for Alcohol Use Disorder, with plans to conduct the study in South Africa [6] - The partnership with PsyLabs is crucial for the Ibogaine program, with successful production of a GMP-aligned Ibogaine Total Alkaloid extract [7][9] Financial Position - As of August 4, 2025, Psyence BioMed reported a strong cash balance of $11.4 million and no outstanding debt, positioning the company for growth opportunities [11] - The company regained compliance with Nasdaq listing requirements in June 2025, marking a significant milestone in its growth [12] Strategic Vision - The company aims to build a resilient biotechnology firm focused on nature-derived psychedelic therapies, with a commitment to long-term value creation [14][18] - Psyence BioMed is positioned to lead in ethical and scalable production of ibogaine, leveraging its unique sourcing capabilities in Africa [17] Market Outlook - The global market for psilocybin-assisted therapy is projected to grow from $1.5 billion in 2024 to $3.3 billion by 2031, driven by increasing acceptance of psychedelic therapies [27][18]