Core Insights - Protara Therapeutics is on track to report interim results from approximately 25 six-month evaluable patients in the ADVANCED-2 trial in Q1 2026, focusing on BCG-Unresponsive patients [1][5] - The company has received Breakthrough Therapy and Fast Track designations for TARA-002 in lymphatic malformations (LMs), with a regulatory update expected in the first half of 2026 [1][4] - The first patient has been dosed in the THRIVE-3 registrational trial of IV Choline Chloride, with interim results anticipated in the second half of 2026 [1][7] - Protara completed a public offering of approximately $86 million, extending its cash runway into 2028 [1][8] Protara's Pipeline and Progress - The CEO emphasized the company's commitment to delivering transformative therapies for cancer and rare diseases, highlighting the promising clinical data for TARA-002 in non-muscle invasive bladder cancer (NMIBC) [2] - TARA-002 has shown meaningful and durable activity in BCG-Naïve NMIBC patients, with plans to provide an interim update on the registrational BCG-Unresponsive trial later this quarter [2][5] - Positive results from the Phase 2 STARBORN-1 trial of TARA-002 in LMs have led to FDA designations, with a regulatory update on the path to registration expected in H1 2026 [2][4] Clinical Trials and Manufacturing - Protara is evaluating subcutaneous dosing combined with intravesical dosing for TARA-002 in NMIBC patients, as well as exploring combination treatments [5] - TARA-002 has been selected for the FDA's CMC Development and Readiness Pilot Program, aimed at facilitating manufacturing development for therapies with compressed clinical timelines [6] Financial Update - The recent public offering of approximately $86 million is expected to support Protara's operations and extend its financial runway into 2028 [8]

Core Insights - The 2026 Drugs to Watch report by Clarivate identifies eleven therapies expected to significantly impact clinical practice and achieve strong commercial potential in the coming year [1][2][3] - The report emphasizes the importance of anticipating emerging drug trends and understanding market dynamics to navigate the complex pharmaceutical landscape [3] Metabolic Disease - Orforglipron and Retatrutide, both developed by Eli Lilly, are highlighted for managing obesity and type 2 diabetes mellitus (T2DM) with innovative delivery methods [4][5] - The report projects obesity drug sales to reach USD 150 billion by 2035, emphasizing the need for real-world effectiveness and differentiation in safety and clinical value [16] Rare Conditions - Development in rare diseases is expanding into neurological, psychiatric, and hematologic conditions, requiring targeted engagement and evidence-driven approaches [17] - Therapies like VOYXACT® for immunoglobulin A nephropathy and Relacorilant for ovarian cancer are noted for their potential in these areas [8][13] Oncology - The report features therapies such as Gedatolisib for breast cancer and Tolebrutinib for multiple sclerosis, showcasing advancements in precision oncology [10][9] - The increasing complexity of regulatory pathways in the U.S. and Europe is highlighted as a challenge for companies developing treatments for rare diseases [17] Delivery Innovations - The report underscores the growing importance of delivery innovations, including extended-release formulations and oral alternatives to injectable drugs, which can enhance patient adherence [18] - Mainland China is emerging as a significant market and source of innovation, influencing global strategies in oncology and metabolic disease [18] Methodology and Analysis - The report's findings are based on evaluations from over 160 analysts using integrated, AI-enhanced datasets covering the full R&D and commercialization lifecycle [20][21] - Therapies were selected based on their potential to achieve blockbuster status, defined as reaching USD 1 billion in annual sales within five years [20]