WATERTOWN, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including two clinical-stage programs, today announced that it will host a conference call and live webcast at 4:30 p.m. ET on Monday, May 12, 2025 to report its first quarter 2025 financial results and provide a business update. A live webcast of the event will be available on the events and present ...

SOUTH SAN FRANCISCO, Calif., April 28, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events.Barclays Hosted: Peter Lawson's Catalyst & Key Debate Calls & Investor 1x1'sThursday, May 8th, 2025 at 11:00 AM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Peter Lawson, D.Phil., Managing Dir ...

WARREN, N.J., April 15, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced the commission of Databricks, Inc., a leader in data, analytics and artificial intelligence (AI), with an aim to accelerate the development of PredicTcell, the Company’s proprietary AI-driven target prediction model for precision immunotherapy. Databricks will provide a dedicated data engineering team and its expertise in building, scaling, and governing data and AI systems. T ...

Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]

Core Viewpoint - The merger between Renovaro Biosciences Inc. and BioSymetrics aims to enhance advanced AI-driven drug development and expand precision medicine applications in oncology and neurology [1][4]. Group 1: Merger Details - Renovaro completed its merger with BioSymetrics on April 8, 2025, to strengthen its capabilities in data repository and biomarker discovery [2][1]. - The merger integrates BioSymetrics' Elion platform, which utilizes AI and machine learning to accelerate the discovery of diagnostics and therapeutics [3][4]. Group 2: Technological Synergy - BioSymetrics' Phenograph and advanced in vivo modeling systems are designed to improve target and biomarker identification, enabling patient stratification and drug repurposing [3][4]. - The combined company aims to streamline the translation of biomarker insights into accelerated drug discovery timelines, enhancing research efficiency [3][5]. Group 3: Strategic Goals - The merger is expected to enhance Renovaro's ability to identify new therapeutic targets and validate diagnostics, particularly in oncology and neurology [4][5]. - The focus will be on integrating AI-powered biomarker discovery with innovative drug development to improve patient outcomes globally [5].

INmune Bio (INMB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Moss - Chief Financial OfficerRaymond Tesi - CEO & ChairmanGeorge Farmer - Managing DirectorMark Lowdell - Chief Scientific Officer & Chief Manufacturing OfficerCJ Barnum - Head of NeuroscienceDenis Reznik - Senior Equity Research AssociateElemer Piros - Senior Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Ph ...

Core Insights - OnKure Therapeutics, Inc. reported a net loss of $17.4 million for Q4 2024, with cash and cash equivalents of approximately $110.8 million expected to fund operations through multiple clinical readouts into Q4 2026 [1][5][10]. Financial Performance - Research and development (R&D) expenses for Q4 2024 were $14.4 million, an increase from $8.8 million in Q4 2023, primarily due to higher clinical trial and manufacturing costs [8]. - General and Administrative (G&A) expenses rose to $4.3 million in Q4 2024 from $1.1 million in Q4 2023, driven by increased personnel-related costs and consulting expenses [9]. - The net loss per share for Q4 2024 was $1.37, compared to $30.14 per share in Q4 2023 [10]. Business Highlights - OnKure is advancing three PI3Ka inhibitor programs, with one in clinical development and another expected to be announced in Q2 2025 [2]. - The PIKture-01 trial has shown encouraging preliminary safety and tolerability data for the OKI-219 monotherapy, with no dose-limiting toxicities observed [7]. - The company initiated patient dosing in Part B of the PIKture-01 trial, evaluating OKI-219 in combination with fulvestrant for metastatic breast cancer [6][7]. - A merger with Reneo Pharmaceuticals closed on October 4, 2024, along with a $65 million financing, leading to a name change and new ticker symbol "OKUR" [6]. Upcoming Milestones - Additional data from the PIKture-01 trial is expected in the second half of 2025, along with the announcement of a pan-mutant selective program [6][3]. - OnKure aims to demonstrate approximately 10-fold selectivity of its pan-mutant inhibitor against common mutations over wild type [6].

Core Viewpoint - OnKure Therapeutics, Inc. is focused on developing novel precision medicines in oncology, with a particular emphasis on targeting biologically validated drivers of cancers that are underserved by existing therapies [1]. Company Overview - OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker OKUR [1]. - The company utilizes a structure- and computational chemistry-driven drug design platform to create a pipeline of tumor-agnostic candidates aimed at achieving optimal efficacy and tolerability [1]. - The lead program, OKI-219, is a selective PI3Kα inhibitor, and OnKure aims to become a leader in targeting oncogenic PI3Kα with multiple programs designed for best-in-class targeting of this key oncogene [1]. Upcoming Events - Nicholas Saccomano, Ph.D., President and CEO of OnKure, will present at the Leerink Partners Global Healthcare Conference on March 11, 2025, at 4:20 p.m. ET, with a live audio webcast available [3]. - OnKure will also participate in a fireside chat at the Stifel Targeted Oncology Forum, which will be held virtually on April 8-9, 2025 [3].

Company Overview - Rapport Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing small molecule precision medicines for central nervous system (CNS) disorders [6] - The company utilizes a unique RAP technology platform that targets receptor associated proteins (RAPs) in the brain, aiming to create precision small molecule candidates that address limitations in conventional neurology drug discovery [6] Leadership Appointment - Dr. Jeffrey Sevigny has been appointed as the chief medical officer (CMO) of Rapport Therapeutics, bringing over 15 years of experience in translational and clinical drug development [1][2] - Dr. Sevigny previously served as CMO at Prevail Therapeutics and held senior roles at Eli Lilly, where he contributed to significant corporate successes including financing rounds, an IPO, and an acquisition [2][4] Clinical Strategy and Pipeline - As CMO, Dr. Sevigny will oversee the clinical strategy and advancement of Rapport's pipeline, particularly the RAP-219 program, which is currently in clinical trials for conditions such as focal epilepsy, diabetic peripheral neuropathic pain, and bipolar mania [3][6] - The RAP-219 program is noted for its compelling Phase 1 data and aims to achieve neuroanatomical specificity by selectively targeting RAPs expressed in specific brain regions [5][6] Company Vision and Goals - The CEO of Rapport, Abraham N. Ceesay, expressed confidence in Dr. Sevigny's ability to lead the clinical development team and emphasized the importance of collaboration with regulatory authorities and patient advocacy organizations [4] - Dr. Sevigny highlighted the company's strong scientific foundation and the potential of its clinical candidates to provide transformative treatment options for patients with neurological disorders [5]

Strategic Combination Aims to Accelerate Biomarker Identification, Enhance Drug Discovery, and Expand Precision Medicine Applications in Cancer and Beyond LOS ANGELES, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Renovaro Biosciences Inc. (NASDAQ: RENB), a TechBio leader focused on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, today announced a definitive agreement to merge with BioSymetrics, an artificial intelligence (AI)-driven drug discovery and biomarker identification co ...