AUSTIN, Texas, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that the U.S. Department of Justice Fraud Section (DOJ) has closed its inquiry into the Company regarding allegations of research misconduct as described in the indictment in United States v. Wang, 8: ...

Core Insights - Nxera Pharma has received a milestone payment of US$1.8 million from Centessa Pharmaceuticals due to the achievement of an early development milestone for the investigational drug ORX489, which is being developed for neuropsychiatric disorders [1] - The milestone payment will be recognized as revenue in the first quarter of 2026 [1] Company Overview - Nxera Pharma is a technology-driven biopharma company focused on developing specialty medicines to address unmet medical needs in Japan and globally [3] - The company operates a new-generation commercial business in Japan, with a pipeline of innovative medicines and several launched products targeting a high-value market in the broader APAC region [3] - Nxera Pharma utilizes its proprietary NxWave™ GPCR structure-based drug discovery platform to advance its extensive pipeline, both internally and through partnerships with leading pharmaceutical and biotech companies [3] - The company has key operational locations in Tokyo, Osaka, London, Cambridge, Basel, and Seoul, and is listed on the Tokyo Stock Exchange under the ticker 4565 [3]

Core Viewpoint - Inotiv, Inc. will release its financial results for the fiscal 2026 first quarter on February 9, 2026, before the market opens, and will host a conference call to discuss these results [1]. Company Overview - Inotiv, Inc. is a leading contract research organization that specializes in nonclinical and analytical drug discovery and development services, as well as research models and related products [3]. - The company's focus is on enhancing the efficiency and data quality of drug and medical device development while reducing costs associated with bringing new products to market [3]. - Inotiv is dedicated to supporting research and development objectives, aiming to help researchers maximize the potential of their projects for a healthier and safer world [3].

Core Insights - Xenon Pharmaceuticals Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, CA [1] - The presentation will be led by Ian Mortimer, President and CEO, and will be available via live audio webcast [2] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics for patients in need [3] - The company's lead molecule, azetukalner, is a selective Kv7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder (MDD), and bipolar depression (BPD) [3] - Xenon is also developing an early-stage portfolio of potassium and sodium channel modulators, including Kv7 and NaV1.7 programs in Phase 1 for potential pain treatment [3]

Core Viewpoint - Cassava Sciences, Inc. has reached a definitive agreement to settle a consolidated securities class action litigation for $31.25 million, allowing the company to focus on the development of its investigational treatment simufilam for TSC-related epilepsy [1][2][3] Financial Settlement - The settlement amount of $31.25 million will resolve all claims from plaintiffs who purchased or acquired the company's common stock or options between September 14, 2020, and October 12, 2023 [2] - The company fully reserved this loss contingency in the second quarter of 2025 [3] Company Focus and Product Development - Cassava is dedicated to the continued development of simufilam, a proprietary investigational oral small molecule aimed at treating TSC-related epilepsy [3][5] - The company is planning a Phase 2 proof-of-concept study for simufilam in collaboration with the TSC Alliance and key opinion leaders, based on a treatment patent issued in 2025 [5]

Core Insights - Autobahn Labs has formed a strategic partnership with Astellas Pharma to transform academic research into investable drug discovery programs [1][4] - Astellas will have exclusive investment opportunities in selected drug discovery programs from Autobahn's translational research pipeline [2][3] - The collaboration aims to combine academic innovation with drug development expertise to accelerate the translation of discoveries into therapies [4] Company Overview - Autobahn Labs is a venture studio that collaborates with leading academic institutions to create de-risked drug discovery programs [5] - The company is backed by Samsara BioCapital and Charles River Labs, and has partnerships with several prestigious academic institutions [5] Partnership Details - Astellas will pay an annual access fee and co-invest in startups created under the partnership with Autobahn [2][3] - Equity interests in new Program Companies will be shared among Autobahn, Astellas, the originating academic institution, and founding academic investigators [3] - Astellas will have the right of first negotiation for exclusive licensing of intellectual property from jointly funded programs [3]

Core Viewpoint - Cassava Sciences, Inc. has appointed Ms. Dawn C. Bir to its Board of Directors, which is seen as a strategic move as the company prepares to initiate its first clinical study for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy in the first half of 2026 [1][3]. Company Overview - Cassava Sciences, Inc. is a biotechnology company focused on developing investigational treatments for central nervous system disorders, including TSC-related epilepsy [4]. - The company's lead product, simufilam, is an oral small molecule believed to modulate the activity of the filamin A protein, which plays a role in neuronal development [4]. Appointment of Dawn C. Bir - Dawn C. Bir is a seasoned biopharmaceutical executive with a history of contributing to the growth and commercialization of biotechnology companies [2]. - Her previous roles include Interim President and CEO of Geron Corporation and Executive Vice President and Chief Commercial Officer at Reata Pharmaceuticals, where she was instrumental in the company's acquisition by Biogen [2][3]. - The Board believes that Ms. Bir's experience in building shareholder value and her relationships with market stakeholders will be beneficial as Cassava advances its clinical programs [3]. Strategic Importance - The appointment of Ms. Bir is considered pivotal for Cassava as it seeks to enhance its strategic capabilities in preparation for the upcoming clinical study [3]. - Ms. Bir expressed her commitment to delivering transformative therapies for TSC-related epilepsy and is eager to collaborate with the management team to guide business and clinical strategies [3].

Core Viewpoint - HCW Biologics Inc. reported its financial results for Q2 2025, highlighting significant developments in its clinical trials, business transactions, and financial performance, while also addressing challenges related to funding and compliance with Nasdaq listing requirements [1][8][14]. Business Highlights - The company completed a $5.0 million equity offering on May 15, 2025, to fund clinical trials for HCW9302, aimed at treating autoimmune disorders [2]. - HCW Biologics is actively negotiating licensing agreements for HCW9206, a molecule intended for CAR-T cell production, after suspending its previous licensing agreement with Wugen [6]. - The company is seeking a commercial partner for its T-cell engager compounds, which target cancer antigens and aim to reduce immunosuppression in tumor microenvironments [6]. Financing Transactions - The company extinguished $7.7 million of debt through restructuring or conversion to equity, strengthening its balance sheet [6]. - The equity offering consisted of 671,140 units priced at $7.45 each, with each unit including two warrants for common stock purchase [6]. Clinical Development and Preclinical Results - HCW Biologics plans to initiate a Phase 1 clinical trial for HCW9302 in Q3 2025, targeting alopecia areata, an autoimmune disease with no FDA-approved treatments [6]. - The company has identified second-generation T-cell engagers and immune checkpoint inhibitors for clinical development, with a focus on a pembrolizumab-based fusion molecule showing promise against pancreatic cancer [7]. Financial Results - Revenues for Q2 2025 were $6,550, a significant decrease from $618,854 in Q2 2024, with total revenues for the first half of 2025 at $11,615 compared to $1.7 million in the same period of 2024 [8]. - R&D expenses decreased by 40% in Q2 2025 to $1.2 million, while G&A expenses increased by 31% to $2.1 million [9][10]. - The net loss for Q2 2025 was $1.9 million, down from $15.3 million in Q2 2024, with a six-month net loss of $4.1 million compared to $22.7 million in the prior year [12]. Financial Guidance - As of June 30, 2025, the company expressed substantial doubt regarding its ability to continue as a going concern without additional funding [13]. - HCW Biologics received confirmation from Nasdaq that it met all listing requirements, although it will remain under a "Panel Monitor" for one year [14][15].

Company Overview - Inotiv, Inc. is a leading contract research organization specializing in nonclinical and analytical drug discovery and development services, as well as research models and related products and services [3] - The company's focus is on enhancing efficiency, improving data quality, and reducing costs associated with bringing new drugs and medical devices to market [3] Financial Results Announcement - Inotiv will release its financial results for the fiscal 2025 third quarter, which ended on June 30, 2025, on August 6, 2025, after the stock market closes [1] - A conference call will be held on the same day at 4:30 p.m. Eastern Time to discuss the financial results [1] Participation Information - Interested parties can participate in the conference call by dialing the provided numbers or accessing the live webcast through the company's website [2] - An online replay of the conference call will be available for those unable to attend the live broadcast [2]

Core Insights - Cellectar Biosciences, Inc. announced promising initial results from the CLOVER-2 Phase 1 clinical trial of iopofosine I 131 for treating relapsed/refractory pediatric high-grade glioma (pHGG) patients, showing an average progression-free survival (PFS) of 5.4 months, which is more than double the previously reported median of 2.25 months [1][2][4] Group 1: Clinical Trial Results - The CLOVER-2 trial involved 14 patients diagnosed with various forms of pHGG, including diffuse midline gliomas and anaplastic ependymomas, with poor historical outcomes of approximately 2.25 months for median PFS and 5.6 months for overall survival (OS) [2] - Patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and an OS of 8.6 months, with all patients achieving disease control [3] - Three patients who received additional dosing cycles had an average PFS of 8.1 months and an OS of 11.5 months, with two achieving an objective response rate [3] Group 2: Safety and Tolerability - Iopofosine I 131 was well tolerated, with a safety profile consistent with previous data, showing no significant cardiovascular, renal, or liver toxicities, and manageable hematologic adverse events [4] - The most common treatment-emergent adverse events were hematologic, including thrombocytopenia, neutropenia, and anemia, all of which were predictable and manageable [4] Group 3: Trial Design and Objectives - The ongoing Phase 1b trial is designed to evaluate the safety and tolerability of iopofosine I 131 in children, adolescents, and young adults with relapsed/refractory high-grade glioma, with two dosing cohorts planned [5] - The study aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction, and to identify the recommended Phase 2/3 dose [5] Group 4: Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [6] - The company's pipeline includes iopofosine I 131 and other programs targeting various solid tumors, with iopofosine I 131 also studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7][9]