MIAMI, Feb. 12, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) plans to report operating and financial results for the three and 12 months ended December 31, 2025, after the close of the U.S. financial markets on Thursday, February 26, 2026. OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourages participants to ...

Core Viewpoint - BioVie Inc. announced the acceptance of two abstracts for its lead candidate bezisterim (NE3107) at the 2026 American College of Psychiatrists annual meeting, focusing on Alzheimer's Disease and Long COVID [1][2]. Group 1: Bezisterim Overview - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression and with low drug-drug interaction risk [3]. - The drug targets neuroinflammation pathways (ERK, NFκB, TNF-α) and has potential applications in Parkinson's disease, Long COVID, and Alzheimer's disease [3]. Group 2: Clinical Trials and Results - In Parkinson's disease, a completed Phase 2 study indicated that patients taking bezisterim with levodopa experienced better motor control and fewer morning symptoms compared to those on levodopa alone, with minimal side effects [4]. - The SUNRISE-PD trial is currently enrolling 60 patients to assess bezisterim's efficacy in improving symptoms for untreated Parkinson's patients, with topline results expected in mid-2026 [4]. - The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data anticipated in mid-2026 [5]. - In Alzheimer's disease, both Phase 2 and Phase 3 trials have been conducted, showing early results that suggest cognitive improvements and biomarker support for further trials [6]. Group 3: Company Background - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7]. - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for its efficacy in patients with cirrhosis and ascites [8].

Core Insights - Aardvark Therapeutics, Inc. has appointed Derrick C. Li as Chief Business Officer and expanded Nelson Sun's role to Chief Operating Officer, effective February 9, 2026, which is seen as pivotal for the company's growth as it advances its clinical programs [1][2] Company Developments - The appointments of Derrick Li and Nelson Sun are crucial as Aardvark progresses ARD-101 through Phase 3 development for hyperphagia associated with Prader-Willi Syndrome and continues Phase 2 development of ARD-201 for obesity-related conditions [2] - Derrick Li will lead Aardvark's business development strategy, focusing on financing, licensing, partnership strategy, and corporate development initiatives [2][3] Product Pipeline - Aardvark is developing ARD-101, an oral compound in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome, and ARD-201, a planned fixed-dose combination with a DPP-4 inhibitor, through two separate Phase 2 trials [4] - Topline Phase 3 data for ARD-101 is expected in the third quarter of 2026, which is a significant milestone for the company [3]

Core Insights - Oryzon Genomics has appointed Dr. Rolando Gutierrez-Esteinou as Chief Medical Officer for CNS Programs, bringing over 20 years of experience in neuroscience and psychiatry drug development [1][2][3] - Dr. Gutierrez-Esteinou will lead the Phase III clinical development of vafidemstat, targeting agitation and aggression in borderline personality disorder, while also expanding its use in autism spectrum disorder and schizophrenia [2][4] - Oryzon is recognized as a leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology, with a clinical portfolio that includes two LSD1 inhibitors [5][6] Company Overview - Oryzon Genomics, founded in 2000 and headquartered in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics [5] - The company has a strong clinical portfolio, including vafidemstat, which is Phase III-ready, and iadademstat, which is in ongoing Phase I and II studies with promising results in acute myeloid leukemia [5][6] - Oryzon is advancing a broader epigenetics pipeline, including a clinical candidate for Charcot-Marie-Tooth disease and amyotrophic lateral sclerosis [6]

Core Viewpoint - Cue Biopharma has appointed Lucinda Warren as Chief Financial and Business Officer, a strategic move aimed at driving business growth and advancing its lead autoimmune asset, CUE-401, toward clinical development [1][2]. Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for treating autoimmune and inflammatory diseases [1][4]. - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects of broad systemic immune modulation [4]. Leadership and Experience - Lucinda Warren has over 30 years of experience in the pharmaceutical and biotechnology sectors, previously serving as Vice President of Business Development at Johnson & Johnson [3]. - Warren's leadership has been pivotal in business development, including licensing, mergers and acquisitions, and alliance management [3]. Product Development - CUE-401, the lead autoimmune asset, is designed to regulate proinflammatory mechanisms and induce tolerance through a bifunctional molecule combining TGF-beta and interleukin 2 (IL-2) [4].

HOUSTON, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that management will participate in the following upcoming investor conferences: JonesTrading C-Suite Fireside Chat SeriesDate: Wednesday, February 19, 2026Time: 11:00 AM ESTRegistration Link here Oppenheimer 36th Annual Healthcare Life S ...

Core Viewpoint - Grace Therapeutics is advancing GTx-104, a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026, for FDA review of its NDA submission [1][2]. Company Developments - The company is engaged in pre-commercial planning in anticipation of potential FDA approval for GTx-104, supported by positive results from the STRIVE-ON trial, which demonstrated improved clinical outcomes for aSAH patients [2][4]. - The STRIVE-ON trial results were presented at the Society of Vascular and Interventional Neurology annual meeting in November 2025, highlighting the safety and tolerability of GTx-104 compared to oral nimodipine [5][11]. - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, enhancing its financial position for ongoing operations [5]. Financial Performance - For the quarter ended December 31, 2025, the company reported a net loss of approximately $2.3 million, a decrease from a net loss of $4.2 million in the same quarter of the previous year, primarily due to reduced research and development expenses [4][22]. - Research and development expenses for the same period were $0.5 million, significantly lower than $2.2 million in the prior year, reflecting the completion of the STRIVE-ON trial [6]. - General and administrative expenses increased to $2.0 million, up from $1.5 million, attributed to costs associated with GTx-104 pre-commercial planning [7]. Cash Position - As of December 31, 2025, the company had cash and cash equivalents of $18.7 million, a decrease from $22.1 million at the end of March 2025, indicating a need for careful cash management moving forward [8][10]. Market Context - aSAH is a rare and serious condition that has not seen significant innovation in treatment for nearly 40 years, positioning GTx-104 as a potentially transformative therapy if approved [2][12]. - The company holds a strong patent estate that could enhance the long-term market value of GTx-104, benefiting shareholders [2].

Core Viewpoint - Aardvark Therapeutics has established a new wholly-owned subsidiary, Ardia Therapeutics, to focus on developing a dermatology pipeline, particularly the lead asset DIA-615, aimed at treating inflammatory skin diseases like psoriasis [1][4]. Group 1: Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company that develops small-molecule therapeutics targeting metabolic diseases and hunger-related conditions, with its lead compound ARD-101 in Phase 3 clinical development for Prader-Willi Syndrome [5]. - The newly formed Ardia Therapeutics will concentrate on DIA-615, a topical treatment designed to target inflammatory cells in the skin, utilizing a mechanism that involves specific G protein-coupled receptors [4]. Group 2: Leadership and Management - Bryan Jones, Ph.D., has been appointed as the CEO of Ardia, transitioning from his previous role as COO at Aardvark, bringing over 30 years of experience in biotech and specialty pharmaceuticals [2][3]. - Dr. Jones has a notable background, having held significant positions in various biotech companies and successfully leading multiple development programs throughout his career [3]. Group 3: Product Development - DIA-615 is positioned as a clinic-ready topical drug aimed at treating various inflammatory skin diseases, including psoriasis, by downregulating stressed endoplasmic reticulum in inflammatory cells [4]. - The development of DIA-615 is expected to address serious unmet needs in the treatment of severe skin diseases, with the potential for significant impact on patient care [2][3].

Core Insights - Calidi Biotherapeutics is set to present data on its innovative use of BiTEs in solid tumors through its RedTail platform at the AACR Immuno-Oncology conference from February 18-21, 2026 [1] Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted genetic medicines, utilizing its proprietary RedTail platform for systemic delivery to metastatic sites [5] - The RedTail platform employs an engineered enveloped oncolytic virus designed to evade immune clearance, allowing effective delivery of genetic medicines to tumor sites [5] Product Development - The lead candidate from the RedTail platform, CLD-401, is engineered to express high levels of IL-15 superagonist, which activates T-cells within the tumor microenvironment [2][3] - CLD-401 is currently in IND-enabling studies and targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs [6] - The company plans to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [4] Technological Advancements - The RedTail platform has shown the ability to remodel the tumor microenvironment and induce T-cell activation, which is crucial for overcoming the limitations of BiTEs in solid tumors [3] - The platform allows for the simultaneous expression of multiple tumor-localized payloads, enhancing the potential for effective treatment [3] Strategic Initiatives - Calidi is actively pursuing strategic partnerships to accelerate the clinical development of its RedTail platform and broaden its impact in the biotechnology sector [4]

Core Insights - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, highlighting significant progress in its clinical pipeline and upcoming milestones for 2026 [1][2] Clinical Developments - Top-line results from the Phase 2a trial of SGX302 for mild-to-moderate psoriasis showed that the gel therapy was well tolerated, with one patient achieving "Almost Clear" status and over 50% improvement in PASI score [1] - The Phase 2a trial of SGX945 for Behçet's Disease demonstrated biological efficacy, with results comparable to apremilast, indicating potential for home-based treatment in future studies [1] - Ongoing studies for HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) show promising results, with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1] Market Opportunities - Peak annual net sales for HyBryte™ in the U.S. are expected to exceed $90 million, with a total addressable worldwide CTCL market estimated at over $250 million annually [2] - The psoriasis market opportunity with SGX302 is projected to exceed $1 billion annually, while SGX945 for Behçet's Disease is estimated at approximately $200 million annually [2] - Overall, the potential for significant commercial returns across the rare disease pipeline is estimated at around $2 billion in global annual sales [2] Financial Position - As of September 30, 2025, the company reported approximately $10.5 million in cash, with additional non-dilutive funding of about $500 thousand from New Jersey's NOL sales program [2] - The company is focused on advancing its development programs and has sufficient capital to meet its goals through 2026 [2]