BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast at 8 a.m. ET on Thursday, February 26, 2026 to report its fourth quarter and full year 2025 financial results and provide a corporate update. To access the live conference call, participants may register here. While ...

Core Viewpoint - Cingulate Inc. successfully closed a $12 million PIPE financing, indicating strong validation of its strategy and technology in the ADHD treatment market [1][2]. Financing Details - The PIPE financing was led by Falcon Creek Capital and completed at a price of $5.04 per share, with 80% warrant coverage [2][9]. - All investors in the PIPE financing are subject to a 180-day lock-up period, aligning long-term interests [3][9]. - The financing proceeds will support general operations and the commercial launch of CTx-1301, pending FDA approval [4][9]. Product Information - CTx-1301 is a once-daily, multi-core tablet designed to provide consistent symptom control for ADHD, utilizing Cingulate's Precision Timed Release™ platform [8][11]. - The FDA accepted Cingulate's NDA for CTx-1301 in October 2025, with a PDUFA target action date set for May 31, 2026 [9]. Company Overview - Cingulate Inc. focuses on developing next-generation pharmaceutical products for ADHD and other CNS disorders, leveraging its proprietary technology [11]. - The company is headquartered in Kansas City, Kansas, and aims to improve therapeutic outcomes for conditions with suboptimal treatment coverage [11]. Investor Relations - Falcon Creek Capital, a specialized investment firm, will designate up to two members to Cingulate's board, enhancing governance and strategic execution [4][12].

Core Viewpoint - Aprea Therapeutics, Inc. is set to provide a corporate update at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, highlighting its innovative cancer therapies that target cancer-specific vulnerabilities while minimizing harm to healthy cells [1]. Group 1: Company Overview - Aprea is a clinical-stage biopharmaceutical company focused on developing therapies that exploit cancer cell mutations to treat various cancer types, including ovarian, endometrial, colorectal, and head and neck squamous cell carcinoma [3]. - The company's lead programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both currently in clinical development for solid tumor indications [4]. Group 2: Presentation Details - The corporate update will be presented virtually on February 26, 2026, at 8:40 am EST, with a webcast available for 90 days [2]. - Investors interested in one-on-one meetings with Aprea management during the conference can contact their Oppenheimer representative [2].

Company Overview - Fulcrum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, particularly in areas of high unmet medical need [4] - The company's lead clinical program is pociredir, designed to increase fetal hemoglobin expression for the treatment of sickle cell disease (SCD) [4] Clinical Development - Fulcrum will present 12-week results from the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease on February 24, 2026 [1] - Pociredir is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED), leading to downregulation of fetal globin repressors and increased fetal hemoglobin [5] - In the PIONEER trial, pociredir has shown dose-dependent increases in fetal hemoglobin, improvements in markers of hemolysis and anemia, and has been generally well-tolerated with no serious adverse events reported [5] Expert Involvement - Dr. Martin Steinberg, a prominent hematologist with extensive research on sickle cell disease, will join Fulcrum management for the conference call [2][3] - Dr. Steinberg has published over 450 articles and has contributed significantly to understanding the genetic basis and pathophysiology of sickle cell disease [3] Regulatory Status - Pociredir has received Fast Track and Orphan Drug Designation from the FDA for the treatment of sickle cell disease [5] Disease Background - Sickle cell disease is a genetic disorder caused by a mutation in the HBB gene, leading to inefficient oxygen transport and sickle-shaped red blood cells, which can cause various serious health complications [6]

Core Viewpoint - Annexon, Inc. is advancing targeted immunotherapies for neuroinflammatory diseases, with a focus on dry age-related macular degeneration (AMD) and geographic atrophy (GA), impacting nearly 10 million people globally [1][8] Company Overview - Annexon is a biopharmaceutical company specializing in immunotherapies aimed at neuroinflammatory diseases [1][8] - The company is developing vonaprument, a C1q inhibitor designed to be the first targeted vision-preserving therapy for GA [6][8] Event Announcement - Annexon will host a key opinion leader (KOL) event in New York on March 18, 2026, featuring presentations on dry AMD and GA [1][2] - The event will include a live Q&A session following the formal presentations [2] Expert Contributions - Dr. Eleonora Lad and Dr. Charles C. Wykoff will present at the event, focusing on the unmet needs in GA treatment and the mechanism of disease [5] - Dr. Lad's research includes the role of neuroinflammation in AMD and the development of innovative diagnostic approaches [3] - Dr. Wykoff has extensive experience in clinical trials and research related to retinal diseases [4] Product Development - Vonaprument is a clinical-stage investigational therapy that selectively inhibits C1q, aiming to protect retinal function [6] - The drug has received Fast Track designation from the FDA and Priority Medicine designation from the European Medicines Agency [6] Clinical Trial Information - The Phase 3 ARCHER II trial has enrolled over 630 patients with advanced dry AMD and GA, with a primary endpoint of preventing a ≥15-letter loss in best corrected visual acuity [7] - Topline data from the trial is expected in the second half of 2026 [7]

Core Insights - Trevi Therapeutics, Inc. is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [2][3] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on Haduvio™, which is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and RCC [2] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in chronic cough control [2] Industry Context - Chronic cough in patients with IPF and non-IPF ILD represents a significant unmet medical need, with approximately 150,000 U.S. patients with IPF, two-thirds of whom experience uncontrolled chronic cough [3] - There are around 228,000 U.S. patients with non-IPF ILD, with 50-60% suffering from uncontrolled chronic cough, leading to severe impacts on morbidity and mortality [3] - RCC affects approximately 2-3 million U.S. patients and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, with significant physical, psychological, and social impacts [4]

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the Company will release its fourth quarter and full year 2025 financial results before the open of the U.S. financial markets on Monday, March 2, 2026. Management will host a conference call and webcast at 8:30 a.m. Eastern Time that day to di. ...

Core Insights - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE NK cell engager platform [1][3] - The company will participate in the Centurion One Capital 9th Annual Toronto Growth Conference on March 5, 2026, where one-on-one meetings with investors will be available [1][2] Company Overview - GT Biopharma is dedicated to the development and commercialization of immuno-oncology therapeutic products utilizing the TriKE platform, which enhances the cancer-killing abilities of natural killer cells in the immune system [3] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the further development and commercialization of therapies using TriKE technology [3]

Core Insights - TG Therapeutics announced five-year data from the ongoing open-label extension of the Phase 3 ULTIMATE I and II studies for BRIUMVI, demonstrating durable clinical efficacy and a consistent safety profile over extended treatment [1][2][3] Efficacy Results - The annualized relapse rate (ARR) for patients on BRIUMVI decreased significantly over five years, with rates of 0.053, 0.032, and 0.020 for Years 3, 4, and 5 respectively, indicating one relapse every 50 years of treatment [4] - 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free at Year 5 [4] - After five years, only 8% of patients on continuous BRIUMVI treatment experienced Confirmed Disability Progression (CDP) lasting 24 weeks, compared to 14.3% for those who switched from teriflunomide [4] - 17% of patients on continuous BRIUMVI achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks, compared to 12.2% for switch participants [4] Safety Profile - The overall safety profile of BRIUMVI remained consistent over five years, with no new safety signals emerging during prolonged treatment [1][4][5] - Immunoglobulin levels were stable, with no association found between decreased levels and serious infections [5] Study Details - The ULTIMATE I & II trials involved over 3,600 participant-years of ublituximab exposure, with more than 85% of eligible participants opting for the long-term open-label extension [3][6] - The trials enrolled a total of 1,094 patients with relapsing forms of multiple sclerosis across 10 countries [6] Company Overview - TG Therapeutics is focused on developing and commercializing novel treatments for B-cell diseases, with BRIUMVI approved for treating adult patients with relapsing forms of multiple sclerosis [7][10]

European Commission Approval Based on Results of SEQUOIA-HCM First European Launch Expected in Germany in Q2 2026 SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Commission (EC) has approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. MYQORZO is an allosteri ...