Bexotegrast development in IPF discontinued Clinical oncology program and early-stage programs continue Recent workforce and operational changes align with next steps SOUTH SAN FRANCISCO, Calif., June 27, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following the review of data from the recently terminated BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). BEACON-IPF Trial Update BEA ...

Core Points - Xenon Pharmaceuticals Inc. has been added to the Russell 3000® and Russell 2000® Indexes as part of the annual reconstitution effective June 27, 2025 [1] - The Russell 3000® Index tracks the performance of the largest 3,000 U.S. stocks by market capitalization, while the Russell 2000® Index measures the performance of the 2,000 smallest companies within the Russell 3000® Index [2] - Approximately $10.6 trillion in assets are benchmarked against Russell U.S. indexes, making them widely used by investment managers and institutional investors [3] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics [4] - The company is advancing an ion channel product portfolio to address high unmet medical needs, including epilepsy and depression [4] - Azetukalner, a novel and highly potent selective Kv7 potassium channel opener, is the most advanced clinically validated potassium channel modulator in late-stage clinical development for multiple indications [4]

STOCKHOLM, SWEDEN June 27, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company, Modus Therapeutics carries out a fully secured rights issue of units of SEK 28.3 million. The proceeds from the rights issue are intended to finance the continued development of the drug candidate sevuparin in chronic kidney disease with anemia. On June 26 2025, the portfolio company Modus Therapeutics, listed on Nasdaq First North Growth Market, announced that the company is carry ...

Core Insights - Neurocrine Biosciences announced significant reductions in cognitive and motor-related burdens in adults with Huntington's disease chorea treated with INGREZZA (valbenazine) capsules, based on new patient-reported post-hoc data from the KINECT-HD study [1][4] Group 1: Study Findings - The KINECT-HD study is the first clinical trial to show measurable changes in cognitive and motor disease burden with a vesicular monoamine transporter 2 inhibitor in Huntington's disease patients [1][2] - In the 12-week Phase 3 KINECT-HD clinical trial, INGREZZA showed a significant reduction in chorea severity, with a placebo-adjusted mean reduction in the Total Maximal Chorea (TMC) score of 3.2 units (p<0.0001) [11] - Patient-reported analyses indicated greater reductions in cognitive and motor-related disease burden for INGREZZA compared to placebo across various domains, including memory loss and mobility limitations [3][4] Group 2: Cognitive and Motor-Related Improvements - Statistically significant improvements were observed in cognition-related items, such as memory loss (-0.9 for INGREZZA vs -0.2 for placebo) and decision-making abilities (-1.0 for INGREZZA vs -0.3 for placebo) [3] - For motor-related items, INGREZZA demonstrated larger reductions in scores compared to placebo, including abnormal movements (-1.5 for INGREZZA vs -0.8 for placebo) and impaired coordination (-1.0 for INGREZZA vs -0.4 for placebo) [3][5] Group 3: Background on Huntington's Disease - Huntington's disease is a hereditary progressive neurodegenerative disorder affecting approximately 41,000 adults in the U.S., characterized by motor, cognitive, and psychiatric symptoms [7] - Chorea, a common symptom of Huntington's disease, involves irregular and unpredictable movements that can interfere with motor coordination and daily activities [7] Group 4: About INGREZZA - INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating chorea associated with Huntington's disease and tardive dyskinesia [14][15] - The drug is designed for once-daily administration without the need for titration, making it convenient for patients [16]

TARPON SPRINGS, Fla., June 27, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor today announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Commenting on the development, Thomas Jensen ...

BERKELEY HEIGHTS, N.J., June 27, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced the pricing of its previously announced underwritten public offering of 6,604,507 shares of its common stock. The total gross proceeds from the offering to the Company are expected to be approximately $85 million. In addition, CorMedix granted the underwriters a 30-day o ...

Core Insights - Ultragenyx Pharmaceutical Inc. has received Breakthrough Therapy Designation from the FDA for GTX-102 as a treatment for Angelman syndrome [1][2] - The designation highlights the urgent need for effective treatments and the promising clinical results observed with GTX-102 [2] - The Phase 3 Aspire study is currently enrolling participants, with plans for an additional Aurora study to evaluate GTX-102 in other genotypes and ages expected to start later in 2025 [3] Company Overview - Ultragenyx is a biopharmaceutical company focused on developing therapies for serious rare and ultra-rare genetic diseases [7] - The company has a diverse portfolio of approved medicines and treatment candidates aimed at addressing high unmet medical needs [7] - Ultragenyx's management team has extensive experience in the development and commercialization of rare disease therapeutics [8] Product Information - GTX-102 (apazunersen) is an investigational antisense oligonucleotide therapy designed to reactivate expression of the UBE3A gene [4] - The therapy has received multiple designations from the FDA, including Orphan Drug Designation and Fast Track Designation [4] - The Phase 1/2 study demonstrated consistent developmental gains in 74 patients aged 4-17 with a full maternal UBE3A gene deletion [2] Angelman Syndrome Insights - Angelman syndrome is a rare neurogenetic disorder affecting approximately 60,000 people in commercially accessible geographies [5] - The disorder is characterized by cognitive impairment, motor impairment, and seizures, requiring continuous care for affected individuals [6] - There are currently no approved therapies for Angelman syndrome, but animal models suggest potential for symptom improvement at any age [6]

Core Insights - HCW Biologics has developed second-generation, multi-specific T-cell engagers targeting pancreatic cancer, utilizing its proprietary TRBC product discovery platform, which activates T cells and reduces immunosuppression in the tumor microenvironment [1][2][3] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at chronic inflammation and age-related diseases, with a belief that their products can significantly change cancer treatment and improve patients' quality of life [4][5] - The company has created over 50 molecules using the TRBC platform, which allows for the construction of various classes of immunotherapeutic compounds, including multi-functional immune cell stimulators and multi-specific targeting fusions [5] Product Development - The lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the TRBC platform is designed to create immunotherapeutics that activate immune responses and specifically target cancerous cells [4][5] - The two lead T-cell engagers target tissue factor and mesothelin, demonstrating potent anti-pancreatic cancer activities in preclinical studies, with 100% survival in treated tumor-bearing mice [2][3]

SAN FRANCISCO and SUZHOU, China, June 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) recepto ...

Core Viewpoint - Biocon Biologics Ltd. has received a Notice of Compliance from Health Canada for its biosimilar YESAFILI (aflibercept), marking it as the first biosimilar to EYLEA approved in Canada, with a launch scheduled for July 4, 2025 [1][3]. Company Overview - Biocon Biologics Ltd. is a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., focused on providing affordable access to high-quality biologics [1][10]. - The company has commercialized nine biosimilars and has a pipeline of 20 biosimilar assets across various therapeutic areas, including diabetology, oncology, and ophthalmology [11]. Product Details - YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several serious retinal diseases, including neovascular age-related macular degeneration and diabetic macular edema [6][4]. - The approval of YESAFILI was based on comprehensive data demonstrating its similarity to EYLEA in terms of quality, safety, and efficacy, with no clinically meaningful differences observed in a Phase 3 study [2][4]. Market Impact - The approval of YESAFILI is seen as a significant achievement for Biocon Biologics in Canada, enhancing access to advanced biologic therapies for Canadian patients and ophthalmologists [3][10]. - The launch of YESAFILI will be the company's 10th biosimilar to be commercialized globally, reflecting its commitment to expanding access to affordable biologics [3][11].