Study met primary endpoint (p-value=0.0068) First global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative Supplemental Biologics License Application (sBLA) to be submitted to U.S. Food and Drug Administration (FDA) by end of 2025 August 25, 2025, 7:00 AM CET – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune

Safety and Pharmacokinetic Data Support Dosing of ART26.12 in Fed or Fasted Conditions Completion of Positive Single Ascending Dose Study with a Preliminary Food Effect Assessment Advances ART26.12 Toward Multiple Ascending Dose Trial Aug. 25, 2025 -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or neurological conditions, today announce

Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months* VERSATILE-003 Phase 3 trial in progress Aug. 25, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced final topline survival data from its VERSATILE-002 Phase 2 c

Aug. 22, 2025 -- ViRx@Stanford, a leading biosecurity and pandemic preparedness initiative, and Fifty1 AI Labs, a subsidiary of Fifty1 Labs, Inc. (OTC: FITY), an innovative AI-driven drug repurposing company, today announced a strategic partnership under the "BE READI!" initiative. This collaboration will leverage Fifty1's advanced AI platform to repurpose existing drugs into potent antiviral therapies, addressing urgent viral threats and enhancing global health security. The partnership posit

Aug. 21, 2025 -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) being developed for the treatment of chronic spontaneous urticaria (CSU) and other mast cell-driven diseases. The Phase 1 s

Aug. 21, 2025 -- VeonGen Therapeutics, a clinical-stage genetic medicine company developing next-generation gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to VG801, its lead investigational gene therapy for Stargardt disease and other ABCA4 mutation–associated retinal dystrophies. By delivering a full-length, functional ABCA4 gene, VG801 has the potential to address the underlying genetic roo

Aug. 22, 2025 -- BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, today announced the first patient dosed in the expansion cohorts of the SOLARA trial (NCT06706076), the first-in-human trial of BH-30643, a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFRTM inhibitor having sub-nanomolar potency against classical and atypical EG

Aug. 21, 2025 -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH). Atumelnant is the first and only small molecule ACTH receptor antagonist in clinical development. “Receiving Orphan Drug Designation from the FDA und

Aug. 22, 2025 -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company”, “Jyong Biotech”), a science-driven biotechnology company based in Taiwan committed to developing and commercializing innovative and differentiated new drugs (plant-derived) mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia, announced its participation in the 22nd Urological Association of Asia Congress which was held in conjunction with the 47th Ann

Aug. 21, 2025 -- Cube Biotech, a pioneer in membrane protein stabilization and purification, and X-Chem, the global leader in DNA-Encoded Library (DEL) technology and data-driven drug discovery, are proud to announce the successful conclusion of Project DEL-MP. Project DEL-MP was a collaborative initiative demonstrating that copolymer-stabilized membrane proteins are not only suitable for DEL screening, they also open up completely new possibilities for even the most challenging targets. The g