Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference Aug. 27, 2025 -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN)

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA Outlook Therapeutics plans to work with FDA to address the Agency’s issues Company to host a conference call and webcast today, August 28th at 8:30 AM ET Aug. 28, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete re

Aug. 26, 2025 -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today the award of a new $2.3 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH). The award evaluates Trethera’s lead drug candidate, TRE-515, combined with radiation therapies to treat metastatic castration resistant prostate cancer (mCRPC)— a disease that claims 70% of p

First iadademstat clinical trial in non-malignant hematological indications Aug. 25, 2025 -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA), the European equivalent to an IND, to initiate a Phase Ib trial of iadademstat in sickle cell disease (SCD). This will be the first clinical trial investi

August 26, 2025 Breakthrough Therapy Designation granted to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy Regulatory decision supported by data from the Phase 1/2 RAINFOL™-01 trial showing encouraging responses in heavily pretreated EC patientsi Rina-S continues to be evaluated as a single-agent in patients with advanced EC in th

Aug. 25, 2025 -- Arnatar Therapeutics, a biotechnology company pioneering RNA-based therapies for severe and underserved diseases, emerges from stealth today and announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation and Rare Pediatric Disease Designation to ART4, the company’s up-regulating antisense oligonucleotide (ASO) therapeutic candidate for the treatment of Alagille Syndrome (ALGS). “We are excited to emerge from stealth with a strong scientific

Aug. 25, 2025 -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dua

Aug. 25, 2025 -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced it has secured a $11.25 million extension to its Series B financing. The Series B extension investors include Eshelman Ventures, Eli Lilly and Company, Pharmacosmos and new investor Cape Fear BioCapital. The additional financing will advance Incyclix’s ongoing INX-315-01 (NCT0573508

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