Press Releases

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today announced that the DSMB reviewed safety data in the first 8 patients with Amyotrophic Lateral Sclerosis (ALS) treated with MaaT033 in the IASO clinical trial. The DSMB recommended that the trial continue without modifications. The DSMB, composed o

Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has agreed to subject the Biologics License Application (BIA) to priority review. License Application, BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after the failure of at least two previous lines of systemic treatment. The FDA's decision date under the Prescription Drug User Fee Act (PDUFA) is August 28, 2024. The BLA builds on po

Johnson & Johnson's Janssen Pharmaceutical Companies today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a type II variant for CARVYKTI ® ▼ (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM). The recommended indication for cilta-cel is the treatment of adult patients with RRMM who have received at least one prior treatment

Capricorn Scientific GmbH and ExcellGene SA have established a strategic partnership within the biotechnology sector. Applying their collective expertise and capabilities, the collaboration seeks to help customers by optimizing processes, developing products, and offering solutions in biotechnology. Lastly, this partnership is dedicated to customer-oriented solutions and a commitment to excellence, with the aim of advancing biotech research, development, and production. Capricorn Sc

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity Akili, Inc. (Nasdaq: AKLI) announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese, localized version o

Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.

Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in KOMET-008, the Company’s Phase 1 trial of its menin inhibitor ziftomenib, in combination with gilteritinib, FLAG-IDA or LDAC for the treatment of NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML). “Roughly half of patients with relapsed or r

Lirum Therapeutics, Inc. (“Lirum”), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today that it will present positive data on LX-101, a novel clinical-stage targeted therapy directed to the insulin growth factor-1 receptor (IGF-1R), in patients with high IGF-1R tumor expression at the 2024 European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies Congress in Paris, France on Monday, February 26t

Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2 trial [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without w

Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA