– MAJESTY, the first global Phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years – – Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this – – Gazyva could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus eryth

Clinical Advisory Board formed to support progression of HRN001 into first-in-human studies in 2027 Dr Andy Billinton, CSO will present preclinical data at the upcoming CHDI Foundation Huntington’s Disease Therapeutics Conference 16 February 2026: Harness Therapeutics (‘Harness’), a biotechnology company unlocking previously undruggable targets to transform the treatment of neurodegenerative diseases, today announces the nomination of HRN001 as its lead drug candidate for Huntington's disease

GLP-1 initiation is associated with a 14.6% reduced risk of asthma exacerbation for overweight patients, 12.2% for obese patients and 13.3% for morbidly obese patients Feb. 15, 2026 -- Glucagon-like peptide-1 receptor agonists (GLP-1) is linked to a significant reduction in asthma exacerbations for overweight, obese and morbidly obese patients without diabetes, according to new research being presented at the 2026 AAAAI Annual Meeting. "Asthma exacerbations can be disruptive for patients, espe

CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a significant milestone in the global development of this innovative immunotherapy. The ongoing global multicenter Phase II trial is currently enrolling patients in Australia and China. The study design includes 15 cohorts evaluating both monotherapy and comb

With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. "FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency's threshold of substantial evidence of effe

Novel intravenous anti-inflammatory candidate advances to Phase I evaluation to assess safety, tolerability, and pharmacokinetics. February 11, 2026-- Isosceles Pharmaceuticals today announced that its patented investigational candidate, IPI201, has been accepted to proceed into a Phase I first-in-human clinical trial, marking a milestone in the company’s development pipeline. The study is expected to initiate first patient, first dose in April, beginning with dosing in healthy volunteers. IPI

Study to be conducted by PharmaLegacy, a leading Contract Research Organization February 11, 2026 -- Vidac Pharma Holding Plc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting the HK2/VDAC metabolic checkpoint, today announced the initiation of an in vivo pre-clinical program in psoriasis, marking the first formal evaluation of its proprietary technology platform outside oncology. The study will be conducted by PharmaLegacy, a highly reputable Contract

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026 If approved, Ameluz® would be the first and only PDT photosensitizer indicated for the treatment of superficial Basal Cell Carcinoma (sBCC) in the US BCC is the most common skin cancer in the US with 3.6 million cases diagnosed annually1 Feb. 11, 2026 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of photod

First dose at HOAG Health in FAPI-PRO trial for Pancreatic Ductal Adenocarcinoma A parallel trial focused on gastroesophageal cancers, FAPI-GO, dosed its first patient December 2025 Feb. 11, 2026 -- SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, today announced that the first patient has been dosed in the second of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein

• World’s first clinical study of a fully standardised, multi-alkaloid DMT–harmala formulation designed for regulated medical use • Acute effect scores on MEQ-30 and 5D-ASC exceeded those reported in prior psilocybin and LSD studies using these standardised measures • Psychedelic effects were strongly associated with persisting psychological benefits, including enhanced wellbeing and more positive life attitudes. • Results support advancement of Neurala’s proprietary second-generation product ca