The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA) U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028 OCU410 is designed as a one-time subreti

Signatera demonstrates 100% positive predictive value for treatment response assessment, detects recurrence months earlier than imaging, and supports precise, individualized lymphoma management through serial ctDNA monitoring Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of new data in Blood Neoplasia, validating the prognostic and predictive value of Signatera in patients with both newly diagnosed and relapsed/refractory (

–4-year data from the Phase 1/2a open-label extension (OLE) studies support the potential disease-modifying effects of zorevunersen– –Improvements in cognition and behavior sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile– –New data from sub-analyses of patients treated with zorevunersen in the Phase 1/2a OLEs include effects on severe seizures and quality of life Sept. 01, 2026 -- Stoke Therapeutics, Inc. (Nasdaq: STOK), a biot

Positive Toxicology Results From 7-Day Rat and Dog Studies Characterize Tolerability and Inform Dose Selection for Next Phase of IND-Enabling Program, Targeting Q1 2027 IND Submission Sept. 01, 2026 -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced positive results from completed 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs

Partnership will support Resolution’s pivotal clinical program in 2027, as well as future commercial preparedness for RTX001, its lead asset in patients with end-stage liver disease (ESLD) Primary goal is to ensure patients can access treatment in the community setting, where the majority of decompensated patients are managed RTX001 has the potential to be the first treatment that demonstrates a clear and durable improvement in transplant free survival for ESLD patients Sept. 01, 2026 -- Reso

– Following productive FDA discussions, Upstream Bio will study 400 mg of verekitug administered every 12 weeks, versus placebo, in severe asthma and CRSwNP with one pivotal Phase 3 trial in each indication – – The Company’s Phase 3 strategy is designed to deliver best-in-class efficacy across both indications by evaluating a high-dose, quarterly regimen of verekitug in broad patient populations – – The Company remains on track to initiate both Phase 3 trials in Q1 2027 – Sept. 01, 2026 -- Upst

Roivant Sciences' Pulmovant subsidiary announced that its once-daily, inhaled soluble guanylate cyclase (sGC) activator mosliciguat cleared a mid-stage study, delivering a notable reduction in pulmonary vascular resistance (PVR) over placebo in pulmonary hypertension associated with interstitial lung disease (PH-ILD). The findings were unveiled Tuesday at the European Respiratory Society (ERS) congress, sending Roivant's shares up nearly 29% in premarket trading. Pulmovant CEO Drew Fromkin said

FDA clearance enables initiation of a Phase 1 clinical trial and advances the first AD2C-generated candidate into clinical development Sept. 4, 2026 -- Acepodia (6976: TT), a clinical-stage biotechnology company developing next-generation cell therapies and antibody-drug conjugates, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate (ADC) developed

Paxalisib Monotherapy Significantly Reduced Tumor Burden in Pre-Clinical Model of MSS/pMMR Colorectal Cancer, With the Addition of Pembrolizumab Driving a Further Reduction Paxalisib Was Well Tolerated as Monotherapy and in Combination with Checkpoint Inhibition Kazia is Preparing to Advance Paxalisib Into a Phase 2 Clinical Study to Evaluate Paxalisib in Immunotherapy-Resistant MSS/pMMR Colorectal Cancer Sept. 1, 2026 -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnol

XTMAB-16-201 Part A pharmacokinetic exposure, target-coverage, immunogenicity, safety and feasibility findings provided an integrated basis for further clinical evaluation and informed the proposed next-stage development plan Proposed amendment to XTMAB-16-201 Part B will evaluate 4mg/kg every four weeks in a 52-week efficacy study called the XAtlas study Sept. 1, 2026 -- Xentria, Inc., a clinical-stage biotherapeutics company, today announced its proposed next-stage clinical development plan f