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

GSK has linked its mRNA seasonal flu vaccine candidate to higher immune responses than conventional jabs in a phase 2 trial, emboldening the company to start a pivotal study this month. The limited, variable effectiveness of flu vaccines, which has ranged from 20% to 60% over the past 15 years, presents an opportunity for new shots to disrupt the multibillion-dollar market. GSK’s pursuit of the opportunity centers on mRNA vaccines targeting hemagglutinin (HA) and neuraminidase (NA). While licen

Sept. 01, 2026 -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), today announced that it has closed on a financing of $16.5 million in gross proceeds, with Paulson Investment Company acting as placement agent. The

IND clearance enables U.S. clinical development of KT501, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager for B cell–mediated autoimmune diseases, building on safety data generated in the ongoing Australian first-in-human study in rheumatoid arthritis. Sept. 3, 2026 -- Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the compa

The collaboration will support Genprex's AAV-based diabetes gene therapy candidate for IND-enabling preclinical studies and cGMP clinical manufacturing. Sept. 1, 2026 -- Andelyn Biosciences, a leading contract development and manufacturing organization, announced today that Genprex, Inc. has selected Andelyn to support scale-up manufacturing for its diabetes gene therapy program. Genprex's diabetes gene therapy candidate is designed to deliver the Pdx1 and MafA genes directly to the pancreas v

Aug. 31, 2026 -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has entered into a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical Inc. (“BioMarin”) related to the sale of YUVIWEL® and navepegritide-related products. The binding term sheet provides the terms and conditions upon which the companies agree to resolve all litigation and disputes between the companies. Under the terms, BioMarin has agreed to grant Ascendis a non-exclusive, worldwi

- Expected to enroll approximately 4,600 participants with obesity or overweight across two pivotal trials (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada. - Global Phase III clinical program to investigate efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) over 72 weeks in participants with obesity or overweight without type 2 diabetes (AURORA-1) and with type 2 diabetes (AURORA-2). - Topline data from the AURORA Phase III clinical program are expected in the thir

Roche's Genentech unit inked an agreement with DualityBio, potentially exceeding $1 billion, to develop next-generation antibody-drug conjugates (ADCs) built on the latter's proprietary platform. The collaboration announced Friday aims to integrate DualityBio’s ADC payload and clinical development expertise with Roche’s oncology capabilities to target tumours that do not respond to topoisomerase inhibitor-based ADCs. DualityBio CEO John Zhu said that with topoisomerase inhibitor-based ADCs mov