First patient safely dosed in Phase 1 KOALA trial evaluating KMCAR™ T-cell therapy in patients with relapsed/refractory kappa-restricted multiple myeloma Patient was monitored after initial dose to assess response and side-effects, with the treatment seen as well tolerated, and second patient to be treated imminently The study is the first in-human trial for the novel KMCAR™ T-cell immunotherapy, which targets the Kappa Myeloma Antigen (KMA), a tumour-specific receptor found only on malignant pl

Summit Therapeutics and Akeso said Wednesday their bispecific PD-1/VEGF antibody ivonescimab (SMT112/AK112) scored yet another Chinese Phase III win, this time demonstrating an overall survival (OS) benefit in front-line advanced biliary tract cancer (BTC) — its first pivotal success beyond four positive non–small-cell lung cancer (NSCLC) readouts. "The breakthrough clinical value of ivonescimab is now expanding from lung cancer to a broader range of solid tumours," said Akeso CEO Michelle Xia.

The FDA has approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, introducing a new mechanism of action to the nonmalignant rare blood cancer and handing CEO Julie Kim another major regulatory win since taking the helm. A form of myeloproliferative neoplasm, polycythemia vera (PV) causes the bone marrow to make too many red blood cells, which can result in life-threatening cardiovascular events, such as stroke and heart attack. Mimrylo offers a new approach to curtailing the overproduc

Collaboration leverages DualityBio's proprietary DUPAC payload platform and early global clinical development capabilities, with Genentech assuming further clinical development and global commercialization DUPAC, one of the DualityBio's four proprietary ADC technology platforms, comprises multiple payloads with novel mechanism of action designed to address resistance to the payload classes underlying currently approved ADCs DualityBio to receive a US$45 million upfront payment, more than US$1

Designation supports the global development of RTX-117 and may provide potential future access to a transferable Priority Review Voucher, subject to approval and applicable requirements Aug. 26, 2026 -- ReviR Therapeutics, a clinical-stage biotechnology company advancing small-molecule therapies through the integration of artificial intelligence and RNA biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RTX-117, the

NBI-1117567 is an investigational oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera and advancing through clinical development under a multi-program collaboration with Neurocrine Nxera to receive a US$10 million milestone payment upon IND Acceptance, as part of the overall milestone package Nxera retains development and commercialization rights to the M1 receptor agonist for all indications in Japan 26 August 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TS

The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway® (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) as an adjuvant treatment (after surgery) in patients with muscle invasive urothelial cancer (MIUC) at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy. Datrow

COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients Aug. 28, 2026 -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major ma

Spyre Therapeutics' stock was down about 14% Wednesday after a topline readout for one of its experimental TL1A antibodies underwhelmed in a Phase II rheumatoid arthritis (RA) study. While SPY072 showed activity, it failed to meet the company's internal efficacy bar for moving it forward as a stand-alone therapy. The candidate is being evaluated in the SKYWAY-RD basket trial across several rheumatic diseases, with separate sub-studies in RA, psoriatic arthritis (PsA) and axial spondyloarthritis

The RAS revolution is officially here, thanks to the FDA's approval of Rasonque (daraxonrasib) for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) on Wednesday. Revolution Medicines' RAS inhibitor was greenlit less than five months after it first revealed "practice-changing" data suggesting the candidate could help patients live twice as long as standard chemotherapy (see – Spotlight On: Daraxonrasib set to revolutionise pancreatic cancer treatment landscape). "This drug showed u