Zemcelpro is authorised in the European Union for eligible adults with blood cancers who need an allogeneic stem cell transplant and have no other suitable donor cells available. Avanzanite secures exclusive commercialisation rights to Zemcelpro across 32 countries covering the European Economic Area, UK and Switzerland including potential indication expansion. Avanzanite will become the EU marketing authorisation holder following regulatory transfer and support a planned Phase 3 trial. Zemcelpr

A regimen combining two of Johnson & Johnson's bispecific antibodies has delivered deep and sustained PSA responses in patients with advanced prostate cancer, whilst also demonstrating an encouraging safety profile. The findings, representing the first-in-human results for the pairing, were presented at the Society for Immunotherapy of Cancer (SITC) annual meeting. The regimen combines the KLK2/CD3 bispecific antibody pasritamig and the PSMA/CD28 costimulatory bispecific antibody JNJ-9401. J&J

More than 50,000 doses of SKY-0515 have now been administered to patients. Nov. 5, 2026 -- Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate RNA targets, today announced that the first U.S. patients have been dosed in the global pivotal FALCON-HD study evaluating SKY-0515 in Huntington's disease (HD). Dosing in the U.S. began at the CenExel Movement Disorder Center in Colorado. Additional U.S. sites, including Beth

Chai Discovery, the AI company building a computer-aided design suite for protein-based therapeutics, today announced a collaboration with Roche to use Chai’s AI models and platform in a number of drug discovery programs across its therapeutic areas. “We are delighted to see Chai's models being used by Roche in their portfolio,” said Joshua Meier, co-founder and CEO of Chai Discovery. “This expands the range of therapeutic programs that can benefit from AI-driven molecular design.” "Chai’s pla

First clinical trial combining a Vβ-directed selective T-cell agonist with an ADC supports invikafusp alfa’s potential as a precision immune amplifier and IO backbone for broader cancer patient populations Encouraging clinical activity observed across two different metastatic breast cancer populations including HR-positive/HER2-negative metastatic breast cancer, where most patients derive limited benefit from checkpoint inhibition, and metastatic TNBC Maturing results demonstrate reductions in t

Mentari is advancing a robust pipeline of biologics for the prevention of migraine, including MT-001 and MT-002, which target clinically validated pathways and have potential to address the two-thirds of people who have a suboptimal response to existing anti-CGRP therapies Phase 1 clinical trial for MT-001, a monoclonal antibody targeting PACAP, ongoing with initial data expected mid-2027 MT-002, a bispecific antibody targeting both PACAP and CGRP, is on track for regulatory filing in Q1 2027 wi

Nov. 08, 2026 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in registrational Phase III study of the Company's novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML). Mesutoclax is a novel, oral BCL2 inhibitor

Data presented at AASLD The Liver Meeting demonstrated 100% of participants (28/28) who completed Week 96 of combination therapy reached undetectable virus (as defined by HDV RNA TND) Separate, exploratory analysis suggests curative potential with 10/10 patients who discontinued treatment after at least 96 weeks of undetectable virus showing sustained viral response (SVR) after 12 to 48 weeks of follow-up Conference call to discuss topline ECLIPSE 1 results and expanded SOLSTICE data scheduled f

In myositis, 5/6 (83%) patients treated at 4 billion cells per dose with at least three months of follow-up achieved moderate or major responses, as measured by the Total Improvement Score (TIS) in the Ntrust-2 study of NKX019, an investigational, allogeneic CAR NK cell therapy. In systemic sclerosis, 6/7 (86%) patients treated at 4 billion cells per dose with at least three months of follow-up achieved a revised Composite Response Index in Systemic Sclerosis (rCRISS)-25 response or greater, wit

FDA assigns a PDUFA target action date of April 9, 2027 Combination achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months Nov. 05, 2026 -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, today announced the U.S. Food and Drug Administration (FDA) acknowl