Biopharmaceuticals

IDEAYA, Servier Dose First Patient in Phase 3 Uveal Melanoma Trial

South San Francisco, Calif. – September 12, 2026 -- IDEAYA Biosciences and Servier have dosed the first patient in OptimUM-11, a global Phase 3 trial testing darovasertib combined with crizotinib as adjuvant therapy for primary uveal melanoma, targeting a disease segment with no approved systemic treatment options.

Trial design pairs oral PKC and cMET inhibitors for high-risk patients post-local therapy

OptimUM-11 will enroll approximately 450 patients who have completed local therapy for primary uveal melanoma and face elevated risk of metastatic recurrence. Patients will be randomized 1:1 to receive darovasertib plus crizotinib for 12 months or to observation, regardless of HLA status. The primary endpoint is relapse-free survival.

EpilepsyGTx Taps Viralgen to Scale AAV Gene Therapy EPY201

London and San Sebastián, Spain – September 12, 2026 -- EpilepsyGTx has partnered with AAV-focused CDMO Viralgen to manufacture EPY201, an investigational gene therapy targeting focal refractory epilepsy (FRE), a condition affecting an estimated 10 million patients worldwide, including 2 million across the US, UK and EU.

Viralgen's Aava platform will scale EPY201 production ahead of first-in-human trials

Under the agreement, Viralgen will deploy its proprietary Aava manufacturing platform to produce EPY201 at scale. The platform has already supported production of 1,500 AAV batches and is designed to handle all AAV serotypes with high-yield output. Viralgen's San Sebastián facility operates three cGMP suites, each with 2,000-liter capacity, certified by AEMPS/EMA, alongside plasmid production, process optimization, fill-finish and internal QC testing.

Base-Editing Therapy tBE Shows Durable Remission Across Ethnic Groups

Shanghai – September 12, 2026 -- CorrectSequence Therapeutics (Correctseq) reported that its transformer Base Editor (tBE) platform achieved sustained transfusion independence or elimination of vaso-occlusive crises (VOCs) in four new patients from Nigeria, Laos, Malaysia and Pakistan, extending clinical validation beyond the Chinese cohort where five patients previously achieved full transfusion independence.

Study published in Cell Stem Cell confirms cross-genetic efficacy of CS-101/CS-206

The peer-reviewed paper, published online September 7, 2026, details results from one sickle cell disease (SCD) patient and three transfusion-dependent β-thalassemia (TDT) patients treated with CS-101/CS-206. All four achieved rapid hematopoietic reconstitution, sustained high-level pancellular fetal hemoglobin (HbF) expression, and no detectable off-target edits or product-related adverse events.

CD&R Names Ex-BMS CEO Giovanni Caforio Operating Advisor

London – September 9, 2026 -- CD&R has appointed Giovanni Caforio, current Chair of Novartis and former CEO of Bristol Myers Squibb (BMS), as an Operating Advisor to its funds, tasking him with sourcing and evaluating healthcare investment opportunities globally.

Caforio brings 35 years of biopharmaceutical leadership to CD&R's healthcare strategy

Dr. Caforio has led Novartis' board since 2025 and previously spent over two decades at BMS after 12 years at Abbott Laboratories. He will support CD&R funds in identifying new healthcare deals and work directly with the firm's portfolio companies worldwide.

SkylineDx Completes Direct U.S. Buildout for Merlin CP-GEP Test

Rotterdam – September 12, 2026 -- SkylineDx has completed its transition from third-party distribution to a fully integrated U.S. commercial organization for Merlin CP-GEP, scaling its dedicated sales, marketing and clinical staff from three representatives in early 2025 to more than 25 professionals across key U.S. territories.

SkylineDx ends third-party U.S. distribution deals for melanoma test

The Rotterdam- and San Diego-based diagnostics company has concluded all third-party commercialization and licensing collaborations that previously handled U.S. market access for Merlin CP-GEP. The newly built direct organization now supports healthcare professionals, institutions and patients nationwide, with most new hires working directly with clinicians in the field.

Evotec Biologics Moves U.S. War Dept. Antibody JST-018 to Phase 1

Seattle – September 12, 2026 -- Just – Evotec Biologics has initiated a first-in-human Phase 1 clinical trial for JST-018, a monoclonal antibody cocktail targeting orthopoxviruses, developed under a U.S. Department of War contract.

Just – Evotec Biologics advanced JST-018 from sequence selection to clinical trial under a 2023 Department of War contract

The biologics CDMO, a wholly owned subsidiary of Evotec SE (NASDAQ: EVO; Frankfurt: EVT), executed the full development chain — preclinical work, process development, regulatory submission and cGMP manufacturing of clinical trial material — at its J.POD® facility in Redmond, Washington, using its continuous bioprocessing platform.

IBM, Cleveland Clinic, RIKEN Simulate 12,635-Atom Protein via Quantum

Cleveland – September 12, 2026 -- A research team from Cleveland Clinic, RIKEN and IBM has been named a finalist for the 2026 ACM Gordon Bell Prize after simulating a 12,635-atom protein complex, the largest biologically meaningful molecule ever modeled using quantum computers. The winner will be announced at SC26 in Chicago, running Nov. 15-20, 2026.

Quantum-classical hybrid method scales computation 40-fold in under a year

The team's approach, called quantum-centric supercomputing, combines IBM Quantum Heron processors with classical supercomputers Fugaku and Miyabi-G, operated respectively by RIKEN and a University of Tokyo-University of Tsukuba consortium. The quantum systems executed up to 94 qubits and nearly 6,000 quantum operations on portions of the calculation critical to accuracy, while the classical machines reassembled full molecular representations.

Kaneka to Appeal After Court Invalidates CoQ10 Patent

Tokyo -- Kaneka Corporation will appeal a September 2, 2026 ruling by the U.S. District Court for the Eastern District of New York that invalidated its U.S. Patent No. 7,829,080 covering reduced coenzyme Q10, known as ubiquinol.

New York court dismisses infringement case on enablement grounds

The court dismissed Kaneka's litigation against Cocrystal Technology (Jiaxing) Co., Ltd. and Cocrystal Health Industry (Zhejiang) Co., Ltd., ruling the '080 Patent invalid for lack of enablement. The case, filed October 5, 2023 under case number 1:23-cv-7483-SJB-SDE, had alleged that CoCrystal's ubiquinol supplements infringed claims 5 and 15 of the patent.

Google DeepMind Launches AlphaGenome Atlas, Mapping 9 Billion DNA Variants

Kansas City, Mo. – September 12, 2026 -- Google DeepMind has released AlphaGenome Atlas, a one-petabyte AI resource containing molecular-effect predictions for more than 9 billion possible single-letter DNA changes across the human genome, giving researchers browser-based access to the largest catalogue of its kind without writing code.

Atlas condenses billions of genetic variants into a single searchable score

The human genome's approximately 3 billion DNA letters create over 9 billion possible single-letter substitutions, a scale impossible to test experimentally in a lab. AlphaGenome Atlas assigns each variant thousands of molecular-effect predictions across hundreds of human cell types and tissues, feeding into a new AlphaGenome Variant Impact (AVI) score that combines AlphaGenome, AlphaMissense and evolutionary conservation data to rank variants across both protein-coding and non-coding regions.

ZAGENO Wins Frost & Sullivan 2026 Life Sciences E-Commerce Award

Cambridge, Massachusetts – September 12, 2026 -- Frost & Sullivan has named ZAGENO its 2026 North America Life Sciences E-Commerce Company of the Year, citing the platform's shift from online marketplace to full procurement orchestration infrastructure for research organizations.

Platform connects 50 million products from over 5,000 suppliers into one workflow

Founded in 2015 and headquartered in Cambridge, Massachusetts, ZAGENO gives researchers access to more than 50 million laboratory products from over 5,000 suppliers through a single entry point. The platform integrates directly with enterprise systems including SAP, Coupa, and Oracle NetSuite, allowing procurement teams to consolidate purchases from multiple suppliers into one purchase order and invoice while maintaining configurable approval workflows and spend visibility.