Biopharmaceuticals

Carmiel, Israel – September 11, 2026 -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) confirmed that Chief Financial Officer Gilad Mamlok will represent the company at two investor conferences in New York City this month.

Mamlok addresses H.C. Wainwright's 28th Annual Global Investment Conference on September 14

The presentation is scheduled for 2:00 p.m. EDT during the three-day event running September 14-16, 2026.

Morgan Stanley's 24th Annual Global Healthcare Conference hosts a fireside chat on September 16

The session is set for 1:05 p.m. EDT and will be streamed via a live audio webcast, with an archived replay available afterward on Protalix's investor relations site.

Taipei – September 12, 2026 -- HanchorBio Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing a Phase 1 patient who showed clinical benefit to continue receiving the investigational drug beyond the parent trial.

FDA authorizes continued treatment for a single Phase 1 patient

The clearance permits the patient to keep receiving HCB101 outside the standard clinical trial structure under the FDA's Expanded Access, or compassionate use, framework. The agency's review weighed the patient's clinical circumstances, including whether the potential benefit justified the risks given the severity of the disease. HanchorBio noted the determination applies only to this individual-patient protocol and does not constitute approval of HCB101 or an FDA finding on its broader safety or efficacy.

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.

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.

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.

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.

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.

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.

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.

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.