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Biopharmaceuticals

Halozyme Expands argenx Deal to Eight Exclusive ENHANZE Targets

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Halozyme Expands argenx Deal to Eight Exclusive ENHANZE Targets

San Diego – – October 06, 2026 -- Halozyme Therapeutics (Nasdaq: HALO) has expanded its global collaboration and license agreement with argenx, adding two new exclusive targets for its ENHANZE drug-delivery platform and raising the partner's total exclusive target count from six to eight.

Halozyme adds two exclusive ENHANZE targets to argenx licensing deal

The expanded agreement builds on the companies' existing collaboration, which already delivered VYVGART Hytrulo, a subcutaneous treatment for myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Under the new terms, Halozyme is eligible for milestone payments tied to development and regulatory progress on the additional targets, plus royalties on future net sales of any resulting products using ENHANZE.

Enliven Secures FDA Alignment on Phase 3 CML Trial Design

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Enliven Secures FDA Alignment on Phase 3 CML Trial Design

Burlingame, Calif. – October 06, 2026 -- Enliven Therapeutics, Inc. (Nasdaq: ELVN) has reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, a pivotal Phase 3 trial testing relcobatinib against standard second-generation therapies in previously treated chronic myeloid leukemia (CML). The company remains on track to initiate the trial before year-end 2026.

FDA clears path for 450-patient head-to-head comparison

ENABLE-2 is designed to enroll approximately 450 adults with CML who have already received one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib at 80 mg once daily or an investigator-selected second-generation TKI -- dasatinib, nilotinib, or bosutinib. The primary endpoint is major molecular response (MMR) at Week 24, with MMR at Week 96 as a key secondary measure.

CMS Grants NTAP Reimbursement for icotec's CMORE CT Spine Implant

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CMS Grants NTAP Reimbursement for icotec's CMORE CT Spine Implant

Altstätten, Switzerland and Boston – October 06, 2026 -- The Centers for Medicare & Medicaid Services has approved a New Technology Add-On Payment for icotec's CMORE® CT spine implant system, effective October 1, 2026, opening expanded reimbursement access for eligible hospitals treating Medicare patients.

CMS reimbursement decision follows April 2025 Break-Through Device Designation

icotec's CMORE® Cervicothoracic System received FDA Break-Through Device Designation in April 2025, a status that preceded the latest NTAP approval. The NTAP program provides eligible hospitals additional payment for qualifying technologies used in traditional Medicare procedures, applying here to specified spinal conditions and surgeries.

C5 Biomedical CEO Named AATB '50 at 50' Honoree

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C5 Biomedical CEO Named AATB '50 at 50' Honoree

Boca Raton, Fla. – October 06, 2026 -- C5 Biomedical LLC CEO Tim Maye, CTBS, is being honored tonight in San Francisco as one of 50 individuals named to the Association for Advancing Tissue and Biologics' (AATB) one-time "50 at 50" list, marking the organization's 50th anniversary.

Maye's 28-year tissue banking career includes six years chairing AATB's Standards Committee

Maye has held his Certified Tissue Bank Specialist (CTBS) credential since 1999 and spent six years chairing AATB's Standards Committee, the body responsible for the tissue banking standards the industry operates under today. He founded C5 Biomedical in 2021 and remains on the Standards Committee.

Luminous Mind Wins Patent for Non-Hallucinogenic Psychedelic Mushrooms

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Luminous Mind Wins Patent for Non-Hallucinogenic Psychedelic Mushrooms

Boston – October 06, 2026 -- Luminous Mind, Inc. (LMI) has secured U.S. Patent No. 12,697,362, covering technology that produces non-hallucinogenic psychedelic fungi, targeting a functional mushroom market Grand View Research values at $38.2 billion for 2025.

Patent strips psilocybin while preserving secondary metabolites

The patent isolates beneficial compounds found in psilocybin-containing mushrooms -- secondary metabolites and active fungal molecules typically overshadowed by the hallucinogen. By removing psilocybin, LMI says the resulting products retain potential nutraceutical benefits without triggering hallucinations, opening a path to mass-market commercialization that psychedelic-based products cannot access under current regulatory frameworks.

ARUP Labs Wins Redtail AI Supercomputer Access for Cancer Diagnostics

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ARUP Labs Wins Redtail AI Supercomputer Access for Cancer Diagnostics

Salt Lake City – October 06, 2026 -- ARUP Laboratories has secured a spot in the second cohort of challenge projects on Utah's Redtail AI Factory, gaining access to a supercomputer ranked No. 159 globally to accelerate a proprietary diagnostic AI model for blood cancer detection.

ARUP's EventHorizon model targets faster, more accurate blood cancer diagnosis

The project, titled "Scaling EventHorizon with Redtail: A Foundation Model for Clinical Flow Cytometry," aims to build a foundation model that helps pathologists interpret complex flow cytometry data used to diagnose blood cancers and other hematologic diseases. The tool is being developed by a team at the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine, including David Ng, MD, FCAP, and research data scientists Muir Morrison and Mattia Medina Grespan.

Compugen to Join AI Drug Discovery Fireside Chat Oct. 8

Holon, Israel – October 6, 2026 -- Compugen Ltd. (NASDAQ: CGEN; TASE: CGEN) will join a fireside chat at the H.C. Wainwright 3rd Annual AI Based Drug Discovery & Development Conference, a virtual event running October 8-9, 2026.

Management confirms October 8 session with live investor webcast

The fireside chat is scheduled for Thursday, October 8, 2026, at 9:30 AM ET. A live webcast will stream via the Investor Relations events page on Compugen's website, with a replay available afterward.

Nanoscope to Present 4-Year RP Data, Dry AMD Poster at AAO 2026

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Nanoscope to Present 4-Year RP Data, Dry AMD Poster at AAO 2026

Dallas – October 06, 2026 -- Nanoscope Therapeutics will present four-year durability data from its RESTORE Phase 2b/3 trial of optogenetic therapy MCO-010 in retinitis pigmentosa at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting, running October 8–13 in New Orleans.

Four-year REMAIN data to show durability of vision gains in retinitis pigmentosa

Dr. Kenneth C. Fan will present the REMAIN study results on Sunday, October 11, highlighting sustained vision improvement among patients treated with MCO-010 in the RESTORE trial. A separate scientific poster from Dr. David S. Boyer will detail vision improvement with sonpiretigene isteparvovec in dry age-related macular degeneration, drawn from what the company describes as the first direct-to-Phase 2 randomized controlled trial in that indication.

Veeva DQS Cleans Data for 1M+ Trial Subjects, Cuts Manual Work

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Veeva DQS Cleans Data for 1M+ Trial Subjects, Cuts Manual Work

Barcelona – October 06, 2026 -- Veeva Systems (NYSE: VEEV) said its Data Quality System (DQS) has aggregated and cleaned data for more than 1 million subjects across over 1,000 clinical studies, automating over 500,000 queries and eliminating thousands of hours of manual data reconciliation for sites and sponsors.

Veeva DQS automates over 500,000 queries to speed analysis-ready data delivery

The platform classifies and visualizes critical trial data while orchestrating risk-based actions across the clinical ecosystem, removing manual reconciliation steps that have historically slowed data lock and submission timelines.

Novo cites rising trial data volume as key driver for automated data management

Ibrahim Kamstrup-Akkaoui, vice president at Novo, said managing data from a growing number of clinical trials is a priority, and that Veeva DQS helps the company manage, format, clean, and prepare data for submission more efficiently.

Viking Launches Phase 2 Study of Oral VK2735 Maintenance Dosing

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Viking Launches Phase 2 Study of Oral VK2735 Maintenance Dosing

San Diego – October 06, 2026 -- Viking Therapeutics (NASDAQ: VKTX) has initiated Part 2 of a maintenance dosing study for VK2735, its dual GLP-1/GIP receptor agonist, testing oral tablet regimens alongside subcutaneous options to sustain weight loss after initial treatment.

Trial enrolls 195 obese adults to test five maintenance pathways

The randomized, double-blind, placebo-controlled study will enroll approximately 195 adults with obesity (BMI ≥30 kg/m2). All participants first receive 21 weeks of weekly subcutaneous VK2735 or placebo before transitioning to one of five maintenance arms: daily oral doses, weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. The study runs through Week 33, tracking safety, tolerability, pharmacokinetics, and body weight change from baseline and from Week 21.