https://www.biopharmawatch.com/news/IMNN/imunon-phase-2-mrd-study-imnn-001-update BiopharmaWatch en 2026-09-22T12:05:00.000Z IMUNON Reports Independent Data Monitoring Committee Recommends Continued Phase 2 Development of IMNN-001 Following Favorable Safety Review https://www.biopharmawatch.com/news/RNAZ/transcode-therapeutics-patent-advancements-australia-japan BiopharmaWatch en 2026-09-22T12:04:00.000Z TransCode Therapeutics Announces Patent Advancements in Australia and Japan Strengthening Global IP Position in RNA-Based Immuno-Oncology https://www.biopharmawatch.com/news/NTRA/signatera-regulatory-approval-japan-bladder-cancer BiopharmaWatch en 2026-09-22T12:00:00.000Z Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer https://www.biopharmawatch.com/news/BIAF/bioaffinity-technologies-cypath-lung-navref-2026 BiopharmaWatch en 2026-09-22T12:00:00.000Z bioAffinity Technologies to Present Positive Clinical and Veteran-Focused Data on CyPath® Lung at NAVREF 2026 Annual Conference https://www.biopharmawatch.com/news/VRTX/vertex-positive-results-amplified-study-inaxaplin BiopharmaWatch en 2026-09-22T12:00:00.000Z Vertex Announces Positive Results From Phase 2b AMPLIFIED Study of Inaxaplin in Additional Populations of People With APOL1-Mediated Kidney Disease (AMKD) and Completion of Enrollment in the Phase 2/3 AMPLITUDE Trial https://www.biopharmawatch.com/news/TRLV/trulieve-added-to-sp-indices BiopharmaWatch en 2026-09-22T12:00:00.000Z Trulieve Cannabis Corp. Added to S&P Total Market and S&P Completion Indices https://www.biopharmawatch.com/news/ENLV/enlivex-terminates-financing-rain-tokens BiopharmaWatch en 2026-09-22T12:00:00.000Z Enlivex Announces Termination of Previously-Announced Financing Payable in RAIN Tokens https://www.biopharmawatch.com/news/FLNA/filana-therapeutics-fda-lift-clinical-hold-simufilam BiopharmaWatch en 2026-09-22T12:00:00.000Z Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy https://www.biopharmawatch.com/news/RYTM/rhythm-pharmaceuticals-health-canada-approval-imcivree BiopharmaWatch en 2026-09-22T12:00:00.000Z Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity https://www.biopharmawatch.com/news/ADAG/adagene-nmpa-clearance-adg138-bispecific-engager BiopharmaWatch en 2026-09-22T12:00:00.000Z Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager https://www.biopharmawatch.com/news/MRKR/marker-therapeutics-manufacturing-support-kincellis-advanced-therapies BiopharmaWatch en 2026-09-22T12:00:00.000Z Marker Therapeutics Highlights Expanded Manufacturing Support of CDMO Partner Following Formation of Kincellis Advanced Therapies https://www.biopharmawatch.com/news/SCYX/scynexis-appoints-steven-burke-board-directors BiopharmaWatch en 2026-09-22T12:00:00.000Z SCYNEXIS Appoints Seasoned Industry Veteran Steven K. Burke, M.D., to its Board of Directors https://www.biopharmawatch.com/news/SNN/smith-nephew-fda-clearance-landmark-knee-system BiopharmaWatch en 2026-09-22T12:00:00.000Z Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical cases of LANDMARK™ Total Knee System https://www.biopharmawatch.com/news/IONS/ionis-ulefnersen-phase-3-fusion-trial-results BiopharmaWatch en 2026-09-22T12:00:00.000Z Ionis announces positive topline results from Phase 3 FUSION study of ulefnersen marking significant milestone in advancing first potential disease modifying treatment for FUS-ALS https://www.biopharmawatch.com/news/CDRE/biocon-chmp-favorable-opinion-pertuzumab-biosimilar BiopharmaWatch en 2026-09-22T11:56:00.000Z Biocon obtient un avis favorable du CHMP pour son biosimilaire du pertuzumab, une première dans le cadre de la nouvelle approche clinique pour l'approbation des biosimilaires de l'EMA https://www.biopharmawatch.com/news/LUCD/lucid-diagnostics-esoguard-esocheck-payment-advances BiopharmaWatch en 2026-09-22T11:55:00.000Z Lucid Diagnostics Advances Multiple EsoGuard® and EsoCheck® Payment, Billing and Coding Pathways https://www.biopharmawatch.com/news/LTRN/lantern-pharma-usppto-allowance-lp1284-patent BiopharmaWatch en 2026-09-22T11:45:00.000Z Lantern Pharma Secures USPTO Notice of Allowance for LP‑284 Treatment Patent in Aggressive B‑Cell Lymphomas https://www.biopharmawatch.com/news/CGC/canopy-growth-expands-uk-medical-cannabis-supply BiopharmaWatch en 2026-09-22T11:30:00.000Z Canopy Growth Expands European Medical Cannabis Supply Into the UK https://www.biopharmawatch.com/news/DCOY/decoy-therapeutics-pan-filovirus-fda-animal-rule BiopharmaWatch en 2026-09-22T11:30:00.000Z Decoy Therapeutics Exploring Pan-Filovirus Program via FDA Animal Rule Pathway and Non-Dilutive Funding https://www.biopharmawatch.com/news/KZIA/kazia-therapeutics-sovargen-first-patient-phase-1b-2a-trial BiopharmaWatch en 2026-09-22T11:30:00.000Z Kazia Therapeutics Announces Sovargen Co. Doses First Patient in Phase 1b/2a Trial of Paxalisib for Rare Seizure Disorders https://www.biopharmawatch.com/news/CRVO/cervomed-participate-5th-annual-roth-healthcare-opportunities-conference BiopharmaWatch en 2026-09-22T11:30:00.000Z CervoMed to Participate in the 5th Annual ROTH Healthcare Opportunities Conference https://www.biopharmawatch.com/news/WVE/wave-life-sciences-appoints-dr-monika-vnuk-cbo BiopharmaWatch en 2026-09-22T11:30:00.000Z Wave Life Sciences Announces Appointment of Dr. Monika Vnuk as Chief Business Officer https://www.biopharmawatch.com/news/CNSY/cerenome-secures-agreement-blue-cross-michigan BiopharmaWatch en 2026-09-22T11:30:00.000Z Cerenome Secures In-Network Agreement with Blue Cross Blue Shield of Michigan, Expanding CNSide® Contracted Coverage to Approximately 158 Million Covered Lives https://www.biopharmawatch.com/news/BBNX/betabionics-senseonics-integration-ilet-eversense BiopharmaWatch en 2026-09-22T11:30:00.000Z Beta Bionics Announces Agreement Integrate the iLet® Bionic Pancreas and mint™ with Senseonics’ Eversense® 365 https://www.biopharmawatch.com/news/VKTX/viking-therapeutics-vk2735-maintenance-study-results BiopharmaWatch en 2026-09-22T11:05:00.000Z Viking Therapeutics Announces Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735 Demonstrating the Promise of Multiple Maintenance Dosing Regimens https://www.biopharmawatch.com/news/ZBIO/zenas-biopharma-obexelimab-presentations-igg4-rd BiopharmaWatch en 2026-09-22T11:05:00.000Z Zenas BioPharma Announces Upcoming Presentations of Obexelimab Data in IgG4-Related Disease at the IgG4ward! 6th International Symposium on IgG4-Related Disease and ACR Convergence 2026 https://www.biopharmawatch.com/news/KIDS/orthopediatrics-1000-pnp-tibia-nail-implantations BiopharmaWatch en 2026-09-22T11:05:00.000Z OrthoPediatrics Surpasses 1,000 PNP Tibia Nail Implantations https://www.biopharmawatch.com/news/JNJ/chmp-recommends-tecvayli-approval-johnson-johnson BiopharmaWatch en 2026-09-22T11:01:00.000Z Der CHMP empfiehlt die Zulassung von TECVAYLI®▼ (teclistamab) von Johnson & Johnson zur Behandlung des rezidivierten bzw. refraktären multiplen Myeloms nach mindestens einer vorherigen Therapie https://www.biopharmawatch.com/news/ELDN/eledon-phase-2-bestow-study-results BiopharmaWatch en 2026-09-22T11:00:00.000Z Eledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society https://www.biopharmawatch.com/news/CSTL/castle-biosciences-new-laboratory-facility-scottsdale BiopharmaWatch en 2026-09-22T11:00:00.000Z Castle Biosciences to Open New Laboratory Facility in Scottsdale https://www.biopharmawatch.com/news/CGEN/compugen-virtual-kol-event-com701-ovarian-cancer-update BiopharmaWatch en 2026-09-22T11:00:00.000Z Compugen to Host Virtual KOL Event on COM701 in Ovarian Cancer & Unigen™ Platform Update on October 5, 2026 https://www.biopharmawatch.com/news/EWTX/edgewise-therapeutics-edg-7500-mechanism-action BiopharmaWatch en 2026-09-22T11:00:00.000Z Edgewise Therapeutics Unveils the Differentiated Mechanism of Action (MoA) of its Cardiac Sarcomere Modulator EDG-7500 https://www.biopharmawatch.com/news/TNXP/tonix-pharmaceuticals-tonmya-medicare-agreement BiopharmaWatch en 2026-09-22T11:00:00.000Z Tonix Pharmaceuticals Announces Second Major Managed Medicare Payer Agreement for TONMYA® https://www.biopharmawatch.com/news/LXEO/lexeo-therapeutics-acquires-mantle-therapeutics BiopharmaWatch en 2026-09-22T11:00:00.000Z Lexeo Therapeutics Enters Into Agreement to Acquire Mantle Therapeutics and Announces Multiple New Strategic Collaborations to Expand Leadership in Friedreich Ataxia https://www.biopharmawatch.com/news/MDWD/medi-wound-awarded-funding-nexobrid-development BiopharmaWatch en 2026-09-22T11:00:00.000Z MediWound Awarded Additional $3.3 Million from U.S. Department of War to Advance Room-Temperature-Stable Formulation of NexoBrid® https://www.biopharmawatch.com/news/CLDX/celldex-positive-results-phase-3-barzolvolimab BiopharmaWatch en 2026-09-22T10:58:00.000Z Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints https://www.biopharmawatch.com/news/MRK/fda-approves-winrevair-label-update-hyperion-trial BiopharmaWatch en 2026-09-22T10:45:00.000Z U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) https://www.biopharmawatch.com/news/SMMT/harmoni-gi1-phase-iii-trial-esmo-2026 BiopharmaWatch en 2026-09-22T10:00:00.000Z HARMONi-GI1, a Phase III Trial Featuring Ivonescimab Plus Chemotherapy Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract 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2026-09-22T00:00:00.000Z Aytu BioPharma to Report Fiscal 2026 Full Year and Fourth Quarter Operational and Financial Results on September 22, 2026 https://www.biopharmawatch.com/news/HELP/helus-pharma-td-cowen-summit-participation BiopharmaWatch en 2026-09-21T21:15:07.000Z Helus Pharma to Participate at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit https://www.biopharmawatch.com/news/BDX/arthur-hu-joins-bd-as-chief-information-officer BiopharmaWatch en 2026-09-21T20:30:00.000Z Arthur Hu to Join BD as Chief Information and Digital Officer https://www.biopharmawatch.com/news/PTCT/ptc-acquisition-st-920-fabry-gene-therapy BiopharmaWatch en 2026-09-21T20:30:00.000Z PTC Completes Acquisition of ST-920 Fabry Disease Gene Therapy https://www.biopharmawatch.com/news/CVKD/cadrenal-therapeutics-lytham-partners-fall-2026-conference BiopharmaWatch en 2026-09-21T20:30:00.000Z Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2026 Investor Conference https://www.biopharmawatch.com/news/ANAB/anaptysbio-q2-2026-financial-results-update BiopharmaWatch en 2026-09-21T20:15:00.000Z Anaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update https://www.biopharmawatch.com/news/TVTX/travere-therapeutics-ceo-transition BiopharmaWatch en 2026-09-21T20:05:00.000Z Travere Therapeutics Announces Planned Chief Executive Officer Transition https://www.biopharmawatch.com/news/ABVX/abivax-business-updates-first-half-2026-results BiopharmaWatch en 2026-09-21T20:05:00.000Z Abivax Presents Business Updates and First Half 2026 Financial Results https://www.biopharmawatch.com/news/NYXH/nyxoah-cfo-transition-2026 BiopharmaWatch en 2026-09-21T20:01:00.000Z Nyxoah Announces Chief Financial Officer Transition https://www.biopharmawatch.com/news/XENE/xenon-presents-td-cowen-summit BiopharmaWatch en 2026-09-21T20:01:00.000Z Xenon to Present at TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit https://www.biopharmawatch.com/news/NAMS/menarini-newamsterdam-eu-approval-ubeslo-evlarco BiopharmaWatch en 2026-09-21T19:04:00.000Z Menarini Group und NewAmsterdam Pharma erhalten von der Europäischen Kommission die Zulassung für Ubeslo® (Obicetrapib als Monotherapie) und Evlarco® (Fixkombination aus Obicetrapib und Ezetimib) https://www.biopharmawatch.com/news/HYFT/mindwalk-openfold3-deployment-amd-vultr BiopharmaWatch en 2026-09-21T18:03:00.000Z MindWalk met OpenFold3 en production en quelques minutes grâce aux microservices d’inférence AMD sur Vultr Kubernetes Engine https://www.biopharmawatch.com/news/CGEM/cullinan-therapeutics-stifel-2026-forum BiopharmaWatch en 2026-09-21T16:00:00.000Z Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum https://www.biopharmawatch.com/news/NAMS/menarini-newamsterdam-european-approval-ubicetrapib BiopharmaWatch en 2026-09-21T14:57:00.000Z Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) https://www.biopharmawatch.com/news/SNN/smith-nephew-showcase-shoulder-technologies-icses-2026 BiopharmaWatch en 2026-09-21T14:00:00.000Z Smith+Nephew to showcase leading shoulder technologies for joint repair and reconstruction at ICSES 2026 https://www.biopharmawatch.com/news/GRML/greenland-mines-sarfartoq-expansion BiopharmaWatch en 2026-09-21T13:30:00.000Z Greenland Mines More Than Doubles Control Position in the Sarfartoq Rare Earth Magnet District in West Greenland https://www.biopharmawatch.com/news/QTTB/q32-bio-signals-results-bempikibart-eadv-2026 BiopharmaWatch en 2026-09-21T13:15:00.000Z Q32 Bio Announces Upcoming Late-Breaking Presentation of Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata at the European Academy of Dermatology and Venereology Congress 2026 https://www.biopharmawatch.com/news/AVLN/avalyn-phase-1-data-ap02-lung-delivery-safety BiopharmaWatch en 2026-09-21T13:00:23.000Z Avalyn Publishes Phase 1 Data Highlighting AP02’s Lung-Targeted Delivery and Encouraging Safety Profile https://www.biopharmawatch.com/news/CODX/co-diagnostics-global-health-roundtable-ebola BiopharmaWatch en 2026-09-21T13:00:00.000Z Co-Diagnostics to Participate in Global Health Roundtable on Ebola and Outbreak Innovation https://www.biopharmawatch.com/news/PALI/palisade-bio-stifel-2026-forum-presentation BiopharmaWatch en 2026-09-21T13:00:00.000Z Palisade Bio to Present at Stifel 2026 Virtual Immunology and Inflammation Forum https://www.biopharmawatch.com/news/NAMS/newamsterdam-pharma-menarini-approval-ubicetrapib BiopharmaWatch en 2026-09-21T13:00:00.000Z NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) https://www.biopharmawatch.com/news/NSPR/inspiremd-amendments-series-j-k-warrants-fda-approval BiopharmaWatch en 2026-09-21T13:00:00.000Z InspireMD Announces Amendments to Certain Series J and Series K Warrants, Providing Potential Gross Proceeds of Up to $11 Million https://www.biopharmawatch.com/news/HYFT/mindwalk-openfold3-production-amd-vultr BiopharmaWatch en 2026-09-21T12:46:00.000Z MindWalk Brings OpenFold3 into Production in Minutes with AMD Inference Microservices on Vultr Kubernetes Engine https://www.biopharmawatch.com/news/ANIX/anixa-biosciences-granted-first-australian-patent-breast-cancer-vaccine-broadening BiopharmaWatch en 2026-09-21T12:45:00.000Z Anixa Biosciences Granted First Australian Patent for its Breast Cancer Vaccine, Broadening Global Protection Through 2040 https://www.biopharmawatch.com/news/NAGE/cd38-driver-nad-decline-nicotine-riboside-pregnancy-outcomes BiopharmaWatch en 2026-09-21T12:32:00.000Z Newly Published Preclinical Study Demonstrates CD38 as a 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