© Globe Newswire
08.12.2025
WVE
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Wave Life Sciences Announces Positive Interim Data from Phase 1 INLIGHT Trial of WVE-007 (INHBE) for Obesity; Single Dose Resulted in Improvement in Body Composition With Fat Loss Similar to GLP-1 at Three Months Without Muscle Loss
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Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01), with no statistically significant changes in the placebo g...
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08.12.2025
COGT
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Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
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-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggreg...
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08.12.2025
ABEO
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Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy
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CLEVELAND, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the first commercial patient treatment with FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, autologous gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). Z...
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20.10.2025
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08.12.2025
PCVX
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NASDAQ
Vaxcyte Doses First Participants in the OPUS Phase 3, Noninferiority Trial Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults
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Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration ...
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20.10.2025
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08.12.2025
OCUL
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Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD
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Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive...
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08.12.2025
AGIO
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Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia
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Agios today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the sNDA for mitapivat in thalassemia...
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08.12.2025
CRDF
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Cardiff Oncology to Present at Sidoti’s Year-End Virtual Investor Conference
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SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that company management will present and host one-on-one meetings at Sidoti’s Year-End Virtual Investor Conference, which is tak...
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08.12.2025
KYMR
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Kymera Therapeutics Announces Positive Results from BroADen Phase 1b Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader, in Patients with Moderate to Severe Atopic Dermatitis
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KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy volunteers to atopic dermatitis (AD) patients...
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08.12.2025
OBIO
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Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
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NEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced three presentations at the 2025 Innovation in Cardiology Intervention (“IC...
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08.12.2025
HBFG
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CSE
Happy Belly Food Group Announces Executive Leadership Plan to Support Next Phase of Growth
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Toronto, Ontario--(Newsfile Corp. - December 8, 2025) - Happy Belly Food Group Inc. (CSE: HBFG) (OTCQB: HBFGF) ("Happy Belly" or the "Company"), a leader in acquiring and scaling emerging food brands is pleased to announce executive management updates to support its 2026 growth plan as the Company advances its objective of doubling the size of its...
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08.12.2025
DYN
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Dyne Therapeutics Announces Positive Topline Results from Phase 1/2 DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD)
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- Registrational Expansion Cohort (REC) met primary endpoint, demonstrating statistically significant increase in dystrophin to 5.46% at 6 months (muscle content-adjusted; p<0.0001), replicating the same 7-fold change from baseline previously observed at the registrational dose -...
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08.12.2025
ONCO
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NEO
Onco-Innovations beauftragt Investmentbank mit der Prüfung einer Nasdaq-Notierung und eines möglichen gleichzeitigen Emissionsangebots
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Onco-Innovations Ltd. (ISIN: CA68237C1059 / WKN: A3EKSZ), Onco oder das Unternehmen, freut sich bekannt zu geben, dass es eine US-Investmentbank als Kapitalmarktberater beauftragt hat, um mit seiner Absicht eine mögliche zusätzliche Notierung (Cross-Listing) an der “Nasdaq Stock Market LLC” (Nasdaq oder die Börse) anzustreben und parallel eine mögl......
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08.12.2025
MNOV
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MediciNova Announces Update and Basic Characteristic Randomized Patients’ of Phase 2/3 Clinical Trial of MN-166 (Ibudilast) in ALS (COMBAT-ALS Clinical Trial) Presented at the 36th International Symposium on ALS/MND
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LA JOLLA, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code: 4875), today announced an update and the patients’ basic characteristics data from its Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amy...
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08.12.2025
SNWV
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NASDAQ
Sanuwave Announces the Addition of UltraMIST to Healogics Group Purchasing Organization (GPO), iSupply
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Sanuwave Announces the Addition of UltraMIST to Healogics Group Purchasing Organization (GPO), iSupply...
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© ACCESS Newswire
08.12.2025
MDCE
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OTC
Medical Care Technologies (OTC Pink:MDCE) Positions Itself in the Multi-Billion Dollar AI Dermatology Market With Google-Backed Melanoma Detection Technology
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MESA, ARIZONA / ACCESS Newswire / December 8, 2025 / Medical Care Technologies Inc. (OTC Pink:MDCE) is thrilled to announce a major technology advancement in the development of its soon-to-launch AI wound and skin monitoring platform. The Company has strategically aligned with Derm Foundation, a Google-backed pretrained dermatology imaging model, e...
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© Globe Newswire
08.12.2025
VIRP
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EURONEXT
Virbac : Declaration of the number of shares and voting rights 11/2025
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DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS...
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08.12.2025
CASI
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CASI Pharmaceuticals Announces Results from CID-103 Immune Thrombocytopenia Study at the 67th American Society of Hematology (ASH) Annual Meeting
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SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced data presented from its Phas...
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© ACCESS Newswire
08.12.2025
RGNT
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XASE
Regentis Biomaterials Commences Trading on NYSE: Set to Transform Cartilage Repair Market with Off-the-Shelf Regenerative Product
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Lead product GelrinC®, a hydrogel synchronized erosion and resorbable implant, the only restorative product for knee cartilage repair, is a breakthrough effective and economical procedure to address a large unmet needGelrinC is approved for knee cartilage repair in the European Union and is currently at midpoint in a pivotal FDA trial for the...
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© ACCESS Newswire
08.12.2025
LIXT
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NASDAQ
LIXTE's Strategy Comes Into Focus: Building an Oncology Platform Around Complementary Modalities
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BOCA RATON, FL / ACCESS Newswire / December 8, 2025 / In recent years, LIXTE (NASDAQ:LIXT) has been defined by LB-100, its first-in-class PP2A inhibitor with a mechanism that unlocks new therapeutic angles for resistant cancers. The company built its early identity around that science, and for good reason. LB-100 remains one of the few agents capab...
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© ACCESS Newswire
08.12.2025
WGRX
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NASDAQ
Wellgistics Health Announces Launch of Diabetes Drug Brenzavvy(R) to Wellgistics Pharmacy Network
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Launch targets $16 billion SGLT-2 inhibitor market that serves 33 million type II diabetics in the US, many of whom are uninsured and underinsured and whose out-of-pocket costs exceed Brenzavvy's cash priceProprietary EinsteinRx™ artificial intelligence pharmacy platform empowers the 6,500+ pharmacies in the Wellgistics Pharmacy Network to ed...
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© PR Newswire
08.12.2025
006280
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KOE
GC Biopharma Ships First Doses of World's First Recombinant Anthrax Vaccine, 'BARYTHRAX inj.'
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- First anthrax vaccine developed using recombinant DNA technology- Annual production capacity of up to 10 million doses at GC Biopharma's facility YONGIN, South Korea, Dec. 8, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, today announced the first shipment of BARYTHRAX inj., the world's first recombina...
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© ACCESS Newswire
08.12.2025
AVNT
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TSX
Avant Brands Fully Repays $9.5M Secured Convertible Debenture
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KELOWNA, BC / ACCESS Newswire / December 8, 2025 / Avant Brands Inc. (TSX:AVNT)(OTCQX:AVTBF)(FRA:1BU0) ("Avant" or the "Company"), a leading producer of innovative and award-winning cannabis products, today announced the full repayment of its $9.5 million amended and restated convertible debenture (the "A&R Debenture&qu...
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© BusinessWire
08.12.2025
GALD
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XWSX
Galderma Welcomes Increased Equity Investment From L’Oréal
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Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that L’Oréal Groupe intends to increase its equity investment in the company, acquiring an additional 10% stake from Sunshine SwissCo GmbH (a consortium led by EQT, Abu Dhabi Investment Authority (ADIA), and Auba Investment Pte. Ltd., acting as sellers).
Foll...
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© EQS Newswire
08.12.2025
SDZ
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XWSX
Sandoz completes strategic acquisition of Just-Evotec Biologics EU SAS, asserting biosimilars leadership
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Sandoz Group AG
/ Key word(s): Acquisition
Sandoz completes strategic acquisition of Just-Evotec Biologics EU SAS, asserting biosimilars leadership 08.12.2025 / 07:00 CET/CEST
Expands in-house development and manufacturing capabilities for biosimilars, consolidating position as undisputed leader in the sector
Strengthens posi......
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© EQS Newswire
08.12.2025
EVT
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XETR
Evotec schließt Verkauf von Just – Evotec Biologics Toulouse Standort an Sandoz ab
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Alle Abschlussbedingungen wurden nach Ankündigung über die Vereinbarung eines nicht-bindenden Term Sheet im Juli und Unterzeichnung des Vertrags im November erfüllt
Die Vereinbarung beinhaltet rund 350 Mio. US$ in bar für die Just – Evotec Biologics Produktionsanlage in Toulouse sowie Vorab-Technologielizenzgebühren für Evotecs kontinuierliche ......
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© EQS Newswire
08.12.2025
NWRN
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SIX
Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)
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Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)
ENIGMA-TRS 2 is a global, randomized, double-blind, placebo-controlled 12-week Phase III clinical study designed to enroll at least 400 patients; topline results are ex......
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© EQS Newswire
08.12.2025
NWRN
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SIX
Newron gibt US-Start der globalen klinischen Phase-III-Studie ENIGMA-TRS 2 mit Evenamide als Zusatztherapie für Patienten mit behandlungsresistenter Schizophrenie (TRS) bekannt
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Newron gibt US-Start der globalen klinischen Phase-III-Studie ENIGMA-TRS 2 mit Evenamide als Zusatztherapie für Patienten mit behandlungsresistenter Schizophrenie (TRS) bekannt
ENIGMA-TRS 2 ist eine globale, randomisierte, doppelt verblindete, placebokontrollierte 12-wöchige klinische Phase-III-Studie, an der mindestens 400 Patienten teilnehmen so......
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© EQS Newswire
08.12.2025
EVT
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XETR
Evotec closes sale of Just – Evotec Biologics’ Toulouse site to Sandoz
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All closing requirements satisfied following announcement of a non-binding term-sheet agreement in July and signing of contract in November
Agreement includes approximately US$ 350 m in cash for Just – Evotec Biologics manufacturing site in Toulouse and upfront technology license fees to Evotec’s continuous manufacturing platform
In additio......
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© Globe Newswire
08.12.2025
GLPG
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EURONEXT
Galapagos Presented New ATALANTA-1 Cell Therapy Data in MCL at ASH 2025
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High complete response rates and minimal residual disease (MRD) negativity, with durable responses, in high-risk mantle cell lymphoma (MCL) with GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time...
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© Globe Newswire
08.12.2025
OSE
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EURONEXT
OSE Immunotherapeutics Announces Strategic Amendment to AbbVie’s Partnership on ABBV-230 Development
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Strategic Amendment Enhances OSE Immunotherapeutics’ Role in ABBV-230 Development While Preserving AbbVie’s Long-Term Commitment...
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© Globe Newswire
08.12.2025
IBAB
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EURONEXT
YAS Healthcare signs contract for a Proteus®ONE solution, the first proton therapy system to be installed in Dubai, UAE
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Louvain-La-Neuve, Belgium, December 8, 2025 – IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology and the world’s leading provider of proton therapy solutions for the treatment of cancer, announces today it has signed a contract with YAS Healthcare, a subsidiary of DAS Holding, to install a Proteus®ONE1 c...
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© PR Newswire
08.12.2025
2171
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HKSE
CARsgen Announces Data of Allogeneic BCMA CAR-T Cell Therapy CT0596 for Relapsed/Refractory Multiple Myeloma at the 2025 ASH Annual Meeting
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SHANGHAI, Dec. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that clinical data from its allogeneic BCMA-targeted CAR T-cell product candidate, CT0596, for the treatment of relapsed/refractory multiple myeloma (R/R MM) was presented in...
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08.12.2025
CUV
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ASX
CLINUVEL expands Singapore RD&I Centre to pioneer next-generation peptide therapies
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EXECUTIVE SUMMARY...
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© PR Newswire
08.12.2025
1801
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HKSE
ASH 2025 Oral Presentation: Innovent Biologics Announces Initial Results of the First-in-Human Phase 1 Study of Trispecific Antibody IBI3003 in Relapsed or Refractory Multiple Myeloma
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SAN FRANCISCO and SUZHOU, China, Dec. 7, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, annou...
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© ACCESS Newswire
08.12.2025
EVT
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XETR
Evotec Closes Sale of Just - Evotec Biologics' Toulouse Site to Sandoz
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All closing requirements satisfied following announcement of a non-binding term-sheet agreement in July and signing of contract in NovemberAgreement includes approximately US$ 350 m in cash for Just - Evotec Biologics manufacturing site in Toulouse and upfront technology license fees to Evotec's continuous manufacturing platformIn addition, Evotec...
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08.12.2025
2171
LISTED
HKSE
CARsgen Announces Data of Allogeneic BCMA CAR-T Cell Therapy CT0596 for Relapsed/Refractory Multiple Myeloma at the 2025 ASH Annual Meeting
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SHANGHAI, Dec. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that clinical data from its allogeneic BCMA-targeted CAR T-cell product candidate, CT0596, for the treatment of relapsed/refractory multiple myeloma (R/R MM) was presented in...
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© Globe Newswire
08.12.2025
6855
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HKSE
ASH 2025 | Ascentage Pharma Presents Encouraging Data from Phase Ib/II Study of Bcl-2 Inhibitor Lisaftoclax in Venetoclax–Exposed Patients with Myeloid Malignances
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ROCKVILLE, Md. and SUZHOU, China, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development, and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced th...
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08.12.2025
13
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HKSE
HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China
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HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 08, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 20...
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08.12.2025
ONC
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NASDAQ
Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies
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BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematolo...
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07.12.2025
IMMX
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NASDAQ
Immix Biopharma Announces Pricing of Upsized $100 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
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LOS ANGELES, CA, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced the pricing of an underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per share, and to certain inv...
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© Globe Newswire
07.12.2025
GPCR
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NASDAQ
Structure Therapeutics to Report Data from ACCESS Clinical Program of Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron, on December 8, 2025
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SAN FRANCISCO, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced plans to release topline data from its ACCESS clinical program of aleniglipron, the compan...
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07.12.2025
IMMX
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NASDAQ
At ASH 2025 Oral Presentation, Immix Biopharma Reports Positive Phase 2 NXC-201 Results, Advancing Toward BLA Submission as a Potentially First- and Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
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– NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee –...
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© PR Newswire
07.12.2025
TLX
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ASX
ProstACT Global Phase 3 Update: First Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed
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MELBOURNE, Australia and INDIANAPOLIS, Dec. 8, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the first patient has been dosed in Part 2 (randomized treatment expansion) of its ProstACT Global Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosop...
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07.12.2025
LLY
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NYSE
Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib)
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In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) populationProgression-free survival data were immature but trended in favor of pirtobrutinib with a 43% redu...
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07.12.2025
LYEL
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NASDAQ
Lyell Immunopharma Presents New Clinical Data from Ongoing Trial of Ronde-Cel Showing High Rates of Durable Complete Responses in Patients with Large B-cell Lymphoma at the 67th ASH Annual Meeting and Exposition
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SOUTH SAN FRANCISCO, Calif., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced new clinical and translational data from the ongoing clinical trial of rondecabtagene au...
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07.12.2025
REGN
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NASDAQ
Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment
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All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time...
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© Globe Newswire
07.12.2025
WVE
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NASDAQ
Wave Life Sciences to Announce Interim Data from the Phase 1 INLIGHT Trial of WVE-007 (INHBE) for Obesity on Monday, December 8, 2025
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CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, will announce interim data from the ongoing Phase 1 INLIGHT clinical trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA...
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© ACCESS Newswire
07.12.2025
MSPR
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NASDAQ
MSP Recovery, Inc. Announces Conclusion of SEC Investigation: No Intention to Recommend Enforcement Action Against the Company, its CEO, John H. Ruiz, or its Officers
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MIAMI, FLORIDA / ACCESS Newswire / December 7, 2025 / MSP Recovery, Inc. (NASDAQ:MSPR) (the "Company"), a Medicare, Medicaid, commercial, and secondary payer reimbursement recovery and technology leader, announces that the staff of the U.S. Securities and Exchange Commission ("SEC") has informed the Company that it has concluded...
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© BusinessWire
07.12.2025
LFCR
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NASDAQ
Halper Sadeh LLC Encourages Lifecore Biomedical, Inc. Shareholders to Contact the Firm to Discuss Their Rights
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Halper Sadeh LLC, an investor rights law firm, is investigating whether certain officers and directors of Lifecore Biomedical, Inc. (NASDAQ: LFCR) breached their fiduciary duties to shareholders.
If you currently own Lifecore stock and are a long-term shareholder, you may be able to seek corporate governance reforms, the return of funds back to t...
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© PR Newswire
07.12.2025
CSL
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Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five Years
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- 94% of patients (51 of 54) remained free from the burden of continuous prophylaxis treatment through five years following a single infusion of HEMGENIX, demonstrating sustained therapeutic benefit- At year five, mean factor IX activity levels remained strong at 36.1% and HEMGENIX continued to demonstrate a favorable safety profile, reinforcing i...
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© Globe Newswire
07.12.2025
DYN
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Dyne Therapeutics to Host Investor Conference Call and Webcast to Review Topline Results from Registrational Expansion Cohort (REC) of DELIVER Clinical Trial of Z-Rostudirsen (DYNE-251) in Duchenne Muscular Dystrophy; Tomorrow, December 8 at 8:00 a.m. ET
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WALTHAM, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it plans to announce topline clinical results from the Registrational Expansion Cohort (REC) of the Ph...
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© PR Newswire
07.12.2025
RIGL
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Rigel Presents Updated Data from the Ongoing Phase 1b Study Evaluating R289 in Patients with Lower-Risk MDS at the 67th ASH Annual Meeting and Exposition
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R289 continues to be generally well tolerated and at doses of ≥500 mg QD preliminary efficacy was observed in elderly, heavily pre-treated lower-risk MDS patientsRBC-TI was achieved by 33% (6/18) of evaluable transfusion dependent patients receiving R289 doses ≥500 mg QD, including 40% (2/5) in the 500 mg BID dose groupSOUTH SAN FRANCISCO, Calif.,...
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© BusinessWire
07.12.2025
INCY
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Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025
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Incyte (Nasdaq:INCY) today announced new clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). These preliminary results are from the dose escalation...
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07.12.2025
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Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA
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Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia (ET) harboring a Type 1 CALR mutation who are resistant or intole...
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07.12.2025
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Yescarta® Delivers Consistent Safety, Efficacy, and Quality of Life Benefits Across Broad Range of Relapsed/Refractory Large B-cell Lymphoma Patients in New Analysis at ASH 2025
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Kite, a Gilead Company (Nasdaq: GILD), presented a new analysis today demonstrating that second-line Yescarta® (axicabtagene ciloleucel) therapy offers consistent benefits in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL), even among those ineligible for the previous standard of care, high-dose chemotherapy followed by an autol...
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© BusinessWire
07.12.2025
GMAB
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Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma
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Genmab A/S (Nasdaq: GMAB) today announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study showed that treatment with EPKINLY + R2 reduce...
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© Globe Newswire
07.12.2025
PRME
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Prime Medicine Announces The New England Journal of Medicine Publication of PM359 Clinical Data for the Treatment of Chronic Granulomatous Disease
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CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product...
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© Globe Newswire
07.12.2025
ALXO
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ALX Oncology Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with Indolent B-cell Non-Hodgkin Lymphoma, at ASH Annual Meeting
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- Combination of evorpacept plus rituximab and lenalidomide (R2) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R2 alone...
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© Globe Newswire
07.12.2025
GMAB
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Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma
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Media ReleaseCOPENHAGEN, Denmark; December 7, 2025...
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© Globe Newswire
07.12.2025
MOLN
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Molecular Partners Presents Updated Data from Ongoing Phase 1/2a Trial of MP0533 in AML at ASH Annual Meeting
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ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), has today announ...
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