clinical development

65 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Mesoblast Limited

Mesoblast Taps Regeneron Veteran as Clinical Chief to Expand Cell Therapy Pipeline

Mesoblast appoints veteran biotech executive Dr. Teresa Montagut as Head of Clinical Development, signaling acceleration in cell therapy pipeline expansion and Ryoncil® indication broadening.
MESOclinical developmentRyoncil®
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Moleculin Advances MIRACLE Study as Annamycin Shows Promise in AML Treatment

Moleculin Biotech releases CEO update on Phase 3 MIRACLE trial evaluating Annamycin for relapsed/refractory acute myeloid leukemia, with enrollment progressing on schedule.
MBRXclinical developmentPhase 3 trial
BenzingaBenzinga··Vandana Singh

Vertex's Kidney Drug Povetacicept Wins Pivotal Trial, Shares Jump 6%+

$VERX surges 6.3% after kidney drug povetacicept achieves Phase 3 trial success with 52% proteinuria reduction, positioning FDA approval by year-end.
VRTXIBBBBHFDA approvalclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Diamond Equity Research

MAIA Biotech Raises $30M, Eyes 2026 Milestones with Ateganosine Trial Data

MAIA Biotech secures $30M funding and FDA Fast Track designation for ateganosine cancer therapy, with Phase 2 data showing 17.8-month median survival.
MAIAclinical developmentPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Biorestorative Therapies, Inc.

BioRestorative Therapies to Showcase Regenerative Skincare Tech at Major NYC Wellness Event

BioRestorative Therapies will exhibit at Be+Well Beauty and Wellness Show in NYC (March 8-10, 2026) to advance its BioCosmeceutical platform commercialization.
BRTXclinical developmentregenerative medicine
GlobeNewswire Inc.GlobeNewswire Inc.··Can-Fite Biopharma Ltd.

Can-Fite's Namodenoson Clears Safety Hurdle in Pancreatic Cancer Study

Can-Fite's namodenoson meets primary safety endpoint in Phase IIa pancreatic cancer trial with no new safety signals; survival data pending.
CANFclinical developmentorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Hutchmed (China) Limited

HUTCHMED Launches Global Trial for Dual-Action Tumor Therapy HMPL-A580

HUTCHMED initiates Phase I/IIa trial of HMPL-A580, a novel antibody-targeted therapy combining PI3K/PIKK inhibitor with anti-EGFR antibody for solid tumors across China and US.
HCMclinical developmentsolid tumors
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Teva, Blackstone Life Sciences Team Up on $400M Deal for GI Drug duvakitug

Teva and Blackstone Life Sciences announce $400 million four-year funding agreement to develop duvakitug for inflammatory bowel disease, supporting Teva's specialty pharma pivot.
SNYTEVAmonoclonal antibodyclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Absci Bolsters Clinical Expertise with Vertex Pharma Veteran as New CMO

Absci appoints Vertex Pharma veteran Dr. Ransi Somaratne as Chief Medical Officer to lead clinical development of AI-designed therapeutics, signaling execution focus.
VRTXABSIclinical developmentVertex Pharmaceuticals
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Medidata Earns Top 'Luminary' AI Rating as Solutions Back 80% of FDA Drug Approvals

Medidata secures top 'Luminary' AI rating from Everest Group, supporting 80% of FDA approvals with up to 37% faster patient enrollment.
DASTYagentic AIclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Maia Biotechnology, Inc.

MAIA Biotech Taps Capital Markets for Cancer Drug Development Push

MAIA Biotechnology launches underwritten public offering of common stock and pre-funded warrants to fund clinical trials for its lead cancer therapy ateganosine.
MAIAclinical developmentpublic offering
BenzingaBenzinga··Prnewswire

Psychedelic Drug Developers Entering Final Testing Phase for Mental Health Treatments

Five biotech firms advance psychedelic therapies to Phase 3 trials for depression and anxiety, with multiple readouts expected in 2026, marking progress toward regulatory approval.
ATAIDFTXGHRSLBRXpsychedelic biotechnologyPhase 3 trials
BenzingaBenzinga··Prnewswire

Psilocybin Pipeline Expands as Regulatory Support Strengthens for CNS Applications

Psilocybin gains regulatory momentum with first Phase 3 success in treatment-resistant depression. DEA increases production quota 67%, while five pharma companies advance psychedelic programs across multiple CNS indications.
CMPSRLMDANROAXSMFDA approvalPhase 3 trials
BenzingaBenzinga··Globe Newswire

Tevogen Bio Explores Strategic Acquisition of Clinicus Platform Developer

Tevogen Bio pursues acquisition of Sciometrix to gain Clinicus digital care platform, integrating it with its AI division to expand into healthcare services alongside biotech operations.
TVGNTVGNWacquisitionclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Juvenescence Advances PAI-1 Program With Phase 1 Success, Expands Leadership Team

Juvenescence completes Phase 1 trial of PAI-1 inhibitor MDI-2517 with positive safety results. Company expands leadership and plans Phase 2 study in late 2026.
PFEbiotechclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Prime Medicine, Inc.

Prime Medicine to Present at Three Major Biotech Conferences in March

Prime Medicine will present at three major biotech conferences in March 2026, including TD Cowen and Citizens Life Sciences, with webcasts available afterward.
PRMEclinical developmentinvestor conference
BenzingaBenzinga··Vandana Singh

GSK Acquires 35Pharma for $950M to Strengthen Pulmonary Hypertension Portfolio

GSK acquires 35Pharma for $950M, adding pulmonary hypertension treatment HS235 to its pipeline. Move strengthens GSK's position in the growing $18B market.
GSKRAPTacquisitionclinical development
BenzingaBenzinga··Globe Newswire

GSK Acquires 35Pharma for $950M to Advance Pulmonary Hypertension Treatment

GSK acquires 35Pharma for $950M to gain HS235, a clinical-stage pulmonary hypertension drug with improved safety profiles versus existing treatments.
GSKacquisitionclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Kyverna Bolsters Board With Beam, Karuna Executives Ahead of Cell Therapy Launch

Kyverna appoints two biotech executives to its board ahead of cell therapy commercialization. New directors bring expertise from Beam Therapeutics and Karuna Therapeutics.
BMYCELGrKYTXBEAMclinical developmentautoimmune diseases
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Aclaris Advances Dual-Target Antibody into Asthma Study Following Dermatitis Trial Launch

Aclaris launches Phase 1b asthma trial for ATI-052, a dual-target antibody also in dermatitis trials. Results expected mid-2026.
ACRSclinical developmentatopic dermatitis