Drugs - Clinical Trial Results
Clinical trial news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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Johnson & Johnson’s Dual-Targeting CAR T-Cell Therapy Shows Encouraging First Results in Large B-Cell Lymphoma
MILAN (June 13, 2025) – Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric... -
Alligator Bioscience Receives FDA Endorsement of Mitazalimab Phase 3 Dose for Pancreatic Cancer
Lund, Sweden – 13 June 2025 – Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has... -
Merck Initiates Phase 3 Study Evaluating V181 Dengue Vaccine Candidate
RAHWAY, N.J.--(BUSINESS WIRE) June 12, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a... -
New Results for Johnson & Johnson’s Bleximenib Demonstrate Promising Antileukemic Activity in Combination with Venetoclax and Azacitidine for Acute Myeloid Leukemia
MILAN (June 12, 2025) – Johnson & Johnson (NYSE:JNJ) today announced new Phase 1b data showing encouraging antileukemic activity and a promising safety profile for bleximenib (JNJ-75276617) in combination with venetoclax and azacitidine... -
Novo Nordisk to Advance Subcutaneous and Oral Amycretin for Weight Management Into Phase 3 Clinical Development
Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous... -
Cantargia's Nadunolimab Antibody Awarded Fast Track Designation by FDA
June 11, 2025 - Cantargia (Cantargia AB (publ); NASDAQ Stockholm: CANTA), today announced that the U.S. Food and Drug Administration (FDA) has granted nadunolimab, Cantargia's anti-IL1RAP antibody, Fast Track Designation (FTD) for the treatment of... -
Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia
NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF)... -
Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia
RAHWAY, N.J.--(BUSINESS WIRE) June 9, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of... -
Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM)
FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the... -
Pheast Therapeutics Receives FDA Fast Track Designation for PHST001 for the Treatment of Ovarian Cancer
Redwood City, Calif., June 3, 2025 – Pheast Therapeutics, a clinical-stage biotechnology company developing novel therapies to unleash the power of macrophages on aggressive, difficult-to-treat cancers, today announced that the U.S. Food and... -
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
LEXINGTON, Mass. and AMSTERDAM, June 02, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today provided a regulatory update on AMT-130... -
Amylyx Pharmaceuticals Receives U.S. FDA Fast Track Designation for AMX0114 for the Treatment of Amyotrophic Lateral Sclerosis
CAMBRIDGE, Mass.--(BUSINESS WIRE) June 03, 2025 -- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to... -
Rilzabrutinib Granted Orphan Drug Designation in the US for Sickle Cell Disease
Paris, June 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation, to target a... -
Early Results from Johnson & Johnson’s Trispecific Antibody JNJ-5322 Show Promising Response in Heavily Pretreated Multiple Myeloma Patients
Chicago (June 3, 2025) – Johnson & Johnson announced today initial Phase 1 results of JNJ-79635322 (JNJ-5322), a novel investigational trispecific antibody (TsAb) in patients with relapsed or refractory multiple myeloma. Among the 36... -
Lyra Therapeutics Reports Positive Results from the ENLIGHTEN 2 Phase 3 Trial of LYR-210 Achieving Statistically Significant Results for Primary and Key Secondary Endpoints in the Treatment of Chronic Rhinosinusitis (CRS)
WATERTOWN, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the... -
ImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors
CULVER CITY, Calif.–(BUSINESS WIRE)–Jun. 2, 2025– ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the... -
Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in... -
Elinzanetant Significantly Reduces Frequency of Moderate to Severe Vasomotor Symptoms Associated with Endocrine Therapy for Breast Cancer in Phase III OASIS-4 Study
Berlin, June 2, 2025 – Detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also... -
Johnson & Johnson Unveils First-in-Human Results for Pasritamig, Showing Early Anti-Tumor Activity in Prostate Cancer
CHICAGO, JUNE 1, 2025 – Johnson & Johnson announced today new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body’s immune system against... -
Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer
NEW HAVEN, Conn. and NEW YORK, May 31, 2025 – Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus... -
Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations
RAHWAY, N.J.--(BUSINESS WIRE) May 30, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084... -
Merck’s Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory DLBCL in Phase 2 Portion of waveLINE-003 Trial
RAHWAY, N.J.--(BUSINESS WIRE) May 30, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in... -
Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials
TARRYTOWN, N.Y. and PARIS, May 30, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 trial, AERIFY-1, evaluating the investigational use of itepekimab in adults who were former smokers... -
NIH Scientists Pioneer Promising Treatment for Intractable Cancer Pain
May 29, 2025 -- National Institute of Health (NIH) scientists report that a first-in-human clinical trial of a new therapy based on the plant-derived molecule resiniferatoxin (RTX) shows that it is a safe and effective agent for pain control in... -
Genentech’s Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple Sclerosis
South San Francisco, CA -- May 29, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no... -
PIVOT-PO Phase III Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee
May 28 2025 -- GSK plc (LSE/NYSE: GSK) and Spero Therapeutics today announced that the pivotal phase III PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including... -
Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
Singapore, 28 May 2025 – The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track... -
Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST - Modifier Gene Therapy for the Treatment of Stargardt Disease
MALVERN, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the United States Food and Drug Administration (U.S... -
Rocket Pharmaceuticals Provides Update on Phase 2 Clinical Trial of RP-A501 for Danon Disease
CRANBURY, N.J.--(BUSINESS WIRE)--May 27, 2025-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing an integrated pipeline of genetic therapies for rare diseases, today announced an update... -
Teva Celiac Disease Candidate TEV-53408 Granted Fast Track Designation by US FDA
TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15... -
Phase 3 Clinical Study of Mazdutide in Chinese Adults with Overweight or Obesity (GLORY-1) Published in The New England Journal of Medicine (NEJM)
SAN FRANCISCO, U.S., SUZHOU, China May 26, 2025 – Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment... -
Prothena Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary Endpoint
DUBLIN--(BUSINESS WIRE) May 23, 2025 --Prothena Corporation plc (NASDAQ:PRTA) today announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680)... -
Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma
TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome... -
Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea
CAMBRIDGE, Mass., May 19, 2025 – Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related b... -
Global Phase III Trials Demonstrate That Nerandomilast Slowed Lung Function Decline in IPF and PPF, with Similar Discontinuation Rates to Placebo
Ingelheim, Germany, May 19, 2025 - Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials. These studies evaluated nerandomilast, an investigational oral, preferential inhibitor... -
IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Tokyo and Basking Ridge, NJ – May 19, 2025 – The first patient has been dosed in the IDeateEsophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice... -
Savara Presented New Data From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
LANGHORNE, Pa.--(BUSINESS WIRE) May 18, 2025 -- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced new data in two poster presentations at the ATS International... -
Infant with Carbamoyl Phosphate Synthetase 1 (CPS1) Deficiency First to Successfully Receive Personalized Gene Therapy Treatment
Thursday, May 15, 2025 -- A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant... -
The New England Journal of Medicine Publishes Data from Phase 2b Trial of Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) in People with Narcolepsy Type 1
OSAKA, Japan and CAMBRIDGE, Massachusetts, May 14, 2025 – Takeda (TSE: 4502/NYSE:TAK) today announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1... -
In New SELECT Trial Analysis, Early Reduction in Cardiovascular Events Was Observed with Wegovy®, Before Clinically Meaningful Changes in Body Weight
PLAINSBORO, N.J., May 13, 2025 /PRNewswire/ -- Today, Novo Nordisk will present data at the European Congress of Obesity (ECO) from a secondary, post hoc analysis of the SELECT trial that showed within the first three months of treatment, reductions...
