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Latest Phase 3 Clinical Trial News

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Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)

April 8
Last Trade: 150.00 -0.62 -0.41

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study  45% of the patients receiving steroids at open-label extension baseline...Read more


Amneal Pharmaceuticals Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease

April 7
Last Trade: 6.99 -0.22 -3.05

Analysis of RISE-PD presented at AAN 2025 showed CREXONT treatment significantly improved patients’ Parkinson’s Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores Treatment with CREXONT also resulted in significantly more patients waking up in an “On” state compared to immediate-release CD/LD patients, as part of separate study analysis Sleep disturbances affect up to 80% of patients with Parkinson’s disease1, highlighting the...Read more


Rhythm Pharmaceuticals Announces Pivotal Phase 3 TRANSCEND Trial Meets Primary Endpoint with -19.8% Placebo-adjusted BMI Reduction in Patients (N=120) with Acquired Hypothalamic Obesity

April 7
Last Trade: 57.73 2.77 5.04

Patients with acquired hypothalamic obesity on setmelanotide therapy (n=81) achieved mean BMI change of -16.5% compared with +3.3% for placebo (n=39) at 52 weeks (p<0.0001)  -19.2% placebo-adjusted BMI reduction achieved in adult patients 18 years old and older (n=49) at 52 weeks  -20.2% placebo-adjusted BMI reduction achieved in patients younger than 18 years old (n=71) at 52 weeks  Regulatory submissions in the...Read more


Johnson & Johnson: TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis

April 4
Last Trade: 150.00 -0.62 -0.41

TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today...Read more


Axsome Therapeutics Presents Positive Pivotal Phase 3 Results of the ACCORD-2 Trial of AXS-05 in Alzheimer’s Disease Agitation and the SYMPHONY Trial of AXS-12 in Narcolepsy at the 2025 American Academy of Neurology (AAN) Annual Meeting

April 4
Last Trade: 97.55 -0.95 -0.96

Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 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 multiple...Read more


Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN

April 3
Last Trade: 18.86 -1.08 -5.42

On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025) U.S. FDA BLA submission for accelerated approval planned for 2H 2025 BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it...Read more


Intellia Therapeutics Announces First Patient Dosed in the MAGNITUDE-2 Phase 3 Study of Nexiguran Ziclumeran (nex-z), a One-Time Gene Editing-Based Treatment for Transthyretin (ATTR) Amyloidosis with Polyneuropathy

April 3
Last Trade: 6.28 -0.26 -3.98

CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient has been dosed in MAGNITUDE-2, a global, pivotal Phase 3 trial of nexiguran ziclumeran (nex-z) for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). “We are pleased to have...Read more


Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis

April 2
Last Trade: 35.90 -0.10 -0.28

MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals...Read more


BioMarin Pharmaceutical Announces Positive Pivotal Data for PALYNZIQ® (pegvaliase-pqpz) in Adolescents with Phenylketonuria

April 2
Last Trade: 55.89 -3.27 -5.53

Company plans to submit for regulatory approval later this year SAN RAFAEL, Calif., April 2, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Phase 3 PEGASUS trial evaluating PALYNZIQ® (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone....Read more


Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial

April 2
Last Trade: 9.07 -0.52 -5.42

STAFFORD, Texas, April 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label immune response data. FLAMINGO-01 Immune Response Data Summary The Company has...Read more


RenovoRx Reports Initial Revenues from RenovoCath® Commercialization, and Provides Update on Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial

April 1
Last Trade: 0.80 0.01 1.27

Revenues from RenovoCath Expected to Grow Sequentially During 2025 with Expansion of New Customer Purchase Orders and Customer Reorders Completion of TIGeR-PaC Clinical Trial Enrollment and Review of Second Interim Analysis by Data Monitoring Committee on Target for 2025 Reports 2024 Financial Results Including $7.2 Million Cash Position as of December 31, 2024, with Additional $12.1 Million in Gross Proceeds Raised in February...Read more


Moleculin Biotech Doses First Patient in Pivotal, Adaptive Phase 3 MIRACLE Trial

April 1
Last Trade: 0.74 -0.05 -6.36

Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine (also known as...Read more


Axsome Therapeutics Announces Topline Results of PARADIGM Phase 3 Proof-of-Concept Trial of Solriamfetol in Major Depressive Disorder (MDD) with and without Excessive Daytime Sleepiness (EDS)

April 1
Last Trade: 97.55 -0.95 -0.96

Results support continued development in MDD with concomitant EDS; Phase 3 trial planned in 2025 Approximately 50 percent of MDD patients experience EDS1, highlighting high unmet need NEW YORK, April 01, 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 results of the PARADIGM Phase 3...Read more


New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable

March 31
Last Trade: 13.59 -0.35 -2.51

More than 92% of schizophrenia patients taking TEV-'749 in the SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1 New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial Teva continues its commitment to generating clinical insights that...Read more


Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years

March 31
Last Trade: 2.01 0.03 1.26

Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell...Read more


Primary Endpoint Met in Corcept Therapeutics’ Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

March 31
Last Trade: 70.49 -4.16 -5.57

Relacorilant plus nab-paclitaxel improved progression-free and overall survival and did not increase side effect burden Results will support a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer REDWOOD CITY, Calif. / Mar 31, 2025 / Business Wire...Read more


Novo Nordisk: Rybelsus® (oral semaglutide 14 mg) demonstrates superior reduction in cardiovascular events in the SOUL trial at ACC 2025

March 29
Last Trade: 61.70 -1.94 -3.05

Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1...Read more


Alnylam Pharmaceuticals Presents New Data from the HELIOS-B Phase 3 Study of Vutrisiran in Patients with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM) at the American College of Cardiology’s Annual Scientific Session 2025

March 29
Last Trade: 230.19 -2.76 -1.18

New Data Follow Recent U.S. FDA Approval of AMVUTTRA® (vutrisiran) as First RNAi Therapeutic to Reduce Cardiovascular Death, Cardiovascular Hospitalizations and Urgent Heart Failure Visits in Patients with ATTR-CM Vutrisiran Favorably Impacted Echocardiographic Systolic and Diastolic Function Vutrisiran Treatment Led to Maintenance or Improvement in Functional Capacity, Health Status, and Quality of Life, Compared to Placebo Benefits...Read more


Novo Nordisk: Ozempic® (once-weekly semaglutide 1.0 mg) shown to improve walking distance and quality of life in adults with type 2 diabetes and peripheral artery disease (PAD) at ACC 2025

March 29
Last Trade: 61.70 -1.94 -3.05

Ozempic® improved maximum walking distance by 13% vs placebo in adults with type 2 diabetes and peripheral artery disease (PAD) in the phase 3 STRIDE trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in The Lancet2. Approximately 230 million people globally have PAD, a severe form of atherosclerotic cardiovascular...Read more


Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial

March 27
Last Trade: 78.95 -2.23 -2.75

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment...Read more


BREAKING: Dermata Therapeutics' XYNGARI™ Phase 3 Trial Topline Data Meets All Primary Endpoints

March 27
Last Trade: 0.84 -0.05 -5.20

XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne  XYNGARI™ is the first once-weekly topical product candidate to demonstrate clinical benefit in a Phase 3 clinical trial for moderate-to-severe acne  Over 30 million acne patients seek treatment in the U.S. each year  SAN DIEGO, March 26, 2025 /PRNewswire/ -- Dermata...Read more


Equillium Announces Results of the Phase 3 EQUATOR Study of Itolizumab in First-Line Treatment of Patients with Acute Graft-Versus-Host Disease

March 27
Last Trade: 0.46 0.01 2.62

Treatment with itolizumab did not improve complete or overall response rates at Day 29 Itolizumab achieved statistical significance in multiple secondary endpoints demonstrating compelling clinical benefit in longer-term outcomes, including complete response at Day 99, duration of complete response and failure-free survival Breakthrough Therapy designation and meeting requests to discuss potential for Accelerated Approval submitted to...Read more


Lipocine Announces Initiation of Outpatient Phase 3 Postpartum Depression Trial of LPCN 1154

March 26
Last Trade: 2.81 -0.03 -1.06

48 hour at-home dosing Patient dosing expected in Q2/2025 SALT LAKE CITY, March 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD)....Read more


Compass Pathways Announces Completion of Recruitment for the Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression

March 26
Last Trade: 2.66 -0.04 -1.48

Highlights: Screening closed for all sites and final participants being scheduled for dosing On track for top-line 6-week primary endpoint results in late Q2 LONDON & NEW YORK / Mar 26, 2025 / Business Wire / Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the completion of recruitment in the COMP005 phase 3 trial for treatment...Read more


 Johnson & Johnson: RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer

March 26
Last Trade: 150.00 -0.62 -0.41

Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, N.J., March 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™...Read more


Cassava Sciences Reports Topline Phase 3 REFOCUS-ALZ Data

March 25
Last Trade: 1.25 -0.06 -4.73

Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease Simufilam continued to demonstrate an overall favorable safety profile Cassava’s Alzheimer’s disease development program with simufilam will be completely discontinued by the end of Q2 2025 AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences,...Read more


First Patient Dosed in Immutep’s TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer

March 25
Last Trade: 1.45 0.03 2.11

First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for Immutep Global Phase III with efti will enrol approximately 756 patients at more than 150 clinical sites Trial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology  SYDNEY, AUSTRALIA, March 25, 2025 (GLOBE NEWSWIRE) --  Immutep...Read more


Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint

March 25
Last Trade: 97.55 -0.95 -0.96

Demonstrated substantial and statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, primary endpoint, 150 mg solriamfetol) Statistically significant reduction in overall ADHD disease severity as measured by the CGI-S score compared to placebo (p=0.017, key secondary endpoint, 150 mg solriamfetol) Statistically significant rate of clinical response on the AISRS compared...Read more


Mural Oncology Provides Update on Phase 3 ARTISTRY-7 Trial of Nemvaleukin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Platinum-Resistant Ovarian Cancer

March 25
Last Trade: 1.09 -0.07 -6.03

Based on overall survival data observed in interim analysis in platinum-resistant ovarian cancer, Mural will not progress trial to final analysis Continued demonstration of favorable tolerability profile generally consistent with previously reported data; over 800 patients treated across the greater nemvaleukin clinical program The company remains on track to share topline results from potentially registrational, phase 2 trial in...Read more


Can-Fite BioPharma Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol

March 24
Last Trade: 1.33 -0.08 -5.67

The psoriasis market is estimated at $30 Billion by 2030 and has shifted significantly to oral drugs Ramat Gan, Israel, March 24, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug...Read more


CG Oncology: Cretostimogene Grenadenorepvec Data Continues to Demonstrate Best-in-Class Durability of Response as well as Consistent and Compelling Safety and Efficacy

March 24
Last Trade: 15.59 -1.33 -7.86

Latest BOND-003 data show 75.5% of patients achieved a complete response at any time Median duration of response exceeds 28 months and is ongoing No close contact precautions needed post cretostimogene treatment  IRVINE, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing...Read more


Opthea Announces COAST Phase 3 Trial Topline Results

March 24
Last Trade: 3.41 0.00 0.00

COAST Phase 3 trial failed to meet primary endpoint of mean change in BCVA from baseline to week 52 Opthea considering impact of negative trial results under its Development Funding Agreement and on the Company as a going concern MELBOURNE, Australia and PRINCETON, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies...Read more


Omeros Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial Program

March 21
Last Trade: 6.04 -0.86 -12.46

Phase 3 Data Needed for BLA Submission Expected in the Fourth Quarter 2026 SEATTLE / Mar 21, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of...Read more


Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies

March 19
Last Trade: 13.31 -1.08 -7.51

Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab...Read more


Roivant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies

March 19
Last Trade: 9.08 -0.18 -1.94

Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across...Read more


Biofrontera Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk

March 18
Last Trade: 0.67 -0.05 -6.81

First US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremities Protocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over a surface area of up to 240 cm2 Treatment phase expected to be complete by Q3 2025 WOBURN, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the...Read more


Incyte Announces Positive Topline Results From Two Phase 3 Clinical Trials of Povorcitinib in Patients With Hidradenitis Suppurativa

March 17
Last Trade: 56.97 -3.32 -5.51

- Statistically significant results for primary endpoints in both STOP-HS1 and STOP-HS2 Phase 3 studies for both doses tested - Favorable safety profile, with no safety concerns - Data will support planned regulatory submission for povorcitinib in hidradenitis suppurativa (HS) worldwide - Incyte to hold an analyst and investor call on Monday, March 17, 2025 from 8:00-9:00 a.m. ET WILMINGTON, Del. / Mar 17, 2025 / Business Wire /...Read more


Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01

March 17
Last Trade: 9.07 -0.52 -5.42

STAFFORD, Texas, March 17, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label safety data. FLAMINGO-01 Data Safety Monitoring Board (DSMB) The FLAMINGO-01 DSMB...Read more


Scholar Rock Presents New Phase 3 SAPPHIRE Data at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference

March 16
Last Trade: 24.47 -1.57 -6.03

Primary endpoint showed clinically meaningful improvement in patients with SMA receiving apitegromab as measured by gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo (p=0.0192), with consistent outcomes across all major sub-groups including age, SMN-targeted background therapy, and age at initiation of SMN-targeted therapy Pre-specified secondary endpoint showed that 30.4% of patients receiving apitegromab...Read more


AbbVie: ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients

March 15
Last Trade: 175.67 -28.41 -13.92

Final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE compared to chemotherapy in folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) Data presented in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle NORTH CHICAGO, Ill., March 15, 2025 /PRNewswire/ --...Read more


Amgen: UPLIZNA (inebilizumab-cdon) Significantly Improves Generalized Myasthenia Gravis Symptoms In Acetylcholine Receptor Autoantibody-Positive Patients Over 52 Weeks

March 13
Last Trade: 280.26 -9.43 -3.26

Patients Reported Improvement in Ability to Conduct Daily Activities with Twice-Yearly Dosing* Late-Breaking Data to be Presented at AAN 2025 THOUSAND OAKS, Calif., March 13, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). The results...Read more


Vir Biotechnology Enrolls First Patient in Phase 3 ECLIPSE Registrational Program for Chronic Hepatitis Delta

March 13
Last Trade: 5.19 -0.33 -5.98

First patient enrolled in ECLIPSE 1 Phase 3 clinical trial evaluating combination of tobevibart and elebsiran for chronic suppressive treatment ECLIPSE program designed to enable regulatory submissions and support reimbursement and access Rapid study start indicative of significant unmet need for chronic hepatitis delta treatment SAN FRANCISCO / Mar 13, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the...Read more


Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48

March 12
Last Trade: 78.95 -2.23 -2.75

DOR/ISL demonstrated non-inferiority and a similar safety profile to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 RAHWAY, N.J. / Mar 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir...Read more


Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment

March 12
Last Trade: 2.86 0.20 7.52

SALT LAKE CITY, March 12, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced new evidence from a cross-regimen, post hoc analysis of long-term survival in HEALEY ALS Platform Trial...Read more


Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients

March 11
Last Trade: 114.05 -5.14 -4.31

Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMR AMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S1 Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen’s late-stage immunology portfolio CAMBRIDGE, Mass., March...Read more


PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections

March 11
Last Trade: 2.43 0.03 1.25

PETACH TIKVA, Israel, March 11, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the...Read more


Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial

March 11
Last Trade: 6.19 -0.18 -2.83

VERITAC-2 achieved its primary endpoint in the estrogen receptor 1-mutant population, demonstrating statistically significant and clinically meaningful improvement in progression-free survival  Vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial  NEW HAVEN, Conn. and NEW YORK, March 11, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today...Read more


Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy

March 10
Last Trade: 2.06 -0.12 -5.50

Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary endpoints with high statistical significance PALO ALTO, Calif., March 10, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with...Read more


Novo Nordisk: CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial

March 10
Last Trade: 61.70 -1.94 -3.05

Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2...Read more


4D Molecular Therapeutics Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD

March 10
Last Trade: 2.51 -0.14 -5.28

EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating...Read more


Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN and Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension

March 10
Last Trade: 11.77 -0.28 -2.32

Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001)...Read more


Eli Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study

March 8
Last Trade: 720.90 -2.84 -0.39

Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo Positive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest...Read more


Protagonist Therapeutics: Icotrokinra Clinical Study Results Demonstrate Its Potential to Shift Treatment Paradigm and Set a New Standard for Treatment in Plaque Psoriasis

March 8
Last Trade: 41.67 -1.54 -3.56

Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD study Topline results from Phase 3 ICONIC-ADVANCE 1&2studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe PsO Results pave the way to initiate the first-ever head-to-head study (ICONIC-ASCEND)...Read more


Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis

March 8
Last Trade: 53.07 -2.12 -3.84

Significantly more patients treated with Sotyktu achieved ACR and PASI response rates and had greater improvements in patient-reported quality of life compared with placebo at Week 16 Sotyktu was well-tolerated in comparison with placebo and apremilast, demonstrating safety consistent with its established clinical profile PRINCETON, N.J. / Mar 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced positive data...Read more


New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older

March 8
Last Trade: 11.65 -0.87 -6.95

Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting JERSEY CITY, N.J. / Mar 08, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare...Read more


Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 Ignite Study in Adults with Moderate to Severe Atopic Dermatitis

March 8
Last Trade: 280.26 -9.43 -3.26

Ongoing Studies are Evaluating Long-Term Maintenance and Durability THOUSAND OAKS, Calif., and TOKYO, March 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). The...Read more


Incyte Announces Results of Phase 3 Clinical Trials Evaluating Ruxolitinib Cream 1.5% (Opzelura®) in Patients with Prurigo Nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting

March 8
Last Trade: 56.97 -3.32 -5.51

Full data from the Phase 3 TRuE-PN1 study, presented today in a late-breaking oral presentation, showed the study met all primary and key secondary endpoints Topline data from a separate Phase 3 study, TRuE-PN2, showed that while the primary endpoint did not reach statistical significance, the primary and all key secondary endpoints were in favor of ruxolitinib cream 1.5% versus vehicle These Phase 3 data will inform planned discussions...Read more


Johnson & Johnson: Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

March 8
Last Trade: 150.00 -0.62 -0.41

Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed...Read more


PDS Biotechnology Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer

March 7
Last Trade: 0.94 -0.03 -2.93

PRINCETON, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment. “We are thrilled to share that the first trial site has been initiated and...Read more


AstraZeneca: IMFINZI® (durvalumab)-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers

March 7
Last Trade: 64.90 -0.89 -1.35

MATTERHORN is first global, randomized Phase III trial to demonstrate superior event-free survival with an immunotherapy combination over standard of care in this setting IMFINZI plus chemotherapy more than doubled pathologic complete response rate in previously reported analysis of this trial in 2023 WILMINGTON, Del. / Mar 07, 2025 / Business Wire / Positive high-level results from the MATTERHORN Phase III trial showed perioperative...Read more


BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

March 7
Last Trade: 1.47 -0.09 -5.77

Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home...Read more


aTyr Pharma Announces Fourth Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis

March 6
Last Trade: 2.72 -0.13 -4.56

SAN DIEGO, March 06, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™...Read more


Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF

March 5
Last Trade: 5.83 0.08 1.39

Amendment to Enlarge Phase 3 LEVEL Study, Increasing Statistical Powering, Accepted by FDA, Expected to be Fully Enrolled Around Year End 2025 Agreement by FDA to Initiate Second Global Phase 3 Study, LEVEL-2, with First Patient Expected to be Enrolled this Year CHAPEL HILL, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage...Read more


Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025

March 4
Last Trade: 3.61 -0.13 -3.48

Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY, Kan., March 04, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of...Read more


Adverum Biotechnologies Initiates ARTEMIS Phase 3 Study Evaluating Ixo-vec for Wet AMD

March 3
Last Trade: 3.40 -0.86 -20.19

Ixo-vec is a potential best-in-class one-time gene therapy designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF and improve vision outcomes for patients with wet AMD ARTEMIS is the first-ever initiation of a registrational intravitreal gene therapy trial in patients with wet AMD Non-inferiority study to evaluate a single Ixo-vec injection compared to on-label aflibercept 2mg in both treatment-naïve and...Read more


Spectral Medical Provides February Tigris Trial Update

March 3
Last Trade: 0.69 -0.01 -1.43

152 patients enrolled TORONTO, March 03, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic...Read more


Protagonist Therapeutics and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera

March 3
Last Trade: 14.06 -0.32 -2.23

Study met the primary endpoint, with a significantly higher proportion of clinical responders on rusfertide compared to placebo All four key secondary endpoints were met, including EU primary endpoint and patient-reported outcomes Rusfertide was generally well tolerated; no new safety findings were observed in the study NEWARK, Calif. & OSAKA, Japan & CAMBRIDGE, Mass. / Mar 03, 2025 / Business Wire / Protagonist Therapeutics,...Read more


Roche: Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies

March 2
Last Trade: 35.90 -0.10 -0.28

First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) Results were featured as late-breakers at the 2025 AAAAI Annual Meeting Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies SOUTH SAN FRANCISCO, Calif. / Mar 02, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive...Read more


Astria Therapeutics Initiates ALPHA-ORBIT Phase 3 Pivotal Trial of Navenibart in Hereditary Angioedema

February 27
Last Trade: 3.75 -0.75 -16.67

Trial Designed to Demonstrate Efficacy and Safety of Every 3- and Every 6-Month Administration in a 6-Month Treatment Period  BOSTON / Feb 27, 2025 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the initiation of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living with...Read more


Belite Bio Announces Interim Analysis Results from the Pivotal Global Phase 3 DRAGON trial of Tinlarebant in Adolescent Stargardt Disease Subjects

February 27
Last Trade: 54.10 -1.57 -2.82

An independent Data Safety Monitoring Board (DSMB) for the Phase 3 DRAGON trial recommends trial continuation without any modifications, maintaining the sample size at 104 subjects following a planned interim efficacy analysis; trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has been granted Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S.,...Read more


AstraZeneca: Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumor mutation in SERENA-6 Phase III trial

February 26
Last Trade: 64.90 -0.89 -1.35

First and only next-generation oral SERD and complete ER antagonist to demonstrate 1st-line benefit in combination with widely approved CDK4/6 inhibitors WILMINGTON, Del. / Feb 26, 2025 / Business Wire / Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or...Read more


Madrigal Pharmaceuticals Announces New Two-Year Data from the Compensated MASH Cirrhosis Arm of the MAESTRO-NAFLD-1 Trial Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis

February 26
Last Trade: 302.78 -7.74 -2.49

Patients achieved a mean 6.7 kPa reduction in liver stiffness as measured by vibration-controlled transient elastography (VCTE); this represents the largest reduction in liver stiffness reported in a compensated MASH cirrhosis patient population 51% of patients achieved a ≥25% reduction in liver stiffness; a reduction of this magnitude has been associated with reduced progression to end-stage liver disease Company to review topline...Read more


Recruitment Spotlight: Telix Pharmaceuticals' Phase 3 Clinical Trial of Novel Prostate Cancer Radiopharmaceutical Now Active in Miami

February 25
Last Trade: 14.31 0.06 0.42

MELBOURNE, Australia and INDIANAPOLIS, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT  Global Phase 3 trial1 of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out. ProstACT Global is trialling a...Read more


AN2 Therapeutics Provides Strategic Update for Phase 3 EBO-301 Trial in Treatment Refractory MAC Lung Disease

February 24
Last Trade: 1.25 0.01 0.81

AN2 Selects QOL-B as New Phase 3 Primary Efficacy Endpoint Goal to Accelerate Unblinding Phase 3 Data in Q2 2025 Ahead of Potential FDA Meeting MENLO PARK, Calif. / Feb 24, 2025 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today announced its submission of an amended statistical...Read more


Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors

February 24
Last Trade: 97.55 -0.95 -0.96

SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint) 2-hour pain freedom for most attacks reported at least half the time by 47.9% of patients after SYMBRAVO versus 1.0% after oral CGRPs (p<0.001) 24-hour or greater sustained pain relief after a single dose reported by 47.9% of patients after...Read more


Johnson & Johnson: TREMFYA® (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis

February 21
Last Trade: 150.00 -0.62 -0.41

Phase 3 ASTRO study achieves primary and all secondary endpoints at Week 12 in ulcerative colitis patients The only SC induction data for an IL-23 inhibitor show statistically significant and clinically meaningful improvements across clinical and endoscopic measures versus placebo, consistent with IV induction SPRING HOUSE, Pa., Feb. 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from the...Read more


Bristol Myers Squibb Announces Opdivo® Plus Chemotherapy as the First and Only Neoadjuvant-Only Immuno-Oncology Therapy to Demonstrate Statistically Significant and Clinically Meaningful Overall Survival in Resectable Non-Small Cell Lung Cancer

February 19
Last Trade: 53.07 -2.12 -3.84

PRINCETON, N.J. / Feb 19, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC). The results showed a statistically significant...Read more


Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite BioPharma's Namodenoson

February 18
Last Trade: 1.33 -0.08 -5.67

Liver cirrhosis treatment market is estimated to reach approximately $15 billion in the U.S. by 2030 Ramat Gan, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced a significant clinical development: the disappearance of episodes of...Read more


Opthea Completes COAST Final Week 52 Patient Visit

February 18
Last Trade: 3.41 0.00 0.00

COAST Phase 3 trial evaluates superiority and safety of sozinibercept combined with aflibercept in wet AMD Company confirms topline results for COAST anticipated in early 2Q CY25 MELBOURNE, Australia and PRINCETON, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ:OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal...Read more


Bristol-Myers Squibb: New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis

February 16
Last Trade: 53.07 -2.12 -3.84

No new safety signals observed at Year 5 in the POETYK PSO long-term extension trial, consistent with the established Sotyktu safety profile Following five years of continuous Sotyktu treatment, clinical response was maintained in nearly half of patients for Psoriasis Area and Severity Index (PASI) 90 in the POETYK PSO long-term extension trial PRINCETON, N.J. / Feb 16, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today...Read more


Exelixis Announces Final Five-Year Follow-up Results from CheckMate -9ER Trial Evaluating CABOMETYX® (cabozantinib) in Combination with Opdivo® (nivolumab) in Patients with Advanced Kidney Cancer at ASCO GU 2025

February 15
Last Trade: 34.13 -0.71 -2.04

After more than five years of follow-up, CABOMETYX in combination with Opdivo continued to show survival benefit compared with sunitinib Long-term efficacy seen across subgroups, including site of metastases ALAMEDA, Calif. / Feb 15, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo®...Read more


IMFINZI® (durvalumab) perioperative regimen improved event-free survival and overall survival across muscle-invasive bladder cancer patients regardless of complete pathology response status in post-hoc exploratory analysis of NIAGARA Phase III trial

February 14
Last Trade: 64.90 -0.89 -1.35

IMFINZI reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Feb 14, 2025 / Business Wire / Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival (EFS) and overall...Read more


Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer

February 13
Last Trade: 21.84 -0.79 -3.49

TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of HRR mutation status TALZENNA + XTANDI improved median OS by almost 9 months in unselected patients (Cohort 1) and by 14 months in patients selected for HRR mutations (Cohort 2)...Read more


Bristol Myers Squibb Provides Update on Phase 3 RELATIVITY-098 Trial

February 13
Last Trade: 53.07 -2.12 -3.84

PRINCETON, N.J. / Feb 13, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 RELATIVITY-098 trial evaluating Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of Opdualag observed in this analysis was consistent with the known profiles of...Read more


Agios Pharmaceuticals’ Phase 3 ACTIVATE-Kids Study of Mitapivat in Children with Pyruvate Kinase (PK) Deficiency Not Regularly Transfused Met Primary Endpoint

February 13
Last Trade: 24.53 -1.37 -5.29

ACTIVATE-Kids is the First Study to Demonstrate Efficacy of an Oral Therapy for Children with PK Deficiency Who Are Not Regularly Transfused  Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adults with PK Deficiency Who Are Not Regularly Transfused  First Mitapivat Pediatric Clinical Program for a Rare Hemolytic Anemia; Double-blind Period Completed for Both PK Deficiency Trials...Read more


MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg Ulcers

February 12
Last Trade: 15.35 0.27 1.79

Phase III trial to assess the efficacy and safety of EscharEx® for debridement and facilitation of active wound closure Interim analysis planned after 65% of patients complete treatment, expected in mid-2026 Strategic research collaborations with Solventum, Mölnlycke, and MIMEDX YAVNE, Israel, Feb. 12, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue...Read more


Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial

February 11
Last Trade: 0.74 -0.05 -6.36

First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the...Read more


Pfizer and Astellas’ PADCEV® (enfortumab vedotin-ejfv) plus KEYTRUDA® (pembrolizumab) Shows Long-Term Efficacy in First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

February 10
Last Trade: 21.84 -0.79 -3.49

Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/mUC At nearly 30 months of follow-up in the Phase 3 EV-302 trial, the combination doubled median overall survival and progression-free survival compared to chemotherapy, with no new safety signals identified NEW YORK & TOKYO /...Read more


Grace Therapeutics Announces Results From Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH

February 10
Last Trade: 1.87 0.07 3.89

Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodipine New Drug Application (NDA) Submission Expected in the First Half of 2025 PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel,...Read more


Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01 

February 10
Last Trade: 9.07 -0.52 -5.42

STAFFORD, Texas, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label HLA data. Analysis of the open label data from FLAMINGO-01 has commenced and has...Read more


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