Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses The investigational once-daily oral pill reduced weight by an average 16.0 lbs (7.9%) at the highest dose in a key secondary endpoint The overall safety and tolerability profile of orforglipron in ACHIEVE-1 was consistent with injectable GLP-1 therapies INDIANAPOLIS, April 17,...Read more
Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago. Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application. Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart...Read more
157 patients enrolled Topline results expected to be released in August 2025 Company to host Corporate Update Call on May 15, 2025 TORONTO, April 16, 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 announced the completion of full enrollment in the Company’s Tigris trial, a Phase 3 follow-on...Read more
Dermata previously announced XYNGARI(TM) produced highly statistically significant topline data for all primary endpoints at week 12 in Phase 3 trial Additional data analysis revealed that XYNGARI(TM) separated from placebo after just four once-weekly treatments XYNGARI(TM) could be the first once-weekly topical product candidate for moderate-to-severe acne SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 /...Read more
Emerge is the first Phase 3 study of lysergide D-tartrate (LSD) in MDD; primary endpoint will measure change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between MM120 Orally Disintegrating Tablet (ODT) 100 µg and placebo Emerge builds on positive Phase 2b study results in generalized anxiety disorder (GAD), which showed MM120’s potential antidepressant effects Topline data from the...Read more
PRINCETON, N.J. / Apr 14, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy...Read more
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif.,...Read more
First Global Phase 3 Trial Showing Substantial Survival Advantage Over Chemotherapy, for Patients With Progression On or After Platinum-Based Chemotherapy THOUSAND OAKS, Calif., April 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single...Read more
84% of adolescents with moderate-to-severe plaque psoriasis treated with investigational icotrokinra achieved clear or almost clear skin (IGA 0/1) at Week 16 ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously NEWARK, CA / ACCESS Newswire / April 10, 2025 / Protagonist Therapeutics, Inc....Read more
ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously 84% of adolescents with moderate-to-severe plaque psoriasis treated with investigational icotrokinra achieved clear or almost clear skin (IGA 0/1) at Week 16 SPRING HOUSE, Pa., April 10, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:...Read more
DIAMOND is the first and only pivotal trial program ever conducted with a topical treatment for diabetic macular edema (DME) Over 800 patients randomized in DIAMOND-1 or DIAMOND-2 Phase 3 trials at an industry-leading record speed across 119 sites worldwide primarily in the US; topline data readout expected in Q2 2026 with NDA submission to follow Company to provide an update on the DIAMOND program and its innovative late-stage...Read more
Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US New Next-Generation HCV Therapies are Needed to Improve Patient Outcomes BOSTON, April 09, 2025 (GLOBE NEWSWIRE) -- Atea...Read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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