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Amgen's Repatha Phase 3 VESALIUS-CV Trial Data to be Presented at AHA 2025

November 3, 2025

Amgen announced that new data from its cardiovascular portfolio, including results from the Phase 3 VESALIUS-CV clinical trial of Repatha (evolocumab)...

September 25

Amgen's Repatha Phase 3 VESALIUS-CV Trial Data to be Presented at AHA 2025

Amgen announced that new data from its cardiovascular portfolio, including results from the Phase 3 VESALIUS-CV clinical trial of Repatha (evolocumab)...

November 3, 2025

Genentech's Gazyva Shows Positive Phase III Data with Significant Reduction in Disease Activity for Systemic Lupus Erythematosus

Genentech announced positive results from the Phase III ALLEGORY study of Gazyva in adults with systemic lupus erythematosus (SLE) on standard therapy...

November 3, 2025

GeneSight Test Shows Faster Remission and Response in Depression Treatment: Post-Hoc Analysis

Myriad Genetics announced a post-hoc analysis of the PRIME study, revealing that patients with Major Depressive Disorder (MDD) treated based on GeneSi...

November 3, 2025

Foghorn Therapeutics Announces Updates for Selective ARID1B, CBP, and EP300 Degrader Programs

Foghorn Therapeutics announced updates on its Selective ARID1B, CBP, and EP300 degrader programs. The Selective ARID1B degrader selectively binds and ...

October 31, 2025

Wave Life Sciences Announces Positive Target Engagement Data from INLIGHT Clinical Trial of WVE-007 for Obesity

Wave Life Sciences announced positive Activin E target engagement data from the INLIGHT clinical trial of WVE-007, a GalNAc-siRNA, for obesity. The tr...

October 30, 2025

Anaptys Announces Positive Phase 2b Results for Rosnilimab in Rheumatoid Arthritis

AnaptysBio announced positive late-breaking data from its Phase 2b trial of rosnilimab in rheumatoid arthritis (RA). The study demonstrated deepening ...

October 30, 2025

AbbVie Announces Positive Phase 3 Results for Upadacitinib (RINVOQ®) in Vitiligo

AbbVie announced positive topline results from two replicate Phase 3 studies evaluating upadacitinib (RINVOQ®) in adult and adolescent patients with n...

October 30, 2025

TG Therapeutics Completes Enrollment in Phase 3 ENHANCE Trial of Simplified Dosing for BRIUMVI in Multiple Sclerosis

TG Therapeutics announced the completion of enrollment in the Phase 3 ENHANCE trial, which is evaluating a simplified dosing schedule for BRIUMVI (ubl...

October 29, 2025

Kyverna Therapeutics Announces Positive Phase 2 Interim Data for KYV-101 in Generalized Myasthenia Gravis

Kyverna Therapeutics announced positive interim Phase 2 data from the KYSA-6 study of KYV-101 in generalized myasthenia gravis (gMG). The data showed ...

October 29, 2025

Sionna Therapeutics Announces Phase 1 Data for SION-719 and SION-451 and Preclinical Data on NBD1 Stabilizers in Cystic Fibrosis

Sionna Therapeutics announced the presentation of Phase 1 clinical trial data for SION-719 and SION-451, first-in-class NBD1 stabilizers, at the 2025 ...

October 27, 2025

Daewoong Pharmaceutical's Bersiporocin Receives Positive IDMC Safety Review in Phase 2 IPF Trial

Daewoong Pharmaceutical announced that Bersiporocin (DWN12088), its first-in-class drug candidate for idiopathic pulmonary fibrosis (IPF), received a ...

October 27, 2025

Innovent's Mazdutide Demonstrates Superior Glycemic Control and Weight Loss Compared to Semaglutide in Phase 3 DREAMS-3 Trial

Innovent Biologics announces positive results from its Phase 3 DREAMS-3 clinical trial of mazdutide, a glucagon-like peptide-1 (GLP-1) and glucagon (G...

October 27, 2025

Xencor Presents Phase 1 Data for XmAb819 in Clear Cell Renal Cell Carcinoma

Xencor announced initial results from the Phase 1 dose-escalation study of XmAb819, a first-in-class ENPP3 x CD3 bispecific T-cell engager, in patient...

October 27, 2025

Cullinan Therapeutics Presents Preclinical Data for CLN-978 Supporting Clinical Development in Autoimmune Diseases at ACR Convergence 2025

Cullinan Therapeutics presented preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at the American College of Rheumatology (ACR) Conv...

October 27, 2025

Lilly's Omvoh (mirikizumab-mrkz) Shows Improvement in Bowel Urgency for Ulcerative Colitis Patients

Eli Lilly and Company announced positive data from the Phase 3b LUCENT-URGE study, demonstrating that Omvoh (mirikizumab-mrkz) significantly improved ...

October 27, 2025

August 25

Sionna Therapeutics Announces Phase 1 Data for SION-719 and SION-451 and Preclinical Data on NBD1 Stabilizers in Cystic Fibrosis

Sionna Therapeutics announced the presentation of Phase 1 clinical trial data for SION-719 and SION-451, first-in-class NBD1 stabilizers, at the 2025 ...

October 27, 2025

Daewoong Pharmaceutical's Bersiporocin Receives Positive IDMC Safety Review in Phase 2 IPF Trial

Daewoong Pharmaceutical announced that Bersiporocin (DWN12088), its first-in-class drug candidate for idiopathic pulmonary fibrosis (IPF), received a ...

October 27, 2025

Innovent's Mazdutide Demonstrates Superior Glycemic Control and Weight Loss Compared to Semaglutide in Phase 3 DREAMS-3 Trial

Innovent Biologics announces positive results from its Phase 3 DREAMS-3 clinical trial of mazdutide, a glucagon-like peptide-1 (GLP-1) and glucagon (G...

October 27, 2025

Xencor Presents Phase 1 Data for XmAb819 in Clear Cell Renal Cell Carcinoma

Xencor announced initial results from the Phase 1 dose-escalation study of XmAb819, a first-in-class ENPP3 x CD3 bispecific T-cell engager, in patient...

October 27, 2025

Cullinan Therapeutics Presents Preclinical Data for CLN-978 Supporting Clinical Development in Autoimmune Diseases at ACR Convergence 2025

Cullinan Therapeutics presented preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at the American College of Rheumatology (ACR) Conv...

October 27, 2025

Lilly's Omvoh (mirikizumab-mrkz) Shows Improvement in Bowel Urgency for Ulcerative Colitis Patients

Eli Lilly and Company announced positive data from the Phase 3b LUCENT-URGE study, demonstrating that Omvoh (mirikizumab-mrkz) significantly improved ...

October 27, 2025

Moderna's Phase 3 CMV Vaccine Trial Fails to Meet Primary Efficacy Endpoint

Moderna announced that its Phase 3 trial evaluating mRNA-1647, an investigational cytomegalovirus (CMV) vaccine, did not meet its primary efficacy end...

October 23, 2025

Kyverna Therapeutics Announces Conference Call on Interim Phase 2 Data of KYV-101 in Generalized Myasthenia Gravis

Kyverna Therapeutics will host a conference call to discuss interim data from the KYSA-6 Phase 2 clinical trial evaluating KYV-101 in generalized myas...

October 23, 2025

Rozanolixizumab Prevents Congenital Heart Block Recurrence in High-Risk Pregnancy

NYU Langone Health researchers found that rozanolixizumab, a neonatal Fc receptor (FcRn) inhibitor, can prevent congenital heart block in newborns of ...

October 22, 2025

OS Therapies Announces Positive Survival Data for OST-HER2 in Metastatic Osteosarcoma Subgroups

OS Therapies Inc. announced additional overall and event free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected,...

October 22, 2025

AskBio Announces Positive 12-Month Data from Phase 1 Trial of AB-1002 Gene Therapy for Congestive Heart Failure in Nature Medicine

AskBio, a subsidiary of Bayer AG, announced the publication of 12-month data from its Phase 1 trial of AB-1002 gene therapy for congestive heart failu...

October 22, 2025

IDEAYA Biosciences Announces Positive Phase 2 Data for Darovasertib in Neoadjuvant Primary Uveal Melanoma

IDEAYA Biosciences announced positive Phase 2 clinical data for darovasertib in the neoadjuvant setting of primary uveal melanoma (UM). The OptimUM-09...

October 21, 2025

Sionna Therapeutics Initiates Phase 2a Trial of SION-719 for Cystic Fibrosis

Sionna Therapeutics has initiated the PreciSION CF Phase 2a trial to evaluate SION-719, a novel NBD1 stabilizer, in cystic fibrosis (CF) patients. The...

October 21, 2025

Apnimed Presents Phase 3 Data for AD109 in Obstructive Sleep Apnea at CHEST 2025

Apnimed announced additional data from its Phase 3 SynAIRgy and LunAIRo trials evaluating AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg) for obstructiv...

October 20, 2025

CatalYm Presents Positive Long-Term Phase 1/2a Data for Visugromab in CPI-Refractory Tumors at ESMO 2025

CatalYm announced updated long-term data from its GDFATHER-1/2a trial at ESMO Congress 2025, showcasing the potential of visugromab to reverse resista...

October 20, 2025

Olema Oncology Announces Positive Phase 1b/2 Data of Palazestrant Plus Ribociclib in ER+/HER2- Metastatic Breast Cancer at ESMO 2025

Olema Oncology announced updated data from the Phase 1b/2 study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or ...

October 20, 2025

Disc Medicine to Present Phase 1b Data of DISC-0974 in CKD Patients with Anemia at ASN Kidney Week 2025

Disc Medicine will present data from its Phase 1b trial of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anem...

October 20, 2025

SystImmune and Bristol Myers Squibb Announce Phase I Results of Iza-bren (EGFR x HER3 ADC) in Advanced Solid Tumors

SystImmune and Bristol Myers Squibb announced the first global Phase I results of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjuga...

October 20, 2025

Exelixis Announces Positive Phase 3 Results for Zanzalintinib and Atezolizumab Combination in Metastatic Colorectal Cancer

Exelixis announced detailed results from the Phase 3 STELLAR-303 trial evaluating zanzalintinib in combination with atezolizumab versus regorafenib in...

October 20, 2025

AlphaMedix Phase 2 Data Shows Potential in Gastroenteropancreatic Neuroendocrine Tumors

AlphaMedix phase 2 study (ALPHAMEDIX-02) evaluating AlphaMedix (212Pb-DOTAMTATE) in patients with advanced gastroenteropancreatic neuroendocrine tumor...

October 20, 2025

AB Science Announces Initial Phase 1 Data for AB8939 and Venetoclax Combination in Refractory or Relapsed Acute Myeloid Leukemia

AB Science SA announced initial Phase 1 data for the combination of AB8939 with venetoclax for treating refractory or relapsed acute myeloid leukemia ...

October 17, 2025

Praxis Announces Positive Phase 3 Results for Ulixacaltamide in Essential Tremor

Praxis Precision Medicines announced positive topline results from two pivotal Phase 3 studies (Essential3 program) of ulixacaltamide HCl in patients ...

October 17, 2025

Vor Bio Announces Positive Phase 3 Results of Telitacicept in Systemic Lupus Erythematosus Published in NEJM

Vor Bio announces the publication of positive results from a Phase 3 trial in China evaluating telitacicept for systemic lupus erythematosus (SLE) in ...

October 17, 2025

Nuvectis Pharma Announces Upcoming Presentations for NXP900 at AACR-NCI-EORTC Conference

Nuvectis Pharma, Inc. announced upcoming poster presentations for NXP900 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and ...

October 17, 2025

Aicuris' Pritelivir Meets Primary Endpoint in Phase 3 Trial for Refractory Herpes Simplex Virus in Immunocompromised Patients

Aicuris Anti-infective Cures AG announced positive results from its Phase 3 trial (PRIOH-1) of pritelivir for treating refractory Herpes Simplex Virus...

October 16, 2025

Spago Nanomedical Announces Positive Data and Dose Increase Recommendation for 177Lu-SN201 in Phase I/IIa Tumorad-01 Study

Spago Nanomedical announced that the Data Monitoring Committee (DMC) recommended a dose increase in the ongoing Phase I/IIa clinical trial Tumorad-01 ...

October 14, 2025

Gilead and Kite Present New Cancer Data at ESMO 2025, Highlighting Trodelvy's Potential in Metastatic TNBC

Gilead and Kite will present new data at the ESMO 2025 Congress, showcasing progress in cancer treatment. Key highlights include Phase 3 ASCENT-03 stu...

October 14, 2025

Boehringer and Click Therapeutics present positive Phase III data for CT-155 in Schizophrenia

Boehringer Ingelheim and Click Therapeutics announced positive results from the Phase III CONVOKE study of CT-155, an investigational prescription dig...

October 14, 2025

Encoded Therapeutics Announces Positive Preclinical Data for Non-Opioid Gene Therapy Candidate for Chronic Pain

Encoded Therapeutics announced preclinical data for its AAV9 microRNA (miRNA) gene therapy candidate targeting SCN9A (NaV1.7) for chronic pain. The da...

October 10, 2025

Taysha Gene Therapies Presents New Data on TSHA-102 for Rett Syndrome at CNS Annual Meeting

Taysha Gene Therapies announced new supplemental data analysis from Part A of the REVEAL Phase 1/2 trials evaluating TSHA-102 in females with Rett syn...

October 10, 2025

GlyTR Therapeutics Announces Publication of Pan-Cancer Immunotherapy Platform Study in Cell

GlyTR Therapeutics announced the publication of a study in Cell detailing their Glycan-Dependent T cell Recruiter (GlyTR1 & GlyTR2) therapeutics. Thes...

October 9, 2025

BrYet US Receives Approval to Initiate Phase 1/2 Trial of ML-016 in Advanced Cancers with Lung and/or Liver Involvement in Australia

BrYet US, Inc. has received approval to initiate a first-in-human Phase 1/2 clinical trial of ML-016 in Australia. The trial will evaluate the safety,...

October 7, 2025

Prilenia and Ferrer Announce Phase 3 ALS Study of Pridopidine at NEALS 2025

Prilenia Therapeutics and Ferrer announced the presentation of their planned pivotal Phase 3 study of pridopidine in Amyotrophic Lateral Sclerosis (AL...

October 7, 2025

Editas Medicine Announces EDIT-401 Oral Presentation at ESGCT Congress and Participation in Investor Conferences

Editas Medicine announced an oral presentation on EDIT-401, a CRISPR gene editing medicine for lowering LDL-cholesterol by upregulating LDLR, at the E...

October 7, 2025

Myrtelle Announces Encouraging Interim Results from Phase 1/2 Gene Therapy Trial for Canavan Disease

Myrtelle Inc. announced encouraging interim results from its Phase 1/2 clinical trial of rAAV-Olig001-ASPA (MYR-101), an investigational gene therapy ...

October 7, 2025

Candel Therapeutics to Present CAN-2409 Data at SITC 2025

Candel Therapeutics will present data from its enLIGHTEN™ Discovery Platform and CAN-2409 program in non-small cell lung cancer (NSCLC) at the SITC 20...

October 6, 2025

Invivyd Announces U.S. IND Clearance and FDA Alignment for VYD2311 COVID Prevention Program

Invivyd announced that the FDA has cleared its IND application and provided feedback to advance its REVOLUTION clinical program for VYD2311, a vaccine...

October 6, 2025

DATROWAY® Improves Overall and Progression-Free Survival in Metastatic Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo's DATROWAY® (datopotamab deruxtecan-dlnk) demonstrated statistically significant and clinically meaningful improvements...

October 6, 2025

Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program for AML and MDS

Marker Therapeutics announced the treatment of the first patient in their Phase 1 RAPID study, evaluating MT-401, an off-the-shelf (OTS) multi-antigen...

October 6, 2025

Abivax Announces Positive Results from ABTECT Induction Trials of Obefazimod in Ulcerative Colitis Patients

Abivax announced late-breaking presentation of 8-Week ABTECT Induction Trial results in participants with and without prior inadequate response to adv...

October 6, 2025

Bolt Biotherapeutics Updates on BDC-4182 and Extends Cash Runway into 2027

Bolt Biotherapeutics announced an update on its Phase 1 dose escalation study of BDC-4182, an ISAC targeting claudin 18.2 for cancer treatment. Initia...

October 2, 2025

EG 427 Announces Positive Topline Results for EG110A in Neurogenic Bladder Patients

EG 427 announced positive initial results from a clinical trial of EG110A, a novel DNA therapy for neurogenic bladder. The study showed an over 88% re...

October 2, 2025

Lisata Therapeutics Announces Positive Preliminary Results from CENDIFOX Trial in Pancreatic Cancer

Lisata Therapeutics announced encouraging preliminary data from the Phase 1/2a CENDIFOX trial evaluating certepetide in combination with FOLFIRINOX fo...

September 30, 2025

July 25

CeleCor Therapeutics Announces Positive Phase 3 Results for Disaggpro in Heart Attack Patients

CeleCor Therapeutics announced positive topline results from its Phase 3 CeleBrate trial evaluating Disaggpro™ (zalunfiban) for heart attack treatment...

September 24, 2025

OS Therapies to Present at BioFuture 2025 and Discuss OST-HER2 Clinical Development

OS Therapies Inc. announces its participation in the BioFuture 2025 conference, where it will present an overview of the company with a focus on the c...

September 19, 2025

ONWARD Medical Announces Positive Results for ARC-IM Therapy in Blood Pressure Regulation after Spinal Cord Injury

ONWARD Medical N.V. announced concurrent publications in Nature and Nature Medicine highlighting the benefits of its investigational ARC-IM System for...

September 18, 2025

Skyhawk Therapeutics Announces Positive Interim Phase 1 Results for SKY-0515 in Huntington's Disease

Skyhawk Therapeutics announced positive interim results from its Phase 1 clinical trial of SKY-0515 for Huntington's disease (HD). The trial showed do...

September 18, 2025

Palvella Therapeutics Announces Publication on Rapamycin for Venous Malformations

Palvella Therapeutics announces a publication in Lymphatic Research and Biology highlighting advances in understanding venous malformation pathogenesi...

September 18, 2025

Protagonist Announces Clinical Data Presentations for Icotrokinra and PN-881 at EADV 2025 Congress

Protagonist Therapeutics announced new clinical data for Icotrokinra in plaque psoriasis from Phase 3 ICONIC-ADVANCE and ICONIC-LEAD studies, being pr...

September 18, 2025

Atossa Therapeutics Seeks Accelerated Approval for Low-Dose (Z)-Endoxifen for Breast Cancer Risk Reduction

Atossa Therapeutics has requested a Type C meeting with the FDA to discuss a regulatory strategy for accelerating the development of low-dose (Z)-endo...

September 9, 2025

CASI Pharmaceuticals Announces Dose Escalation in Phase 1 CID-103 ITP Study

CASI Pharmaceuticals announced that the Safety Monitoring Committee (SMC) recommended dose escalation of CID-103, an anti-CD38 monoclonal antibody, to...

September 9, 2025

Alto Neuroscience Validates EEG Biomarker for Schizophrenia, Strengthening Phase 2 Trial of ALTO-101

Alto Neuroscience announced positive results from an independent, prospective replication study validating theta-band inter-trial coherence (ITC) as a...

September 9, 2025

Positive Phase 1/2 Data for IDE397 and Trodelvy Combination in MTAP-Deletion Urothelial Cancer

IDEAYA Biosciences announced positive data from a Phase 1/2 trial evaluating the combination of IDE397, a MAT2A inhibitor, and Trodelvy (sacituzumab g...

September 9, 2025

Positive Phase 1 Data for IDE849 (SHR-4849) in Small Cell Lung Cancer

IDEAYA Biosciences and Hengrui Pharma presented positive Phase 1 data for IDE849 (SHR-4849), a DLL3-targeting TOP1 antibody-drug conjugate (ADC), at t...

September 8, 2025

Oncolytics Biotech Highlights Pelareorep Efficacy in Metastatic Colorectal Cancer

Oncolytics Biotech announced positive clinical and translational data for pelareorep in metastatic colorectal cancer (mCRC). In the REO 022 trial, pe...

September 8, 2025

RYBREVANT® and LAZCLUZE® Combination Prevents Acquired Resistance in First-Line EGFR-Mutated NSCLC

Johnson & Johnson announced new analyses from the Phase 3 MARIPOSA study demonstrating that the combination of RYBREVANT® (amivantamab-vmjw) and LAZCL...

September 8, 2025

iMDx Enrolls First Patient in GraftAssureDx Clinical Trial

Insight Molecular Diagnostics (iMDx) announced the enrollment of the first patient in its clinical trial for GraftAssureDx, a kitted organ transplant ...

September 8, 2025

Regeneron's Positive Phase 3 Allergy Trials Advance First-in-Class Antibody Blockers

Regeneron Pharmaceuticals announced positive results from two Phase 3 trials evaluating its first-in-class allergen-blocking antibodies for cat and bi...

September 8, 2025

Rapport Therapeutics to Announce Topline Phase 2a Results for RAP-219 in Focal Onset Seizures

Rapport Therapeutics will release topline data from its Phase 2a clinical trial of RAP-219 in patients with drug-resistant focal onset seizures on Sep...

September 8, 2025

SCYNEXIS Presents Data on Second-Generation Antifungal SCY-247 at TIMM-12

SCYNEXIS announced multiple presentations at the 12th Congress on Trends in Medical Mycology (TIMM-12) highlighting data on its second-generation anti...

September 5, 2025

Valitor Presents Preclinical Data on VLTR-559 for Wet AMD

Valitor announced positive preclinical data for VLTR-559, a long-acting anti-VEGF drug candidate for wet age-related macular degeneration (AMD). A no...

September 5, 2025

Gain Therapeutics Receives Approval for Phase 1b Dosing Extension of GT-02287 for Parkinson's Disease

Gain Therapeutics announced Australian approval to extend the Phase 1b clinical trial of its drug candidate, GT-02287, for Parkinson's disease by nine...

September 5, 2025

Clene Presents Preclinical Data Supporting CNM-Au8 for Parkinson's Disease

Clene Inc. announced positive preclinical data for CNM-Au8 in treating Parkinson's disease (PD). A novel neuronal model demonstrated CNM-Au8's abilit...

September 5, 2025

AL-S Pharma Announces Positive Phase 2 Results for AP-101 in ALS Treatment

AL-S Pharma reported positive topline results from its Phase 2 clinical trial of AP-101, a first-in-class monoclonal antibody targeting misfolded SOD1...

September 4, 2025

Sanofi's Amlitelimab Shows Promise in Phase 3 Atopic Dermatitis Study

Sanofi announced positive topline results from the COAST 1 Phase 3 clinical trial of amlitelimab, a monoclonal antibody targeting OX40L, in adults and...

September 4, 2025

Aspire Biopharma Announces Positive Final Results for Sublingual Aspirin in Treating Heart Attacks

Aspire Biopharma announced positive final results from a clinical trial evaluating its investigational sublingual aspirin product for suspected acute ...

September 4, 2025

Personalis' NeXT Personal MRD Test Shows Superiority in Neoadjuvant Lung Cancer Trial

Personalis, Inc. announced positive data from AstraZeneca's phase 3 NeoADAURA trial, demonstrating that their NeXT Personal molecular residual disease...

September 4, 2025

Zymeworks Discontinues ZW171 Clinical Development

Zymeworks Inc. announced the discontinuation of clinical development for ZW171, a T cell engager targeting gynecological, thoracic, and digestive syst...

September 2, 2025

Compass Pathways Announces Positive Phase 2 Results for COMP360 Psilocybin in PTSD

Compass Pathways announced the publication of positive Phase 2 results for their investigational drug COMP360, a synthetic psilocybin, in treating pos...

September 2, 2025

Ascletis to Present ASC30 Data at EASD Annual Meeting

Ascletis Pharma Inc. announced that it will present data from a 28-day multiple ascending dose study of its oral small molecule GLP-1 receptor (GLP-1R...

September 2, 2025

Merck's Enlicitide Decanoate Meets Primary Endpoints in Phase 3 Hypercholesterolemia Trial

Merck announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating enlicitide decanoate, an investigational oral PCSK9 inhibi...

September 2, 2025

Olezarsen Shows Significant Reduction in Triglycerides and Acute Pancreatitis in sHTG Patients

Ionis Pharmaceuticals announced positive topline results from pivotal Phase 3 CORE and CORE2 studies of olezarsen in patients with severe hypertriglyc...

September 2, 2025

Baxdrostat Shows Significant Blood Pressure Reduction in Phase III Hypertension Trial

Positive results from the BaxHTN Phase III trial demonstrated that baxdrostat, a highly selective aldosterone synthase inhibitor, significantly reduce...

September 1, 2025

Alnylam to Advance Zilebesiran into Global Phase 3 Cardiovascular Outcomes Trial

Alnylam Pharmaceuticals announced plans to initiate a Phase 3 cardiovascular outcomes trial (CVOT) for zilebesiran, an investigational RNAi therapeuti...

September 1, 2025

Roche and Alnylam Advance Zilebesiran into Phase III Cardiovascular Outcomes Trial for Uncontrolled Hypertension

Roche and Alnylam announced the initiation of a Phase III cardiovascular outcomes trial (CVOT) for zilebesiran, an RNAi therapeutic, to reduce major a...

September 1, 2025

Merck's VERQUVO (vericiguat) Shows Mixed Results in Chronic Heart Failure Trials

Merck announced results from the Phase 3 VICTOR trial and a pooled analysis of VICTOR and VICTORIA trials evaluating VERQUVO (vericiguat) in chronic h...

September 1, 2025

Tourmaline Bio Presents Positive Phase 2 Data for Pacibekitug at ESC Congress 2025

Tourmaline Bio announced positive data from the ongoing Phase 2 TRANQUILITY trial of pacibekitug, a long-acting anti-IL-6 monoclonal antibody, present...

September 1, 2025

Telomir-1: A Novel Epigenetic Therapy Targeting DNA Methylation Pathways

Telomir Pharmaceuticals announced in vitro data supporting the potential of Telomir-1, a first-in-class epigenetic therapy, in treating cancer, aging,...

August 29, 2025

Zevra Therapeutics to Present Multiple Datasets on MIPLYFFA® (arimoclomol) at ICIEM

Zevra Therapeutics announced that four posters on MIPLYFFA® (arimoclomol), its approved therapy for Niemann-Pick disease type C (NPC), will be present...

August 29, 2025

Breath Diagnostics' OneBreath™ Technology Predicts Pneumonia Onset Through Exhaled Breath Analysis

Breath Diagnostics announced results from a peer-reviewed clinical study published in The Journal of Thoracic and Cardiovascular Surgery, demonstratin...

August 28, 2025

Airiver Medical Receives FDA IDE Approval for Pivotal Clinical Study of Airiver Pulmonary Drug Coated Balloon

Airiver Medical announced that it has received Investigational Device Exemption (IDE) approval from the FDA to conduct a pivotal clinical trial of its...

August 28, 2025

June 25

Actuate Therapeutics' Elraglusib Shows Promising Results in Metastatic Pancreatic Cancer

Actuate Therapeutics announced positive Phase 2 results for elraglusib (elra) in combination with gemcitabine and nab-paclitaxel (GnP) for metastatic ...

August 26, 2025

Coya Therapeutics Announces FDA Acceptance of IND for COYA 302 to Treat ALS

Coya Therapeutics announced that the FDA has accepted its Investigational New Drug (IND) application for COYA 302, a biologic combination therapy for ...

August 25, 2025

Immuneering and Lilly Partner to Evaluate Atebimetinib and Olomorasib in Phase 2 NSCLC Trial

Immuneering Corporation announced a clinical supply agreement with Eli Lilly and Company for olomorasib, to be used in combination with Immuneering's ...

August 25, 2025

ITF Therapeutics Announces Positive Long-Term Givinostat Data for Duchenne Muscular Dystrophy

ITF Therapeutics announced the publication of positive long-term safety and efficacy data for givinostat in treating Duchenne muscular dystrophy (DMD)...

August 25, 2025

Napo Pharmaceuticals to Meet with FDA Regarding Crofelemer for Ultrarare Pediatric MVID

Napo Pharmaceuticals, a Jaguar Health family company, plans to meet with the FDA to discuss the clinical development program for crofelemer in treatin...

August 20, 2025

MIRA Pharmaceuticals Completes Phase 1 Trial of Oral Ketamir-2 for Neuropathic Pain

MIRA Pharmaceuticals announced the successful completion of the single ascending dose (SAD) portion of its Phase 1 clinical trial for oral Ketamir-2, ...

August 20, 2025

Rocket Pharmaceuticals' Phase 2 Danon Disease Trial Resumes After FDA Lifts Clinical Hold

Rocket Pharmaceuticals announced that the FDA has lifted the clinical hold on its pivotal Phase 2 trial of RP-A501 for Danon disease. The hold was lif...

August 20, 2025

IDEAYA Biosciences Announces Agenda for 10-Year Anniversary R&D Day

IDEAYA Biosciences, Inc. announced the agenda for its 10-year anniversary R&D Day on September 8, 2025. The event will feature presentations on the c...

August 18, 2025

ZyVersa Therapeutics Highlights Data on Kidney Lipotoxicity in Diabetic Kidney Disease

ZyVersa Therapeutics announced data highlighting the critical need for therapies targeting kidney lipotoxicity in diabetic kidney disease (DKD). The ...

August 15, 2025

Largest-Ever Sickle Cell Disease Study Completed, Paving Way for New Treatments

Fifty1 AI Labs, in collaboration with The Gates Foundation and leading universities, has completed the largest-ever study of Sickle Cell Disease (SCD)...

August 15, 2025

Avant Technologies and Ainnova Tech Enhance Patient Recruitment for Diabetic Retinopathy AI Platform Clinical Trial

Avant Technologies and its joint venture partner, Ainnova Tech, announced an enhanced patient recruitment strategy for their Vision AI platform clinic...

August 13, 2025

Ocugen Announces Positive EMA Scientific Advice for OCU410ST Gene Therapy for Stargardt Disease

Ocugen, Inc. announced positive scientific advice from the European Medicines Agency (EMA) regarding the approval pathway for OCU410ST, a modifier gen...

August 13, 2025

Spectral Medical's Tigris Trial Shows Positive Results for PMX in Endotoxic Septic Shock

Spectral Medical and Vantive announced positive topline results from the Tigris Phase 3 trial evaluating Polymyxin B Hemoadsorption (PMX) for endotoxi...

August 13, 2025

Lilly's Oral GLP-1 Agonist, Orforglipron, Shows Significant Weight Loss in Phase 3 Trial

Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-1 trial of orforglipron, an investigational oral GLP-1 receptor agoni...

Cassava Sciences Reports Positive Preclinical Study of Simufilam for TSC-Related Epilepsy

Cassava Sciences announced positive preclinical results for simufilam in a mouse model of tuberous sclerosis complex (TSC)-related epilepsy. The stud...

Praxis Precision Medicines Announces Positive Phase 2 Results for Vormatrigine in Focal Onset Seizures

Praxis Precision Medicines announced positive topline results from the Phase 2 RADIANT study of vormatrigine in patients with focal onset seizures. T...

Akebia Initiates Post-Marketing Study for Vafseo® (vadadustat) in CKD Anemia

Akebia Therapeutics announced the initiation of VOCAL, a post-marketing study evaluating the efficacy and safety of Vafseo® (vadadustat) administered ...

NeuroStar TMS Shows Efficacy in Treating Depression in Adolescents and Young Adults

Neuronetics, Inc. announced the publication of real-world data in JAACAP Open demonstrating the effectiveness of NeuroStar TMS therapy in adolescents ...

Research Advances from the 2025 Alzheimer's Association International Conference

The Alzheimer's Association International Conference® 2025 (AAIC®) presented new research on Alzheimer's disease and other dementias. Key findings in...

Anika Therapeutics Announces Topline Results from Hyalofast® Phase III Cartilage Repair Study

Anika Therapeutics announced topline results from its U.S. pivotal Phase III FastTRACK clinical trial of Hyalofast, a hyaluronic acid scaffold for car...

Neuvivo Secures FDA Alignment for NP001 ALS Treatment and Appoints Dr. John Curnutte to Board

Neuvivo, Inc., a late-stage biopharmaceutical company, announced it has reached an agreement with the FDA on the regulatory pathway for NP001, an immu...

VYNE Therapeutics' Phase 2b Repibresib Gel Trial for Vitiligo Misses Primary Endpoint

VYNE Therapeutics announced topline results from its Phase 2b trial evaluating Repibresib gel in nonsegmental vitiligo. The trial, involving 177 subje...

Tenaya Therapeutics Receives Positive Safety Reviews for TN-201 and TN-401 Gene Therapy Trials

Tenaya Therapeutics announced positive safety reviews from independent Data Safety and Monitoring Boards (DSMBs) for its two cardiovascular gene thera...

Atossa Therapeutics Receives Positive FDA Feedback for (Z)-Endoxifen in Metastatic Breast Cancer

Atossa Therapeutics announced positive feedback from the FDA regarding its proposed dose optimization trial of (Z)-endoxifen for ER+/HER2- metastatic ...

TauGen Files Patent Application for Novel TBI Drug Candidates

TauGen, LLC, in collaboration with CereMark Pharma, has filed a US patent application for a new class of drug candidates targeting traumatic brain inj...

EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Wet AMD

EyePoint Pharmaceuticals announced the completion of enrollment for its Phase 3 LUCIA trial evaluating DURAVYU™ for wet age-related macular degenerati...

Lilly's Jaypirca (pirtobrutinib) Meets Primary Endpoint in Phase 3 CLL/SLL Trial

Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent BTK...

Moderna Announces Data Presentation at ESMO Congress 2025

Moderna announced that three abstracts on its investigational mRNA therapeutics will be presented at the 2025 European Society for Medical Oncology (E...

Alterity Therapeutics Reports Positive Phase 2 Data for ATH434 in Multiple System Atrophy

Alterity Therapeutics announced positive topline data from the open-label Phase 2 clinical trial (ATH434-202) of ATH434 in patients with multiple syst...

Fulcrum Therapeutics Announces Positive Phase 1b Results for Pociredir in Sickle Cell Disease

Fulcrum Therapeutics reported positive results from the 12 mg dose cohort of its Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD). Th...

Serina Therapeutics Advances POZ-VMAT2i for Tardive Dyskinesia

Serina Therapeutics announced the advancement of SER-270 (POZ-VMAT2i), a novel, once-weekly injectable VMAT2 inhibitor, for treating tardive dyskinesi...

May 25

IDEAYA Biosciences Announces Positive Phase 2 Data for Darovasertib in Uveal Melanoma

IDEAYA Biosciences announced that data from a Phase 2 clinical trial of neoadjuvant darovasertib in primary uveal melanoma will be presented at the 20...

GH Research Announces Global Pivotal Program Plans for GH001 and GH002

GH Research PLC provided updates on its clinical-stage biopharmaceutical programs. The company announced a response from the FDA regarding its Invest...

Xenetic Biosciences Expands Collaboration to Advance DNase-Based Oncology Platform

Xenetic Biosciences announced the expansion of its research collaboration with The Scripps Research Institute (TSRI) to further develop its DNase I-ba...

Diakonos Oncology Initiates Phase 2 Trial of DOC1021 for Glioblastoma

Diakonos Oncology announced the first patient has been dosed in a Phase 2 clinical trial evaluating DOC1021, a novel patient-derived double-loaded den...

IDEAYA Biosciences Announces 10-Year Anniversary R&D Day

IDEAYA Biosciences will host an R&D Day on September 8, 2025, to present clinical data updates across its pipeline and outline its future growth strat...

ANI Pharmaceuticals Announces NEW DAY Clinical Trial Results for ILUVIEN in Diabetic Macular Edema

ANI Pharmaceuticals announced results from the NEW DAY clinical trial evaluating ILUVIEN (fluocinolone acetonide intravitreal implant) for diabetic ma...

Abivax Announces Positive Phase 3 Results for Obefazimod in Ulcerative Colitis

Abivax announced positive topline results from its Phase 3 ABTECT-1 and ABTECT-2 trials evaluating obefazimod, a first-in-class oral miR-124 enhancer,...

Oruka Therapeutics Announces IND Clearance for Phase 2a Trial of ORKA-001 in Psoriasis

Oruka Therapeutics announced that the FDA cleared its Investigational New Drug (IND) application for a Phase 2a trial (EVERLAST-A) of ORKA-001, a long...

UroGen's ZUSDURI Shows Long-Term Efficacy in Non-Muscle Invasive Bladder Cancer

UroGen Pharma announced the publication of five-year long-term extension study results from the Phase 2b OPTIMA II trial. The study evaluated ZUSDURI...

Tiziana Life Sciences Announces Promising Immunologic Findings of Nasal Foralumab in Alzheimer's Disease

Tiziana Life Sciences announced compelling immunologic findings from a moderate Alzheimer's Disease patient treated with intranasal foralumab. Transc...

4B Technologies Announces Positive Phase 1 Results for Novel Non-Opioid Chronic Pain Therapy

4B Technologies announced positive topline results from a Phase 1 study of 4B03-04, a humanized monoclonal antibody for chronic pain. The trial demon...

Renovaro's Genetically Engineered Dendritic Cell Therapy Shows Potent Anti-Tumor Efficacy in Preclinical Study

Renovaro Biosciences announced the publication of a peer-reviewed study in *Vaccines* demonstrating the significant anti-tumor efficacy of its next-ge...

Ocugen Initiates Phase 2/3 Trial for Stargardt Disease Gene Therapy

Ocugen, Inc. announced the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST, a novel modifier gene therapy for Starg...

Keros Therapeutics Initiates Phase 3 Trial of Elritercept for MDS

Keros Therapeutics announced the first patient dosing in the Phase 3 RENEW clinical trial of elritercept for adults with transfusion-dependent anemia ...

OKYO Pharma's Urcosimod Shows Promising Phase 2 Results for Neuropathic Corneal Pain

OKYO Pharma announced positive top-line data from its Phase 2 trial of urcosimod for treating neuropathic corneal pain (NCP). The 18-patient trial sh...

Oragenics Announces U.S. Manufacturing Agreement for ONP-002 Concussion Treatment

Oragenics, Inc. has partnered with Sterling Pharma Solutions for the Good Manufacturing Practice (GMP) production of ONP-002, its lead drug candidate ...

NervGen Announces Leadership Transition and Positive Chronic Spinal Cord Injury Trial Results for NVG-291

NervGen Pharma Corp. announced a leadership transition with Dr. Adam Rogers appointed as Interim CEO, following the positive topline results from the ...

Voyager Therapeutics Expands Alzheimer's Disease Pipeline with Novel APOE Gene Therapy Program

Voyager Therapeutics announced a new wholly-owned Alzheimer's disease (AD) program targeting apolipoprotein E (APOE), a major genetic risk factor for ...

Avant Technologies and Ainnova Complete Pivotal FDA Meeting for Vision AI Diabetic Retinopathy Platform

Avant Technologies and its JV partner, Ainnova, announced the completion of a pre-submission meeting with the U.S. FDA regarding Ainnova's Vision AI p...

Neurocrine Biosciences Presents CAHtalog Registry Analysis at ENDO 2025

Neurocrine Biosciences announced results from a new analysis of the CAHtalog registry, showing that most patients with classic congenital adrenal hype...

Palatin Announces Positive Preclinical Data for Oral MC4R Agonist PL7737 in Obesity

Palatin Technologies announced positive preclinical results for PL7737, an oral MC4R agonist, demonstrating significant weight loss in obese rodent mo...

Danish Study Finds No Link Between Aluminum in Vaccines and 50 Health Conditions

A large-scale Danish register-based study involving over 1 million children found no association between aluminum in childhood vaccines and 50 health ...

Monteris Medical Announces Positive JAMA Neurology Publication on NeuroBlate System for Epilepsy

Monteris Medical announced the publication of a landmark study in JAMA Neurology demonstrating the safety, durability, and efficacy of laser interstit...

4TEEN4 Announces Promising First-in-Human Data for Procizumab in Cardiogenic Shock

4TEEN4 Pharmaceuticals announced the publication of data in the European Journal of Heart Failure demonstrating the efficacy and safety of procizumab,...

Takeda's Oveporexton Shows Positive Phase 3 Results for Narcolepsy Type 1

Takeda announced positive topline results from two pivotal Phase 3 studies (FirstLight and RadiantLight) of oveporexton (TAK-861) in narcolepsy type 1...

MiNK Therapeutics Announces Complete Remission in Metastatic Testicular Cancer Using iNKT Cell Therapy

MiNK Therapeutics announced the publication of a case report in *Oncogene* showing complete and durable remission in a patient with metastatic, treatm...

Cerevance to Present Phase 1 Data on CVN293, a KCNK13 Inhibitor, at AAIC 2025

Cerevance announced upcoming presentations at the Alzheimer's Association International Conference (AAIC) 2025. Key presentations include Phase 1 dat...

Silexion Therapeutics Announces Positive Preclinical Results for SIL204 in Lung Cancer

Silexion Therapeutics announced positive preclinical data showing SIL204's significant efficacy in human lung cancer cell lines. SIL204, an RNA inter...

KALA BIO Completes Enrollment in CHASE Trial for KPI-012 in Persistent Corneal Epithelial Defect

KALA BIO announced the completion of patient enrollment in the CHASE Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secreto...

Cizzle Bio Submits NIH Grant for Lung Cancer Biomarker Blood Test

Cizzle Bio, a biotechnology company, submitted a grant application to the NIH for a two-year study validating its CIZ1B biomarker for early-stage lung...

MediView Launches Multicenter Study for XR90 Surgical Navigation System in Soft Tissue Biopsy

MediView has initiated a multicenter clinical study to evaluate the XR90 Holographic Surgical Navigation system's effectiveness in percutaneous soft t...

Plus Therapeutics Announces Initial Patient Treatment in REYOBIQ™ Leptomeningeal Metastases Dose Optimization Trial

Plus Therapeutics announced the treatment of the first patients in its ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re186 obisbemeda) in l...

BriaCell's Phase 2 Trial Shows Promising Survival Rates in Metastatic Breast Cancer

BriaCell Therapeutics Corp. announced updated survival data from its Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer (MBC...

Caris Assure® Blood-Based Assay Shows Promise for Multi-Cancer Early Detection and Monitoring

Caris Life Sciences announced a study published in Scientific Reports demonstrating the accuracy and clinical utility of its Caris Assure® blood-based...

MapLight Therapeutics Initiates Phase 2 Trial for ML-007C-MA in Schizophrenia

MapLight Therapeutics has begun a Phase 2 clinical trial (ZEPHYR) to assess the efficacy, safety, and tolerability of ML-007C-MA, a novel M1/M4 muscar...

Ascletis Initiates Phase IIa Trial of Oral GLP-1R Agonist ASC30 for Obesity

Ascletis Pharma announced the first participants have been dosed in a Phase IIa clinical trial (NCT07002905) evaluating ASC30, a novel small molecule ...

Soleno Therapeutics Announces Presentations on VYKAT™ XR for Prader-Willi Syndrome at ENDO 2025

Soleno Therapeutics announced that two presentations featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets for the treatment of hyp...

OS Therapies Announces Positive Phase 2b Data for OST-HER2 in Osteosarcoma

OS Therapies announced positive one-year event-free survival (EFS), overall survival, and safety data from its Phase 2b trial of OST-HER2 in patients ...

Clene Provides Regulatory Update on CNM-Au8 for ALS and MS

Clene, Inc. announced a positive Type C meeting with the FDA regarding its statistical analysis plan for CNM-Au8 in ALS patients. The FDA provided co...

Klotho Neurosciences Advances Manufacturing of ALS Gene Therapy KLTO-202

Klotho Neurosciences announced it is progressing with manufacturing and process development for KLTO-202, a gene therapy targeting amyotrophic lateral...

MeCo Score: A Novel Biomarker for Predicting Response to Antifibrotic Therapy in Breast Cancer

A multinational study published in the journal *Cancers* reveals that the MeCo Score, a novel biomarker, quantifies mechanical conditioning in breast ...

Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Pain Treatment

Artelo Biosciences announced positive results from its first-in-human Phase 1 study of ART26.12, a novel, orally administered FABP5 inhibitor for pers...

Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine

Moderna announced positive Phase 3 results for its seasonal influenza vaccine candidate, mRNA-1010. The study demonstrated a 26.6% higher relative va...

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