Clinical Trial Insights

Clene Presents Preclinical Data Supporting CNM-Au8 for Parkinson's DiseaseClinical Trial Updates

05 Sept 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...

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

05 Sept 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...

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

05 Sept 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...

Valitor Presents Preclinical Data on VLTR-559 for Wet AMDClinical Trial Updates

05 Sept 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...

AL-S Pharma Announces Positive Phase 2 Results for AP-101 in ALS TreatmentClinical Trial Updates

04 Sept 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...

Aspire Biopharma Announces Positive Final Results for Sublingual Aspirin in Treating Heart AttacksClinical Trial Updates

04 Sept 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 ...

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

04 Sept 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...

Sanofi's Amlitelimab Shows Promise in Phase 3 Atopic Dermatitis StudyClinical Trial Updates

04 Sept 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...

Ascletis to Present ASC30 Data at EASD Annual MeetingClinical Trial Updates

02 Sept 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...

Compass Pathways Announces Positive Phase 2 Results for COMP360 Psilocybin in PTSDClinical Trial Updates

02 Sept 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...

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

02 Sept 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...

Olezarsen Shows Significant Reduction in Triglycerides and Acute Pancreatitis in sHTG PatientsClinical Trial Updates

02 Sept 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...

Zymeworks Discontinues ZW171 Clinical DevelopmentClinical Trial Updates

02 Sept 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...

Alnylam to Advance Zilebesiran into Global Phase 3 Cardiovascular Outcomes TrialClinical Trial Updates

01 Sept 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...

Baxdrostat Shows Significant Blood Pressure Reduction in Phase III Hypertension TrialClinical Trial Updates

01 Sept 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...

Merck's VERQUVO (vericiguat) Shows Mixed Results in Chronic Heart Failure TrialsClinical Trial Updates

01 Sept 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...

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

01 Sept 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...

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

01 Sept 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...

Telomir-1: A Novel Epigenetic Therapy Targeting DNA Methylation PathwaysClinical Trial Updates

29 Aug 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,...

Zevra Therapeutics to Present Multiple Datasets on MIPLYFFA® (arimoclomol) at ICIEMClinical Trial Updates

29 Aug 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...

Airiver Medical Receives FDA IDE Approval for Pivotal Clinical Study of Airiver Pulmonary Drug Coated BalloonClinical Trial Updates

28 Aug 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...

Breath Diagnostics' OneBreath™ Technology Predicts Pneumonia Onset Through Exhaled Breath AnalysisClinical Trial Updates

28 Aug 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...

Actuate Therapeutics' Elraglusib Shows Promising Results in Metastatic Pancreatic CancerClinical Trial Updates

26 Aug 2025

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 ...

Coya Therapeutics Announces FDA Acceptance of IND for COYA 302 to Treat ALSClinical Trial Updates

25 Aug 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 ...

ITF Therapeutics Announces Positive Long-Term Givinostat Data for Duchenne Muscular DystrophyClinical Trial Updates

25 Aug 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)...

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

25 Aug 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 ...

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

20 Aug 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, ...

Napo Pharmaceuticals to Meet with FDA Regarding Crofelemer for Ultrarare Pediatric MVIDClinical Trial Updates

20 Aug 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...

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

20 Aug 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...

IDEAYA Biosciences Announces Agenda for 10-Year Anniversary R&D DayClinical Trial Updates

18 Aug 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...

Largest-Ever Sickle Cell Disease Study Completed, Paving Way for New TreatmentsClinical Trial Updates

15 Aug 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)...

ZyVersa Therapeutics Highlights Data on Kidney Lipotoxicity in Diabetic Kidney DiseaseClinical Trial Updates

15 Aug 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 ...

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

13 Aug 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...

Ocugen Announces Positive EMA Scientific Advice for OCU410ST Gene Therapy for Stargardt DiseaseClinical Trial Updates

13 Aug 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...

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

13 Aug 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...

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

07 Aug 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...

Akebia Initiates Post-Marketing Study for Vafseo® (vadadustat) in CKD AnemiaClinical Trial Updates

05 Aug 2025

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 ...

Cassava Sciences Reports Positive Preclinical Study of Simufilam for TSC-Related EpilepsyClinical Trial Updates

05 Aug 2025

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 SeizuresClinical Trial Updates

05 Aug 2025

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...

Anika Therapeutics Announces Topline Results from Hyalofast® Phase III Cartilage Repair StudyClinical Trial Updates

31 Jul 2025

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...

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