Clinical Trials - Phase III

Found 21,262 articles

• LianBio Announces Positive Topline Results from Phase 3 EXPLORER-CN Trial Evaluating Mavacamten in Chinese Patients

  4/26/2023

  LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced positive topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

• Geron Announces Upcoming Oral Presentation at 2023 American Society of Clinical Oncology Annual Meeting of Imetelstat Data from IMerge Phase 3 Lower Risk MDS Trial

  4/26/2023

  Geron Corporation, today announced that data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS), was accepted for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

• Novocure Announces Presentation of Results of the LUNAR Phase 3 Clinical Trial in Non-Small Cell Lung Cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

  4/26/2023

  Novocure (NASDAQ: NVCR) today announced the results of the LUNAR phase 3 clinical trial in metastatic, non-small cell lung cancer (NSCLC) will be presented for the first time at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from June 2 to June 6.

• 

  Vedanta Raises $106.5M to Advance New Class of C. diff Therapeutics

  4/25/2023

  Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
• 

  Bluebird Submits BLA for Sickle-Cell Disease Gene Therapy

  4/25/2023

  The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
• 

  Applied Therapeutics Seeks NDA for Rare Pediatric Disease Drug Despite Phase III Failure

  4/25/2023

  Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.

• Lyra Therapeutics Announces Restart of Pivotal Phase 3 ENLIGHTEN II Clinical Trial of LYR-210 in Chronic Rhinosinusitis

  4/25/2023

  Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that it has resumed screening and enrollment in ENLIGHTEN II, its second pivotal Phase 3 clinical trial of LYR-210 in patients with CRS.

• Reviva Pharmaceuticals to Host Key Opinion Leader Event on Brilaroxazine (RP5063) in Phase 3 Clinical Trials for Schizophrenia

  4/25/2023

  Reviva Pharmaceuticals Holdings, Inc. today announced it will host a KOL webinar on brilaroxazine (RP5063), a serotonin-dopamine modulator in late-stage development for schizophrenia, on May 2 nd at 11:00am ET.

• Prilenia Shares Preliminary Topline Results from Phase 3 PROOF-HD Clinical Trial in Huntington’s Disease and Data from Phase 2 HEALEY ALS Platform Trial of Pridopidine at the 75th American Academy of Neurology (AAN) Annual Meeting

  4/25/2023

  Prilenia Therapeutics B.V. today announced preliminary topline results of its Phase 3 PROOF-HD clinical study evaluating the safety and efficacy of pridopidine in individuals with Huntington’s disease (HD).

• 

  Ionis and AstraZeneca Seek to Challenge Alnylam with New ATTR Data

  4/24/2023

  Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.

• Soligenix Submits Type A Meeting Request to U.S. FDA to Review Proposed Study Design for a Second Phase 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma

  4/24/2023

  Soligenix, Inc. announced today that the Company has submitted a Type A Meeting Request to the United States (U.S.) Food and Drug Administration (FDA) to initiate formal discussions regarding the design of a second, Phase 3 pivotal study evaluating HyBryte™.

• Virios Therapeutics Announces Initial FDA Feedback on Proposed IMC-1 Phase 3 Program for Treatment of Fibromyalgia

  4/24/2023

  Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), today announced a program summary based on initial feedback from the U.S. Food & Drug Administration (“FDA”) on its Phase 3 FM program proposal featuring its lead development candidate IMC-1.

• NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia

  4/24/2023

  NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”) today announced the completion of patient enrollment in the pivotal Phase 3 BROOKYLN clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”), whose low-density lipoprotein cholesterol (“LDL-C”) is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.

• Eplontersen halted ATTRv-PN disease progression and improved neuropathy impairment and quality of life in Phase 3 study through 66 weeks

  4/24/2023

  Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the Phase 3 NEURO-TTRansform study for AstraZeneca and Ionis' eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) met all co-primary endpoints and secondary endpoints at 66 weeks versus an external placebo group.

• I-Mab Announces First Patient Dosed in Phase 3 Registrational Study of CD47 Antibody Lemzoparlimab in MDS in China

  4/24/2023

  I-Mab (the "Company") (Nasdaq: IMAB) today announced that the first patient in a Phase 3 registrational trial (ClinicalTrials.gov Identifier: NCT05709093) in China for patients with higher-risk myelodysplastic syndrome (MDS) has been treated with lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA). 

• Citius Pharmaceuticals Advances Mino-Lok® Phase 3 Trial Achieving 85 of 92 Events to Date

  4/24/2023

  Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that it has advanced its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections.

• Can-Fite Announces New Management Structure as Advanced Stage Pipeline Moves Toward Commercialization

  4/24/2023

  Can-Fite BioPharma Ltd today announced executive changes to support the Company’s continued success in advancing its pipeline toward commercialization through two pivotal Phase III trials in psoriasis and liver cancer.

• NEURO-TTRansform Phase III results presented at AAN showed eplontersen demonstrated consistent and sustained improvement in all measures of disease and quality of life through 66 weeks

  4/24/2023

  Detailed results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed AstraZeneca and Ionis’ eplontersen met all co-primary endpoints and secondary endpoints at 66 weeks versus an external placebo group.

• MaaT Pharma Announces U.S. FDA Lifts Clinical Hold on Phase 3 Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease

  4/24/2023

  MaaT Pharma reported that the U.S. Food and Drug Administration has lifted the clinical hold and cleared the Investigational New Drug application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 to treat gastrointestinal acute Graft-versus-Host Disease as a third line of treatment.

• Viatris and Mapi Pharma to Highlight Latest Results of Multiple Sclerosis Research at American Academy of Neurology 75th Annual Meeting

  4/24/2023

  Viatris Inc. and Mapi Pharma today announced that recent data from ongoing studies of GA Depot 40 mg will be presented at the American Academy of Neurology (AAN) 75th Annual Meeting in Boston taking place April 22-27.