Clinical Trial

SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes

First subject has been dosed in the first-in-man Phase 1 clinical study of SAB-142, the first fully-human anti-thymocyte immunoglobulin (ATG)…

1 year ago

Eagle Pharmaceuticals Announces Management Change

– CEO and Founder Scott Tarriff Retires – – Chairman Michael Graves to Serve as Interim Executive Chairman – WOODCLIFF…

1 year ago

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease

Patient enrollment expected to begin in first half of 2024LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure…

1 year ago

KSQ Therapeutics Announces FDA Clearance of IND Application for KSQ-001EX, a CRISPR/Cas9 Engineered Tumor Infiltrating Lymphocyte (eTIL®) Therapy

Phase 1/2 clinical study will evaluate the safety, pharmacokinetics, and preliminary efficacy of KSQ-001EX in melanoma, head and neck squamous…

1 year ago

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina

RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the National Administration…

1 year ago

Verge Genomics Will Use Modality.AI in Its ALS Phase 1b Clinical Trial of Its Lead Drug Candidate VRG50635

Modality’s multimodal AI platform will capture critical speech and language changesSOUTH SAN FRANCISCO, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) --…

1 year ago

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for…

1 year ago

SpringWorks Therapeutics to Participate in the 6th Annual Evercore ISI HealthCONx Conference

STAMFORD, Conn., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe…

1 year ago

Generation Bio Announces Strategic Reorganization to Extend Cash Runway for Development of ctLNP and iqDNA Platforms

Company to invest in highly selective cell-targeted lipid nanoparticle (ctLNP) delivery platform to develop wholly-owned programs for extrahepatic cell typesDevelopment…

1 year ago

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

BX004 showed clinically meaningful improvement in pulmonary function as measured in FEV11 and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in…

1 year ago