Small Molecules

04 Dec 2020 New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint
04 Dec 2020 Cortexyme’s Phase 2/3 GAIN Trial of Atuzaginstat (COR388) in Patients with Alzheimer’s Disease Successfully Advances Past Interim Analysis
04 Dec 2020 Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta’s MGTA-145 for Mobilizing and Collecting Stem Cells in Adults and Adolescents with Sickle Cell Disease
03 Dec 2020 Jazz Pharmaceuticals and PharmaMar Announce Results of ATLANTIS Phase 3 Study Evaluating Zepzelca™ in Combination with Doxorubicin for Patients with Small Cell Lung Cancer Following One Prior Platinum-containing Line
02 Dec 2020 Agios Announces the Phase 3 ACTIVATE Trial of Mitapivat Achieved Its Primary Endpoint in Adults with Pyruvate Kinase Deficiency Who Are Not Regularly Transfused
02 Dec 2020 Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-803 to Treat Leukocyte Adhesion Deficiency Type II
02 Dec 2020 BridgeBio Pharma and Affiliate QED Therapeutics Announce FDA Acceptance of New Drug Application for Infigratinib for the Treatment of Cholangiocarcinoma
02 Dec 2020 Athira Pharma Announces Initiation of Patient Dosing for ACT-AD Clinical Trial of ATH-1017, Small Molecule HGF/MET Activator, for Treatment of Mild-to-Moderate Alzheimer’s Disease
02 Dec 2020 Galapagos announces first dosing in MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease
02 Dec 2020 Ovid Therapeutics Announces Phase 3 NEPTUNE Clinical Trial of OV101 for the Treatment of Angelman Syndrome Did Not Meet Primary Endpoint
02 Dec 2020 FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
02 Dec 2020 FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome
02 Dec 2020 Insmed Announces Initiation of Phase 3 ASPEN Study of Brensocatib in Patients with Bronchiectasis
02 Dec 2020 Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
02 Dec 2020 LG Chem Life Sciences and TransThera Biosciences Announce FDA Clearance of IND for TT-01025, a SSAO/VAP-1 Inhibitor
02 Dec 2020 Bacainn Therapeutics Reports Positive Topline Results from Phase 1 Study of BT051, a Novel Therapeutic Approach to Treat Inflammatory Diseases Such As Ulcerative Colitis
01 Dec 2020 Ascentage Pharma Enters into an Agreement with University of Michigan to obtain an exclusive license for a MDM2 Degrader using PROTAC Technology
01 Dec 2020 PTC Therapeutics Announces Initiation of Global Phase 3 Clinical Trial to Evaluate Vatiquinone in Friedreich Ataxia
01 Dec 2020 Verastem Oncology Initiates Phase 2 Registration-Directed Trial of VS-6766 and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
01 Dec 2020 Mirum Pharmaceuticals Announces European Medicines Agency Validation of the Marketing Authorization Application for Maralixibat in Patients with PFIC2
28 Nov 2020 Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis
27 Nov 2020 Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
26 Nov 2020 European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations
26 Nov 2020 Karyopharm Announces Ongoing Phase 3 SIENDO Study of XPOVIO® (Selinexor) in Patients with Endometrial Cancer Passes Planned Interim Futility Analysis: Data and Safety Monitoring Board Recommends the Study Should Proceed as Planned Without Any Modification
26 Nov 2020 Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations

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