$XBI $123.22 -2.3%
Covid Updates
$BNTX -2.3% Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union. source
$DVAX +1.7% Dynavax and U.S. Department of Defense Announce Collaboration to Develop an Adjuvanted Plague Vaccine Using Dynavax's CpG 1018 Adjuvant. source
$RDHL +11.7% RedHill Biopharma Reports Further Analysis of Phase 2/3 Data Including a 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients. source
Pipeline Updates
$MRTX -2.9% Mirati Therapeutics to Present New Research From its Innovative Oncology Pipeline at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer source
$ERYP +7.3% ERYTECH ANNOUNCES MAXIMUM TOLERATED DOSE DECLARED IN A PHASE 1 INVESTIGATOR SPONSORED TRIAL OF ERYASPASE IN FIRST-LINE PANCREATIC CANCER source
$GLPG -4.5% Galapagos presents new data from the SELECTION Phase 3 program at the United European Gastroenterology Week (UEGW) 2021 congress source
$SIOX +6.0% Sio Gene Therapies to Present New Data at the European Society of Gene and Cell Therapy Virtual Congress 2021. source
$TPTX -0.6% Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients with NTRK-Positive, TKI-Pretreated Advanced Solid Tumors. source
$ACXP -10.6% Acurx Presents Positive Ibezapolstat Microbiome Data from Its Phase 2a Trial at IDWeek. source
$CFRX -1.5% ContraFect’s New Phase 2 Exebacase Data Presented at IDWeekTM Demonstrates Rapid Symptom Resolution Among Patients with Staphylococcus aureus Bacteremia. source
$PDSB -1.0% PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer. source
$BSGM -6.7% Clinical Data Acquired by the PURE EP™ System Published in the Journal of Cardiovascular Electrophysiology. source
$HRTX -2.5% Heron Therapeutics Announces Filing of a Supplemental New Drug Application for Significant Expansion of ZYNRELEF® Indication Statement Based on Successful Outcome of FDA Type C Meeting. source
$HZNP +1.5% New Analysis Published in Multiple Sclerosis Journal Assesses Long-Term Use of UPLIZNA® (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD). source
$IBRX -1.7% National Cancer Institute Selects ImmunityBio’s N-803 IL-15 Receptor Agonist to Combine with Keytruda in 700-Site Lung-MAP Clinical Trial of a Chemo-Free Therapy. source
$RLMD +0.3% Relmada Therapeutics Provides Regulatory and Development Updates on Ongoing Late-Stage Clinical Program for REL-1017 for Treatment of Major Depressive Disorder. source
$ZSAN -2.4% Zosano Pharma Granted Type C Meeting with FDA Regarding NDA Resubmission for M207 Following Preliminary Top-Line Pharmacokinetic Study Results. source
$SELB +1.2% Selecta Biosciences Announces Strategic Licensing Agreement with Takeda to Develop Next-Generation Gene Therapies for Patients with Lysosomal Storage Disorders. source
$XFOR +1.0% X4 Pharmaceuticals Completes Enrollment in Phase 3 Mavorixafor Trial in Patients with WHIM Syndrome. source
$XENE +102.0% Xenon Pharmaceuticals Announces Positive Topline Results from Phase 2b ‘X-TOLE’ Clinical Trial of XEN1101 for the Treatment of Focal Epilepsy. source
$SURF -2.5% Surface Oncology Announces New Randomized Phase 2 Clinical Study Evaluating SRF388 in Patients with First-Line Hepatocellular Carcinoma in Clinical Collaboration with Roche. source
$ADMA -3.4% ADMA Biologics Announces the Presentation of Real-World Experience in the Management of Respiratory Syncytial Virus (RSV) Presented at IDWeek 2021. source
$SRPT -1.5% Sarepta Therapeutics Announces Initiation of EMBARK, a Global Pivotal Study of SRP-9001, a Gene Therapy for the Treatment of Duchenne Muscular Dystrophy. source
$XNCR +5.5% Xencor Enters Global Collaboration and License Agreement With Janssen to Advance Plamotamab and XmAb CD28 Bispecific Antibody Combinations for the Treatment of Patients With B-Cell Malignancies. source
$ALVR -12.2% FDA Grants Orphan Drug Designation (ODD) to AlloVir’s Posoleucel, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy, for the Treatment of Virus-Associated Hemorrhagic Cystitis. source
$CARA -5.3% Cara Therapeutics Presents Late-Breaking Results of KARE Phase 2 Trial of Oral Difelikefalin (Oral KORSUVA™) in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress. source
$ENTA -1.3% Enanta Pharmaceuticals Provides Update on NASH FXR Agonist Programs. source
$MDGL -2.0% Madrigal Pharmaceuticals Announces Support of Fatty Liver Foundation’s Screening Fund to Improve Diagnosis and Staging of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). source
$SAGE -2.1% Sage Therapeutics and Biogen Announce Consistent Clinically Meaningful Data for Zuranolone Across the LANDSCAPE and NEST Clinical Development Programs Presented at the European College of Neuropsychopharmacology (ECNP) Congress. source
$GLPG -4.5% Galapagos announces completion of patient enrollment for DIVERSITY Phase 3 study with filgotinib in Crohn’s Disease. source
Financial & Business Updates
$PROG -21.8% Progenity Announces $20 Million Registered Direct Offering of Common Stock Priced at Premium to Market Under Nasdaq Rules source
Posted by FS/JM
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