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Biopharma Daily Stock Updates - 09/07/21

$XBI $133.47 -0.70%

 

Covid Updates

$BNTX $PFE +3.7% Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY®. source


$MRNA +4.7% Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster for conditional marketing approval (CMA). source



Pipeline Updates

$ASND -1.7% Ascendis Pharma A/S Submits Investigational New Drug Application to Initiate TransCon™ IL-2 β/γ Clinical Program source


$MGNX -3.2% MacroGenics Announces Final Overall Survival Results from SOPHIA Study of MARGENZA™ in Patients with HER2-Positive Metastatic Breast Cancer source


$CTXR +1.0% Citius Pharmaceuticals Acquires Dr. Reddy's Laboratories' License for Late-Phase 3 Oncology Immunotherapy (E7777) for the Treatment of Cutaneous T-Cell Lymphoma and other Cancer Indications source


$BDSI +6.8% BioDelivery Sciences to Exhibit Three Scientific Posters Comparing BELBUCA® to Oxycodone at the PAINWeek 2021 Conference source


$HZNP -1.0% Horizon Therapeutics plc Initiates Randomized Controlled Clinical Trial Evaluating TEPEZZA® (teprotumumab-trbw) for the Treatment of Chronic (Inactive) Thyroid Eye Disease (TED) source


$SRPT -2.4% Sarepta Therapeutics Announces Recipients of Route 79, The Duchenne Scholarship Program source


$MRNA +4.7% Moderna and the Institute for Life Changing Medicines Announce a New Collaboration to Develop an mRNA Therapeutic for Ultra-Rare Disease, Crigler-Najjar Syndrome Type 1 source


$GBT -1.3% U.S. FDA Accepts for Priority Review Supplemental New Drug Application for Oxbryta® (voxelotor) for the Treatment of Sickle Cell Disease in Children Ages 4 to 11 source


$TVTX +7.1% Travere Therapeutics Announces Successful Outcome from Type A Meeting with U.S. FDA for Sparsentan in Focal Segmental Glomerulosclerosis source


$CYTK -4.3% CYTOKINETICS TO HOST INVESTOR CALL AND WEBCAST TO DISCUSS THE FULL RESULTS FROM REDWOOD-HCM AT THE HFSA ANNUAL SCIENTIFIC MEETING source


$TMDX -2.7% TransMedics Receives FDA Approval for its OCS Heart System Enabling Broader Utilization of Donor Hearts for Transplantation in the U.S.­ source


$RDHL +0.6% RedHill Biopharma's Opaganib Demonstrates Significant Decrease of Kidney Fibrosis source

$PLRX -0.8% Pliant Therapeutics Reports Positive Interim Results from Phase 2a PET Imaging Clinical Trial in Patients with Idiopathic Pulmonary Fibrosis. source


$ZYNE +0.2% Publication of Results of Phase 2 BELIEVE Open-Label Study of Zygel™ in Children and Adolescents with Developmental and Epileptic Encephalopathies (DEE) in JAMA Network Open. source


$RHDL +0.6% RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021. source


$UTHR -1.3% United Therapeutics Presents Tyvaso DPI™ BREEZE Clinical Data At The European Respiratory Society International Congress 2021. source


$HCM -7.2% HUTCHMED Highlights Clinical Data to be Presented at the Upcoming 2021 ESMO Virtual Conference. source



Finance & Business Updates

$TVTX +7.1% SEC 8-K Filed source


$IMPL -1.3% Impel NeuroPharma Announces Launch of Proposed Public Offering source


$ALBO -0.3% Albireo Sells Priority Review Voucher (PRV) for $105 Million source


$PLRX -0.8% SEC 8-K Filed source


$ADAP +29.0% Adaptimmune Enters into a Strategic Collaboration with Genentech to Research, Develop, and Commercialize Cancer-targeted Allogeneic T-cell Therapies source


$TXMD -3.1% Update on ongoing litigation with TEVA over generic. source


$TLSA -4.3% To Host Investor Call to Discuss Exclusive License Agreement to Evaluate Foralumab, a Novel, Fully Human Anti-CD3 Monoclonal Antibody, in Conjunction with Allogeneic CAR T Candidates for Cancer Treatment. source

 

Posted by DV/JM

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