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Biopharma Daily Stock Updates - 01/10/22

$XBI $103.14 +0.2% %


 

Covid Updates

$NVAX +6.5% Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax' COVID-19 Vaccine in South Africa. source


$MOLN +30.2% Molecular Partners and Novartis Report Positive Topline Data from Phase 2 Study for Ensovibep (MP0420), a DARPin Antiviral Therapeutic for COVID-19. source


$OCGN +6.4% COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety. source


$NRXP +6.6% NRx Pharmaceuticals to Announce New Details for Planned Investigational BriLife™ COVID-19 Vaccine. source



Pipeline Updates

$FUSN -0.6% Fusion Pharmaceuticals Announces Nomination Of First Targeted Alpha Therapy Candidate In Collaboration With AstraZeneca To Advance Into IND-Enabling Studies For Phase 1 Development source


$SRPT -10.9% Sarepta Therapeutics’ Gene Therapy SRP-9001 Shows Statistically Significant Functional Improvements Compared to Pre-specified Matched External Control in Part 2 of Study SRP-9001-102 for the Treatment of Duchenne Muscular Dystrophy source


$NGM -1.4% NGM Bio Outlines 2022 Strategic Priorities Across Its Portfolio of Clinical-Stage Oncology, Retinal and Liver and Metabolic Programs. source


$RIGL -0.8% Rigel Pharmaceuticals Provides Business Update. source


$ALLO -9.4% Allogene Therapeutics Announces Removal of FDA Clinical Hold Across All AlloCAR T™ Clinical Trials. source


$XENE -5.9% Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2022. source


$ADPT -5.3% Adaptive Biotechnologies Announces Preliminary, Unaudited 2021 Revenue Results and CFO Transition. source


$VERU -2.2% Veru Announces FDA Grant of Fast Track Designation for Enobosarm for the Treatment of AR+ ER+ HER2- Metastatic Breast Cancer. source


$BMEA -3.4% Biomea Fusion Announces 2022 Clinical Development Plan to Initiate Studies in up to Seven Different Tumor Types and in Diabetes for BMF-219. source


$CPRX -3.1% Catalyst Pharmaceuticals Announces 11th Circuit Court of Appeals Denial of Jacobus Pharmaceutical Company Inc.'s Petition for Rehearing. source


$BPMC -4.6% Blueprint Medicines Provides 2022 Portfolio Goals Targeting Expanded Precision Therapy Leadership. source


$DVAX +6.8% Dynavax Highlights 2022 Priorities and Announces Initiation of Phase 1 Clinical Trial for Its Shingles Vaccine Candidate. source


$DNLI -2.8% Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022. source


$GBT +1.9% Oxbryta® (voxelotor) Tablets for Oral Suspension, A New Dispersible Tablet Dosage Form, Now Available for Patients with Sickle Cell Disease in the United States. source


$FATE +2.1% Fate Therapeutics Announces FDA Clearance for FT536, a First-in-class MICA/B-targeted CAR NK Cell Product Candidate for the Treatment of Solid Tumors. source


$HALO -3.5% HALOZYME PROVIDES 2022 FINANCIAL GUIDANCE AND OUTLOOK. source


$SLDB -3.2% Solid Biosciences Outlines its Strategic Priorities for 2022 and Announces Corporate Updates. source


$CYDY -3.5% Published Paper Indicates Leronlimab Shows Activity Against 4-Class Drug Resistant HIV-1 From Heavily Treatment Experienced (“HTE") Subjects. source


$EYPT -10.6% EyePoint Pharmaceuticals Announces 2022 Clinical Plans and Highlights Recent Corporate and Clinical Achievements. source


$MGTA -4.8% Magenta Therapeutics Highlights Recent Pipeline Progress and Milestone Expectations for 2022. source


$FDMT -3.3% 4D Molecular Therapeutics Announces FDA Fast Track Designation Granted to 4D-125 for the Treatment of X-linked Retinitis Pigmentosa. source


$AGRX -11.2% Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System. source


$RUBY +3.1% Rubius Therapeutics Recaps 2021 Achievements and Outlines 2022 Objectives Across the RED PLATFORM at the 40th Annual J.P. Morgan Healthcare Conference. source


$RCUS +0.5% Arcus Biosciences Provides Update on Clinical Programs, Including Key 2022 Milestones. source


$NLTX +2.4% Neoleukin Therapeutics Announces Clinical Collaboration with Merck to Evaluate NL-201 in Combination with KEYTRUDA® (pembrolizumab). source


$CLVS +1.6% Clovis Oncology Announces Preliminary Financial Results for the Fourth Quarter and Full Year 2021. source


$ORIC -0.4% ORIC Pharmaceuticals Provides Corporate Update and Highlights Key Upcoming Milestones. source


$CARA +3.2% Cara Therapeutics Announces Difelikefalin (KORSUVA™) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients. source


$CYAD +1.0% Celyad Oncology Provides Outlook for 2022. source


$KNSA +1.4% Kiniksa Provides Corporate Update and Outlines Anticipated 2022 Milestones. source


$BNTX +8.6% BioNTech and Crescendo Biologics Announce Global Collaboration to Develop Multi-specific Precision Immunotherapies. source


$GMTX -12.6% Gemini Therapeutics Provides GEM103 Program Update. source


$IFRX +10.1% InflaRx Announces New Pipeline Program – Oral C5aR Inhibitor. source


$ADMP +27.0% Adamis Pharmaceuticals Submits Fast Track Application to FDA for Tempol for the Treatment and Prevention of COVID-19. source


$CHRS -2.5% Coherus and Junshi Biosciences Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody. source


$HZNP -3.3% Horizon Therapeutics plc Submits Supplemental Biologics License for the Concomitant Use of KRYSTEXXA® (pegloticase injection) Plus Methotrexate for People Living with Uncontrolled Gout. source


$SRRK +2.2% Scholar Rock Provides Corporate Update and Highlights Priorities for 2022. source


$IRWD +0.9% Ironwood Pharmaceuticals Provides Update on FY 2021 Financial Guidance and Announces FY 2022 Financial Guidance. source


$RGNX -3.2% REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subretinal Delivery. source


$REPL +0.08% Replimune Provides 2021 Year End Review and Overview of Expected 2022 Milestones. source


$SELB -2.4% Selecta Biosciences and Ginkgo Bioworks Announce New Collaboration to Develop Next-Generation Gene Therapy Capsids. source


$AGIO +1.4% Agios Highlights 2022 Anticipated Milestones and Priorities to Drive Company’s Strategic Vision in Genetically Defined Diseases. source


$TLSA +3.0% Tiziana Enrolls Second Patient in Ongoing Intranasal Foralumab Evaluation for Secondary Progressive Multiple Sclerosis. source


$PDSB -1.4% PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy. source


$TVTX +0.8% Travere Therapeutics Provides Corporate Update and 2022 Outlook. source


$ACAD +0.5% Acadia Pharmaceuticals and Stoke Therapeutics Announce Collaboration to Pursue Multiple RNA-based Treatments for Severe and Rare Genetic Neurodevelopmental Diseases. source


$AMRN +2.5% Amarin Provides Preliminary 2021 Revenue and Outlook for 2022. source


$DCPH +1.2% Deciphera Pharmaceuticals Provides Corporate Update and Highlights Key 2022 Corporate Milestones. source


$AUTL +0.9% Autolus Therapeutics announces 2022 priorities. source


$FOLD -17.2% Amicus Therapeutics Reports Preliminary 2021 Revenue and Provides 2022 Strategic Outlook and Revenue Guidance. source


$EPZM +7.1% Epizyme Provides Business Highlights, Preliminary Fourth Quarter and Full Year 2021 Financials and Clinical Trial Updates. source


$PASG -3.4% Passage Bio Announces 2022 Research and Clinical Development Goals to Advance Robust CNS Pipeline. source


$TCRX -8.3% TScan Outlines 2022 Priorities as Programs Enter Clinic. source


$NUVB -3.6% Nuvation Bio Provides Corporate Update and Highlights Key 2022 Milestones. source


$VKTX +1.4% Viking Therapeutics Announces Initiation of Phase 1 Clinical Trial of VK2735, Company's Lead Dual GLP-1/GIP Receptor Agonist. source


$AXGN -3.5% Axogen Reports Preliminary Unaudited Revenue for Fourth Quarter and Full-Year 2021. source


$SYRS -2.9% Syros Announces Clinical Updates and 2022 Goals to Support its Advancement to a Fully Integrated Biopharmaceutical Company. source


$NRIX -15.9% Nurix Therapeutics Advances Clinical and Preclinical Pipeline and Outlines 2022 Catalysts. source


$ORTX -0.8% Orchard Therapeutics Announces Recent Commercial and Regulatory Progress for Late-stage HSC Gene Therapy Programs and Outlines Key 2022 Milestones. source


$CCCC +8.5% C4 Therapeutics Announces 2022 Key Milestones to Advance Targeted Protein Degradation Portfolio. source


$BDTX -11.8% Black Diamond Therapeutics Announces Strategic Priorities and Expected Milestones for 2022. source


$BCRX +27.9% BioCryst Announces Preliminary Full Year 2021 ORLADEYO® (berotralstat) Net Revenue and Provides Full Year 2022 ORLADEYO Net Revenue and Peak Sales Guidance. source


$KYMR -1.8% Kymera Therapeutics Announces Key 2022 Goals and Milestones to Support Its Evolution into a Fully Integrated Degrader Medicines Company. source


$FULC +2.8% Fulcrum Therapeutics® Announces Upcoming Milestones to Support Its Mission of Treating the Root Cause of Rare Genetic Diseases. source


$MYOV +4.0% Myovant Sciences Announces Preliminary Financial Results for Third Quarter of Fiscal Year 2021. source


$KPTI +9.9% Karyopharm Announces Preliminary Unaudited Fourth Quarter and Full Year 2021 Net Product Revenues and Outlines 2022 Objectives. source


$TCRR -2.2% TCR² Therapeutics Announces 2022 Strategic Priorities and Anticipated Milestones. source


$CGEM -0.1% Cullinan Oncology Forms Strategic Collaboration Agreement with Mount Sinai to Advance Oral HPK1 Protein Degrader for Cancer Treatment. source


$VERV +0.9% Verve Therapeutics Announces 2022 Anticipated Milestones and Preclinical Data on Potential Additional Dosing Regimens for its Novel Base Editing Programs. source


$TBPH -1.2% Theravance Biopharma, Inc. Announces Enrollment of First Patient in YUPELRI® Phase 4 Study. source


$ALXO +2.9% ALX Oncology Provides Corporate Update and Highlights Key Milestones in 2022. source


$HGEN +0.6% Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T. source


$BHVN +1.3% Biohaven Enters Exclusive License and Research Collaboration Agreement with KU Leuven to Advance First-in-Class TRPM3 Antagonists for the Treatment of Pain. source


$HCM -1.3% HUTCHMED Initiates Phase I Study of BTK Inhibitor HMPL-760 in Patients with Previously Treated B-Cell Non-Hodgkin Lymphoma in China. source


$EXEL -2.5% Exelixis Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results, Provides 2022 Financial Guidance, and Outlines Key Priorities and Milestones for 2022. source


$EBS +2.9% Emergent BioSolutions Announces 2022 Financial Guidance, Provides Preliminary 2021 Results. source



Business Updates

$BEAM -2.7% & $PFE +0.9% Pfizer and Beam Enter Exclusive Multi-Target Research Collaboration to Advance Novel In Vivo Base Editing Programs for a Range of Rare Diseases. source


 

Posted by FS/JM

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