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Biopharma Daily Stock Updates - 12/20/21

$XBI $115.79 +0.16%%


Covid Updates

$NVAX -7.1% World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine source

$NVAX -7.1% Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine. source

$BNTX -4.2% Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply. source

$MRNA -6.3% Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant. source

Pipeline Updates

$DBVT -2.5% DBV Technologies Provides Update on Investigational Viaskin™ Peanut source

$CTMX +0.9% CytomX Therapeutics Announces Preliminary Results for Ongoing Phase 2 Expansion Study of CX-2029, a First-in-Class Antibody-Drug Conjugate Candidate Targeting the Transferrin Receptor, CD71 source

$ACAD +5.2% Acadia Pharmaceuticals Announces Plan for a Resubmission of its Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) source

$ALDX -38.0% Aldeyra Therapeutics Announces Top-Line Results from the Phase 3 TRANQUILITY Trial in Dry Eye Disease source

$SRNE -3.8% Sorrento Therapeutics Announces FDA Clearance of Its IND Application of Next Generation oHSV Oncolytic Virus STI-1386 for Patients With Relapsed and Refractory Solid Tumors. source

$CFRX -1.2% Compassionate Use Case Study Demonstrating the Potential of Investigational Direct Lytic Agent Exebacase to Treat MRSA Bacteremia in Pediatric Populations Published in Clinical Infectious Diseases. source

$SMMT -48.0% Summit Therapeutics Announces Topline Results for Phase III Ri-CoDIFy Study for C. Difficile Infection. source

$SCYX +6.2% BREXAFEMME® (ibrexafungerp tablets) Added to Major National Formulary, Providing Access for Millions More Commercially Insured Patients. source

$PTCT +2.9% Oral Splicing Modifiers that Systemically Lower Huntington Disease Protein Discovered Through PTC Therapeutics' Innovative Splicing Platform. source

$PSTX +4.0% Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors. source

$BLUE +0.9% bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program. source

$TPTX +2.8% Turning Point Therapeutics Provides Regulatory Updates. source

$ZGNX +6.8% Zogenix Submits Type II Variation Application to the European Medicines Agency (EMA) to Expand the Use of FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome. source

$UBX -5.0% UNITY Biotechnology Announces Exclusive License Agreement with Jocasta Neuroscience to Continue Development of α-Klotho Program. source

$GLTO +1.6% Galecto Provides Enrollment Update on Phase 2a MYLOX-1 Trial and Reiterates Expected Timing of Multiple Data Readouts in 2022. source

$ICPT -2.7% Intercept Pharmaceuticals Provides Update on Phase 3 REVERSE Trial in Compensated Cirrhosis Due to NASH. source

$FGEN +0.2% FibroGen Exercises Exclusive License Option for HiFiBiO’s CCR8 Program. source

$CHRS +5.5% Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh). source

$ETON -0.2% Eton Pharmaceuticals and ANI Pharmaceuticals Announce Commercial Availability of Carglumic Acid Tablets, the First and Only FDA-Approved Generic Version of Carbaglu® (carglumic acid). source

$APTO -7.3% Aptose Provides Update on APTO-253 Program. source

$CYTK +3.2% Cytokinetics and JI XING Announce Expansion of Collaboration to Include Licensing of Omecamtiv Mecarbil in China; RTW to Add to Its Investment in Cytokinetics. source

$MDWD -3.7% MediWound Announces Positive Initial Data from its U.S. Phase 2 Pharmacology Study of EscharEx Showing Effective and Rapid Debridement in Chronic and Hard to Heal Wounds. source

$EDIT +1.1% Editas Medicine Announces FDA Clearance of Investigational New Drug (IND) Application for EDIT-301 for the Treatment of Transfusion-Dependent Beta Thalassemia. source

$CARA -1.9% Cara Therapeutics Announces CMS Grants TDAPA to KORSUVA™ (difelikefalin) Injection. source

$CMPI +10.5% Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Phase 2 Multi-Indication Trial Using Vidutolimod. source

$LCTX +21.2% Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders. source

Business Updates

$JAGX +1.8% Jaguar Health’s Subsidiary Napo EU Changes Name to Napo Therapeutics, Reflecting the Italian Company’s Focus on Rare Diseases & Orphan Drugs. source


Posted by FS/JM



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