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Biopharma Daily Stock Updates - 09/20/21

$XBI $128.76 -3.10%

 

Covid Updates

$EIGR -2.5% Eiger BioPharmaceuticals Announces Interim Analysis and Continuation of Dosing of Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients. source


$GRTS +2.7% Gritstone Announces Dosing of First Volunteer in Trial Evaluating Self-Amplifying mRNA as a COVID-19 Vaccine Booster and Immunogenicity Enhancer. source


$BNTX -5.6% & $PFE +0.7% Pfizer and BioNTech Announce Positive Topline Results from Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years. source


$ADGI -10.2% Adagio Therapeutics Provides COVID-19 Antibody Program Updates as well as Business Highlights and Second Quarter 2021 Financial Results. source


$SRNE -3.4% Sorrento Announces an Independent Real-World Study That Reports Superior Sensitivity Results in Detecting COVID-19 Virus Infections in All-Comer General Population by COVISTIX as Compared to a Globally Leading Rapid Antigen Test. source


$BNTX -5.6% & $PFE 0.7% FDA Advisory Committee Votes Unanimously in Favor of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-Risk Populations. source



Pipeline Updates

$PTCT -2.4% PTC Therapeutics to Host Conference Call to Discuss Results of PTC518 Phase 1 Study for Huntington's Disease Program source


$SLDB -5.0% Solid Biosciences to Provide Update on Long-Term Outcomes Data from Patients in the Ongoing IGNITE DMD Phase I/II Clinical Trial of SGT-001 source


$VRCA -24.0% Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum source


$ERYP -8.0% ERYTECH PROVIDES BUSINESS UPDATE AND REPORTS FINANCIAL RESULTS FOR THE FIRST HALF OF 2021 source

$SYRS -2.0% Syros Presents New Data from Phase 1 Trial of SY-5609 and Details Three-Pronged Combination Strategy to Advance SY-5609 in Solid Tumors and Blood Cancer source


$PDSB -1.1% PDS Biotech Achieves Safety Requirement Milestone For the First 12 Patients in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Advanced Head and Neck Cancer. source


$PTCT -2.4% STRIDE Data Show Translarna™ Delays Loss of Ambulation by More Than Five Years in Boys with Nonsense Mutation Duchenne Muscular Dystrophy. source


$VERU -5.4% Veru Announces Positive Updated Data from Phase 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer at the 2021 ESMO Congress. source


$MRTX +2.0% Mirati Therapeutics Announces Long-term Survival Results from an Exploratory Analysis of Sitravatinib plus Nivolumab in Patients with Non-squamous Non-Small Cell Lung Cancer Who are Resistant to Checkpoint Inhibitors. source


$RYTM -5.0% Rhythm Pharmaceuticals Completes Submission of Supplemental New Drug Application to U.S. Food and Drug Administration for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström Syndromes. source


$TGTX -1.9% TG Therapeutics Announces Combination Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL). source


$DYN -0.6% Dyne Therapeutics Presents New In Vivo Data for its Myotonic Dystrophy Type 1 Candidate (DYNE-101) Demonstrating Robust Splicing Correction During World Muscle Society 2021 Virtual Congress. source


$MRTX +2.0% Mirati Therapeutics Announces Positive Phase 2 Topline Results for Investigational Adagrasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer. source


$MRNS -2.6% Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder. source


$AVEO -4.4% AVEO Oncology Announces Ficlatuzumab Granted Fast Track Designation by the U.S. FDA for the Treatment of Relapsed or Recurrent Head and Neck Squamous Cell Carcinoma. source


$VSTM +1.8% Verastem Oncology and Amgen Partner to Evaluate VS-6766 in Combination with LUMAKRASTM (Sotorasib) in Patients with KRAS G12C-Mutant Non-Small Cell Lung Cancer. source


$LYRA +1.0% Lyra Therapeutics Announces Four Abstracts Selected for Presentations at Upcoming ERS and ARS Meetings, Including New LANTERN 6-Month Follow-Up and Pharmacokinetic Data. source


$IMCR +2.5% Immunocore presents data at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating a reduction in circulating tumor DNA (ctDNA) while on tebentafusp is associated with overall survival in the Phase 2 clinical trial. source


$LABP +1.5% Landos Biopharma to Collaborate on a Phase 2 Study of Omilancor in Crohn’s Disease with the Icahn School of Medicine at Mount Sinai. source


$SYBX +12.8% Synlogic Announces Positive Phase 2 Data Demonstrating Reduction in Plasma Phenylalanine Levels in Patients with Phenylketonuria. source


$ANNX -4.2% Annexon Biosciences to Highlight Neurodegeneration Franchise in Upcoming Virtual C1q Series R&D Event. source


$HCM -1.9% HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors. source


$VSTM +1.8% Verastem Oncology Announces Updated Investigator-Sponsored Phase 1/2 FRAME Study Data of VS-6766 with Defactinib in Low-Grade Serous Ovarian Cancer Showing Encouraging Response Rates and Progression-Free Survival Presented at ESMO 2021. source


$SPPI -4.5% Spectrum Pharmaceuticals Presents Late Breaker Oral Presentation of Poziotinib Data in First-Line NSCLC Patients with HER2 Exon 20 Insertion Mutations at ESMO Congress 2021. source


$EXEL -4.3% Exelixis Announces Detailed Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2021. source



Finance & Business Updates

$GLPG -1.5% Galapagos increases share capital through subscription right exercises source


$CLVS -5.6% Clovis Oncology Retires Remaining 2021 Notes and Raises Additional Capital through its ATM Equity Offering Program. source


$PSNL -4.8% Personalis Receives New VA MVP Task Order and Record Quarterly Orders From Oncology Customers; Reconfirms Total Revenue Outlook for 2021 with Further Accelerated Oncology Growth. source


 

Posted by FS/JM

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