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Biopharma Daily Stock Updates - 10/18/21

$XBI $122.47 -2.1%

 

Covid Updates

$BNTX +5.4% New Formulation of COMIRNATY® Receives Positive Opinion from CHMP. source


$DVAX +1.2% COVID-19 Vaccine Developed by Valneva Using Dynavax's CpG 1018 Adjuvant Meets Both Co-Primary Endpoints in Phase 3 COV-COMPARE Trial. source


$VALN +39.8% Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001. source



Pipeline Updates

$PRTK -4.4% Paratek Pharmaceuticals Announces Enrollment of First Patient in Phase 2b Study Evaluating NUZYRA® (omadacycline) for Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc) source


$TERN -0.1% TERNS PHARMACEUTICALS TO PRESENT POSITIVE CLINICAL DATA ON NASH PROGRAMS AT AASLD THE LIVER MEETING® DIGITAL EXPERIENCE 2021 source


$IOVA -4.0% Iovance Biotherapeutics to Host Conference Call and Webcast to Highlight Data at Society for Immunotherapy of Cancer (SITC) Annual Meeting source


$DRMA -1.5% Dermata Announces Positive Results from Phase 1b Clinical Trial of DMT310 for the Treatment of Mild-to-Moderate Psoriasis source



$RNA -5.2% FDA Grants Fast Track Designation to AOC 1001 for the Treatment of Myotonic Dystrophy Type 1. source


$FIXX -2.6% Homology Medicines Initiates Clinical Trial for HMI-203, a One-Time Investigational Gene Therapy Candidate for Adults with MPS II (Hunter Syndrome). source


$RDUS +5.7% Radius Announces Positive Phase 3 Topline Results for TYMLOS® (abaloparatide) Subcutaneous Injection in Males with Osteoporosis. source


$DMAC +2.2% DiaMedica Therapeutics Announces Late Breaking Data from REDUX Phase 2 Trial to be Presented at ASN Kidney Week 2021. source


$IMCR -1.0% Immunocore and Medison Pharma Partner for Future Commercialization of Tebentafusp in Canada, Central Eastern Europe, and Israel. source


$MBRX -1.1% Moleculin Announces Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases. source


$LOGC +1.0% LogicBio Therapeutics Announces Early Clinical Trial Results Demonstrating First-Ever In Vivo Genome Editing in Children. source


$AKBA -1.4% Akebia Announces Vadadustat Efficacy and Safety Data to be Presented at American Society of Nephrology Kidney Week 2021. source


$RAPT -4.1% RAPT Therapeutics Announces Upcoming Oral Presentation of RPT193 Phase 1b Data at the 4th Inflammatory Skin Disease Summit. source


$VACC 0.0% Vaccitech Announces Data Presentations at AASLD’s Liver Meeting® 2021. source


$CDXS -1.9% Codexis, Almelo and RC2 Announce a Tri-Party Collaboration for the Enzymatic Production of Low Cost Sitagliptin API for the Generic Market, Including a License to Codexis Enzyme Technology in India. source


$GILD -2.6% U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations. source


$ADMP +8.9% Adamis Receives FDA Approval for ZIMHI. source


$IMCR -1.0% Immunocore and Medison Pharma Partner for Future Commercialization of Tebentafusp in Canada, Central Eastern Europe, and Israel. source


$BCLI +0.7% BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at NYSCF 2021 VIRTUAL Meeting. source


$CRDL +10.5% Cardiol Therapeutics Expands LANCER, a Phase II/III Trial of CardiolRx™, into Brazil, Mexico, and Canada. source


$GERN +0.7% Geron Announces Completion of Patient Enrollment in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes. source


$ALKS -4.3% Alkermes Announces Commercial Availability of LYBALVI® for the Treatment of Schizophrenia and Bipolar I Disorder. source


$BTAI +3.5% BioXcel Therapeutics Announces Expansion of Phase 2 Trial of BXCL701 in De Novo and Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer. source


$PHAT -16.2% Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial. source


$ALSN 0.0% ASLAN Pharmaceuticals Announces KOL Event Series to Discuss Atopic Dermatitis Treatment Landscape and ASLAN004. source


$APLT -3.3% Applied Therapeutics Reports Additional Pediatric Biomarker Data from ACTION-Galactosemia Kids. source


$OMER -26.7% Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA. source


$OYST +1.9% Oyster Point Pharma Announces FDA Approval of TYRVAYA™ (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease. source


$MNKD -18.5% Progress Update on Tyvaso DPI™ New Drug Application. source


$UTHR -1.5% United Therapeutics Provides an Update on the Progress of the Tyvaso DPI™ New Drug Application. source


$IONS -13.8% Ionis' partner Biogen provides update on tofersen Phase 3 VALOR study in SOD1-ALS. source


$NBIX -0.5% Neurocrine Biosciences to Present ONGENTYS® (opicapone) and INGREZZA® (valbenazine) Data at the American Neurological Association 2021 Virtual Annual Meeting. source



Financial & Business Updates

$BLUE +0.6% bluebird bio Sets Record Date and Distribution Date for Planned Business Separation. source


$RDHL -0.4% RedHill Biopharma Announces Insider Buying. source


$ESPR -3.1% ESPERION Announces Plan for Transformative Long-Term Growth. source


$BCYC -3.4% Bicycle Therapeutics Announces Closing of Public Offering of American Depositary Shares and Full Exercise of Underwriters’ Option to Purchase Additional Shares. source


$LPCN +4.4% Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®. source


$LMNL -0.5% Liminal BioSciences Announces Closing of Sale of Remaining Plasma-Derived Therapeutics Business. source

 

Posted by FS/JM

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