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Biopharma Daily Stock Updates - 06/08/22

$XBI $73.21 | +0.84%



Table of Contents:


Covid Updates

#MRNA +2.2% Moderna Announces Omicron-Containing Bivalent Booster Candidate mRNA-1273.214 Demonstrates Superior Antibody Response Against Omicron



Pipeline Updates


#TLSA +11.1% Tiziana Life Sciences Announces Positive Clinical Results in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) Following Three Months of Dosing with Intranasal Foralumab


#ALLO +10.2% Allogene Therapeutics Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to ALLO-501A for Large B Cell Lymphoma


#MNOV +8.9% MediciNova Announces Positive Top-Line Results from Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome


#NTLA +8.1% Intellia Therapeutics to Present Updated Interim Clinical Data from Ongoing Phase 1 Study of NTLA-2001 for the Treatment of Transthyretin (ATTR) Amyloidosis at the International Liver Congress™ 2022


#SCYX +3.9% SCYNEXIS Announces Submission of Supplemental New Drug Application of BREXAFEMME® (ibrexafungerp tablets) to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections.


#OCUL +3.2% Ocular Therapeutix™ Announces Organizational Changes to Support Development for Retinal Diseases


#PASG +3.1% Passage Bio Receives FDA Clearance of IND Application for PBML04 for Treatment of Metachromatic Leukodystrophy


#TNXP +1.8% Tonix Pharmaceuticals Announces Presentation on TNX-801 Vaccine Protection Against Monkeypox at the 4th Symposium of the Canadian Society for Virology


#ASMB +1.0% Assembly Biosciences to Highlight Data from HBV Core Inhibitor Programs at EASL’s International Liver Congress™ 2022.


#IMCR +0.9% The UK Medicines and Healthcare products Regulatory Agency (MHRA), Australian Therapeutic Goods Administration (TGA) and Health Canada approve KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma


#BCRX +0.8% FDA Grants Fast Track Designation for BioCryst’s ALK-2 Inhibitor, BCX9250


#SLS +0.3% SELLAS Life Sciences Reports Encouraging Updated Clinical Data Indicating Increased Survival from Ongoing Phase 1 Mesothelioma Study of Galinpepimut-S Combined with Opdivo.


#MRNS 0.0% Marinus Pharmaceuticals Expands Enrollment Criteria to Support Recruitment in Phase 3 RAISE Trial in Refractory Status Epilepticus


#ENTA -0.1% Enanta Pharmaceuticals Announces Data Presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022


#CVM -0.5% CEL-SCI Corporation to Present at LD Micro Invitational.


#FGEN -1.8% FibroGen Announces Completion of Patient Enrollment in LELANTOS-2, a Phase 3 Clinical Study of Pamrevlumab in Duchenne Muscular Dystrophy


#BCYC -1.9% Bicycle Therapeutics Announces First Patient Dosed in Expansion Cohorts of Phase I/II Trial of Bicycle® Toxin Conjugate BT5528 in Patients with Advanced Solid Tumors Associated with EphA2 Expression


#ALDX -2.8% Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 TRANQUILITY‑2 Trial in Dry Eye Disease and Intends to Submit New Drug Application for Symptoms and Three Sign Endpoints of Dry Eye Disease


#KALV -5.1% KalVista Pharmaceuticals Presents Promising Preclinical Data for Oral Factor XIIa Inhibitor Program


#IMVT -8.2% Immunovant Achieves Alignment with FDA on Plans for Phase 3 Clinical Trials of Batoclimab in Thyroid Eye Disease and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2022


#DTIL -12.9% Precision BioSciences Provides Update on Allogeneic CAR T Programs and Path Forward with Its Lead PBCAR0191 Candidate for CAR T Relapsed Patient Population


#RIGL -60.2% Rigel Announces Top-line Results from FORWARD Phase 3 Clinical Trial of Fostamatinib in Patients with Warm Autoimmune Hemolytic Anemia

 

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Posted by FS/JM

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