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Biopharma Daily Stock Updates - 05/31/22

$XBI $68.78 | -3.25%

Table of Contents:

Covid Updates

$NVAX +0.07% Novavax Initiates Phase 3 Trial of its COVID-19 Omicron Strain Vaccine as a Booster source

Pipeline Updates

$BIOR +0.7% Biora Therapeutics Shares Presentation of Patient Data Establishing Correlation Between Drug Levels in Colon and Patient Outcomes in Ulcerative Colitis. Source

$YMAB +6.7% Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS® (omburtamab) for the Treatment of Neuroblastoma for Priority Review. source

$FBIO -4.3% Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the United States. Source

$VERU +0.9% Veru to Present Three Presentations at the 2022 American Society for Clinical Oncology Annual Meeting on June 3-7. source

$PDSB -27.1% PDS Biotech Announces Expansion of its VERSATILE-002 Clinical Trial into Europe. source

$OTLK -32% Outlook Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet AMD. source

$GRTS +9.2% Gritstone Announces Updated Overall Survival Results in Advanced Colorectal Cancer Patients from Phase 1/2 Study of GRANITE and Trial in Progress Poster at ASCO. source

$IMAB +5.2% I-Mab Announces Completion of Patient Enrollment in Phase III Clinical Trial of Eftansomatropin alfa for Treatment of Pediatric Growth Hormone Deficiency. source

$CGEM -6.9% Cullinan Oncology to Present Updated Data Demonstrating the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting. source

$HZNP -5.4% Analysis from the Phase 3 N-MOmentum Study Demonstrates the Effectiveness of UPLIZNA® (inebilizumab-cdon) Among Neuromyelitis Optica Spectrum Disorder Patients with Genetic Variations. source

$DNLI -3.7% Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease. source

$JANX -5.0% Janux Therapeutics Announces FDA Clearance of Investigational New Drug Application for JANX007, a PSMA-TRACTr for Metastatic Castration-Resistant Prostate Cancer. source

$TGTX -14.5% TG Therapeutics Announces FDA Extension of BLA PDUFA Date for Ublituximab to Treat Patients with RMS. source

$TNXP +8.9% Tonix Pharmaceuticals Announces Two Oral Presentations Involving TNX-1500 (Fc-modified anti-CD40L mAb) on Prevention of Rejection in Kidney and Heart Allograft Transplantation at the 2022 American Transplant Congress. source

$AXSM -5.5% Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry. source

$TCRX +1.3% TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-101 for the Treatment of Hematologic Malignancies. source

$ELDN -10.6% Eledon Announces Positive Topline Results from Phase 2a Trial of Tegoprubart Demonstrating Safety, Target Engagement, and Biomarker Response in Patients Living with Amyotrophic Lateral Sclerosis. source

$MRNA -1.6% Moderna and Takeda Announce Plans to Transfer Marketing Authorization for Spikevax(TM) COVID-19 Vaccine in Japan to Moderna. source

$PTCT -3.2% FDA Approves Label Extension for Evrysdi® for Infants with Spinal Muscular Atrophy Under 2 Months Old. source


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Business Updates


$TXMD +364% TherapeuticsMD and EW Healthcare Partners Announce Definitive Agreement for EW Healthcare Partners to acquire TherapeuticsMD. source


Posted by FS/JM

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