Free Biopharma Daily Stock Updates - 09/16/21

$XBI $131.00 +0.40%

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Covid Updates

$ABCL +5.3% Emergency Use Authorization of AbCellera-Discovered Bamlanivimab Administered with Etesevimab Expanded by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19 source

$MRNA +1.4% Moderna Announces Health Canada Approves its COVID-19 Vaccine. source

Pipeline Updates

$BMEA +17.3% Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219. source

$ADMS +2.2% Adamas Announces GOCOVRI Presentations at the Upcoming International Parkinson and Movement Disorder Society’s (MDS) Congress. source

$CALT -2.0% Updated regulatory timeline for review of MAA in Europe. source

$ALRN -6.1% Aileron Therapeutics Presents New Clinical Data at ESMO Virtual Congress 2021 Supporting ALRN-6924’s Best-in-Class Potential as a Chemoprotective Agent. source

$ADPT +4.9% Adaptive Biotechnologies to Present New SARS-CoV-2 Data from its Immune Medicine Platform During IDWeek 2021. source

$RVNC -0.1% Revance to Showcase Data from Phase 3 ASPEN-1 Clinical Trial Evaluating Efficacy, Duration of Effect and Safety of DaxibotulinumtoxinA for Injection for Cervical Dystonia at International Parkinson and Movement Disorder Society Virtual Congress 2021. source

$NGM -7.0% NGM Bio Presents Preliminary Findings from Ongoing Phase 1a/1b Dose Escalation Study of NGM120 in Patients with Advanced Solid Tumors at the ESMO Virtual Congress 2021. source

$AYLA -13.7% Ayala Pharmaceuticals Presents Preliminary Clinical Data from the Ongoing Phase 2 ACCURACY Trial and Announces Pre-Clinical Proof of Concept Data for Enhanced Activity of AL101 in Combination with Approved Cancer Therapies in ACC. source

$NCNA -1.7% NuCana Announces Four Poster Presentations at the ESMO Congress 2021. source

$NTLA +2.3% Intellia Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug Application for NTLA-5001, its CRISPR/Cas9-Engineered TCR-T Cell Candidate for Acute Myeloid Leukemia. source

$AXSM +2.9% Axsome Therapeutics Initiates SYMPHONY Phase 3 Trial of AXS-12 in Narcolepsy. source

$ALXO +3.5% ALX Oncology Announces Initiation of Investigator-Sponsored Trial of Evorpacept (ALX148) in Patients with Indolent and Aggressive Non-Hodgkin Lymphoma. source

$TIL -3.4% Instil Bio Presents Subset Analysis of Patients with Checkpoint-Refractory Advanced Melanoma from Compassionate Use Study at 2021 ESMO Congress. source

$ZYME +9.3% Zanidatamab Phase 2 Clinical Trial Demonstrates Promising Response Rate and Durability in First-Line HER2-Positive Gastroesophageal Adenocarcinoma (GEA) at the European Society for Medical Oncology (ESMO) Annual Congress. source

$SBTX -23.0% Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors. source

$MGNX -23.8% MacroGenics Announces Preliminary Clinical Results from Phase 1 Cohort Expansion of the Ongoing MGC018 Study Presented at ESMO 2021 Virtual Annual Congress. source

$LPTX +31.1% Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress. source

$EXEL -0.3% Exelixis Announces CABOMETYX® in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients with Previously Untreated Advanced Renal Cell Carcinoma Based on CheckMate -9ER Analysis Presented at ESMO 2021. source

$ATNX +5.0% Athenex Presents Data from Oral Paclitaxel + Pembrolizumab Phase 1 Study at ESMO 2021. source

$BCRX +0.9% NICE Recommends BioCryst’s ORLADEYO® (berotralstat), the First Oral, Once-daily Therapy, to Prevent Attacks in HAE Patients in the UK. source

$AMPE -0.6% Ampio Pharmaceuticals Announces Top-line Results from AP-013 Phase III Study of Ampion in Adult Patients Suffering from Severe Osteoarthritis of the Knee (OAK). source

Finance & Business Updates

$GRTS +5.9% Gritstone Announces Private Placement Financing of $55.0 Million source

$SVA Sernova Signs Collaboration Agreement to Advance Conformal Coated Immune Protected Therapeutic Cells for Diabetes with the University of Miami. source

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Posted by FS/JM