$XBI $111.78 -4.2%
Covid Updates
$BNTX -2.7% & $PFE +1.4% Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older source
$NRXP -2.7% NRx Pharmaceuticals and Hungarian Health Officials Agree on Pathway for ZYESAMI® and BriLife COVID-19 Vaccine Trials source
$CYDY -1.9% CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population source
Pipeline Updates
$ANGN -2.8% ANGION AND VIFOR PHARMA REPORT TOPLINE RESULTS FROM PHASE 2 GUARD TRIAL OF ANG-3777 IN CARDIAC SURGERY-ASSOCIATED ACUTE KIDNEY INJURY source
$IMUX -0.8% Immunic, Inc. Announces Enrollment of the First Patient in its Phase 1 Trial of IMU-935 in Metastatic Castration-Resistant Prostate Cancer source
$ITOS -1.4% iTeos Announces New Data for its Anti-TIGIT Antibody, EOS-448, at the American Society of Hematology Annual Meeting and TIGIT Therapies Digital Summit 2021 source
$AZN -0.3% Enhertu additional analyses further reinforce ground-breaking efficacy in patients with HER2-positive metastatic breast cancer source
$SRNE -1.6% Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary, Announces Highly Significant Positive Top-Line Results from its Phase 3 Non-Opioid Injectable SP-102 (SEMDEXA™) Pivotal Trial C.L.E.A.R. Program for Sciatica Pain Management Supporting the source
$VIR +0.9% Vir Biotechnology Announces Initiation of Phase 2 Clinical Trial Evaluating VIR-2218, Selgantolimod and Nivolumab for the Treatment of Chronic Hepatitis B Virus Infection source
$ZYME -14.9% Zymeworks Announces Expansion Of Zanidatamab Pivotal Trial In Asia In Collaboration With BeiGene And Associated Milestone Payment source
$CYDY -1.9% CytoDyn Files for Expanded Access Use of Leronlimab for Multi-Drug Resistance HIV Patients source
$HRTX +11.4% Heron Therapeutics Announces FDA Approval of a Significant Indication Expansion for ZYNRELEF® source
$SESN -17.6% Sesen Bio Announces Anticipated Regulatory Path Forward for Vicineum™ source
$VBI -4.5% VBI Vaccines Announces Filing of New Drug Submission for 3-Antigen Hepatitis B Vaccine to Health Canada source
$APRE +2.2% Aprea Therapeutics Announces Removal of FDA Clinical Hold on Eprenetapopt in Lymphoid Malignancies source
$ALGS -9.2% Aligos Therapeutics Begins Dosing with NASH Drug Candidate, ALG-055009, in Healthy Volunteers in a Phase 1 First-in-Human Study source
$FREQ -1.8% Frequency Therapeutics Shares Results from FX-322-113 Severe Sensorineural Hearing Loss Study Showing Speech Perception Improvements in Noise source
$CYTK -5.5% CYTOKINETICS ANNOUNCES RECEIPT OF BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR AFICAMTEN source
$OCGN -6.3% Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration source
$GLSI -9.8% Greenwich LifeSciences Announces Presentation of 5 Year Data for GP2 Phase IIb Clinical Trial, Revealing Potential For New T Cell Platform Technology source
$QURE -4.5% uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B source
$ICPT -14.9% INTERCEPT ANNOUNCES WITHDRAWAL OF EMA MARKETING AUTHORIZATION APPLICATION FOR OBETICHOLIC ACID FOR ADVANCED LIVER FIBROSIS DUE TO NASH source
$ACHL -6.6% Achilles Therapeutics Presents Positive Data at ESMO I-O Congress 2021 on High-Dose Manufacturing Process for Precision T Cell Therapies Targeting Clonal Neoantigens source
$RETA -46.5% Reata Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting of Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome source
$AUPH +0.7% Aurinia Announces Positive Topline Results From the AURORA 2 Continuation Study of LUPKYNIS™ (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN) source
Business Updates
$RLMD +6.3% Relmada Therapeutics Announces Pricing of Upsized Public Offering of Common Stock source
Posted by JM
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