$XBI $115.05 +1.5%
Covid Updates
$GRTS -5.6% The Omicron Variant of SARS-CoV-2 has Minimal Impact on the T Cell Epitopes (Targets) Contained within Gritstone’s Self-Amplifying mRNA COVID-19 Vaccines. source
$NRXP +20.0% NRx Pharmaceuticals Identifies Significantly Higher Likelihood of Surviving and Recovering from Critical COVID-19 in ZYESAMI® (aviptadil) Treated Patients Previously Administered Remdesivir. source
$ADGI +86.2% ADAGIO THERAPEUTICS REPORTS THAT NONE OF THE MUTATIONS PRESENT IN SARS-COV-2 VARIANT, OMICRON, ARE ASSOCIATED WITH ESCAPE FROM ADG20 NEUTRALIZATION IN VITRO. source
$MRNA +11.8% Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant. source
$NRXP +20.0% NRx Pharmaceuticals Notes New Data on BriLife® COVID-19 Vaccine Effectiveness Against Delta Variant Posted by Israel Institute for Biological Research. source
$PFE -3.0% & BNTX +4.2% Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union. source
Pipeline Updates
$ADAG -2.2% Adagene Announces FDA Clearance of IND for Phase 1b/2 Trial of Anti-CTLA-4 Monoclonal Antibody ADG116 in Combination Therapy with Anti-PD-1 Antibody Pembrolizumab source
$ERYP -0.6% ERYTECH Secures US Patent Directed to Sequential Use of Methioninase & Asparaginase against Solid Tumors source
$GILD +0.5% Gilead’s Bold Ambition of Transforming Triple-Negative Breast Cancer Treatment to Be Highlighted With New Data at SABCS. source
$BCRX -0.2% BioCryst Begins Patient Enrollment in REDEEM-2 Pivotal Trial Evaluating BCX9930 as Oral Monotherapy for Patients with PNH. source
$LNTH -3.9% PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. source
$TCON -4.1% TRACON Pharmaceuticals Reports Regulatory Approval Of Envafolimab In China. source
$ATXI +53.2% Avenue Therapeutics Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA Tentatively Scheduled for February 15, 2022. source
$ATNX -1.7% Athenex Announces UK MHRA Validation of the Marketing Authorization Application for Oral Paclitaxel and Encequidar for Review. source
$PRAX +2.0% PRAXIS PRECISION MEDICINES TO PRESENT DATA FROM RARE DISEASE PROGRAMS AT THE AMERICAN EPILEPSY SOCIETY 2021 ANNUAL MEETING. source
$VIRX -5.6% Viracta Therapeutics Announces Orphan Drug Designation Granted by FDA for its All-Oral Combination of Nanatinostat and Valganciclovir (Nana-val) for the Treatment of Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma. source
$BCLI +1.9% BrainStorm Cell Therapeutics Announces the Presentation of New Analyses from the Phase 3 Trial of NurOwn® in ALS at the 4th Annual ALS ONE Research Symposium. source
$VRCA +0.8% Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum. source
$KRYS +121.7% Krystal Biotech Announces Positive Topline Results from GEM-3 Pivotal Trial of VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa. source
$GTHX +3.5% G1 THERAPEUTICS ANNOUNCES INITIATION OF NEW PHASE 2 TRIAL OF TRILACICLIB IN COMBINATION WITH THE ANTIBODY-DRUG CONJUGATE (ADC), TRODELVY® (SACITUZUMAB GOVITECAN-HZIY). source
$ACET +1.3% Adicet Bio to Host Webcast Presentation of ADI-001 Interim Clinical Data in B Cell Non-Hodgkin’s Lymphoma. source
$KRON -5.8% Kronos Bio Announces Positive Data from Ongoing Phase 1/2 Trial of Oral CDK9 Inhibitor KB-0742. source
$SGTX -4.6% SIGILON THERAPEUTICS ANNOUNCES UPDATE ON SIG-001 PHASE 1/2 STUDY IN HEMOPHILIA A. source
$IMNM +12.6% Immunome Announces Submission of an Investigational New Drug (IND) Application for IMM-BCP-01 for the Treatment of COVID-19. source
$SWTX -1.3% SpringWorks Therapeutics Announces Full Enrollment of Phase 2b ReNeu Trial Evaluating Mirdametinib in Adult and Pediatric Patients with NF1-Associated Plexiform Neurofibromas. source
$FENC -50.4% FENNEC PHARMACEUTICALS EXPECTS TO RECEIVE COMPLETE RESPONSE LETTER FROM THE FDA FOR ITS NEW DRUG APPLICATION FOR PEDMARK™ TO PREVENT OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS WITH LOCALIZED, NON-METASTATIC, SOLID TUMORS. source
$IDYA -6.2% IDEAYA Announces Investor Webcast to Review Clinical Data from Phase 1/2 Trial of Darovasertib Combination with Crizotinib in Metastatic Uveal Melanoma. source
$OCGN -0.3% Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152). source
Business Updates
$KRYS +121.7% Krystal Biotech Announces Proposed $200 Million Public Offering of Common Stock source
$OTLK +5.1% Outlook Therapeutics Announces Closing of $57.5 Million Bought Deal, Including Full Exercise of Underwriter’s Option to Purchase Additional Shares source
$SRNE -0.8% Abivertinib – A Franchise Oral Therapeutic for Cancer, COVID-19 and Autoimmune Diseases. source
$CLSN +6.9% Celsion Corporation Invited to Present Poster at Cytokine-Based Cancer Immunotherapies Summit. source
$SCYX -0.4% SCYNEXIS to Host Ibrexafungerp Hospital Pipeline Update Call and KOL Webcast for Investors on December 6. source
$APTO -4.4% Aptose to Hold Corporate Update Monday, December 13th. source
$BPMC -2.5% Blueprint Medicines to Expand Precision Therapy Leadership in Lung Cancer with Acquisition of Lengo Therapeutics. source
$ATAI -1.8% atai Life Sciences Increases its Ownership Position in COMPASS Pathways. source
$SAGE -2.0% Sage Therapeutics to Host Sage FutureCast Webcast 12/14/21. source
$SUPN -0.5% Supernus Pharmaceuticals Targeted in Ransomware Incident. source
$SUPN -0.5% Update on M&A with ADMS. source
$ADMS -0.7% Update on M&A with SUPN. source
Posted by DV/JM
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