$XBI $129.16 +1.1%
Covid Updates
$BNTX +2.1% Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older source
$MRNA +0.70% Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine source
$ANIX +9.0% Anixa Biosciences' Covid-19 Compounds Expected to be Effective Against the Delta Variant source
$EBS +2.5% Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Evaluated in NIH-Sponsored Phase 3 Clinical Trial (INSIGHT-012) of Hyperimmune Intravenous Immunoglobulin for Outpatient Treatment of COVID-19 source
Pipeline Updates
$TRVN +3.3% Trevena Announces Wake Forest Baptist Health Joining OLINVYK® Clinical Outcomes Study source
$TSHA +1.0% TAYSHA GENE THERAPIES RECEIVES ORPHAN DRUG DESIGNATION FOR TSHA-105 FOR THE TREATMENT OF EPILEPSY CAUSED BY SLC13A5 DEFICIENCY FROM THE EUROPEAN COMMISSION source
$FGEN -2.0% FibroGen Announces Positive Topline Results from Phase 2 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia source
$EGRX -1.7% Eagle Pharmaceuticals Announces Worldwide Licensing Agreement with Combioxin SA for Phase 2b/3, Novel First-in-Class Antitoxin Agent CAL02 in Development for Combination Use with Antibiotics for the Treatment of Severe Pneumonia source
$LPCN -0.7% Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study source
$MRTX +5.4% Mirati Therapeutics Clinical Research at ESMO Congress 2021 to Highlight Progress with Investigational Adagrasib and Sitravatinib in Patients with Lung and Colorectal Cancers source
$EXEL -0.1% Exelixis Announces Partner Takeda and Ono Receive Approval in Japan for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma source
$BCRX +0.1% BioCryst Announces Acceptance of Regulatory Applications for ORLADEYO® (berotralstat) by Health Canada and Swissmedic source
$IMNB -4.1% INmune Bio, Inc. Announces Biomarker Data Demonstrating that the First Patient Treated with its NK Cell Priming “Pseudokine”, INKmune™, Successfully Produced Memory-Like NK Cells source
$AMRX +0.2% Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations source
$RFL +18.5% Rafael Pharmaceuticals Announces the Successful Completion of Phase 1b Clinical Trial and Initiates Phase 2 for CPI-613® (devimistat) in Combination with Gemcitabine and Cisplatin in Patients with Biliary Tract Cancer source
$NVAX +2.2% Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems source
$SPRB -3.8% SPRUCE BIOSCIENCES ANNOUNCES PEDIATRIC CLASSIC CAH PROGRAM DETAILS DURING VIRTUAL R&D DAY source
$CRDF +9.2% Cardiff Oncology to Present New Data from Lead Clinical Program in KRAS-mutated Metastatic Colorectal Cancer on September 8, 2021 source
$CYDY +1.5% CytoDyn’s Final mTNBC Report Indicates as Much as 980% Increase in 12-Month Overall Survival and Up to 660% in 12-Month Modified Progression Free Survival source
$CRTX -2.9% Cortexyme Presents New Data Demonstrating Evidence of P. Gingivalis Infection of the Central Nervous System in Alzheimer’s Disease at Annual Biomarkers for Alzheimer’s Disease Summit source
$ARQT +1.3% Arcutis Enrolls First Patient in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Scalp and Body Psoriasis source
$ACHL +4.2% Achilles Therapeutics Announces Grant of US and European Patents source
$IBIO +0.0% iBio Expands Immuno-Oncology Pipeline in AI Partnership with RubrYc Therapeutics source
$FLXN +14.0% Flexion Therapeutics Announces Expansion of Phase 1b Trial Investigating FX301 for the Management of Post-Operative Pain source
$BBIO +0.90% bridgebio pharma and lianbio announce first patient treated in phase 2a trial of infigratinib in patients with gastric cancer and other advanced solid tumors source
$SAVA -31.4% Cassava Sciences Responds to Allegations source
Market update
$PSNL +1.2% Personalis Announces Corporate Headquarters Expansion to Accelerate Growth in Laboratory Operations and Research & Development source
$CTI +1.5% CTI BioPharma and DRI Healthcare Trust Announce up to $135 Million Debt and Royalty Transaction source
Posted by JM
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