Free Biopharma Daily Stock Updates - 06/28/21

$XBI $137.85 -0.60 %

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Covid Updates

$RDHL +1.0% RedHill Biopharma's Opaganib Inhibits COVID-19 Variants in Preclinical Study. source

$AZN +1.20% First COVID-19 variant vaccine AZD2816 Phase II/III trial participants vaccinated. source

Pipeline Updates

$CPRX -1.8% Catalyst Pharmaceuticals Comments on Recent Decision by Health Canada to Re-issue an NOC for Ruzurgi® source

$GILD +-0.0% Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options source

$SNSE -1.0% Sensei Biotherapeutics Announces Prioritization of Next-Generation Multi-Antigenic ImmunoPhage Platform, Monoclonal Antibody and Nanobody Programs source

$CVM -45.5% CEL-SCI’s Multikine® Immunotherapy Produces Significant 14.1% 5-Year Survival Benefit (62.7% Vs 48.6%) in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head and Neck Cancer Phase 3 Study source

$IBRX +5.3% ImmunityBio and NantOmics Announce Clinical Validation of a Proprietary Method to Identify Unique Targets for Immunotherapy in Individual Breast Cancer Patients. source

$VERU +6.2% Veru Announces the Presentation of a Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer at the 2021 European Association of Urology Annual Congress. source

$CPRX -1.8% Catalyst Pharmaceuticals Announces Exclusive License and Supply Agreement with DyDo Pharma for the Development and Commercialization of Firdapse® in Japan. source

$EIGR +3.0% Eiger BioPharmaceuticals Announces Presentation of Positive Phase 2 Results of Avexitide in Congenital Hyperinsulinism at the American Diabetes Association Virtual 81st Scientific Session. source

$DNLI _0.50% Denali Therapeutics Announces Initiation of Phase 2 Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in Cutaneous Lupus Erythematosus (CLE) Patients. source

$CBIO +1.3% Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency. source

$LUMO -0.7% Lumos Pharma Announces OraGrowtH212 Trial of LUM-201 in PGHD Is Open for Enrollment. source

$ORIC -3.5% ORIC Pharmaceuticals Announces FDA Clearance of IND Application for ORIC-533, a Highly Potent, Orally Bioavailable Small Molecule CD73 Inhibitor. source

$ONTX +4.0% Onconova Therapeutics Provides an Update on the Phase 1/2a Trial of Rigosertib-Nivolumab Combination in KRAS+ Non-Small Cell Lung Cancer. source

$SNDX -1.5% SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias. source

$AGIO -1.0% Agios Submits Marketing Authorisation Application to European Medicines Agency for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency. source

$RMTI +5.3% Rockwell Medical, Inc. Files Pre-IND Meeting Request with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion. source

$DTIL +6.6% Precision BioSciences and SpringWorks Therapeutics Dose First Patient in Expanded Phase 1/2a Clinical Trial Evaluating PBCAR269A with Nirogacestat in Patients with Relapsed/Refractory Multiple Myeloma. source

$ZNTL -5.0% Zentalis Pharmaceuticals Announces Updates Across its Pipeline Including Promising New Interim Clinical Data on ZN-c3 (WEE1i) and ZN-c5 (SERD) and Two Potentially Registrational Trials for ZN-c3, with the First Trial Already Initiated. source

$CMPS +9.6% COMPASS Pathways completes COMP360 psilocybin therapy administration for 216 patients in large-scale phase IIb psilocybin therapy trial for treatment-resistant depression. source

$GRTX +3.3% Galera Announces Completion of Enrollment in Pivotal 455-Patient Phase 3 Trial of Avasopasem for Severe Oral Mucositis. source

$AVXL +16.7% Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Improved both Primary Cognitive and Secondary MDS-UPDRS Efficacy Endpoints with Significant Biomarker Correlation in Placebo-Controlled Phase 2 Clinical Trial for the Treatment of Patients with Parkinson’s Disease Dementia. source

$CLVS -5.7% Initial Clinical Experience of FAP-2286 in Independent Named Patient Use Published in The Journal of Nuclear Medicine. source

$MNKD +11.6% Policy Change Allows Approval For Medicare Patients Living With Diabetes To Use Both Afrezza® And Continuous Glucose Monitoring Devices Beginning July 18. source

$SVA +4.2% Sernova’s Principal Investigator Presents Interim Data and Positive Patient Outcomes of Phase I/II T1D Study at the American Diabetes Association 81st Scientific Sessions. source

$KYMR +6.3% Kymera Therapeutics Announces Positive Interim Results from Single Ascending Dose Phase 1 Trial of KT-474 Demonstrating Degrader Proof-of-Mechanism. source

$IDYA -1.0% IDEAYA Announces IDE397 Phase 1 Clinical Pharmacodynamic Data and Phase 2 Initiation of Darovasertib and Crizotinib Combination. source

$SLGL -6.8% Sol-Gel Announces Pipeline Update and Future Development Plans. source

$RNLX -2.0% KidneyIntelX™ Enables Monitoring of SGLT2 Inhibitor Therapy Response and Corresponding Risk Reduction Over Time. source

$EXEL -23.0% Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer. source

$NTLA +50.0% Intellia and Regeneron Announce Landmark Clinical Data Showing Deep Reduction in Disease-Causing Protein After Single Infusion of NTLA-2001, an Investigational CRISPR Therapy for Transthyretin (ATTR) Amyloidosis. source

$SANA -0.50% Sana Biotechnology Presents Data at ISSCR 2021 Virtual Annual Meeting Showing Survival of Transplanted Hypoimmune Stem Cells Without Immunosuppression in Non-Human Primates. source

$ABUS +-0.0% Arbutus Announces New Data on AB-729 and AB-836 Programs with Presentation of Five Abstracts at the EASL International Liver Congress™ 2021 - All Selected for Best of ILC™. source

Financial Updates

$KYMR +6.3% Kymera Therapeutics Announces Proposed Public Offering of Common Stock source

$ZNTL -4.8% Zentalis Pharmaceuticals Announces Proposed Public Offering Of Common Stock source

$NTLA +50.0% Intellia Therapeutics Announces Proposed Public Offering of Common Stock source

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Posted by FS JM