Axsome Therapeutics Inc and Major Depressive Disorder In a teleconference on August 20, 2021, the U.S. Food and Drug Administration (FDA) informed Axsome Therapeutics (AXSM) that its review of the new drug application (NDA) for AXS-05, for the treatment of major depressive disorder, would not be completed by the Prescription Drug User Fee Act (PDUFA

Virpax Pharmaceuticals  Virpax Pharmaceuticals (VRPX) - a company specializing in developing product candidates for pain management, CNS and anti-viral indications, announced the receipt of a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use . . . This content is for paid subscribers. Please click here to subscribe …

Agenus Inc News and Q2 Results for 201 Agenus (AGEN) announced results with better than usual news including the following:  $200 million received from BMS for anti-TIGIT bispecific antibody collaboration FDA cleared IND for AGEN1777 clinical enrollment AGEN1181 rapidly advancing in the clinic - data to be presented in 2H 2021 Cell therapy . . . This content is for paid subscribers. Please click here to …

Sanofi Will Acquire Translate Bio Sanofi (SNY) will acquire all the outstanding shares of Translate Bio (

GlaxoSmithKline and Vir Biotechnology Signed a Joint Procurement Agreement with the EC GlaxoSmithKline (GSK) and Vir Biotechnology (

bluebird bio Receives EC Approval for  bluebird bio (BLUE) announced that the European Commission (EC) has granted marketing authorization of SKYSONA™ (elivaldogene autotemcel, Lenti-D™) one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age with an ABCD1 genetic mutation, and for whom a human leukocyte antigen . . . This content is for paid subscribers. Please click here to subscribe or here to …

Cytokinetics Positive Topline Results of CK-274 Cytokinetics (CYTK) announced positive topline results of Phase 2 clinical trial of CK-274 - an investigational cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM). The results inform dose selection. They also support the progression of CK-274 to a planned Phase 3 registrational clinical trial, expected to start before . . . This content is …

Vir Biotechnology Vir Biotechnology (VIR) announced the dosing of the first patient in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial to evaluate VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure. VIR-2218 is an investigational . . . This content is for paid subscribers. …

Halozyme Therapeutics Announced US FDA Approval for Janssen Biotech's DARZALEX FASPRO® Halozyme Therapeutics (HALO) announced that Janssen Biotech, Inc. (Janssen) received U.S. FDA approval of DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for adult patients with multiple myeloma who have received at least one prior line of therapy, including . . . This content is for paid subscribers. Please click here to …

IVERIC bio GATHER2 Trial of Zimura® for Geographic Atrophy  IVERIC Bio (ISEE) announced that it received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the pivotal clinical trial of IVERIC product Zimura® (avacincaptad pegol) for the treatment of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …

Halozyme Therapeutics Approvals for DARZALEX®SC Halozyme Therapeutics (HALO) announced that the European Commission (EC) has granted Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union.  The first authorization relates to the use of DARZALEX® SC in combination with bortezomib . . . This content is for paid subscribers. Please click here to …

Blackstone Life Sciences, Intellia Therapeutics and Cellex Cell Professionals New Company Blackstone (BX) announced that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company with Intellia Therapeutics (

Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.

Veracyte Inc Decipher® Prostate Test Veracyte Inc (VCYT): New data that demonstrated the prognostic utility of its Decipher® Prostate genomic classifier in men with non-metastatic castration-resistant prostate cancer (nmCRPC) has been published online in

Vertex Pharmaceuticals Receives FDA Approval for TRIKAFTA® Vertex Pharmaceuticals (VRTX) announced the U.S. FDA approved the expanded use of TRIKAFTA® to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive . . . This content is for paid subscribers. Please click here to …

Clinical Holds on bluebird bio Gene Therapies were Lifted by the FDA The U.S. FDA has lifted the clinical holds on the bluebird bio (BLUE) Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Focus on Intellia Therapeutics Upcoming Presentation for NTLA-2001 Data to offer insight into safety and pharmacodynamics of NTLA-2001, the first-ever systemically administered in vivo CRISPR therapy candidate Late-breaking abstract selected for oral presentation on June 26 Intellia Therapeutics NTLA-2001 for People Living with hATTR-PN Intellia Therapeutics (NTLA) announced that Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

BridgeBio Pharma Granted Fast Track Designation for Encaleret BridgeBio Pharma (BBIO) announced the U.S. FDA granted Fast Track designation for Encaleret – a treatment of autosomal dominant hypocalcemia (ADH1), on World Hypoparathyroidism Awareness Day, an annual global awareness event meant to support people who are living with ADH1 and with other types of hypoparathyroidism. ADH1 is a rare, genetic form of . . . This …

Annovis Bio Inc and Neurodegenerative Diseases Annovis Bio Inc (ANVS), a clinical-stage drug platform company. This firm's focus is the treatment of neurodegenerative diseases. Annovis Bio Inc announced today new results from a double-blind, placebo-controlled study of its product ANVS401, the Company's lead . . . This content is for paid subscribers. Please click here to subscribe or here to log in.