Seagen and Genmab Granted FDA Accelerated Approval for TIVDAK™ The U.S. FDA granted accelerated approval to Seagen Inc (SGEN) and Genmab A/S (

Intellia Therapeutics IND Application of NTLA-5001 for AML is Accepted by the US FDA NTLA-5001 is Intellia Therapeutics (NTLA) first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. It is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor (WT1) antigen for the treatment of all genetic subtypes . . . This content is for paid …

Regenxbio and AbbVie in the NEWS Regenxbio (RGNX) stock soared today. The Company, along with AbbVie (ABBV

IVERIC bio Stock Rally IVERIC bio (ISEE) stock rallied in early, premarket trading today as Stifel Nicolaus initiated a buy rating and a price target of $22. In premarket the stock was trading over $13.37, UP over $4 and still moving. Following the tumbling of the firm's stock . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Impel NeuroPharma FDA Approval for TRUDHESA The U.S. Food and Drug Administration (FDA) approved Impel NeuroPharma (IMPL) product TRUDHESA (dihydroergotamine mesylate (DHE)), previously known as INP104, a nasal spray for the treatment of acute migraine with or without aura in adults. Using Impel’s proprietary Precision Olfactory Delivery (POD®) technology enables a gentle, quick delivery of . . . This content is for paid subscribers. Please …

TCR2 Therapeutics TCR2 Therapeutics (TCRR) is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from cancer. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In . . . This content is for paid subscribers. Please …

Cassava Sciences Responds to Misleading Posts Cassava Sciences (SAVA) today issued a response to claims that were posted online yesterday after market hours. Cassava Sciences believes the claims made in this post regarding scientific integrity are false and misleading. The Company stands behind its science, its scientists, and its scientific collaborators; it is responding to ensure the facts are known and respected . . . …

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 (