Travere Therapeutics Sparsentan for IgAN Positive Results Phase 3 PROTECT Study of Travere Therapeutics (TVTX) product sparsentan for the treatment of IgA nephropathy (IgAN) demonstrated positive topline interim results. The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than a threefold reduction of proteinuria from baseline after 36 weeks of treatment . . . This content is for paid …

Akero Therapeutics Inc Akero Therapeutics Inc (AKRO) is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero’s investigational drug product candidate, efruxifermin (EFX), is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates . . . This content is for paid subscribers. Please click here …

Vir Biotechnology: What We've Learned from Dr. George Scangos George Scangos, PhD. is the chief executive officer of Vir Biotechnology (VIR), we don't know if you remember him from our previous postings, so we will remind that Dr. Scangos has said that Vir Biotechnology made strong progress across its extensive infectious disease portfolio, the most notable of which . . . This content is for …

Reata Pharmaceuticals Two Stories  Omaveloxolone in Patients with Friedreich’s Ataxia  Several communications between Reata Pharmaceuticals (RETA) and the FDA have taken place in the past regarding omaveloxolone for Friedreich’s Ataxia (FA) without reaching clear results that could satisfy either the Firm or the FDA. However, recent communication by the FDA seems to have finally satisfied both.  Following . . . This content is for paid …

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 …

Exelixis sNDA Accepted by the US FDA for CABOMETYX® The U.S. Food and Drug Administration (FDA) accepted Exelixis (EXEL) supplemental New Drug Application (sNDA) for CABOMETYX ® (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive . . . This content is for paid subscribers. Please click here …

Novartis Partial Clinical Trial Hold for OAV-101 IT for SMA Lifted Novartis (NVS) announced that the U.S. FDA has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. The decision to lift the hold was based on data from . . . This content is for paid subscribers. …

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

Cassava Sciences There is no doubt in our minds that Cassava Sciences’ (SAVA) product simufilam will play a major role in the treatment of Alzheimer’s disease. We have no doubt that simufilam has improved cognition in patients with mild to moderate Alzheimer’s disease. The cognition gained 3.0 Points on ADAS-Cog in 9 months. The Alzheimer’s patients’ disordered . . . This content is for paid …

Cassava Sciences Inc Following Cassava Sciences Inc successful and promising presentations, all the titles of the news and articles written by fair professionals have been as follows: “Cassava Sciences announces positive biomarkers’ data and positive Cognition Data following the treatment with Simufilam” These titles never moved from the Internet even after a huge sell-off occurred.  Indeed, the improvement in cognition demonstrated by the data was …

Cassava Sciences Inc Press Release Related to Positive Biomarker Data  Cassava Sciences Inc (SAVA) announced today, in a press release, positive biomarker data from an open-label study of simufilam, the Company’s investigational drug for the treatment of Alzheimer’s disease. In a clinical study funded by the National Institutes of Health (NIH), simufilam significantly improved all measured biomarkers in patients with Alzheimer’s disease following 6 months of open-label …

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

Cassava Sciences: Positive Clinical Data with SavaDX Cassava Sciences (SAVA) today announced positive clinical data with SavaDx, an investigational diagnostic/biomarker to detect Alzheimer’s disease with a simple blood test. SavaDx was used to measure plasma levels of altered filamin A before and after simufilam treatment in patients with Alzheimer’s disease. In this Phase 2b randomized, controlled trial sponsored by the National Institutes of Health (NIH), simufilam significantly reduced …

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 …

Cassava Sciences Soared Cassava Sciences (SAVA) stock soared today. The firm announced that it will present two new clinical datasets for its product candidates at the 2021 Alzheimer’s Association International Conference (AAIC), which will be held virtually in Denver, CO from July 26th through July 30th. Cassava Sciences’ investigational product candidates include simufilam treatment . . . This content is for paid subscribers. Please click here to subscribe or …

Immunome Inc: Neutralizing SARS-C0V-2 Delta Variant Immunome Inc (IMNM) is a small biotech firm whose stock soared after announcing today that its three-antibody cocktail (IMM-BCP-01) demonstrated potent neutralizing activity against the SARS-CoV-2 (the virus that cause COVID-19) Delta variant in pre-clinical pseudovirus testing. The IMM-BCP-01 cocktail demonstrated in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance. From the …

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. …

Hoth Therapeutics Hoth Therapeutics (HOTH) announced that its product, HT-003, has yielded positive results in an in vivo acne therapeutic model. The model showed that HT-003 reduces the expression of toll-like receptor 2 (TLR2

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 …