Author: Prohost

Cassava Sciences Issued a Response to Claims Posted After Market Yesterday. See Also: Cassava Sciences Good News

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 . . . …

Cara Therapeutics and Vifor Pharma Announced the U.S. FDA Approval of KORSUVA™

Cara Therapeutics and Vifor Pharma Granted US FDA Approval of KORSUVA™ Indeed, the U.S. Food and Drug Administration (FDA) approved Cara Therapeutics (CARA) and Vifor Pharma injectable product KORSUVA™ (difelikefalin) - a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, for moderate-to-severe pruritus associated with chronic kidney . . . This content is for paid subscribers. Please click here to subscribe or here to …

Axsome Therapeutics: Treating Major Depressive Disorder. Vivos Therapeutics: Improving the Treatment of Obstructive Sleep Apnea

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

The US FDA Granted Fast Track Designation for Sutro Biopharma Product STRO-002

Sutro Biopharma Inc Granted Fast Track Designation for STRO-002 by the US FDA Sutro Biopharma Inc (STRO) announced that the U.S. FDA granted Fast Track designation for its STRO-002 – a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior lines of systemic therapy. From …

Why Virpax Pharmaceuticals Stock Soared on Two Consecutive Days

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 …

BeiGene Ltd and EUSA Pharma Product QARZIBA® Approval from China NMPA. See Also: Sagimet Sciences and NASH  

BeiGene Ltd and EUSA Pharma Receive Approval from China NMPA for QARZIBA®  BeiGene Ltd (BGNE) and EUSA Pharma announced that China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell …

Travere Therapeutics: Positive Trial Results of its Product Sparsentan in Treating IgA Nephropathy

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 Q2 Business Updates and Financial Results

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 …

A Biotechnology Company to Remember and Appreciate

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: Updated News of its Clinical Programs and Finances

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 Corporate Update and Financial Results for Q2 2021. See Also: Why Intellia Was Down Today

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 …

The U.S. FDA Accepts Exelixis sNDA of CABOMETYX® for Priority Review

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 Announces Lift of Partial Clinical Trial Hold. See Also: Plans to Initiate a New SMA Study

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. …

AstraZeneca: Big Step Towards Improving the Lives of SLE Patients and More on Cassava Sciences

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 Good News and an Unwarranted Sell-Off. A New Drug Approval for Bristol-Myers Squibb and ImmunoGen Quarterly Results

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: Today’s Press Releases

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 …

Cassava Sciences Announces Positive Data with SavaDx from a Randomized Controlled Phase 2b Study of Simufilam

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 Approval for its Gene Therapy SKYSONA™ for Young People with Early CALD Without a Matched Sibling Donor

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 …