Category: Today’s Highlights

Intellia Therapeutics: Authorized to Initiate Phase 1/2 Clinical Trial of NTLA-2002 for Hereditary Angioedema

Intellia Therapeutics Authorization of CTA for Phase 1/2 Study of NTLA-2002 Intellia Therapeutics (NTLA) announced the authorization of its Clinical Trial Application (CTA) by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to initiate a Phase 1/2 study evaluating NTLA-2002 for the treatment of adults with hereditary angioedema (HAE). About Hereditary . . . This content is for paid subscribers. Please click here to subscribe or …

Reata Pharmaceuticals Plans to Submit Omaveloxolone NDA for Friedreich’s Ataxia in Q1 2022

Reata Pharmaceuticals to Submit Omaveloxolone for NDA in Early 2022 In a press release following the completion of pre-NDA meeting with the FDA, Reata Pharmaceuticals (RETA) stated that the purpose of the pre-NDA meeting was to discuss the content of Reata’s planned NDA submission. The firm plans to submit the NDA . . . This content is for paid subscribers. Please click here to subscribe or here to …

AstraZeneca Saphnelo Approved in Japan for Adult Patients with SLE

AstraZeneca Saphnelo Approved by Japanese Ministry of Health, Labor and Welfare Developed by AstraZeneca (AZN), Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in patients with systemic lupus erythematosus. The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical . . . This content is for paid subscribers. …

Encouraging News from Cassava Sciences

Cassava Sciences Announces Top-Line Clinical Data for Simulfilam Cassava Sciences Press Release Today Cassava Sciences (SAVA) announced top-line clinical data today from a pre-planned interim analysis of an on-going open-label study with its drug candidate simufilam in patients with mild-to-moderate Alzheimer’s disease. In a study funded by the National Institutes of Health (NIH), ADAS-Cog11 . . . This content is for paid subscribers. Please click here to subscribe …

The U.S. FDA Accepted Intellia Therapeutics IND Application of NTLA-5001 for Acute Myeloid Leukemia

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 …

Why IVERIC bio Stock Rallied Today

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.

Interesting, Good News for Impel NeuroPharma and Migraine Sufferers

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 …

Positive News for TCR2 Therapeutics – The U.S. FDA Granted Orphan Drug Designation to Gavo-Cel for Cholangiocarcinoma

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 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 . . . …

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

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 …

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 …

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 …

Why Cytokinetics’ Stock Price Soared in a Bad Market Day

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 …

Important Steps Forward Taken by Vir Biotechnology and Separately by Compugen

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 Announced Janssen Received U.S. FDA Approval of DARZALEX FASPRO®. See Also: IVERIC bio News

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 …