Category: Today’s Highlights

Arcturus Therapeutics Additional Updates from ARCT-154 and ARCT-165 Clinical Trials and More

Arcturus Therapeutics Holdings Arcturus Therapeutics Holdings (ARCT) is a clinical-stage mRNA medicines company of enabling technologies with an interesting pipeline of treatments and vaccines as well as other products for diseases that have yet to find treatments. Arcturus Therapeutics’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense . . . This …

AstraZeneca Granted FDA EUA for Long Acting Antibody Evusheld for Pre-Exposure Prophylaxis of Covid-19

AstraZeneca Long Acting Antibody Granted FDA EUA for COVID-19 Prevention AstraZeneca (AZN) product Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with the first doses expected to become available very soon. The EUA for Evusheld was granted for . . . This content is for paid subscribers. Please click here …

Celldex Therapeutics Dosed the First Patient in a Phase 1 Study of CDX-0159 for Prurigo Nodularis

Celldex Therapeutics Dosed the First Patient with CDX-0159 for Prurigo Nodularis Celldex Therapeutics (CLDX) announced that the first patient in a Phase 1 study of CDX-0159 for prurigo nodularis (PN) has been already dosed.  From Celldex Therapeutics Diane C. Young, MD, Senior Vice President and Chief Medical Officer of . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Great News: Vertex Pharmaceuticals Announced Successful Phase 2 Study Results of VX-147

Vertex Pharmaceuticals Phase 2 Results of VX-147 Vertex Pharmaceuticals (VRTX) announced today that, in a Phase 2 proof-of-concept (POC) study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147, on top of standard of care, achieved a statistically significant, substantial and clinically meaningful . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Omicron Variant and the Bizarre Stock Market Chaos

The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms  We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …

Crispr Therapeutics and ViaCyte Inc to Start Trial of First Gene-Edited Cell Replacement Therapy for Type 1Diabetes

Crispr Therapeutics and ViaCyte Inc to Start Trial of First Gene-Edited Cell Replacement Therapy CRISPR Therapeutics (CRSP) and ViaCyte, Inc., announced that Health Canada approved their Clinical Trial Application (CTA) for the product VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy, for the treatment of type 1 diabetes (T1D). The Initiation of patient . . . This content is for paid subscribers. Please click here to …

Merck and Ridgeback Biotherapeutics: U.S. Government to Purchase 1.4 M Additional Courses of Molnupiravir for COVID-19

U.S. Government to Purchase More of Merck and Ridgeback Biotherapeutics Molnupiravir for COVID-19 Merck (MRK) and Ridgeback Biotherapeutics announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir - an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or . . . This content is for paid …

Reata Pharmaceuticals Third Quarter Financial Results and Other Company Updates

Reata Pharmaceuticals Business Operations and Clinical Development Updates Reata Pharmaceuticals (RETA) – a clinical-stage biopharmaceutical company announced financial results for the quarter ended September 30, 2021, and provided an update on the Company’s business operations and clinical development programs. Recent Highlights Bardoxolone in Patients with Chronic Kidney Disease (CKD) Caused by Alport Syndrome The New Drug Application (NDA

Reata Pharmaceuticals Submits MAA to the EMA for Chronic Kidney Disease Caused by Alport Syndrome

Reata Pharmaceuticals MAA Submission for Bardoxolone Methyl Reata Pharmaceuticals (RETA) announced the submission of a Marketing Authorization Application (MAA) for bardoxolone methyl to the European Medicines Agency (EMA) for chronic kidney disease (CKD) caused by Alport syndrome. The MAA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. This . . . This content is for paid subscribers. …

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 …