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 …

GlaxoSmithKline and Vir Biotechnology Sotrovimab Retains In Vitro Activity Against Omicron GlaxoSmithKline plc (GSK) and Vir Biotechnology (

Amgen Announces Positive Results from Otezla Study for Psoriasis Amgen (AMGN) announced positive top-line results from the DISCREET trial - a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study demonstrated that oral Otezla 30 mg twice daily achieved a . . . This content …

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 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 …

Ionis Pharmaceuticals Announced Pfizer Update of Vupanorsen Ionis Pharmaceuticals (IONS) announced that Pfizer's (

Takeda Pharmaceutical Granted FDA Approval for LIVTENCITY for Post-Transplant Cytomegalovirus On November 23, 2021 Takeda Pharmaceutical Co Ltd (TAK) announced that the U.S. FDA has approved LIVTENCITY™ (maribavir) for adults and pediatric patients (12 years of age or older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or …

Regenxbio Granted Orphan Drug Designation for RGX-202 Regenxbio (RGNX) announced the U.S. FDA granted Orphan Drug Designation for RGX-202 - a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy. RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal domain and a . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences All Have Good News Cassava Sciences & Alzheimer's Disease Cassava Sciences (SAVA) announced the initiation of a second Phase 3 trial of simufilam, its investigational drug for Alzheimer’s disease. This second Phase 3 study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 Alzheimer’s . . . This content is for …

Gilead Sciences Collaboration with Arcus Biosciences Sends Stock Through the Roof There is no doubt that Gilead Sciences (GILD) is appreciating Arcus Biosciences (

GlaxoSmithKline and Vir Biotechnology Announces US Gov't Contracts to Purchase Sotrovimab for COVID-19 GlaxoSmithKline plc (GSK) and Vir Biotechnology (

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 …

Regenxbio and AbbVie Inc Agreement Regenxbio (RGNX) announced the successful closure of the collaboration and license agreement with AbbVie Inc (

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 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

Intellia Therapeutics to Present at ASH Intellia Therapeutics (NTLA) announced the presentation of data from its ex vivo research and development efforts in two poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Atlanta, GA, as well as virtually, December 11-14, 2021. From the CSO at Intellia Therapeutics Laura Sepp-Lorenzino, Ph.D., Chief Scientific Officer, Intellia Therapeutics, said, “As we continue to …

Sangamo Therapeutics Preliminary Results Evaluating Isaralgagene Civaparvovec for Fabry Disease Sangamo Therapeutics (SGMO) announced preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920 - a wholly owned gene therapy product candidate, for Fabry disease. As of the September 17, 2021 cutoff date, results from the four patients treated in the first two dose cohorts (0.5e13 vg . . . This content is for …

Cassava Science: Journal of Neuroscience Review Shows No Evidence of Data Manipulation Cassava Sciences (SAVA) has been informed by the Journal of Neuroscience that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer’s disease. The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Company’s …

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. …

Merck Stock Soared Great expectations for Merck (MRK) future growth and the future of novel treatments for patients with severe devastating and life-threatening diseases. Keytruda - Merck's cancer immunotherapy drug, has reached a milestone and molnupiravir - its COVID-19 pill, sales revenues are expected to generate $5 billion to $7 billion through 2022, subject to emergency use authorization, at the end of November 2021. The …