Reata Pharmaceuticals Announcement Regarding the NDA for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced that the U.S. Food and Drug Administration (FDA) does not plan to hold an advisory committee meeting in connection with its review of the Company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. From Reata Pharmaceuticals CEO Warren Huff, Reata’s Chief Executive Officer, said, …

Biogen & Eisai Co and Early Alzheimer's Disease  From Tokyo and Cambridge, Eisai Co., Ltd. and Biogen Inc. (BIIB) announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab. The product is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (

Intellia Therapeutics  Intellia Therapeutics.(NTLA) and Regeneron Pharmaceuticals (REGN) today announced positive interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Akero Therapeutics Akero Therapeutics (AKRO) - a clinical-stage company, today released topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). The study met its primary endpoint for both the 50mg . . . This content is for paid subscribers. Please …

Amylyx Pharmaceuticals in the News Amylyx Pharmaceuticals (AMLX): The U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee has voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol ) for the treatment of amyotrophic lateral sclerosis (ALS). The advisory committee’s decision was based on a review . . . This content is …

IVERIC Bio ~ September 6, 2022 IVERIC bio (ISEE) announced positive results from GATHER2 second Phase 3 clinical trial of Zimura® (avacincaptad pegol) - a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA). GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a . . . This content …

Gilead Sciences Good News for Breast Cancer Gilead Sciences' (GILD) product Trodelvy® has significantly improved the Overall Survival (OS) in Pre-Treated HR+/HER2- metastatic breast cancer patients in the TROPiCS-02 study. Today, Gilead Sciences' (

Reata Pharmaceuticals in the NEWS Reata Pharmaceuticals (RETA) on August 8, 2022, after the U.S. financial markets closed, received a communication from the U.S. Food and Drug Administration (FDA) informing us that they have extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich’s ataxia by three . . . This content is for paid subscribers. Please click here …

The clinical-stage Clene Nanomedicine Firm Reported Significantly Decreased Mortality in Amyotrophic Lateral Sclerosis (ALS) CNM-Au8® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs 14 placebo deaths CNM-Au8 treatment was well-tolerated, with no significant safety findings  during this trial Clene Inc in the NEWS Clene Inc (CLNN), along with its subsidiaries, “Clene”, and its wholly owned . . . This content is for paid …

Vertex Pharmaceuticals and ViaCyte Inc are in the NEWS Vertex Pharmaceuticals (VRTX) entered into a definitive agreement under which it will acquire ViaCyte, a private biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. From Vertex Pharmaceuticals and ViaCyte Inc Reshma Kewalramani, M . . . This content is for paid subscribers. …

CureVac N.V. Files Lawsuit Against BioNTech for Infringement  CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …

Regeneron Pharmaceuticals Acquisition of Checkmate Pharmaceuticals  Regeneron Pharmaceuticals (REGN) announced a successful acquisition of Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology. The firm has added a new modality to the company's portfolio of potential combination-ready approaches for difficult-to-treat cancers. Checkmate's lead investigational candidate, vidutolimod, is an advanced generation CPG-4 oligodeoxynucleotide toll-like receptor 9 . . . This content is for paid subscribers. Please click here …

Karyopharm Therapeutics  Karyopharm Therapeutics (KPTI) and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly . . . This content is for paid subscribers. Please click here to subscribe or …

A lot is happening while the Stock Market is tanking and is finally being considered a Bear Market. Trading in this Market as it is now is more like gambling rather than trading. We are working hard towards evaluating our picked stocks and finding the possible time they might reach our new targets.   In the meantime, Vertex's stock, which we believe is one of …

Amgen Repatha Studies Repatha is the Longest Studied PCSK9i Amgen (AMGN) announced top-line results from two Repatha® (evolocumab) open label extension (OLE) studies to the Phase 3 FOURIER cardiovascular outcomes trial. The studies were designed to assess the long-term safety and tolerability of Repatha over five years in adults with clinically evident atherosclerotic cardiovascular disease. The FOURIER-OLE (Further . . . This content is for paid …

Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …

Jazz Pharmaceuticals and Werewolf Therapeutics Agreement Jazz Pharmaceuticals (JAZZ) and Werewolf Therapeutics (HOWL)

Gilead Sciences' Product Yescarta Kite - a Gilead Sciences (GILD) Company, announced the U.S. FDA has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) refractory to first-line chemo-immunotherapy or that which relapses within 12 months of first-line chemo-immunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant . . . This content is for paid subscribers. Please click here to subscribe or …

Some Gains in Biotech Stocks During the War in Europe On Tuesday, Mar 8,2022 the United States’ government decided to ban the importation of Russian oil, liquefied natural gas and coal. This decision was made to further deprive Russia from the resources that enable it to continue with the unwarranted war against Ukraine. This resolution has come at a time when the price of oil …

The Stock Market Today Before the end of 2021 we recognized that investors were not going to swallow what was reiterated about the strong economy. The fact was there were no criteria for a strong economy. Instead, the unparalleled inflation problem was confirmed, which, normally, is expected to negatively impact most of the criteria of a strong economy. The stock market looked to be outperforming …