Category: Impacting News

Humanigen Inc Product Lenzilumab Combination with CAR T in DLBCL Protects from Severe Cytokine Syndrome

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T …

Vir Biotechnology and GlaxoSmithKline: The European Medicines Agency Started a Review of VIR-7831 for COVID-19

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic …

Intellia Therapeutics Announces More Good News

Intellia Therapeutics NTLA-2001 for ATTR Granted Orphan Drug Designation by the EC Intellia Therapeutics (NTLA) announced that the European Commission (EC) has granted its product NTLA-2001 orphan drug designation. The investigational product is being developed as a treatment for transthyretin amyloidosis (ATTR), a rare condition that can impact a number of organs and tissues within the . . . This content is for paid subscribers. Please click here …

Exelixis CABOMETYX: Now Approved in Europe for First-Line Treatment of Renal Cell Carcinoma

Exelixis Boxed in on Good News Exelixis (EXEL) is one of the firms boxed in by rule of thumb traders and short-sellers who put enormous pressure on biotech firms regardless of their good news. We sincerely believe that is what's happening to EXEL. We also believe that these firms, especially the achievers . . . This content is for paid subscribers. Please click here to subscribe …

A Biotech Firm We Love to Discover

Rubius Therapeutics Finding small development-stage biotech firms that contribute to biotechnology's limitless revolution of the biological sciences is difficult, but indispensable. Falling on firms that might have the science, the technological capability and the inspiration towards creating new diagnostics and treatments for severe diseases, is rewarding through improving lives.       Learning about Rubius Therapeutics (RUBY) has given us the impression . . . This content …

The FDA Approved KemPharm Inc’s AZSTARYS™ for ADHD

KemPharm Inc KemPharm Inc (KMPH) - a specialty pharmaceutical focused on the discovery and development of proprietary prodrugs, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for AZSTARYS™, a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Compugen: Good News During Bad Market Days

The market is sinking in a furious mood caused by the failure to figure out the pathway of criteria, which is currently controlling the stocks’ volatile performances. Today we are posting good news coming from a few biotech companies with solid fundamentals. Unfortunately, all of these firms are tumbling instead of soaring, or at least performing positively. The first is under News & Comments and …

Regeneron Pharmaceuticals: Good News During Bad Market Days

The market is sinking in a furious mood caused by the failure to figure out the pathway of criteria, which is currently controlling the stocks’ volatile performances. Today we are posting good news coming from a few biotech companies with solid fundamentals. Unfortunately, all of these firms are tumbling instead of soaring, or at least performing positively. The first is under News & Comments and …

Is There a Possible Comeback for Nektar Therapeutics?

Nektar Therapeutics YoYoing Stock Price Investors who exaggerate their enthusiasm, or their apathy, towards buying and selling biotechnology stocks have sent the Nektar Therapeutics (NKTR) stock price to the Moon but wasted no time bringing it back to Earth. This, of course, after we fell in love with it and selected it for investment purposes. We witnessed the stock reach near $80 only . . …

Regeneron Has Much Good News. Is the Market Paying Attention?

Regeneron Pharmaceuticals Approval of EvkeezaTM for HoFH Regeneron Pharmaceuticals (REGN) has a series of good news that the market does not seem to be aware of as the stock price has yet to react.   On February 11, 2021 Regeneron announced that the U.S. FDA has approved the firm’s product EvkeezaTM (evinacumab-dgnb) as an adjunct to . . . This content is for paid subscribers. Please …

Amgen is Still the King of the Biotech Sector

Amgen KRAS Inhibitor, Sotorasib Amgen (AMGN) has taken on one of the toughest challenges in the last 40 years when it comes to cancer research by developing the KRAS inhibitor, sotorasib. This product was the first KRAS inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents. In . . . This content …

Aurinia Pharmaceuticals: FDA Approved LUPKYNIS for Active Lupus Nephritis in Adults  

Aurinia Pharmaceuticals LUPKYNIS Approved for LN in Adults Aurinia Pharmaceuticals (AUPH) has been granted a U.S. FDA approval of its product LUPKYNIS™ (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Lupus Nephritis LN is a serious progression of systemic lupus erythematosus (SLE) - a chronic, complex and . . . This content is for paid …

Merck Has Interesting News and Impressive Results

Merck Discontinues Development of COVID-19 Vaccine Candidates Merck (MRK) known as MSD outside the United States and Canada announced yesterday that the company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 . . . This content is for paid subscribers. Please click here …

Compugen: Why the Great Expectations from this Firm

The Compugen Story For those who are still asking about the value of Compugen’s (CGEN) discoveries our answer is that the best story written about this firm is its own autobiography.   We believe Compugen's accomplishments are extremely valuable in improving the treatment of cancers. As small as the firm is, Compugen . . . This content is for paid subscribers. Please click here to subscribe …

bluebird bio: The Appealing Decision to Separate its Severe Genetic Disease and Oncology Businesses into Independent Publicly-Traded Firms

bluebird bio Decision to Separate its Businesses bluebird bio (BLUE) will retain focus on its severe genetic disease (SGD) and will launch its oncology business (Oncology Newco) as a new entity. The Board of Directors at bluebird bio approved this decision and it is anticipated that the spin-out of Oncology Newco is to be tax-free . . . This content is for paid subscribers. Please click here to …

Rhythm Pharmaceuticals: Successful Results from Phase 3 Trial with Setmelanotide for Obesity Caused by Genetic BBS

Rhythm Pharmaceuticals Announces Successful Phase 3 Trial Results for Obesity In November 2020, when the U.S. FDA granted approval to the Rhythm Pharmaceuticals (RYTM) product IMCIVREE™ (setmelanotide) for obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/Kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency, the firm has since announced positive results from a pivotal . . . This content is for paid subscribers. Please click here …

Intellia Therapeutics: Reinforcing the Promise of Potentially Curing Diseases

Intellia Therapeutics in the News Intellia Therapeutics (NTLA) presented the first demonstration of physiological protein levels of human alpha-1 antitrypsin (AAT) in non-human primates (NHPs) following a single administration.  Intellia Therapeutics Liver Gene Insertion Technology Intellia’s targeted liver gene insertion technology has the ability to achieve therapeutic levels of protein . . . This content is for paid subscribers. Please click here to subscribe or here to …