The Future is Starting Now Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main topic the Prohost Letter that we are working diligently working on posting at any time now. This is extremely important to know before the hype …

The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion recommending marketing authorization of Alnylam’s (ALNY) RNAi product Onpattro™ (patisiran). The product is designed to treat hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The CHMP opinion is based on conclusive positive results from APOLLO Phase 3 study on patients with hATTR amyloidosis. The results were published in The New England Journal …

AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences (NBIX), announced that the United States FDA approved Orilissa™ (elagolix) under priority review for women with moderate to severe endometriosis pain. Orilissa represents the first FDA-approved oral treatment for moderate to severe endometriosis pain in over a decade. The drug is expected to be available in U.S. retail pharmacies in early August 2018. Endometriosis is a condition where …

The good news from Biogen’s (BIIB) Q2 exciting financial results comprised impressive news for Ionis (IONS) from the commercialization of Ionis’ approved product, Spinraza for Spinal muscular atrophy (SMA).  Biogen is also responsible for the commercialization of Ionis’ products Tegsedi™ (inotersen) and Waylivra™ (volanesorsen) – two antisense drugs that Ionis discovered and successfully advanced through Phase 3 studies. In the second quarter of Biogen’s 2018 …

Yesterday’s news unveiled that PTC Therapeutics (PTCT) has entered into an agreement to acquire Agilis Biotherapeutics. The transaction was approved by the Boards of both companies. The acquisition Agilis Biotherapeutics is expected to bring to PTC Therapeutics an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system. It is supposed to add to PTC Therapeutics’ pipeline an advanced gene therapy candidate, …

Novartis’ (NVS) financials results exceeded analysts’ expectations. The firm’s research institutions’ strategy, well-designed structure, plans for innovation and accurate execution led to a wealthy and competitive pipeline with more than 200 projects in clinical development. Novartis is flying into the future finding its way to more effective treatments and possible cures. As a matter of fact, Novartis is at the end of the road towards …

A Miracle-Like Gene-Editing That People will Sooner or Later Recognize. The Wellcome Sanger Institute’s new findings about CRISPR/Cas9 gene editing is intended to lead to further improvement in the safety of the breakthrough CRISPR gene editing procedure before it is used in clinical practice; the information is not intended to condemn it. Unfortunately, innocent investors got panicky when they heard the Wellcome Sanger findings, which …

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) to the U.S. FDA for the approval of their osteoporosis investigational monoclonal antibody product Evenity™ (romosozumab). The product is indicated for osteoporosis in postmenopausal women at high risk for fracture.The drug increases bone formation and reduces bone resorption simultaneously to increase bone mineral …

The Week in Review #26 IN THE BIOTECH WORLD - RESEARCH - IMPROVING CRISPR GENE EDITING The problem cited with gene editing is that the editing may stay switched on after it succeeded in reaching its goals. To prevent further unwarranted mutations, scientists from the Bath and Cardiff University have invented a switch that aims at controlling protein expression in cultured cells and mouse embryos with the …

The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of Exelixis (EXEL) product Cabometyx® (cabozantinib) in previously treated patients with advanced hepatocellular carcinoma (HCC). The data demonstrate that Cabometyx provided a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. It is important to know that the clinical trial results formed the basis of regulatory …

Finally, we are hearing what we were constantly expecting to hear coming out of Compugen’s (CGEN) technological capability. Yesterday, the U.S. Food and Drug Administration (FDA) has cleared Bayer AG’s investigational new drug (IND) application for BAY 1905254, a first-in-class immuno- oncology therapeutic antibody targeting ILDR2. The target ILDR2 is a novel immune checkpoint protein discovered by Compugen through its predictive computational capabilities, which enable …

The Week in Review #25 When Stocks Plummet for No Relevant Reasons Sometimes investors need to know why some of their stocks plummet when no bad news is broadcast anywhere and when firms announce terrific news promising progressive growth. Yesterday was one of those days where reasons for stocks’ deviant, and probably unwarranted, negative performances must be identified. Let’s have a look at what happened during …