Prohost Letter #452 Treating Untreatable Disease - NASH Non Alcoholic Steatohepatitis  The efforts spent on treating Non Alcoholic Steatohepatitis (NASH) have reached a promising stage where clinical trial data from the clinical-stage and revenue-generating biotech firms have demonstrated capability of treat NASH. The most promising of these firms we believe, are clinical-stage firms, especially those firms that have already demonstrated capability of regressing fibrosis in …

Alnylam Pharmaceuticals Alnylam Pharmaceuticals (ALNY) led the translation of RNA interference (RNAi) into a new class of innovative therapeutics, transforming the lives of people afflicted with rare and prevalent diseases with unmet needs. RNAi is a natural cellular process of gene silencing that represents  promising and rapidly advancing frontiers in biology and drug . . . This content is for paid subscribers. Please click here to …

Prohost Letter #444 The End of the Year Issue was delayed because our 2020 Prohost Portfolio stocks’ targets for the year failed to materialize; nobody not even the authorities were capable of predicting the pandemic, which continues to plague the world. As 2021 approached, we were unable to the End of the Year issue on time as we lacked the information required for the fair …

Alnylam Announces FDA Approval of OXLUMO™ Injection for PH1 Alnylam (ALNY) announced that the US FDA has approved its subcutaneous OXLUMO™ (lumasiran) injection, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Primary Hyperoxaluria Type 1  PH1 is an ultra-rare genetic disease. It is . . . This content is for …

Treating and Preventing COVID-19 Treating COVID-19, Gilead Sciences With regard to treating patients with COVID-19 we believe the most expected product to be used during this virus' outbreak will be Gilead Sciences’ (GILD) product remdesivir. This product has reduced the severity of the coronavirus infection symptoms in animal testing and in a few . . . This content is for paid subscribers. Please click here to …

Prohost Letter #439 The Coronavirus Outbreak - COVID-19 The news announced that the coronavirus (now known as COVID-19) outbreak would affect not only people’s health and survival but the world’s economy, Wall Street’s performance, and especially the international giant industrial firms that are committed to China. British AstraZeneca (AZN

Prohost Letter #438 End of the Year Issue  2019 Happy New Year 2020 The NASDAQ reached 9000 for the first time in the market history on December 30, 2019. However, on the last trading day of 2019, the Nasdaq Composite Index closed at 8,945.99 after giving back 60.62 points or 0.7%. During the departed year, however, the stock exchange was boosted by the outperformance of …

The Week in Review #48 Holiday Edition ******************** Merry Christmas and Happy Hanukkah! We Wish You a Happy New Year Filled with Excellent Health, Peace of Mind, Prosperity and Happiness What a Year for Biotechnology What happened in the biotech sector toward the end of 2019 is briefed in this Review as we focus on the performance of our picked firms’ stocks’ prices. We will …

Ionis Pharmaceuticals Ionis Pharmaceuticals (IONS) announces a private placement of $507.5 million principal amount of 0.125% convertible senior notes due 2024. To read this news go to the original  content to download multimedia by clicking here.  During the announcement of 2019 third-quarter financial results the conference call started citing the firm's improved revenues and income. Revenues have increased by more than 50% to nearly $630 million and …

The Market May be Plummeting But Prohost Picks are Not Biotech stocks had a strong start, but the gains disappeared in many stocks as the market demonstrated bearishness following a long-lasting rally. Currently, during the strong economic conditions, commentators attribute the reasons for the market’s upside and downside moves to China’s positive, or negative ongoing negotiations rather than to fair correction of overbought or oversold …

Novartis to Acquire The Medicines Company Novartis (NVS) decided to buy The Medicines Company (MDCO) at $6.8 million. The Medicines Company’s shareholders will be getting $85 per share in cash  – a 45% premium to its unaffected share price and a 57% premium to its unaffected one-week average price. The Transaction is expected to be completed in the first quarter of 2020 The Medicines Company …

Prohost Letter #437 An All Time High Market More Prohost Picks Have Reached the 2019 Targets The stock market performance has reached an all-time high with more of our picks reaching or nearing the Prohost 2019 price targets. There are stories to tell about some devastated stocks which many believed were dead and buried but were surprisingly resurrected, and their stocks are going up. Another …

Alnylam Granted FDA Early Approval of GIVLAARI™ for AHP Alnylam’s (ALNY) stock outperformed as its subcutaneous injection GIVLAARI™ (givosiran) has been granted FDA early approval. GIVLAARI™ is created and developed for the treatment of adults with acute hepatic porphyria (AHP). AHP is a family of ultra-rare, genetic diseases characterized by debilitating, life-threatening attacks and, for some patients, chronic manifestations that demeans patients’ daily functioning and …

The Week in Review #47 What A Week For Biotechnology Synopsis In this “Week in Review” there is no complicated scientific and clinical information, leaving the details to the articles that we usually post on the Prohost website. Most of the Prohost picked firms’ Q3 financial results have beaten expectations. Three firms have reached the Prohost 2019 targets, and more firms have outperformed, with some …

The Week in Review #46 The Quarterly Financial Results The quarterly financial results that analysts and investors relied on for years to evaluate biotech firms, including development stage firms, seem to change. Investors have finally realized that development-stage firms have no marketed drugs and no revenues, hence, no incomes and should be evaluated based on the clinical trial results of their pipeline products. They saw …

The Week in Review #43 This Past Week After hearing hints about the trade war between China and the United States being avoided the market reversed course from faltering to flying at the speed of light. This trade war replaced all important factors that would usually affect the market performances. Unemployment is the lowest since 1969 and is expected to cause a bullish market, but …

RegenxBio Rebounding RegenxBio (RGNX) has the viral vectors which could safely deliver genes into the cells. The firm has improved the adeno-associated viruses making them safe and effective gene delivery vehicles. One of the three currently approved gene therapy products, Zolgensma® for pediatric spinal muscular atrophy (SMA), marketed by Novartis, used RegenxBio’s adeno-associated . . . This content is for paid subscribers. Please click here to …

The Week in Review #42 During the Departed Week The week started with the market losing over 1000 points and ended recuperating a large extent of the losses. Desperate during the market’s plummeting, some investors were happy for the rebound and some were confused and skeptical about what the unpredictable market might bring next. In the latest Prohost Letter #436, the losses in prices of …

The Medicines Company ORION-10 Study for ASCVD The Medicines Company (MDCO) announced positive topline results from the ORION-10 Phase 3 clinical trial in patients with atherosclerotic cardiovascular disease (ASCVD). The ORION-10 trial conducted with . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #435 The Value of the Biotech Companies A Continuation of Prohost Letter #434 A Recap The biotech near and long-term values, we insist, must be based on the firms’ scientific capabilities, products’ potentials and financial results. In the past months the stocks evaluations by bloggers, and some assessors, have been tailored to mislead investors into serving the purposes of the manipulators’ weird agendas. …

Migraine's Really Effective Treatments The years 2018 and 2019 could be called the years of migraine’s really effective treatments. Three Calcitonin-gene-related peptide (CGRP) monoclonal antibody drugs have been approved in 2018 and 2019. They are: Aimovig for Amgen (AMGN . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gene Therapy Stocks Experiencing Selloffs  Every investor in the biotech sector must have experienced selloffs of the stocks from companies specialized in gene therapy, gene editing, antisense, RNAi and mRNA therapies. Recently, bluebird bio’s (BLUE) stock was devastated. The selloffs occurred for many reasons, most of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Medicines Company The Medicines Company (MDCO) focuses on cardiovascular diseases. Major goals are halting the progression of atherosclerosis and lowering the cardiovascular risk caused by high levels of LDL Cholesterol (LDL-C). The firm announced good news from the results of its first pivotal Phase . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Week in Review #41 We Are Still Witnessing … The bizarre market performance that started in early 2019: In the past couple of months the great enthusiasm and response of the market to the undeniably strong economic indicators and the lowest unemployment figures turned, for mysterious reasons, to a perturbed-looking volatile market beast. The biotech stocks have given back most of their deserved gains …

The Medicines Company Are Inclisiran's Clinical Trial Results Impressive? Our answer is YES. The trial results came out with several, not just one, good news.  Inclisiran's Good News The first good news came from the ORION-3 study, conducted by The Medicines Company (MDCO)

  Conquering NASH Gilead and Novo Nordisk Conquering NASH What was Gilead Sciences' (GILD) announcement at EASL? What is Gilead doing to find effective treatments for NASH? Why would Novo Nordisk's (

Regeneron and Alnylam Agreement Will Benefit Both So Why the Sell-Off? Regeneron Pharmacueticals Founded, and led for 30 years, by physician-scientists Regeneron Pharmaceuticals (REGN) demonstrates an exceptional ability to translate science into medicine. Working diligently Regeneron succeeded in putting seven treatments in the hands of specialists in clinics around the world. Additionally, the firm managed to build a rich pipeline of numerous investigational products; all of …

Thanks to abundant cabozantinib sales’ revenues Exelixis (EXEL) is advancing a new generation of its medicines with its new product XL092 entering clinical trials. The drug is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors & MET and was the subject of an active Investigational New Drug (IND) application the firm had submitted to the U.S. Food and Drug Administration (FDA) in December …

More good news came  from Exelixis (EXEL). It was expected by many but not by those who ignore the good news in favor of any negative news or lack of news. The announced news is that the FDA approved Exelixis’ Cabometyx® (cabozantinib) for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. More good news is Exelixis’ announcement that the firm is prepared to fully support the …

Yesterday, the Stock Market skyrocketed and with it a significant number of Prohost Picks that we keep reminding ourselves are undervalued. The outperformance unveiled the interred strength of firms such as: Illumina (ILMN), Amgen (AMGN) and Vertex (VRTX), the gene therapy firms: RegenxBio (RGNX) and Spark (ONCE), and the gene editing firms: Crispr (CRSP), Intellia (NTLA) and Editas (EDIT), as well as others in the Prohost Portfolio. The rebounding in the …

Prohost Letter #424 Following the Stars Less Science and More Logic We reiterate that while a human star is born every once in a while on Earth, several stars born daily in research labs may be designated every other day by the FDA and other health regulatory agencies around the world. These agencies call these potential stars’ breakthrough drugs, but not all the molecules designated …

The Week in Review #28 The approval of revolutionary products created by biotech firms with solid scientific fundamentals, superior scientists and advanced technologies is what motivates us to pick for investment biotech and biopharmaceutical firms. So, let’s see what has been approved in the parting week  from firms that we picked for investment.       IMPORTANT APPROVALS       Prohost Picked Firm     …

The Week in Review #27 PRIORITY TOPICS: CRISPR GENE EDITING, GENETIC ENGINEERING & ANTISENSE TECHNOLOGY The choice of these topics was dictated by investors who follow the sell side preaching. These negative investors decided to cause a selloff in all kinds of therapeutics that act at the root cause of diseases, i.e., the malfunctioning genes. These therapeutics are what we call the future treatments and cures. Indeed, during …

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 …

The Market The Stock Market is Still under pressure, which is frightening common investors, pressuring them to sell. We see no real reasons for the stock market to be acting as a Bear when the criteria of bullishness are obvious and several. We see no need for us to be scared, overreact and unwillingly contribute to the selloff. In the News ALNYLAM Alnylam (ALNY) announced positive …

Alnylam (ALN) is probably experiencing a stock selloff following the announcement of successful results from Pfizer’s (PFE) drug tafamidis.    Indeed, results from Phase 3 ATT-ACT clinical trial demonstrate that tafamidis succeeded in treating Transthyretin Cardiomyopathy, a subtype of TTR amyloidosis caused by the destabilization of the protein transthyretin. Tafamidis demonstrated a statistically significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months. The drug was …

The Week in Review #20 THE MARKET - My friend asked: “Are  you  scared?” “Of  what?” I asked “The  market?” The  market? No,” I  said.  We are afraid of those who are rendering the market nervous and  temporarily confused, as we observed while monitoring its volatility.  The market has never been chronically confused . . . This content is for paid subscribers. Please click here to …

Regeneron (REGN) and Alnylam (ALNY) announced a collaborative agreement aimed at identifying RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The agreement is not the first between the two firms, but it would not have occurred if not for Regeneron’s identification of an important and unique therapeutic target that influences the liver debilitating and life-threatening nonviral hepatitis diseases, which affect thousands …

Alnylam (ALNY) announced that Sanofi Genzyme declined its opt-in for the development and commercialization of the RNAi product lumasiran, an investigational RNAi therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1). Based on this decision, Alnylam intends to rapidly advance lumasiran into a Phase 3 pivotal study in late 2018, and to commercialize lumasiran globally, assuming product approval. Alnylam has also announced that the FDA has granted lumasiran …

The Week in Review #19 Targeting the Root-­Cause of Diseases - Investing in the Future is Currently the Best Way - Stopping aberrant genes from causing diseases has taken time to move from wishful thinking to reality. Through trial and error, various different approaches have been tested over the years, including attempts at genetic engineering... &nbsp . . . This content is for paid subscribers. …

The Week in Review #16 More Exciting Rallies in Prohost Picks - The past week and for several week fascinating outperformances have been seen for many of the Prohost Portfolio stocks. We continue to articulate that the good news is not only in the stocks’ rallies, but also in the outstanding stories behind them . . . This content is for paid subscribers. Please click here …

Prohost Letter #416 Part 2 2017 - A YEAR OF BREAKTHROUGH TECHNOLOGIES, BREAKTHROUGH PRODUCTS, IMPROVEMENTS ON PROMISING BREAKTHROUGH TREATMENTS, DECIPHERING IMPORTANT LIFE SCIENCE MYSTERIES, PINPOINTING BIOLOGICAL PATHWAYS FOR TREATMENT RESISTANCE, MIRACLE CURES, AND… A LOT OF DISTORTED NEGATIVE INTERPRETATIONS - Prioritizing our choices of breakthroughs has been a dilemma . . . This content is for paid subscribers. Please click here to subscribe or here to log …

The Week in Review #11 A New Era - Faster than the speed of light, the management of diseases is shifting from fast improvement to a total gigantic unprecedented change. Some of the conquering approaches towards providing long-­lasting cures look as if the outcome of magic rather than mere science . . . This content is for paid subscribers. Please click here to subscribe or here to log …

The Week in Review #5 ALNYLAM (ALNY) and Sanofi Genzyme, the specialty care global business unit of Sanofi announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic for hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at …

Alnylam Pharmaceutical (ALNY) calls RNAi (RNA interference) a revolution in biology. The FDA’s just granted the firm’s RNAi therapy breakthrough for a disease nobody has ever dreamed of conquering confirms this reality in spite of spending years of efforts and money towards turning the RNAi molecules into therapeutic molecules that can be used safely and effectively. RNAi-related treatments represent a completely new approach to drug …

An approved rheumatoid arthritis drug developed and sold by Sanofi could become a new treatment for aggressive cancers. The news came in a Mount Sinai press release announcing that researchers have discovered that a rheumatoid arthritis drug can block a metabolic pathway that occurs in tumors with a common cancer-causing gene mutation. The discovery offers a new possible therapy for aggressive cancers with few therapeutic …

Prohost Letter #404 Part 2 Synthetic Biology (2) A Brief History DNA is the software of life. This is how Synthetic Genomics firm, which we believe is now is the leading biotech firm for applied synthetic biology. Synthetic Genomics is still a private firm in spite of that thousands of investors are impatiently waiting for it to turn public and it will. So stay tuned. …

Prohost Letter #404 Part 1 HAPPY SPIRITUAL HOLIDAYS HAPPY NEW YEA

Following recent reports of new onset or worsening peripheral neuropathy in patients with ATTR amyloidosis with cardiomyopathy (hATTR-CM) treated with Alnylam’s (ALNY) RNAi –based drug revusiran, The firm requested that the Data Monitoring Committee (DMC) review the reports and the Clinical trial data on an unblinded basis. After reviewing the reports, the DMC advised suspending the dosing of revusiran. However, the DMC stated that It …

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …

Regulus Pharmaceuticals (RGLS) a biopharmaceutical company that discovers, designs and develop treatments targeting microRNAs announced interim results from one of the company’s ongoing Phase 2 studies of its hepatitis C virus (HCV) product RG-101.  The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral …

Prohost Letter #389 Happy New Year 2016 Wishing You Good Health Peace of Mind Love And happiness  We expect 2016 to be the year that fulfills many of our great expectations about successfully managing intractable and life-threatening malignant and non-malignant disease. We expect the biotech firms to bring us more cures based on the maturation of genetic engineering processes following a lot of trial and …

Prohost Letter #388 TOPICS - 1. AN INDISPENSABLE SHORT INTRODUCTION 2. GENE EDITING 3. GENE THERAPY 4. CANCER IMMUNOTHERAPY 1. GENE EDITING Exon Skipping: Biomarin (BMRN); Sarepta (SRPT); These firms are waiting FDA approvals for Duchenne Muscular Dystrophy (DMD) Gene Editing Technology Competitors: Cellectis S.A. (CLLS); CRISPR; PTC Therapeutics (PTCT) Firms Using Different Approaches For DMD Treatment (see Below) Zink Finger Tech: Sangamo (SGMO); RNAi …

Prohost Letter #384 The Assassination of the Biotech Sector The Market (Part 2) On Friday September 18, 2015, the biotechnology sector occupied the news headlines for two different reasons. The first was the sudden unexplicable and unexpected plummeting of the biotech sector. The stocks were flying sky high until modday and suddenly, all the biotech stocks, without exception, took a dive. The second reason was the triumph of …

Prohost Letter #383 The Market - Recent tails about the market and the biotech sector are true thrillers. By true we mean no-fiction. The accounts lack common sense. Professionals' interpretations of the stocks' and of the market's moves are bizarre and misleading. General investors complain only when the stocks' volatility gets out of hand, yet, do not object to the hype, or interferes against the baseless …

but first: Here is some good news from  SAREPTA Yesterday we wrote about BioMarin (BMRN) being granted FDA “Rare Pediatric Disease Designation for its Duchenne potential muscular dystrophy (DMD) drug drisapersen.Today, Sarepta Therapeutics (SRPT) also a developer of RNA-targeted therapeutics has been granted the same for its drug eteplirsen, also a potential treatment for DMD patients who are amenable to skipping exon 51. The Rare …

Prohost Letter #378 Part 1 Views and Visions TOP-TIER BIOTECHNOLOGY COMPANIES GILEAD We wrote a lot about Gilead (GILD), doing our best to protect investors against negative gossip that filled the media and aimed at misleading and insulting investors’ intelligence. We never lowered our target based on the perpetrated, fabricated stories, which made many investors lose confidence in Gilead’s strategy and sell their stocks, thus, …

Prohost Letter #377 PICKING BIOTECH FIRMS Before Investing in Them Raising the bar in designating small drug developing firms as biotechnology firms has occurred several times since 2011. In that year, many technologies were tremendously enhanced, which enabled them to realize superior goals, i.e., produce safer and more effective breakthrough drugs for chronic debilitating and life-threatening diseases. Prohost Portfolios picks, which have outperformed other industries’ …

Prohost Letter #376 WHILE LOOKING AT THE BIOTECHS SCIENTIFIC FUNDAMENTALS We keep an eye on other factors That influence the stocks Investors who pick their stocks based on the firms’ solid scientific fundamentals, technological capabilities and pipeline products’ promises are mostly long-termers. They usually keep the stock they meticulously picked until they reach the goals that motivated them to pick it in the first place. …