The Chinese National Medical Products Administration (NMPA) has approved Gilead’s (GILD) HIV combination product Descovy®.  In China, Descovy is to be indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with a body weight of at least 35 kg). TAF, which is part of the combination treatment, is a novel, targeted prodrug of …

The Week in Review #35 Politics and the Market The market tumbled today as Theresa May, the Prime Minister of England, delayed the Brexit vote!  The question becomes, what will be put forth next as a legitimate reason for bringing the market down and eroding investors’ gains? The weather? A war among gangs in a fourth-world country? Maybe the resignation of the chairman of a …

Today, the market took another beating as a result of either an intentional or an unintentional lack of clearance by professionals in describing correctly the standing of employment and other current economic realities. They pinpointed irrelevant reasons in an effort to justify the Stock Market's tumbling.  One big headline was that 150,000 added jobs did not meet expectations. They never explained whether those jobs were all …

The Week in Review #33 WE CALL IT THE BAD MARKET The Federal Reserve’s raising of the interest rate does not and should not mean a demise of the companies trading on the NASDAQ and other stock exchanges. The biotech group of firms with strong scientific fundamentals will not stop innovating and bringing breakthroughs to millions of people who are desperate for them if an …

IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …

The Week in Review #30 FROM THE DEPARTED WEEK In the past week, we came across a lot of news announcing research, clinical trial results, collaborations, product approvals and acquisitions. Much of the departed week’s news though, does not represent complete stories, especially the ones related to research. They represented early works in progress offering no concrete results that we can evaluate. Important news for …

Gilead Sciences (GILD) has news that we felt good about it for a company that saved millions of lives from the minute, but monster viruses HIV and HCV. Curing millions of patients with HCV, has led Gilead to decide that the time has come for bringing cures to many horrible diseases. Yesterday, September 12, the news announced that Gilead and Precision BioSciences have entered into …

The Week in Review #29 PROHOST AGGRESSIVE PORTFOLIO  - The aggressive portfolio hosts biotech firms with solid scientific fundamentals and prominent scientists whose stocks have plummeted following some setbacks. A setback could be a failure of an investigational product to meet the endpoints of its clinical trial or that the small biotech firm has taken long to achieve its goals . . . This content …

Gilead Sciences’ (GILD) and Galapagos’ (GLPG) product filgotinib – a highly selective JAK1 inhibitor has met the primary efficacy endpoint in Phase 2 TORTUGA trial in adults with moderately to severely active ankylosing spondylitis (AS). Patients treated with filgotinib achieved significantly greater improvements compared to those who took a placebo. The results came from the Phase 2 of the TORTUGA – a multi-center, randomized, double-blind, …

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 #23  ASCO  2018 - Small  publicly-­traded  oncology  biotech  firms,  large  oncology  biotech  firms,  and  giant  biopharmaceutical  firms,  in  addition  to  some  private  biotech  companies,  all  presented  results  and  observations  about  their  cancer  drugs  at  the  2018  American  Society  of  Clinical  Oncology  (ASCO)   meeting.  Most  presentations  were  useful,...

The Week in Review #22 What Went Right or Wrong in the Biotech Sector During the Departing Week? - A lot happened in the biotech sector during the week, which departed at midnight. Topping the list of the week’s events was the approval of Portola’s (PTLA) product  Andexxa . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for Cancer Kite, a Gilead (GILD) company, and Sangamo Therapeutics (SGMO) announced a worldwide collaboration agreement for using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology. Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating …

Prohost Letter #417 Private Lessons - These lessons are overdue and we had to do this homework before we go into further evaluations of our picks and introduction of new companies as we promised in the past issue. We believe that the Prohost readers, the fans and the critics should know how and why we pick our biotech stocks . . . This content is …

Celgene (CELG) and Juno (JUNO) announced the signing of a definitive merger agreement upon which Celgene has agreed to acquire Juno. Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies. Juno …

Prohost Letter #416 Part 1 The Year In Review - 2017 Unheard of Programs - AN AWESOME YEAR for the biotech sector regarding its accomplishments. Many of the accomplished programs were unheard of regarding the degree of their positive impact on medical practice. Unfortunately, many of these accomplishments, which included the making of new discoveries, the creation of novel advanced technologies and the design of …

Gilead Sciences (GILD) has unsurprisingly agreed to acquire Cell Design Labs in a structured buy out valued for up to $567 million, including the shares of Cell Design Labs held by Kite, the CAR T firm that Gilead has recently acquired. Brian Atwood, President and CEO of Cell Design Labs, Inc., said, “Bringing our robust technology platforms under the Gilead umbrella, with its outstanding research …

The Treatment is Not A New Way as Being Stated, It is Only the Target, Which Has Been Changed   Outstanding news announced that leukemia patients who relapsed after being treated with the chimeric receptor antigen T cell (CAR T) targeting CD-19 were saved from imminent death by a CAR T targeting CD-22. The new treatment, which is being presented in some articles as a …

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 …

Important news has come from the FDA, which issued new guidelines to speed the introduction of treatments with human cells and tissues, including gene therapy. Cracking down on rogue clinics offering dangerous or unproven versions of gene therapy or stem cell therapy is also included in the report. Scott Gottlieb, the commissioner of the FDA stated that regenerative medicine and other important gene therapy treatments …

The Week in Review #10 NO CONSPIRACY THEORIES - But this is what’s happening - In the past issue of The Week in Review, we wrote about the irrational pattern of selling the biotech stocks during the announcement of the quarterly results and how some investors are taking advantage of this pattern to sell their stocks before the quarterly results . . . This content …

The Week in Review #9 KNOCKING DOWN THE BIOTECH STOCKS - Knocking down the biotech companies’ stocks during the announcement of the quarterly reports is no news. Most investors in the stock market, especially those who invest in the biotech sector have become familiar with this pattern . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta.  This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than …

The Week in Review #7 A lot more happened in the past week regarding improving the treatment of cancer and of other devastating diseases. This issue contains discoveries that aim at improving breakthrough immuno-­oncology treatment outcomes. Here are some of the breakthrough technologies and treatments that might improve, by-­far, the management of cancer . . . This content is for paid subscribers. Please click here to …

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 …

In the news, the FDA has placed a clinical hold on two phase 1 trials of Cellectis’ (CLLS) off- the-shelf product UCART123 after the death of a 78-year old patient. Cellectis is working with the FDA towards finding ways that help mitigate the risks expected to have caused the fatality. We experienced deaths with other CAR T products with the cytokine release syndrome on the …

Coming Soon... The Week in Review #3 Gilead Acquisition - Rallying by Association - Improving on Cancer Treatments...

The answer is, indeed, Gilead (GILD) and its CAR T drug approval will be for non-Hodgkin lymphoma (NHL). This is true, as in May, the FDA has accepted for priority review Kite Pharma’s Biologics License Application (BLA) for its genetically engineered Chimeric Antigen Receptor T Cell (CAR-T) product axicabtagene ciloleucel. The submission follows positive data demonstrated after a single infusion of axicabtagene ciloleucel in the …

Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the …

When what you predicted, preached, and wished are realized, this is good news. Today’s news is bringing all Prohost predictions into realization, Yes, Kite (KITE) is on its way to be acquired by Gilead (GILD) and yes both stocks have rallied and yes Juno (JUNO) is also rallying on the Kite’s news because both firms are pioneers in the CAR-T Immunotherapy technology and drugs. Rallied …

THE WEEK IN REVIEW Wall Street As we said in yesterday’s article posted under Today’s Highlights, stocks can plummet at any time, regardless of whether they have the best or the worst grades for their financial or accomplishments reports. Stocks can falter (yet quickly recover) for various reasons, as their prices are decided by thousands of stocks exchanging hands between sellers who need to sell …

Synopsis Most of the Prohost picked stocks gained momentum and closed higher at the end of the week. Some rallied because that’s what they were supposed to do after the quarterly financial when most biotech stocks are subjected to selloffs, including those that have clearly outperformed in real life. The most outperforming of our picked stocks in July and continue to outperform are Illumina (ILMN) …

Prohost Letter #412 Part 3 GLIOBLASTOMA - Is There Hope? Senator John McCain was diagnosed with a malignant brain tumor, glioblastoma – the most common and aggressive form of brain cancer. The cancer is so aggressive that most surgeries did not provide survival. This brain cancer affects around 3 people out of 100,000 in the U.S., with men more than women and whites more than other …

IMPROVING ON CAR IMMUNOTHERAPY APPROACH  When we stated that chimeric antigen receptor CAR immunotherapy process was created to remain and improve, we aimed at demonstrating our conviction that the CAR approach will eventually be improved and become the gold standard for the treatment of many cancers. We observed that many research and medical institutions are using all advanced information, state-of-the-art techniques and technologies in order …

A BIG YES for Novartis CAR-T product has come from the  Food and Drug Administration (FDA) advisory committee. The committee recommended FDA approval for Novartis product CTL019 for pediatric acute lymphoblastic leukemia. The Vote: The panel voted 10-0 in favor of approval. Chimeric antigen receptor T-cell therapy, (CAR-T- Cell therapy) is an immunotherapy that enables the immune system T cells to seek, reach and attack cancer …

Arena (ARNA) announced positive Phase 2 clinical trial results for its drug ralinepag1 for pulmonary arterial hypertension (PAH). In the 61-patient study, the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance (PVR) compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance (6MWD). Additionally, adverse events observed in the study were consistent with other prostacyclin treatments for …

IMPRESSIVE RESULTS?  Bellicum Pharmaceuticals’ (BLCM) drug BPX-501 is described as a safe and effective product that can offer children with cancer and other serious diseases the opportunity to beat their intractable sicknesses. The drug enables the patients who are in desperate need for a bone marrow stem cell transplant to use unmatched donors’ stem cells through lowering their adverse effects. The most recent clinical trial …

Prohost Letter #410 JUNE PDUFA DAYS This month, the FDA will decide on the approvals of drugs belonging to companies that Prohost has picked for investment. Usually, granting approvals rallies the stocks of the drugs’ developing firms. Sending Complete Response Letters for demands that might delay approvals would cut a substantial percentage of the stocks’ values, while rejections would cause the stocks to falter. Let’s …

AT ASCO CAR-T Was Created to Stay BlueBird Bio CAR-T Results Bluebird Bio (BLUE) presentation was well received at ASCO after the firm stated results demonstrating that all the 15 evaluable patients in the clinical trial of its chimeric antigen receptor T cell (CAR-T) drug “bb2121 responded to treatment. Data were convincing demonstrating 89% of the patients observed their tumors shrink with 27% seeing their …

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer a successful treatment. Checkpoint inhibitors have reached the market at the hands of Merck, Bristo-Myers Squibb and Roche, with other firms coming forward with products …

It is obvious that the CAR-T approach to cancer treatment is here to stay and to change the way cancer has been managed for decades. Attempts to improve the novel elegant procedure safety profile and efficacy on solid cancers are being pursued by academia as well as by biotechnology and pharmaceutical companies. Kite Pharma’s (KITE) CAR-T therapy axicabtagene ciloleucel is an investigational therapy in which …

Prohost Letter #409 ASCO The American Society of Clinical Oncology (ASCO) meeting is around the corner. The Meeting, which will begin on Friday June 2, 2017 and will end on Monday 5, 2017 will be different than the past years for many reasons, including the following: -­ Checkpoint inhibition as Immunotherapy for cancer treatment moved from wishful thinking a decade ago, to promising cancer treatments …

Indeed, Saving One Life is Important. Yet, Important Too is Saving Many Lives The Risk Vs. The Reward We keep repeating that the CAR-T treatment is created to stay, not because somebody loves the firms developing the CAR-T immunotherapy, but because this novel approach to cancer is saving the lives of the condemned. In addition, many reasons exist that make oncologists and regulators believe that …

EPIZYME Many oncologists, we believe, must be impatient to learn about the outcome of a first-in-class cancer drug based on epigenetics in upcoming oncology conventions. The drug tazemetostat was created and is being developed by Epizyme. Epizyme (EPZM) is a clinical-stage biotech company having proprietary platform, which  enabled it to identify and develop small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs, …

Prohost Letter #408 AT A GLANCE - Continued from the Previous Prohost Letter #408 In the Past issue #407, we picked the following firms: NEUROCRINE BIOSCIENCES (NBIX) Treating Tardive Dyskinesia CYTOMX Improving On Cancer Immunotherapy CELYAD SA (CYAD) Bringing Solutions To Immunotherapy Problems Please Read the articles written about these firms in the Issue #407 In This Issue We Add  NEW LINK GENETICS...

Prohost Letter #407 AT A GLANCE - Firms Added to Prohost Portfolio PROHOST IS PICKING NEUROCRINE BIOSCIENCES   On March 27, a few days before the FDA approves Neurocrine’s (NBIX) drug Ingrezza, (valbenazine) capsules for adults with tardive dyskinesia (TD), we posted an article titled “Time for Transformation and Achievements”. In the article, we stated that Neurocrine Sciences Ingrezza will highlight Neurocrine Biosciences and its …

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

CANCER IMMUNOTHERAPY 2 Nonstop Improvements and Nonstop Discoveries In CAR-T Immunotherapy As we said in the article about checkpoint inhibition as cancer immunotherapy, the approaches that aim at enabling the immune system to fight cancer cells were created to stay and improve and become the gold standard for cancer treatment. Chimeric antigen receptor T cell (CAR-T) therapeutics are speeding their way towards approval in 2017. …

The FDA Approves Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection First HCV Direct-Acting Antivirals Approved for Adolescents Gilead Sciences (GILD) announced that the FDA has approved its supplemental application for its HCV drugs HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and its HCV drug SOVALDI® …

Prohost Letter #406 A Special Prohost Issue SYNOPSIS REASONS FOR THE FOLLOWING PROHOST PICKS RALLIES VERTEX Vertex (VRTX): Great news about 2016 revenues & earnings Growth and pipeline. FROM YESTERDAY: Tremendous Revenues Growth. Cystic fibrosis (CF) revenues grew up around 75%. FOR TOMORROW:  Boosting  the  pipeline  value  by Advancing CF novel correctors into Phase 2 trials while Producing and advancing new CF correctors. PROJECTIONS: Continued …

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …

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 …

We keep reiterating that CAR-T cancer immunotherapy was created to stay. More frequent updates about the CAR-T approach further solidified our conviction. Almost every week we are getting news eliminating layer by layer of the true problems about CAR-T therapy that transplanted skepticism in investors’ minds towards a successful outcome of this novel immunotherapy approach to cancer treatment. The two essential problems that instilled the …

Making Sure that CAR-T Therapy for Cancer Succeeds Academic Researchers Identify a New Process to Raise Natural Armies of Cancer-Targeting T Lymphocytes Outside the Body Unleashing More Power to the Immune System to Fight All Types of Cancers GOOD NEWS FOR CAR-T IMMUNOTHERAPY DEVELOPERS Researchers from Mayo Clinic and the University of Washington have developed a new culture process to improve the efficacy of engineered …

About the CRISPR/Cas9 Gene Editing Patent Shareholders of biotechnology firms specialized in CRISPR gene editing technology are in a state of confusion regarding the technology's patents. The confusion is caused by the U.S. Patent and Trademark Office (USPTO) decision to sustain the intellectual property awarded to the Broad Institute of MIT and Harvard. This ruling has caused the stock of the firm Editas (EDIT), which …

Gilead Sciences (GILD) was subjected to what we believe is an exaggerated stock selloff following the announcement of its 2016 financial reports, which comprised its projections made for 2017. Investors seemed to have focused only on the HCV sales’ revenues while ignoring the sales’ revenues of Gilead’s HIV franchise and other products, which outperformed? Investors ignored assessing the firm’s pipeline investigational products’ values especially those …

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. …

A few months ago, we heard news that a Belgium firm called Celyad (CYAD) has concluded a deal worth over $300 million with Ono Pharmaceutical. The deal gives Ono the rights to Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This news did not mean a lot to investors as Celyad had yet to recover from a heartbreaking  setback in a late phase trial …

GILEAD (GILD) One analyst who aimed at bringing only the negatives about biotech has finally succeeded in convincing other critics and media bloggers that Gilead would not be good for investment until the firm acquires a company that can expand its meager oncology franchise. His story became the melody hummed by every blogger, ignoring the fact that the firm’s revenues and income have doubled overnight …

ProhostLetter #403 Part 1 On December 8, 2016 under News & Comments Prohost commented on President Elect Trump’s statement that he is going to bring down the exorbitant drug prices. The Skyrocketing Prices of Drugs Like everybody else we happen to talk to, we agree that the prices of drugs have skyrocketed to a level that made them unaffordable. It is a serious problem that …

Prohost Letter #400 NEAR-­TERM INVESTING The Prohost Letter #399 Part 3 has Promised to Des

Results from trials were negative in two phase 2 studies for Gilead (GILD) experimental drug GS-4997 (selonsertib) intended to treat pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). But the same drug selonsertib showed it might hit the jackpot when results demonstrated it succeeded in treating nonalcoholic steatohepatitis (NASH), which is also known as non-alcoholic fatty liver disease, where, according to Gilead, it showed …

GILEAD & GENMAB To Access Genmab’s (GEN) bispecific antibody technology, Gilead (GILD) signed a new agreement with Genmab. The King of HIV treatment objective is to use its exclusive license from Genmab to produce an HIV bispecific monoclonal antibody therapeutic. Gilead is paying around $5 million in upfront payment and up to $277 million in milestones. Genmab will also be entitled to one-digit royalty of …

Immunotherapy Engineered T-Cell Therapy Is Here to Stay Articles aimed at undermining the value of the firms’ chimeric antigen receptor T (CAR T) cells as immunotherapy for cancer are less and less convincing to savvy investors. Most of the bloggers who attack the procedure admit at the end of their articles that the approach is promising, but still needs this or that for the sake of perfection, …

The Royal Divorce On Sunday, the next day after the announcement of the British referendum’s results, a turbulence in the stock markets was in the making by professionals who cited all kind of pessimistic likelihoods and negative projections that England divorce will cause havoc, devastating the stock markets for months, and maybe for years to come. On Monday, the markets were, indeed, devastated and the …

Le CompaGnon Part 2 Wednesday June 22, 2016 From the  American Society of  Clinical  Oncology (ASCO)               Checkpoint inhibitors the CAR T Approach Adoptive cell therapy Oncolytic virus therapy Therapeutic vaccines Cytokines. Le CompaGnon Part 1 dealt with: - The two firms, MERK and BMY, who were the first to get approvals of their checkpoint inhibitors. These two . . . This content is for paid …

GILEAD After years of controversial refraining, official India reversed course and granted Gilead Sciences its patent rights to Sovaldi hepatitis C treatment. More than a victory for Gilead, it was the prevalence of fairness after years of underestimating the power to fairness to keep resurfacing until reinstated. The Indian Patent Office had rejected Gilead’s patent application based on a notion that it did not demonstrate …

GILEAD SCIENCES The people who cause the selloff of Gilead’s (GILD) stock because it missed 5 cents are the same who continue to complain about the high price of its HCV drug. This is intriguing because those who advocated selling the stock said that the reason for the miss is the huge discounts the firm is making on the drug price. Gilead is the undisputed …

In the biotech sector, daily stories (news) are not just announced, but mostly edited in ways that project the narrators’ tendencies and wishes rather than the original news. Last week’s headlines comprised positive news from a firm’s drug aimed at treating a chronic progressive disease, muscular dystrophy, which disables children’s by weakening their voluntary and involuntary muscles, while threatening their hearts and lungs and lives. Other headlines …

Pursuing its goal in treating hepatitis, Gilead Sciences (GILD) is at the finish line of clinical trials on another virus, this time the Hepatitis B virus. HBV not HCV. Two large Phase 3 trials evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met the primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate (TDF) 300 mg.  …

Many in Wall Street have been anxious, sitting on fire while waiting to learn, which biotech company Gilead Sciences (GILD) would decide upon acquiring that would deepen and enhance its pipeline. In Today’s news, a firm called Nimbus Therapeutics, LLC today announced that it has signed a definitive agreement under which terms Gilead will acquire Nimbus Apollo, Inc., a Nimbus Therapeutics wholly-owned subsidiary. Important is that the acquisition …

Prohost Letter #394 Part 1 Gilead - Some people sold Gilead’s (GILD) stock on Wednesday, March 23 after news announced on Tuesday that a jury decided that Gilead has infringed on two HCV molecules patents that Ionis (IONS), formerly Isis, and Merck had secured from their research. Ionis CEO said in a press release that his firm and Merck used their expertise during their collaboration in …

The Diagnosed Dead Is Far from Dying Xoma (XOMA): Stock rallied following report announcing an upfront payment from Novartis, which multiplied the firm’s revenues 10 times over 2014. Novartis paid Xoma $37 million, Novo Nordisk paid $5 million and Pfizer paid the firm a little less than $4 million. CEO John Varian said, “Novel antibodies and technologies created by XOMA scientists to target diseases such as …

Prohost Letter #393 IMMUNOTHERAPY - PROHOST PORTFOLIO - NEW PICKS? - A Brief Reminder of the CAR T –TCR Immunotherapy Approaches In this issue we continue our journey inside the territory of cancer immunotherapy. We remind that in the Prohost Letter issue #391, we dealt with the immunotherapy based on genetically engineered T Cells, enabling them to seek out, attack and neutralize cancer cells. The immune system’s T …

Prohost Letter #392 February 28, 2016 - How could it be possible for any genius to make intelligent guesses about the market's next moves when highly regarded experts, including Nobel Prize winners in economics, remained quizzical about the recent horrifying performances of publicly traded stocks? Since the beginning of 2016, the stock market has been made to look as if a runaway train with many passengers …

Gilead Sciences Gilead (GILD) Shareholders wouldn’t expect to watch short investors make billions of dollars going against Gilead during this firm’s most glorious times. We never imagined negative analysts could have the capability of persuading millions of shareholders to sell and cause a selloff of the most productive, most growing, most achieving and extremely well run biotech company. Gilead reported quarterly earnings and revenue on …

Prohost Letter #391 Frightened by the Market and Politicians’ Debates, Not the Drug Industry, Investors are Fleeing the Biotechnology Sector  1. A fruitless debate over the high prices of drugs 2. The low price of oil, the world’s dream for decades, is now considered a disaster for the world economy? 1. The High Drug Price Debate Again, as in past presidential debates, politicians have chosen an …

The Market is Surely Ignoring the Historical Summit Biotech achievements are standing on Right Now     The latest biotech sector’s breakthroughs we presented was the novel powerful gene editing techniques CRISPR/cas9 and TALEN. Our article in the Prohost Letter #390 meant to enable the reader to understand that the evolution in biological sciences, especially in sequencing and analyzing the genome of the sick and healthy cells, has reached a stage …

Improving the management of inflammatory and autoimmune diseases has been a dream that seems to be happening slowly but surely in the past years. The improvement has gained energy and speed in 2015. The advancement in treatments has been demonstrated on several inflammatory and autoimmune diseases, including psoriatic arthritis, rheumatoid arthritis (RA), Crohn’s disease, systemic lupus erythematosus (SLE) and many other autoimmune diseases. Psoriasis   …

On Oct. 28, 2015, Gilead Sciences (GILD) announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily fixed-dose combination of the approved nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi®) abbreviated as (SOF) and the investigational pan-genotypic NS5A inhibitor velpatasvir, abbreviated as (VEL) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA was supported by …

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations, including the Iran Saudi Arabia crisis, which led to an increase in the oil price whose decrease has caused the previous market’s bad mood. Like …

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 #386 An Evaluation of Prohost Picks and Some Other Interesting Biotechnology Companies (Part 2) (Continued from Previous Prohost Letter #385) See Page Listening to Top-tier biotech firms’ presentations we could not resist appreciating their accomplishments, which made us dare to predict that the time has come for the self-serving preachers to find it extremely hard to convince shareholders to to sell stocks of …

The FDA issued a warning that hepatitis C treatment Viekira Pak and Technivie can cause serious side effects and serious liver injury, mostly in patients with underlying advanced liver disease. The drugs in question belong to AbbVie (ABBV) with some of their  ingredients made by Enanta (ENTA), both were subjected to selloffs after the news, in addition to Express Script (ESRX) Holding, which  operates as a …

Prohost Letter #385 An Evaluation of Prohost Picks and Some Other Interesting Biotechnology Companies The Top-Tier Group The indiscriminate attack on the biotech sector impacted the best biotech firms more than it did the worst. In other words, the attack devastated the undervalued, without correcting the stock price of overvalued, or even valueless, firms. The problem is that those who instigate computer programs selling of …

Stories from Yesterday’s Market We are not claiming that the market volatility has subsided and the leadership has shown and is in full control of the chaos. But yesterday biotech stock performance made us feel that investors are regaining their common sense and trying to benefit from the catastrophic plummeting of the member firms stock prices. Today’s trading seems negative for the biotech stocks, but …

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 …

Kite Pharma (Kite) stock was sliding, raising concern about the firm and all the biotech firms that are designing and developing CAR T Cell immunotherapy treatments for cancer. Many investors are wondering about the plummeting of the stock and obviously others have learned about one death that occurred during clinical trial, which caused Kite selloff. Finally, Kite provided an update from its ongoing Phase 1/2 clinical …

The moment the new IPO NantKwest (NK) landed in the town of publicly traded firms, some called it the “New Golden Boy”. During the IPO, investors who knew about this firm and were waiting for that day seemed confident that the stock would surge. As a matter of fact, the stock did surge. On July 27, NantKwest, Inc. (formerly Conkwest, Inc.), Issued a press release …

Prohost Letter #381 QUARTERLY FINANCIAL RESULTS IN THE BIOTECH SECTOR Investors Concerns, Excitement and Expectations (Part 3) For the past quarter of a century we spent focusing on the biotech sector, observing it from all angles and weighing the possible outcomes of its individual member companies. We conclude that: Regardless of what the firms quarterly financial results might point to success or failure, the market …

Prohost Letter #379 Investors Concerns, Excitments and Expectations It is understandable the fact that bullish and bearish analysts have opposite opinions (opposite wishes too) on biotech firms’ pipelines products and clinical trial results. They differ in assessing important news and in applying different criteria in their evaluation in order to establish proof of concept of their personal views. Articles are filling the media with contradicting …

Prohost Letter #378 Part 2 2015 ASCO ANNUAL MEETING What a Big Revolution in Oncology! The ASCO meeting projected the huge advancement in the understanding, diagnosing and treating cancer. What looked as if a sudden explosion has brought in the big change, the change was, in fact a slow, deep-rooted evolution, built up over a long period of trial and error with the failures constituting …

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, …

For those who ask whether immunotherapy will have a dominant presence at ASCO, we confirm that yes; immunotherapy therapeutics will have a presence and a lot of audience, especially oncologists. There is big reason for oncologists’ interest in the subject. Their patients who have exhausted all standard of care treatments and would usually go home to die, did not lose hope this time. Instead, many …

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. …

They jumped to call the biotech sector a bubble, accentuating its volatility. Instead of saying WOW about Gilead’s (GILD) 3.49 billion net income, calculated as $2.18 a share, they called for a selloff of the stock. The 3.49 billion net income and $2.18 income a share are compared with $791 million, or 47 cents a share, a year earlier. This is big for us, but …

Prohost Letter #375 Part 2 Novel Breakthrough Cancer Immunotherapy Approaches PART 2 In Part 1 of this issue, we described the immunotherapy approach that aims at modulating immune checkpoint proteins, thus unleashing the T cells to do their natural task of detecting, attacking and eliminating cancer cells. The approach is a success, as we reiterated, with greatly encouraging results. Researchers in large oncology centers and drug …