Prohost Letter #457 Discovering The Root Causes of Diseases   Biotech firms with solid scientific fundamentals are racing towards unveiling the root-causes of various diseases that have yet to be completely unveiled. Knowing the root causes of diseases enabled some of the clinical-stage firms and the revenues-generating firms to bring into the clinic novel advanced treatments. Improving the treatments of severe untreatable diseases depends on …

Regeneron Pharmaceuticals EYLEA HD Approved by the FDA Regeneron Pharmaceuticals (REGN) announced that the U.S. FDA has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for EYLEA HD is 8 mg . . . This content is for paid subscribers. Please click here to subscribe or …

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 …

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.

Prohost Comprehensive Letter #451 Shorting Biotech Firms with Solid Fundamentals Unfair shorting of promising stocks seems to have become the norm during the harsh circumstances that not only the United States but several other countries have been living under for more than two years. The bad circumstances in the United States seem to be motivating unfair short-sellers to take advantage of bad news and cause …

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 …

Regeneron Pharmaceuticals and Sanofi Announce FDA Approval of Dupixent® Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. FDA has approved Dupixent (dupilumab . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Comprehensive Prohost Letter Issues Reality The Best of words in informative texts are the smallest in number and the most truthful in contents. That’s what Prohost believes, especially in the presence of the cruel circumstances our entire planet is currently living. Last Friday, the three indexes of the stock market had their best performances since the 4th quarter of 2020. Why? We don’t know, but …

Intellia Therapeutics Loses Technology Patent and Suffers a Selloff A selloff of Intellia Therapeutics (NTLA) stock occured when the U.S. Patent and trademark office ruled that CRISPR genome editing technology patent belongs to the Broad Institute. It's stating that a team of researchers led by Feng Zhang beat Jennifer Doudna and Emmanuelle Charpentier in making CRISPR editing possible. This new . . . This content …

Comprehensive Prohost Letter Issues Coronavirus Variant Omicron A lot has happened since the coronavirus variant Omicron was discovered in South Africa. After having been responsible for a severe plummeting of the stock market, Omicron boosted the market after being described by many scientists as fast spreading with different yet milder symptoms when compared to those caused by SARS-CoV-1, SARS-CoV-2 (the virus that causes COVID-19) and …

Regeneron Welcomes the World Health Organization's Recommendation for Use of REGEN- COVTM to Treat COVID-19 The World Health Organization (WHO) updated its Therapeutics and COVID-19: living guideline to include the casirivimab and imdevimab monoclonal antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve® in other countries. The guideline conditionally recommends REGEN-COV to treat high-risk non-hospitalized patients with non-severe COVID-19 and seronegative (no measurable . …

The Comprehensive Prohost Letter Issues The Comprehensive Prohost Letter Issues will constitute a chain of 7 issues. Today’s issue will include the following: Pinpointing and selecting the biotech firms that demonstrate readiness to treat untreatable, devastating diseases. Presenting an important antibody cocktail for the treatment of COVID-19. Stating our position regarding the Alzheimer’s disease firm Cassava Sciences. Pinpointing Prohost’s . . . This content is …

Prohost Letter #446 A Reevaluation of Prohost Biotech’s Picked Firms We have already pinpointed some of the devastating and life-threatening diseases that have yet to find treatment. Prohost’s plans are about discovering small &/or large biotech or biopharma firms that demonstrate scientific capability for treating or curing these diseases. Most of the firms that we picked for investment in yesteryears had solid scientific and managerial …

Prohost Portfolio PLUS #7 Companies Behind The Biotechnology Revolution Without these firms, basic science discoveries in the universities and the academic institutions and by the firms themselves would remain unutilized and shelved. Most of the firms we picked for the Prohost Portfolio are bringing novel products to newly discovered targets, and most have offered proof of concept of their hypotheses. Having said that, we add …

Prohost Portfolio PLUS #6 Yes, it is a Miracle! Intellia Therapeutics and Regeneron Pharmaceuticals This miracle news from Intellia Therapeutics and Regeneron Pharmaceuticals came Saturday, a day when the Market is taking rest from the usual yo-yoing of good/bad reasons and no reasons. This miracle of great news emanated from Intellia Therapeutics. The first-ever clinical data from a trial that supports safety and efficacy of in vivo CRISPR …

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 …

Negative News from Ionis Pharmaceuticals  Ionis Pharmaceuticals (IONS) announced that its partner, Roche (RHHBY),

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 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 …

Intellia Therapeutics and CRISPR/Cas9 Technology Intellia Therapeutics (NTLA) is a genome editing company, focused on the development of potentially curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by both producing therapeutics that permanently edit and/or correct disease-associated genes in the human body with a single treatment and creating enhanced . . . This content is for …

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 …

COVID-19 Vaccine Updates Pfizer's (PFE)/BioNTech's (BNTX) and Moderna . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Regeneron Pharmaceuticals Receives EUA from the FDA for REGEN-COV2 Regeneron Pharmaceuticals’ (REGN) antibody cocktail therapy casirivimab and imdevimab, known also REGN-COV2 or REGEN-COV2, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA EUA is for the treatment of mild to moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least …

President Trump, the First Lady and COVID-19 Indeed, the complicated, nasty SARS-CoV-2 virus managed to infect President Trump and the First Lady when we were expecting a vaccine to soon be ready to protect the country and the world from COVID-19. The president’s physicians did not treat the him with any of the investigational vaccines in late-phase trials; vaccines being developed by: Moderna (

Johnson & Johnson ENSEMBLE Trial for Its COVID-19 Vaccine Candidate Johnson & Johnson (JNJ) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial, ENSEMBLE, for its COVID-19 vaccine candidate, JNJ-78436735. The initiation of the ENSEMBLE trial follows positive interim results from Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intellia Therapeutics  Reporting operational highlights and financial results for the second quarter ended June 30, 2020, Intellia Therapeutics (NTLA) announced its first Clinical Trial Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 study of NTLA-2001 for transthyretin . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

SARS-CoV-2 Virus Vaccines Moderna On Monday Moderna (MRNA) started its Phase 3 clinical trial on 30,000 people with its product mRNA-1273. Separately, in a press release Moderna announced a preclinical study evaluating its product mRNA-1273 has been published in The New England Journal of Medicine. This study . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Sanofi and Regeneron: Results from Libtayo® Trial Sanofi (SNY) and Regeneron (REGN)

Vertex and Regeneron Will Survive the Coronavirus Market Vertex We picked Vertex (VRTX) on March 18, 2011 at $44.39. The stock closed at $218 at the end of 2019. It rallied in mid-February reaching $247.78 then the unexpected and unseen novel coronavirus started infecting the world. Our 2020 target is still $280. We decided upon this new target in . . . This content is …

Exelixis, Takeda and Japanese RCC Patients Today we learned from Exelixis (EXEL) that Takeda Pharmaceutical Company Limited, which is responsible for the clinical development and commercialization of Exelixis' oncology drug  CABOMETYX® (cabozantinib . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Week in Review #49 The Stars from the Weeks Preceding the Novel Coronavirus Outbreak  Forty Seven Forty Seven (FTSV) was added to the

Regeneron, Moderna, and COVID-19 The spread of COVID-19, minute creatures that seem to be trying to defeat us, has been accused of bringing the market down over 1000 points yesterday. Investors who love the biotech stocks they carefully and accurately hand-picked should take advantage of the temporary market drop to buy more of their preferred stocks at bargain prices. In so doing, the cost of …

Regeneron Pharmaceuticals Stock is Rallying Regeneron Pharmaceuticals (REGN) stock outperformed last week gaining over $27. The stock’s soaring was not the outcome of the market’s outperformance, for several consecutive days, but because the . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Synopsis The way many bloggers are interpreting the quarterly and yearly biotech companies’ financial results seems unfair and has proven to be. Amgen Amgen (AMGN): The stock gained over $10 yesterday and is trading now at $231. Many bloggers continue to attack the firm, mourning the loss of their protective patents on its over 30 years’ old products and ignore the record . . . …

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 …

Firstly, Forty-Seven and IVERIC bio  We remind that the two condemned stocks Forty-Seven (FTSV) and  IVERIC bio (

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 …

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 …

Karyopharm Therapeutics Third Quarter Financial Results Generated Revenues For the first time since its establishment Karyopharm Therapeutics (KPTI) financial results report revenues from a strong launch of its first approved product. Indeed, the firm’s third-quarter 2019 financial results are the first quarter in which Karyopharm generated revenues. In early July the U.S. FDA granted the company’s product Xpovio® (selinexor . . . This content is for …

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 …

Diseases of the Back of the Eye Diseases of the back of the eye, such as: age-related wet macular degeneration, diabetic retinopathy and diabetic macular edema, are currently managed with injections of anti-vascular endothelial growth factor (anti-VEGF) drugs into the gel-like substance (the vitreous humor) that fills the eye between the lens and the retina. The currently used age-related wet macular degeneration injections are: Lucentis, which belongs …

Regeneron Product REGN-EB3 Saving Lives Regeneron (REGN) announced that an independent monitoring board ended its investigational product REGN-EB3 trial after reviewing interim mortality data from 499 patients. REGN-EB3 was found superior to rival therapy from Mapp Biopharmaceuticals (MAPP) in saving the lives in . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Palm Ebola Clinical Trial Stopped Early as Regeneron Product REGN-EB3 Therapy Shows Superiority to ZMapp in Preventing Ebola Deaths TARRYTOWN, N.Y., Aug. 12, 2019,/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Company was informed by study investigators that a randomized, controlled trial evaluating four investigational therapies for Ebola virus infection was stopped early because REGN-EB3 . . . This content is for paid …

The EC Granted Conditional Approval for Regeneron and Sanofi Product Libtayo for CSCC The European Commission (EC) conditional approval for Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) product Libtayo® (cemiplimab) is a historical event and a game changer in the prognosis of metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC).   Before the approval of Libtayo patients with advanced CSCC , who are not candidates for curative surgery or curative radiation, had …

Prohost Letter #432 The ASCO 2019 Special Edition SPRAYING FEAR The Victims Are The most disturbed victim of the instigated and irrelevant fear against investing in the stock market is the market itself. Indeed, baseless fear campaigns frighten positive investors while encouraging short-selling investors to maximize their selling which intensifies the markets volatility. We have been experiencing this phenomenon since the beginning of 2019. Market …

The FDA Approval of Regeneron's EYLEA Is Important The PANORAMA Trial of EYLEA for Diabetic Retinopathy The United States Food and Drug Administration (FDA) has approved Regeneron’s (REGN) product EYLEA® (aflibercept) Injection for all stages of diabetic retinopathy. This approval is important. The data demonstrated from the PANORAMA trial showed EYLEA’s . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Stock Market The Confused and Confusing Stock Market The stock market is confused and confusing. No analysts’ speculations are materializing and no satisfactory explanations for the market’s agitation and selloff. Although not an unprecedented situation, what makes it strange and more puzzling than previous market’s selloffs is that it is happening at a time when all the prerequisites of a healthy economy exist. Historically …

Praluent's Approval Is a Big Deal The approval of the Regeneron / Sanofi supplemental biological license application (sBLA) aimed at updating Praluent’s (alirocumab) prescribing information is, indeed, a big deal. Proven life-saving benefits are confirmed. Comprising reducing the overall risk of major adverse cardiovascular events (MACE), i.e., heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization, would change the lives of …

  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 …

News We Loved to Hear  The First and Only Approval of a Specific Product for Postpartum Depression ZULRESSOTM The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). This makes Zulresso the first and only medicine specifically approved by the FDA to treat PPD; the most common medical complication of childbirth. The product …

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 …

Tanezumab, an investigational humanized monoclonal antibody developed by Pfizer (PFE) and Eli Lilly (LLY), met all three co-primary endpoints in patients with osteoarthritis (OA). The 16-week Phase 3 study, which evaluated subcutaneous administration of tanezumab in patients with OA, demonstrated that the patients who received two doses of tanezumab, separated by eight weeks, experienced a statistically significant improvement in pain, physical function and patients’ overall assessment …

The Week in Review #32 POSITIVE NEWS PROTEOSTASIS THERAPEUTICS Cystic Fibrosis Two days ago, a clinical-­stage small firm called Proteostasis Therapeutics (PTI) announced positive preliminary results from ongoing Phase 1 cystic fibrosis studies. The trial involved the firm’s proprietary combination therapy doublet, PTI-­808 + PTI-­801...

In two pivotal Phase 3 placebo-controlled trials Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) drug, Dupixent® (dupilumab), demonstrated a significant reduction in nasal polyp size, nasal congestion’s severity and the need for systemic corticosteroids and/or surgery. Both trials were evaluating Dupixent® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP). They both met met all their primary and secondary endpoints. Dupixent is a monoclonal antibody designed to …

The FDA Approves Regeneron’s Product EyLea® (aflibercept) sBLA in Wet Age-Related Macular Degeneration Regeneron (REGN) has two good news. The first is from one of its approved products, EYLEA® announcing that the U.S. Food and Drug Administration(FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the …

Regeneron Pharmaceuticals (REGN) and bluebird bio, Inc. (BLUE) announced a collaboration to apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery of human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and …

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 …

What Do We Make of the Following Good News? HERON THERAPEUTICS Will HTX-011 Help in the War Against Opioids?  Heron Therapeutics (HRTX), a commercial-stage biotechnology company announced positive results from its completed Phase 3 studies of the investigational agent HTX-011 in people undergoing bunionectomy and hernia repair. HTX-011 is described as the first and only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain …

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 …

Regeneron’s (REGN) pipeline products have still a lot of good news to announce. The latest is about its product Dupixant (dupilumab) which has already been FDA approved for atopic dermatitis. Now, there are reasons to believe that this drug could be also approved as an add-on maintenance for people with moderate to severe Asthma. The news has come from both Regeneron and its partner Sanofi (SNY), stating that …

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 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 …

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 …

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 #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …

Prohost Letter #401 SYNOPSIS PART 1 In this Letter CONTENTS Duchenne Muscular Dystrophy (DMD) FDA Compassionate Approval of Eteplirsen! PART 2 In The Letter Issue #402 CONTENTS EYE ON IONIS (IONS) Antisense Proof of Concept and Feasibility EYE ON INVIVA (INVA) AND THERAVANCE BIOPHARMA (TBPH) Sales of The Ellipta Inhalers Started to Pick up Before an expected Boom Not Losing . . . This content …

Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab. The drug  is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to severely active rheumatoid arthritis (RA). Nothing in the CRL contents insinuates that sarilumab is not safe, or not effective, or that the clinical trial data were not …

When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments and of firms’ finances. Prioritizing comprises selecting as much as possible the most concrete subjects that are safe to explore. In the upcoming Prohost Letter …

News about investigational drugs, which are expected to make big differences in the lives of people with chronic diseases and deadly diseases does not always materialize. Predicting drugs becoming breakthroughs has proven extremely difficult in the early phases of drugs’ development. Some products keep doing well, going from the preclinical testing into several phases of trials then all of a sudden they unexpectedly fail. They …

Pfizer accepted to pay $14 billion in cash to acquire Medivation. It is important for investors to know what Pfizer is after with regard to this acquisition so that investors could sense the current deep-pocketed biopharmaceutical firms’ preferences in selecting their takeover targets. Recognizing the facts behind Pfizer’s decision could also protect investors from being mislead by negative bloggers who, while serving their own agendas, …

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real …

Le CompaGnon Part 1 TUESDAY June 14, 2016 The Eternal Market Games Unfortunately, the fabrication and misrepresentation of reality in media articles about member firms of the biotech sector succeeded in devastating promising companies having exceptional technologies and products. The damages went far beyond investors unwarranted losses. The damages were grave as to ruin of many firms. Indeed, many promising firms were forced to declare …

Prohost Letter #396 CELEBRATING MEMORIAL DAY - Wish you celebrated the Memorial Day. Memorial Day’s purpose was remembering the people who died while serving in the country’s armed forces. The Memorial Day was initiated as Decoration Day after the Civil War in the year 1868 when the Grand Army of the Republic - an organization of Union Veterans in Illinois established it to decorate the graves …

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon cancer after oncologists block a well known signaling molecule recognized as playing a major role in making, not breaking the cancer. We also have news …

Prohost Letter #395 On the Road TO DEFEATING CANCER - Results of cancer treatment with novel immunotherapy drugs suggest that the hope of conquering cancer has improved from doubtful to conceivable. Immunotherapy treatments are scoring unprecedented successes against a wide variety of malignancies, including liquid cancers, solid cancers, cancers with DNA mutations caused by viruses and other cancer-causing agents. The two Immunotherapy approaches are currently occupying …

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 …

Regeneron and Intellia to Discover and Develop CRISPR/Cas Therapeutics Moving forward is Regeneron Pharmaceuticals’ (REGN) strategy based on strong scientific and technological capability that needs no validation by external validators. The quality, i.e., safety and efficacy, of Regeneron’s approved products and the clinical trial outcomes of the firm’s drugs in late phase trials speak for themselves. Good news from the firm is flooding the media. The most recent …

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 …

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 …

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 …

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 #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 …

Prohost Letter #380 Investors Concerns, Excitments and Expectations PART 2  REGENERON On Friday, July 24, Regeneron (REGN) stock closed at $541.l85 DOWN $14.76. The reason for loss was good news announcing that the FDA approved its cholesterol-lowering drug Praluent! Before the unreasonable sell on good news phenomenon, Regeneron had scored a new all time high on proven accomplishments (Read articles posted in past Prohost Letters). …

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, …

The FDA Advisory Committee Voted 22-1 In Favor of Approval of Its Melanoma Immunotherapy T-VEC Yesterday’s Prohost’s intelligent prediction that the FDA committee will vote in favor of approving Amgen’s melanoma drug T-VEC has proven to be correct. “Amgen (AMGN) cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval” That’s what the independent advisory panel selected by the U.S. …

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. …