AstraZeneca and Merck PARP Inhibitor Lynparza The AstraZeneca (AZN) and Merck (MRK) PARP inhibitor Lynparza (olaparib) has been granted approval in Europe for first-line maintenance monotherapy . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

Incyte's FDA Approval Based on encouraging data from the REACH1 trial the FDA approved a label expansion of the Incyte (INCY) product Jakafi (ruxolitinib) for graft-versus-host disease (GVHD) in people 12 years and older. The FDA previously granted Jakafi Breakthrough therapy designation and orphan drug status for acute GVHD. GVHD is a condition that might occur after an . . . This content is for paid subscribers. Please …

Zolgensma Findings The FDA submission of the gene therapy product Zolgensma was based on positive findings from a trial of 15 babies treated with it. Recently; however, at the Orlando meeting of the Muscular Dystrophy Association Novartis (NVS) presented interim results for 22 babies with Type 1 SMA which is considered the . . . This content is for paid subscribers. Please click here to subscribe …

  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 (

Keytruda and Cabometyx Are Both Winners Keytruda failed to meet co-primary endpoints in Pivotal Phase 3 trial The pivotal Phase 3 KEYNOTE-240 trial evaluating Keytruda, Merck’s (MRK) checkpoint inhibitor anti-PD-1 therapy plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival …

From the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) Prostate Cancer A presentation by Bayer demonstrated improvement in the treatment of non-metastatic castration-resistant prostate cancer. Separate presentations by Bristol-Myers and Janssen also demonstrated improvement in metastatic castration-resistant prostate cancer. Non-Metastatic Castration Resistant Prostate Cancer Bayer Results from pivotal Phase 3 ARAMIS trial with Bayer’s (BAYRY) and Orion Corporation’s jointly-developed product darolutamide plus …

Merck (MRK) announced its Q4 2018 financial results. The firm outperformed itself and delighted us with regard to picking its stock on time. Merck compensated those who bet on it the day it was added to the Prohost Portfolio that comprises only the biotech and bio-pharmaceutical companies with solid scientific fundamentals. The press release issued regarding Merck's financial results started with Kenneth C. Frazier, Chairman and …

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 …

A number of biotech or biopharmaceutical companies have succeeded in the past couple of years in changing their statuses from clinical stage to revenues-generating firms. A number of these firms reside in the Prohost Portfolio, picked up before they generated revenues from their newly approved products’ sales. We are following up on these firms’ news as they come out of their new journeys towards marketing …

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...

The Week in Review #31 IN THE DEPARTED WEEK NOVEL MIGRAINE DRUGS ARE APPROVED ELI LILLY AFTER AMGEN AND TEVA In less than five months, the FDA approved three products belonging to four drug developers – all targeting calcitonin gene-related peptide (CGRP) for the prevention of migraine headache. The latest for Eli Lilly (LLY) last week . . . This content is for paid subscribers. …

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 …

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 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 …

Exciting are the Q2 2018 reported results by Exelixis’ (EXEL) including the firm’s revenues and earnings, compared to 2017. Impressive were Cabometyx’ (cabozantinib) revenues, in addition to the milestone payments from collaborating companies and ex-USA marketing agent. Inspiring also are the efforts the firm is spending on research and development with the aim of further boosting its revenues. Of the Results Revenues and Incomes – …

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 U.S. Food and Drug Administration (FDA) has approved Agilent Technologies’ (NYSE: A) Dako PD-L1 IHC 22C3 pharmDx assay for an expanded use. The expended use is expected to help physicians to identify cervical cancer patients who are most likely to benefit from treatment with Merck’s (MRK) checkpoint inhibitor lmmuno-oncology product Keytruda PD-L1 IHC 22C3 pharmDx assay was FDA approved for non-small cell lung cancer and subsequently expanded approval for gastric …

– Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA granted Merck (MRK) approval for its immuno-oncology checkpoint inhibitor Keytruda® for adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or for those who relapsed after two …

Prohost Letter #420 REAL BREAKTHROUGHS - One Has Already Been Used and the Other Has Extraordinary Promises In  the  NEWS - THE POWER OF CHECKPOINT INHIBITOR IMMUNOTHERAPY WOW It is about the checkpoint inhibitors immunotherapy, which is bringing to the world of cancer a stunning revelation of a combination treatment offering an almost cure for a lung cancer...