The pivotal Phase 3 KEYNOTE-240 trial evaluating 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 (PFS) compared with placebo plus best supportive care. The improvement of OS results demonstrated in the final analysis did …

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...

In today’s news, Incyte’s (INCY) immuno-oncology IDO1 inhibitor product Epacadostat in combination with Merck’s immuno-oncology product Keytruda® did not meet the endpoints of the trial in patients with unresectable or metastatic melanoma. The stock was subjected to a selloff – a market’s reaction pattern that occurs whenever negative news comes out of experimentation without consideration of the extent of their impact. A serious question to ask now would …

Acorda (ACOR) stock was up around 10% reaching over $28 in premarket trading. The stock is trading now around $27 with its gains oscillating between $2 – $2.20. The enthusiasm for ACOR seems to be about rumors that Biogen (BIIB) or possibly other Asian drug makers might have demonstrated the interest in Acorda. What’s going on with Acorda? In June 2017, the stock rallied on news about positive clinical trial …

Checkpoint inhibitors approved for a few firms as immunotherapy for cancer are increasingly demonstrating their superiority in extending the lives of patients when given as first-line treatments. In the news, Merck’s (MRK) anti-PD-1 therapy, pembrolizumab (Keytruda®) in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival …

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.

The Week in Review #8 Potential biotech winners inspired through COLLABORATION - When successful top-­tier drug developing firms such as Amgen (AMGN) or Merck (MRK) sign strategic collaborating agreements with small development-­stage biotech firms,...   &nbsp . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

–The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) – Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million – Merck Acquires 9.9% Stake in KalVista in Private Placement.    -Phase 2 Clinical Trial for the Investigational Intravitreal DME Candidate KVD001 Still Planned to Initiate in 2017. Surprise? Indeed, it is. KalVista Pharmaceuticals …