The Evolution of Liquid Biopsy TWO PIANISTS, GUARDANT HEALTH and C4 THERAPEUTICS Biotech firms are bringing future technologies and treatments into the present days, while Stock Market’s evaluators are assessing their values with out-of-date inappropriate methods. The unfair evaluations add to the firms’ burdens and devastate investors who pick the best biotech firms and lose their money nonetheless. The two players we are presenting today …

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   …

Exelixis Announces Positive Results from Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma - The results will be Presented at ASCO 2016 Genitourinary Cancers Symposium this month. - Data further highlight clinical benefit of cabozantinib across subgroups of patients with advanced renal cell carcinoma   - METEOR data are the foundation for the U.S. NDA filing submitted …

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

When you do your due diligence, you do not lose your faith in what you believed in giving up to the hype that’s sprayed around you. We were happy today to hear Array BioPharma (ARRY) report that results from the Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The trial met its primary endpoints. We are happy, but not surprised, …

Halozyme Therapeutics (HALO) and Eisai Inc. presented a scientific poster entitled, “Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN®) in Triple Negative Breast Cancer Xenografts” at the 38th Annual San Antonio Breast Cancer Symposium (SABCS). The Combination used in the preclinical testing HALAVEN® (eribulin mesylate) injection, which belongs to Eisai inc., is indicated for patients with metastatic breast cancer who have received at least two prior …

XOMA Announces License Agreement with Novo Nordisk for XMetA Program in Diabetes – Novo Nordisk acquires exclusive global rights to XMetA program, but for diabetes only, while XOMA  retains commercialization rights for rare disease indications – $5.0 million upfront payment. But the agreement includes up to $290.0 million in additional potential milestone payments – XOMA is entitled to tiered royalties XOMA (XOMA) announced it has …

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 …

In our yesterday’s article asking about how the FDA advisory committee has to vote regarding Biomarin product Kyndrisa (drisapersen) for Duchenne muscular dystrophy. We got the answer yesterday during the meeting that took a much longer time than committees’ meetings usually take. At the end of the long session that included several patients’ and patients’ relatives’ testimonies, the FDA Advisory Committee was incapable of voting for …

Today, the FDA advisory panel will discuss BioMarin (BMRN) product drisapersen for Duchenne muscular dystrophy based on documents released to the committee by the FDA. The FDA said, “The benefit of drisapersen in exon 51 skip amenable patients is inconclusive at this time. Therefore, the benefit-risk assessments were not made.” Analysts interpreted the FDA statement as a condemnation of the drug, which does not really tell what the FDA meant …

Europe Approves Orkambi® The European Commission has granted Marketing Authorization for Orkambi® (lumacaftor/ivacaftor), for cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. There are approximately 12,000 people with CF ages 12 and older who have two copies of this mutation. Vertex will now begin the country-by-country reimbursement approval process across the European Union (EU). They said: The …

When we hear about a new approach that promises bringing in hopefulness in patients diagnosed with brain glioma, we try to listen and hope for the best, rather than develop and demonstrate  skepticism. Are we not walking the road of genetic engineering, gene therapy approaches and immunotherapy? Our optimism becomes realistic, especially when a scientific rationale is explained by researchers in scientifically solid firms that …

Food allergies are bad, significant, dangerous and growing in the U.S. and the rest of the world. More than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. The prevalence of peanut allergy in children in the United States has increased …

Exelixis (EXEL) received the first of the great news we expected to hear. Today, the U.S. Food and Drug Administration (FDA) approved COTELLIC™ (cobimetinib) a cancer drug discovered by Exelixis in combination with Roche’s drug vemurafenib for BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. COTELLIC is a selective MEK inhibitor is subject of a worldwide collaboration agreement between Exelixis and Genentech (Roche). Switzerland had …

Prohost Letter #387 Topic of the Week DUCHENNE MUSCULAR DYSTROPHY Which Firms Will Get It Right – Deleting DMD Children’s Despair? The topic is important because, first and foremost, Duchenne muscular dystrophy (DMD) disables children. Also because, from no treatment at all, now we have several biotech firms developing various drugs based on different scientific strategies. The new approaches have increased in number and have …

To shareholders who were stupefied with an instigated selloff of Incyte’s (INCY) stock today, we say do not get panicky. Nothing is wrong with Incyte, no bad news was announced with any of the firm’s 12 ongoing clinical trials or with its approved drug Jakafi, which demonstrated progressive growth since it was launched.  So, a clever correct move now would be taking advantage and accumulate …

– Shire to Acquire Dyax for $5.9million and some possible extras. – Angioedema market has treatments for attacks, but not prophylactic products for the prevention of HAE attacks. – A primary reason for the acquisition, but not the only one, is getting to Dyax’s prophylactic Hereditary Angioedema (HAE) product. – What will be the outcome of Biocryst’s lead HAE prophylactic drugavoralstat? -Will Biocryst be able …

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 …