The European Commission Approves Amgen’s New Cholesterol-Lowering Medication Repatha™ (evolocumab). The First PCSK9 Inhibitor to Be Approved in the World for Treatment of High Cholesterol. A Critical Milestone for Patients with Uncontrolled Cholesterol Who Require Additional Intensive LDL-C Reduction. Amgen (AMGN): The European Commission (EC) has granted marketing authorization for Repatha™ (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in …

An Effective Non-Steroid Atopic Dermatitis Ointment Anacor Pharmaceuticals (ANAC) Announces Positive Top-Line Results From Two Phase 3 Pivotal Studies of Crisaborole Topical Ointment, 2% in Patients With Mild-to-Moderate Atopic Dermatitis Crisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both Phase 3 studies, crisaborole achieved statistically significant results on …

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 …

After decades of attempting, but failing, to harness the immune system power to treat cancer (Cancer immunotherapy), novel approaches based on new discoveries have finally demonstrated they can do the hard job. These treatments, however, are facing challenges which must be dealt with. Will TrovaGene (TROV) succeed in dealing with the challenges? Indeed, using the body’s own immune system to fight cancer is working by …

Today it is Greece. What About Tomorrow? Can Greece’s crisis devastate the biotech sector? No sane individual would think so and the hysteria cannot be called other than what it is. The biotech sector is not overvalued and its value must not be insulted by unfairly downgrading great biotech revolutionary firms, while they are obviously undervalued. Those who invest their money against biotech stocks regardless …

On Thursday June 18, 2015, we posted an article under “Today’s Highlights” at the Prohost website about an important agreement Biocryst Pharmaceuticals (BCRX) signed with CSL We expect the agreement to contribute a great deal into bringing effective treatments of disabling chronic progressive diseases and life-threatening acute diseases to the global market The  news that appealed to us and the market came in the announcement by …

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 …

– Immunogen’s recurrent ovarian cancer drug Mirvetuximab soravtansine (IMGN853) has demonstrated promising results. – The firm succeeded in developing and owning the drug. –  ImmunoGen is doing whatever it takes to get the drug to the patients as quickly as possible and to explore the possibility of treating other cancers with the same drug. – The market showed extreme enthusiasm for the news. ImmunoGen’s (IMGN) …

VASCULAR BIOGENICS OPERATING AS VBL THERAPEUTICS Vascular Biogenics Ltd., operating as VBL Therapeutics (VBLT) is a late-stage clinical bio-pharmaceutical company focused on oncology and inflammatory diseases. Founded in 2000 and based in Tel Aviv, Israel, VBL’s has built its clinical pipeline based on two proprietary platform technologies that leverage the body’s natural physiologic and genetic regulatory elements: The proprietary Vascular Targeting System™ (VTS) platform technology, …

Xoma (XOMA) announced good news from Phase 3 EYEGUARD-B trial of its monoclonal antibody drug gevokizumab for Behcet’s uveitis. The study, which is sponsored by Xoma’s development partner Servier, reached its target exacerbation event as specified in the study design. The objective of the first part of this study is to demonstrate the superiority of gevokizumab, inreducing the risk of Behcet’s disease uveitis exacerbation and …

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 …

AS WE AND PREDICTED, the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC), voted in favor of approving Vertex’s (VRTX) drug Orkambi™ (lumacaftor/ivacaftor) for people with Cystic Fibrosis (CF) ages 12 and older who have two copies of the F508del mutation in the CFTR gene. The FDA is expected to make a decision on the approval of Orkambi by July 5, 2015 under the Prescription Drug User …

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’ …

As you would observe when reading the most recent Prohost Letters, our recent enthusiasm for Celldex Therapeutics (CLDX) emanated from its products’ combinationsc with novel immunotherapy drugs. In the past months, yesterday and today CLDX has outperformed for the same reason we mentioned in our most recent Prohost Letters. The reason for the current out-performance was the announcement that Celldex entered into a clinical trial …

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. …

Exelixis Announces Acceptance of New Drug Application for Cobimetinib (NDA) in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma “The FDA Granted Priority Review, Assigns Action Date of August 11, 2015” This is a subtitle in the firm’s news today, which says a lot about Exelixis (EXEL) as an active biotech firm. Exelixis has, indeed, designed, produced and developed a …

AERIE PHARMACEUTICALS (AERI) A YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET – Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. – The firm’s lead drug, Rhopressa™, is a one drop once-daily having triple action that might bring life to over two decades of paralysis in Glaucoma treatments. – Rhopressa™ inhibits Rho Kinase (ROCK) and the …

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 …