In The NEWS IMMUNOTHERAPY MIRATI THERAPEUTICS Mirati Therapeutics (MRTX) is an oncology company focusing on genetic and epigenetic drivers of cancer. The firm’s clinical stage product candidates include MGCD265, a multi-targeted kinase inhibitor that is in Phase 1b clinical development trials for the treatment of solid tumors, including lung, head and neck, and gastric cancers; MGCD516, a kinase inhibitor, which is in Phase 1 clinical …

The moment the new IPO NantKwest (NK) landed in the town of publicly traded firms, some called it the “New Golden Boy”. During the IPO, investors who knew about this firm and were waiting for that day seemed confident that the stock would surge. As a matter of fact, the stock did surge. On July 27, NantKwest, Inc. (formerly Conkwest, Inc.), Issued a press release …

Prohost Letter #381 QUARTERLY FINANCIAL RESULTS IN THE BIOTECH SECTOR Investors Concerns, Excitement and Expectations (Part 3) For the past quarter of a century we spent focusing on the biotech sector, observing it from all angles and weighing the possible outcomes of its individual member companies. We conclude that: Regardless of what the firms quarterly financial results might point to success or failure, the market …

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). …

Why the financing through a secondary public offering was a must for Exelixis. The outcome of the public offering is putting in Exelixis’ (EXEL) coffers around $128 million, which we know the firm will definitely need for the development of its programs, but more important, is for the firm to be able to meet its obligations in case the FDA approves its drug cobimetinib combination with …

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’ …