Lipocine (LPCN), a specialty pharmaceutical company, announced that an approximately eight-week top-line study using LPCN 1144 in subjects with non-alcoholic fatty liver disease (NAFLD) who might have the potential to develop NASH.  Treatment results showed an absolute mean reduction from baseline of 7.6% liver fat and demonstrated a 38% relative mean liver fat reduction from baseline. Moreover, there was an 86% responder rate in which subjects experienced …

On January 8, 2019 the osteoporosis monoclonal antibody Evenity (romosozumab) developed by Amgen and UCB was granted approval by the Japanese Ministry of Health, Labor and Welfare for osteoporosis in patients at high risk of bone fracture. Yesterday, Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced that 19 out of 20 members of the  U.S. FDA, Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted YES for the approval of Evenity™ for osteoporosis …

Gilead Sciences (GILD) has news that begins with an announcement today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa® (sofosbuvir 400mg/velpatasvir 100mg). Epclusa is once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA). In Japan, no treatment option …

Why Loxo Oncology and Sage Therapeutics Have Occupied Today's Headline News LOXO Oncology Eli Lilly (LILY) announced its intention to acquire Loxo Oncology (LOXO) for around $8 billion in cash.  The offer translates to around $235 a share, representing a premium of 69%. Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that can be detected by genomic testing. We remind that last week Bristol-Myers …

Bristol-Myers Squibb (BMY) will acquire Celgene (CELG) in a cash and stock transaction with an equity value of approximately $74 billion. Under the terms of the agreement: Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. They will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a …

We have a few small clinical stage firms in the Prohost Portfolio that were established with the goal of designing safer and more effective versions of the very promising CAR T immuno-oncology products. We intend to revisit these firms and see how far they have reached on what can be described as a very hard road towards the realization of these small ambitious firms’ goals. Among …

We Wish You A Happy Spiritual Season and A Happy New Year 2019. We Hope that Peace of Mind, Serenity  and Optimistic Feelings Replace Unwarranted Pessimistic, False Impressions   That Have No Root in America’s Reality We Love You All Some Common Sense Please If the economy was not solid there would have been no reason for the Federal Reserve to raise interest rates. So, …

Proteostasis (PTI) signed a worldwide, exclusive license agreement with Genentech about licensing rights to potential therapeutic small molecule modulators of an undisclosed target within the proteostasis network. The agreement does not include cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulators and is unrelated to the company’s investigational products or other ongoing research programs in cystic fibrosis. The Proteostasis Network (PN) consists of more than 1,000 proteins organized …

During the departed week, outstanding advancements and improvements in various clinical disciplines filled the media. What’s bad is that all the accomplishments could not bring joy to the deserving investors. The reason is the unpersuasive crazy market behavior. We believe that investors’ unrealized profits have not gone with the cruel blowing wind. Investors will soon be bringing in their confiscated profits. We will elaborate on …

Amgen Higher Dividends For those who invest in top-tier biotech firms for dividend payments, in addition to the firms’ continued growth, Amgen (AMGN) announced last Friday that its Board of Directors declared a $1.45 per share dividend for the first quarter of 2019. The dividend will be paid on March 8, 2019 to all stockholders of record as of the close of business on February 15, 2019. This represents …

Marinus Pharmaceuticals (MRNS) announced positive results from its Phase 2 clinical trials evaluating ganaxolone intravenous (IV), the Magnolia Study, and oral dose, the Amaryllis Study, in women with postpartum depression (PPD). Based on the positive results, the company is advancing both studies into the next phase of development to evaluate IV and oral dose regimens. Postpartum Depression (PPD) PPD is a mood disorder that affects about …

Today, the market took another beating as a result of either an intentional or an unintentional lack of clearance by professionals in describing correctly the standing of employment and other current economic realities. They pinpointed irrelevant reasons in an effort to justify the Stock Market's tumbling.  One big headline was that 150,000 added jobs did not meet expectations. They never explained whether those jobs were all …

Another reason was found to hit the market when the economy is good and sustained and expected to be of a long duration. Of a short duration are the causes presented as economy killers. They are almost all related to China. We believe that the negotiations between China and the United States on the tariffs and other subjects will end up in favor of both …

Celyad (CYAD) is still a clinical-stage biopharmaceutical company developing advanced or improved CAR-T cell-based therapies. Today, Celyad announced that the first patient has received an injection in Phase 1 of the alloSHRINK clinical trial, evaluating its non-gene edited allogeneic CAR-T therapy known as CYAD-101. In this trial, FOLFOX chemotherapy is used simultaneously with CYAD-101 on patients with unresectable metastatic colorectal cancer (mCRC). According to Dr. Christian Homsy, …

We hope you all took advantage of the Thanksgiving holiday to rest and relax. We did. In Today’s NEWS RegenxBio Offers Rocket Pharmaceuticals exclusive, worldwide, rights to adenoviral vector NAV AAV9 for the development of treatments for Danon Disease RegenxBio (RGNX) announced that it awarded an exclusive, worldwide, license agreement to Rocket Pharmaceuticals (RCKT) so it can develop gene therapy for Danon disease. The exclusive license …

This is just to inform that Europe has approved Cabometyx® (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma (HCC). As you know, Cabometyx belongs to Exelixis (EXEL). Today Exelixis announced that its partner, Ipsen, received approval of the drug, from the European Commission (EC), to be used in adults who have HCC and have previously been treated with sorafenib. This approval allows for the marketing of Cabometyx in this indication in …

The Week in Review, which we will post soon, is going to provide news that cancer patients, their parents, their oncologists and investors are anxiously waiting to hear.   The news is about studies with products demonstrating huge improvements in immunotherapy efficacy in addition to preventing checkpoint inhibitors such as: Opdivo, Keytruda and others, from causing adverse effects, including autoimmune reactions that are serious 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 …

Exelixis (EXEL) provided an update that testified to its solid fundamentals, the growth of its approved products’ sales, the professionalism and seriousness of its management. Revenues: Exelixis’ total quarter revenues were $225.4 million vs. $152.5 million for the comparable period in 2017. Its net product sales revenues were $162.9 million for the quarter compared to $96.4 million for the comparable period in 2017, which represents a 69 percent increase year-over-year. …

Celyad (CYAD) announced an exclusive agreement with Horizon Discovery Group plc, for the use of its shRNA technology to generate Celyad’s second non-gene-edited allogeneic platform. The encouragement came from data emanating from preclinical studies demonstrating the versatility of the shRNA platform in the allogeneic setting. The data is expected to be presented at the upcoming 2018 Society for Immunotherapy of Cancer (SITC) annual meeting in Washington, D.C., …