Can a liquid biopsy test be accurate enough for physicians to rely on in differentiating between malignant and benign lung nodules in early stage lung cancer and probably other cancers?  A Yes answer has come out from OncoCyte Corporation (OCX) which announced positive results from its key R&D Validation study demonstrating the accuracy of the Company’s DetermaVu™ liquid biopsy test for lung cancer.  The R&D Validation study …

Data published in Cancer Immunology Research indicate monotherapy and combination opportunities for COM701, a first-in-class cancer immunotherapy antibody targeting PVRIG CompuGen (CGEN) announced the online publication of preclinical data demonstrating the role of PVRIG as a novel immune checkpoint and the potential of its first-in-class inhibitory antibody product COM701 targeting PVRIG, to serve as an effective cancer immunotherapy. The findings were published in two peer-reviewed papers in …

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 …

More good news came  from Exelixis (EXEL). It was expected by many but not by those who ignore the good news in favor of any negative news or lack of news. The announced news is that the FDA approved Exelixis’ Cabometyx® (cabozantinib) for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. More good news is Exelixis’ announcement that the firm is prepared to fully support the …

Exelixis collaborator, Daiichi Sankyo, Receives Regulatory Approval for MINNEBRO™ (Esaxerenone) Tablets for Hypertension in Japan Exelixis (EXEL) and Daiichi Sankyo announced that the the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Minnebro™ (esaxerenone) tablets of ,1.25 mg, 2.5 mg, and 5 mg, for hypertension. Minnebro was identified during a prior research collaboration between Exelixis and Daiichi Sankyo, which was entered into in March 2006. The product has been subsequently developed …

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 …

Earlier this month the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CTX001 for sickle cell disease (SCD). CTX001 is in clinical trials conducted by CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (VRTX). It is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to …

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 …

Rhythm Pharmaceuticals, Inc. (RYTM) is a biopharmaceutical company focused on the development and commercialization of therapeutics for rare genetic disorders of obesity. It is currently evaluating the efficacy and safety of setmelanotide, the company’s first-in-class MC4R agonist in Phase 3 studies, in patients who suffer from POMC deficiency obesity, LEPR deficiency obesity, BBS and Alström Syndrome. It is obvious that this firm has taken advantage of …

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 …

Gilead Sciences (GILD) and Scholar Rock Holding Corporation (SRRK) announced entering into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. Under the terms of the agreement Gilead has exclusive options to license worldwide rights to product candidates that emerge from the following three Scholar Rock TGFβ programs:  – Inhibitors that target activation of latent …

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, …

Agenus (AGEN) announced recently that it entered into an immuno-oncology (I-O) partnership with Gilead Sciences (GILD). The partnership is focused on developing and commercializing up to five novel I-O therapies. The terms of the agreement Agenus is entitled to receive a $120 million upfront cash payment and a $30 million equity investment.   The agreement also includes approximately $1.7 billion in potential future fees and milestones. …

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 …

In the NEWS AstraZeneca (AZN) announced a collaboration with Cancer Research UK to launch a center of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines. During the announcement of the news, Mene Pangalos, the firm’s Executive Vice President, Innovative Medicines & Early Development, said, the best science doesn’t happen in isolation, which is why AstraZeneca …

The Chinese National Medical Products Administration (NMPA) has approved Gilead’s (GILD) HIV combination product Descovy®.  In China, Descovy is to be indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with a body weight of at least 35 kg). TAF, which is part of the combination treatment, is a novel, targeted prodrug of …

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 …