Biogen’s (BIIB) decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE which is designed to evaluate the efficacy and safety of its product aducanumab in patients with Alzheimer’s disease, has caused an exaggerated selloff of the stock. The failure to treat Alzheimer’s disease is well explained by Michel Vounatsos, Biogen’s Chief Executive Officer, who stated that the failure of aducanumab drug confirms the …

We love to read news about gene therapy as it is the only possibility for curing diseases that no known treatment can halt or delay their progression. The attempts to use gene therapy failed ambitious researchers for several decades before the revolution that led to understanding the genome and even decades  more after the publishing of the genomic map that actually started the real revolution. …

Thanks to abundant cabozantinib sales’ revenues Exelixis (EXEL) is advancing a new generation of its medicines with its new product XL092 entering clinical trials. The drug is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors & MET and was the subject of an active Investigational New Drug (IND) application the firm had submitted to the U.S. Food and Drug Administration (FDA) in December …

CRISPR Therapeutics' (CRSP) stock added around $8 today while reporting financial results for the fourth quarter and full year ended December 31, 2018. Here is what Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics, has stated,“This past year was truly transformational for CRISPR Therapeutics as we achieved milestones across our key programs in β-thalassemia, sickle cell disease and immuno-oncology. We’re pleased with the progress we’ve made in …

Cytokinetics’ (CYTK) investigational product omecamtiv mecarbil, the firm’s potential treatment for heart failure with reduced ejection fraction, is advancing in a late phase clinical trial. Cytokinetics is conducting METEORIC-HF clinical trial, in collaboration with Amgen (AMGN), with funding and strategic support from Servier. The trial aims at evaluating the effect of omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) in patients …

Today, at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (GU) held at Moscone West in San Francisco, CA, Nektar (NKTR) will present preliminary efficacy, safety and immune monitoring data from the ongoing metastatic urothelial carcinoma (mUC) patient cohort in the PIVOT-02 study evaluating NKTR-214 in combination with Bristol-Myers immunotherapy product OPDIVO (nivolumab). NKTR-214 is a CD122-biased agonist designed to provide sustained …

Exelixis’ (EXEL) financial results for the fourth quarter and full year 2018 are as inspiring as they are outstanding compared to many other small biotech firms that succeeded in putting products on the market. Revenues  Exelixis total revenues for the quarter ended December 31, 2018 were $228.6 million, compared to $120.1 million for the comparable period in 2017. Total revenues for the year ended December 31, 2018 were $853.8 million, compared to $452.5 million for the comparable period in 2017. The …

Portola Pharmaceuticals (PTLA) announced full results from ANNEXA-4, Phase 3b/4 trial of its Factor Xa inhibitor antidote Andexxa®  in patients experiencing acute major bleeding while taking a Factor Xa inhibitor. The data were presented at the International Stroke Conference 2019 and published simultaneously online by The New England Journal of Medicine (NEJM).  Full data from 352 patients showed that Andexxa rapidly, and significantly, reversed anti-Factor Xa activity when administered as a bolus and sustained …

ImmunoGen & Biogen News About ImmunoGen ImmunoGen (IMGN) is a creator and developer of antibody-drug conjugates (ADCs) aimed at improving cancer treatments. ImmunoGen aims to disrupt the progression of cancer through its conjugated targeted monoclonal antibodies. ImmunoGen’s lead ADC product candidate mirvetuximab soravtansine is in a Phase 3 study for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer, and in Phase 1b/2 trial in combination regimens.

Halozyme Therapeutics (HALO) and argenx (ARGX) announced a global collaboration and license agreement offering argenx the right to use Halozyme's ENHANZE® drug delivery technology to develop multiple subcutaneous product formulations for current or future argenx product candidates. The agreement provides argenx exclusive access to ENHANZE® for any product targeting the human neonatal Fc receptor, FcRn, including argenx's lead asset efgartigimod (ARGX-113) and up to two additional targets, potentially shortening …

Merck (MRK) announced its Q4 2018 financial results. The firm outperformed itself and delighted us with regard to picking its stock on time. Merck compensated those who bet on it the day it was added to the Prohost Portfolio that comprises only the biotech and bio-pharmaceutical companies with solid scientific fundamentals. The press release issued regarding Merck's financial results started with Kenneth C. Frazier, Chairman and …

AGENUS Agenus (AGEN) announced the upcoming launch of its Biotech Electronic Security Token (BEST); the first digital security offering in healthcare. Tokenization enables qualified investors to directly invest in a single biotech product while preserving shareholder equity. Garo Armen, Chairman and CEO of Agenus said, "Today, by announcing the first of its kind asset backed digital security offering in healthcare, we open the doors for a transformative …

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 …