Prohost Letter #407 AT A GLANCE - Firms Added to Prohost Portfolio PROHOST IS PICKING NEUROCRINE BIOSCIENCES   On March 27, a few days before the FDA approves Neurocrine’s (NBIX) drug Ingrezza, (valbenazine) capsules for adults with tardive dyskinesia (TD), we posted an article titled “Time for Transformation and Achievements”. In the article, we stated that Neurocrine Sciences Ingrezza will highlight Neurocrine Biosciences and its …

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

On March 27, we wrote about how positive results of Neurocrine Biosciences (NBIX) drug Ingrezza on Tardive Dyskinesia (TD) will highlight Neurocrine Biosciences and its Scientists. We wrote: The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. We elaborated on the trial that provided …

CANCER IMMUNOTHERAPY 2 Nonstop Improvements and Nonstop Discoveries In CAR-T Immunotherapy As we said in the article about checkpoint inhibition as cancer immunotherapy, the approaches that aim at enabling the immune system to fight cancer cells were created to stay and improve and become the gold standard for cancer treatment. Chimeric antigen receptor T cell (CAR-T) therapeutics are speeding their way towards approval in 2017. …

The FDA Approves Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection First HCV Direct-Acting Antivirals Approved for Adolescents Gilead Sciences (GILD) announced that the FDA has approved its supplemental application for its HCV drugs HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and its HCV drug SOVALDI® …

CANCER IMMUNOTHERAPY Nonstop Improvements and Nonstop Discoveries Checkpoint inhibitors and CAR-T immunotherapy are created to stay and succeed and change the way cancer has been treated for decades. The reason is that the successful results from some early attempts to enable the immune system to attack and fight cancers through these new immunotherapy approaches were unmatched in the history of cancer treatments. These successes, though, …

Agenus (AGEN) is reorganizing its business and operations. The reasons the firm cited comprise sharpening of its focus on clinical development of its two checkpoint inhibitor antibodies and vaccine program. Among others are: - Closing its Basel site and consolidate key functions to its Cambridge, UK and Lexington, MA facilities, - Phasing out approximately 50 positions across the organization. Robert Stein, M.D., Ph.D., President of …

Positive Results of INGREZZA on Tardive Dyskinesia Highlights Neurocrine Biosciences Sciences and Scientists     The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Neurocrine Biosciences (NBIX) drug Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. The positive results came out of the Kinect 3 — a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, …

Everybody knows Bristol-Myers Squibb (BMY), but just a few may know anything about CytomX Therapeutics (CTMX), or about its Probody Program. CytomX is a small, develop-ment-stage firm that created platform known as the Probody Program, which leads to the creation of first in class Probody therapeutics. These therapeutics are meant to overcome safety and efficacy problems encountered by the antibodies that are currently used in …

AMGEN Amgen’s (AMGN) cholesterol lowering drug Repatha is the only drug that has demonstrated protection against heart attack and stroke in high risk patients. Prior to the FOURIER trial, which confirmed the effect of Repatha in lowering cardiovascular events, including heart attack and stroke, other clinical trial data led to the FDA approval of Repatha limited to the following indications: 1) adjunct to diet and …

Nektar Therapeutics (NKTR) announced positive results from the SUMMIT-07 Phase 3 efficacy study of its painkiller drug known as NKTR-181. The drug, which is a first-in-class opioid analgesic is a new chemical entity (NCE). It is the first full mu-opioid agonist molecule designed to provide potent pain relief without leading to abuse and addiction. The FDA has granted NKTR-181 Fast Track designation for moderate to …

OncoCyte (OCX) has news. This firm, which develops non-invasive blood and urine liquid biopsy diagnostic tests has good news about its lung cancer liquid biopsy. Liquid biopsy is a term recently coined for a simple blood test that can replace current invasive and expensive biopsy procedures for the detection of cancers at their early stages. This simple blood test is expected to lessen the need …

Prohost Letter #406 A Special Prohost Issue SYNOPSIS REASONS FOR THE FOLLOWING PROHOST PICKS RALLIES VERTEX Vertex (VRTX): Great news about 2016 revenues & earnings Growth and pipeline. FROM YESTERDAY: Tremendous Revenues Growth. Cystic fibrosis (CF) revenues grew up around 75%. FOR TOMORROW:  Boosting  the  pipeline  value  by Advancing CF novel correctors into Phase 2 trials while Producing and advancing new CF correctors. PROJECTIONS: Continued …

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …

Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals (IONS), announced positive results from the pivotal Phase 3 APPROACH study of the drug volanesorsen. The results demonstrate that the drug met its primary endpoint of reducing triglyceride levels in patients with familial chylomicronemia syndrome (FCS). The Disease familial chylomicronemia syndrome (FCS) is a severe, rare genetic metabolic disorder characterized by an inability of the body …

A few days ago, the FDA approved Lexicon Pharmaceutical’s (LXRX) drug Xermelo™ (telotristat ethyl) 250 mg for the treatment of metastatic neuro-endocrine syndrome (mNET) patients who suffer from carcinoid syndrome diarrhea. The drug will be launched and sold today, March 6, in select specialty pharmacies. Carcinoid syndrome is a rare condition that occurs in patients with mNETs. It is characterized by frequent debilitating diarrhea that …

An approved rheumatoid arthritis drug developed and sold by Sanofi could become a new treatment for aggressive cancers. The news came in a Mount Sinai press release announcing that researchers have discovered that a rheumatoid arthritis drug can block a metabolic pathway that occurs in tumors with a common cancer-causing gene mutation. The discovery offers a new possible therapy for aggressive cancers with few therapeutic …

We keep reiterating that CAR-T cancer immunotherapy was created to stay. More frequent updates about the CAR-T approach further solidified our conviction. Almost every week we are getting news eliminating layer by layer of the true problems about CAR-T therapy that transplanted skepticism in investors’ minds towards a successful outcome of this novel immunotherapy approach to cancer treatment. The two essential problems that instilled the …

Exelixis (EXEL) announced a new collaboration with Roche on a phase 1b dose escalation study of a combination of Exelixis cabozantinib in combination with Roche’s anti-PD-L1 immuno-therapy drug atezolizumab. The study aims at evaluating the safety and tolerability  of the combination in patients with locally advanced or metastatic solid tumors. Enrollment is scheduled to begin mid-year 2017. Exelixis will sponsor the trial, and Roche will …

Incyte Announces a Multi-year Research Collaboration with the Abramson Cancer Center at the University of Pennsylvania. The aim of the agreement with Abramson Cancer Center at the University of Pennsylvania as Incyte (INCY) stated in the press release is to bring together the knowledge and expertise of both collaborators scientists. This cooperation will enable conducting collaborative research in order to advance the understanding of cancer …