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 …

Making Sure that CAR-T Therapy for Cancer Succeeds Academic Researchers Identify a New Process to Raise Natural Armies of Cancer-Targeting T Lymphocytes Outside the Body Unleashing More Power to the Immune System to Fight All Types of Cancers GOOD NEWS FOR CAR-T IMMUNOTHERAPY DEVELOPERS Researchers from Mayo Clinic and the University of Washington have developed a new culture process to improve the efficacy of engineered …

Some investors are selling AGEN in premarket trading for a reason that might be unimportant anymore with Agenus’ totally changed status now with its new immunotherapy pipeline. The new checkpoint inhibitors products and their checkpoint targets products are the talk of the cancer community and having them has attracted large companies, including Incyte. Nevertheless, the stock will be trading down today because in a regulatory …

Watching the outperformance of the new approaches for cancer immunotherapies, especially the checkpoint inhibitors and other immunotherapy successful attempts, oncologists recognized that the ultimate efficacy of empowering the immune system to fight cancer will be reached when immunotherapy products are combined with other suitable products. In this respect, researchers and oncology specialists seem to believe that targeted therapeutics could be among the most fitting products …

About the CRISPR/Cas9 Gene Editing Patent Shareholders of biotechnology firms specialized in CRISPR gene editing technology are in a state of confusion regarding the technology's patents. The confusion is caused by the U.S. Patent and Trademark Office (USPTO) decision to sustain the intellectual property awarded to the Broad Institute of MIT and Harvard. This ruling has caused the stock of the firm Editas (EDIT), which …

Immunomedics (IMMU) and Seattle Genetics (SGEN) announced an exclusive global licensing agreement enabling Seattle Genetics to develop, fund, manufacture, and commercialize Immunomedics’ solid tumor drug candidate IMMU-132. Seattle Genetics accepted to take the responsibility for initiating Phase 3 clinical trial of IMMU-132 for patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the FDA for accelerated approval. Also …

Incyte (INCY) and Agenus (AGEN) announced an amendment of the License, Development and Commercialization Agreement that was originally agreed upon by the two firms on January 9, 2015. The amended converts the ongoing antibodies targeting GITR and OX40 programs from co-funded development and profit-sharing arrangements to royalty-bearing programs. In the 2015 agreement, both firms decided to work together on the INCAGN1876 (anti-GITR agonist) and INCAGN1949 …

The FDA’s Center for Drug Evaluation and Research (CDER) informed Portola (PTLA) that it does not plan to hold an Advisory Committee meeting for its Product betrixaban. What is betrixapan? Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway. Why it is used? Betrixapan …

Gilead Sciences (GILD) was subjected to what we believe is an exaggerated stock selloff following the announcement of its 2016 financial reports, which comprised its projections made for 2017. Investors seemed to have focused only on the HCV sales’ revenues while ignoring the sales’ revenues of Gilead’s HIV franchise and other products, which outperformed? Investors ignored assessing the firm’s pipeline investigational products’ values especially those …

Prohost Letter #404 Part 2 Synthetic Biology (2) A Brief History DNA is the software of life. This is how Synthetic Genomics firm, which we believe is now is the leading biotech firm for applied synthetic biology. Synthetic Genomics is still a private firm in spite of that thousands of investors are impatiently waiting for it to turn public and it will. So stay tuned. …

XOMA Establishes Proof-of-Concept for 358 in Congenital Hyperinsulinism and Hypoglycemia Post-Bariatric Surgery Congenital Hyperinsulinism Phase 2 study completed and multi-dose study protocol approved in the United Kingdom. Xoma initiates multi-dose study in hypoglycemic Post-Bariatric Surgery patients The NEWS A few days ago, Xoma announced news about trial results that the firm believes were promising and successful in establishing proof-of-concept for its . . . This …