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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a Small Molecule Arginase Inhibitor                         Incyte (INCY) and Calithera Biosciences (CALA) announced a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in …

A few months ago, we heard news that a Belgium firm called Celyad (CYAD) has concluded a deal worth over $300 million with Ono Pharmaceutical. The deal gives Ono the rights to Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This news did not mean a lot to investors as Celyad had yet to recover from a heartbreaking  setback in a late phase trial …

Amgen (AMGN) The Journal of the American Medical Association (JAMA) published findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Amgen’s drug Parsabiv in more than 1,700 adults with secondary hyperparathyroidism on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker …

GILEAD (GILD) One analyst who aimed at bringing only the negatives about biotech has finally succeeded in convincing other critics and media bloggers that Gilead would not be good for investment until the firm acquires a company that can expand its meager oncology franchise. His story became the melody hummed by every blogger, ignoring the fact that the firm’s revenues and income have doubled overnight …

Hi and Happy New Year 2017 In a couple of days, you will receive the NEW Year 2017 issue #404 of the Prohost Letter where we will set out our prediction regarding breakthrough achievements that we believe will change the way diseases will be treated. Our long article tackles great technological capabilities that we expect will advance products to the market and improve state-of-the-art approaches …

Observing the biotech sector’s stock prices post losses yesterday, Wednesday, Dec. 21 convinced us that investors and traders in the biotech sector might have wrongly interpreted a bipartisan Senate report regarding the high price of drugs. The report is the outcome of a study that forms the basis of a recommendation that would enable the Congress take the right action against unjustified increases in the …

Ionis Pharmaceuticals (IONS) has further good news with a new revelation from Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals that the Phase 3 COMPASS study met its primary endpoint. COMPASS is a randomized, double-blind, placebo-controlled, 26-week Phase 3 study evaluating the firm’s drug volanesorsen in 113 patients with severe hypertriglyceridemia.   The average incoming triglyceride level of patients in the study was 1,261 mg/dl. …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …