Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab. The drug  is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to severely active rheumatoid arthritis (RA). Nothing in the CRL contents insinuates that sarilumab is not safe, or not effective, or that the clinical trial data were not …

Prohost Letter #400 NEAR-­TERM INVESTING The Prohost Letter #399 Part 3 has Promised to Des

Results from trials were negative in two phase 2 studies for Gilead (GILD) experimental drug GS-4997 (selonsertib) intended to treat pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). But the same drug selonsertib showed it might hit the jackpot when results demonstrated it succeeded in treating nonalcoholic steatohepatitis (NASH), which is also known as non-alcoholic fatty liver disease, where, according to Gilead, it showed …

There is nothing wrong with Nektar Therapeutics (NKTR). The stock is temporarily underperforming as traders are practicing their conviction that they must sell when a firm finances through dilution. The traders practice this law of thumb regardless of whether the financing aims at bringing wealth or invites for a catastrophe. We believe Nektar is walking the road towards creating wealth and growth through continued development …

At the Annual European Congress of Rheumatology (EULAR 2016) in London, Eli Lilly and Company (LLY) and Incyte (INCY) presented data from RA-BEYOND study, demonstrating that their drug baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA). A key goal of rheumatoid arthritis treatment is to impede the structural damage that this disease usually causes to the …

Shares of Ariad Pharmaceuticals declined following Senator Bernie Sanders’ criticism of the high price of the firm’s drug Iclusig (ponatinib) on Twitter. Ariad said, “our pricing reflects our significant investment in R&D, our commitment to the very small, ultra orphan cancer patient populations that we serve and the associated risk with research and development.” The Senator meant well we know. However, it looks as if …

When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments and of firms’ finances. Prioritizing comprises selecting as much as possible the most concrete subjects that are safe to explore. In the upcoming Prohost Letter …

EXELIXIS APPROVED PRODUCTS 1. CABOMETYX™(CABOZANTINIB) For Exelixis (EXEL) the two approved oncology products cabozantinib and cobimetinib and its pipeline of promising investigational products are considered now by more analysts a wealth that will be reflected in the firm’s future growth. The results emanating from the clinical trials of two approved products should not be underestimated. The latest of the good news emanated from the firm’s …

Following recent reports of new onset or worsening peripheral neuropathy in patients with ATTR amyloidosis with cardiomyopathy (hATTR-CM) treated with Alnylam’s (ALNY) RNAi –based drug revusiran, The firm requested that the Data Monitoring Committee (DMC) review the reports and the Clinical trial data on an unblinded basis. After reviewing the reports, the DMC advised suspending the dosing of revusiran. However, the DMC stated that It …

News about investigational drugs, which are expected to make big differences in the lives of people with chronic diseases and deadly diseases does not always materialize. Predicting drugs becoming breakthroughs has proven extremely difficult in the early phases of drugs’ development. Some products keep doing well, going from the preclinical testing into several phases of trials then all of a sudden they unexpectedly fail. They …