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 …

Bellicum Pharmaceuticals (BLCM) announced results from the BP-004 multicenter clinical trial for children with Primary Immune Deficiencies (PIDs) and hemoglobinopathies. The candidates received an add-back of Bellicum’s BPX-501 modified T cells following a haploidentical, T cell-depleted hematopoietic stem cell transplant (haplo-HSCT). The data were presented in oral and poster sessions today during the 58th Annual Meeting of the American Society of Hematology (ASH). Results: All …

Prohost Biotech On   ARRAY PHARMACEUTICALS Under the title “Halozyme has Good News and Array Too”, we wrote the following about Array On Nov. 5, 2015. Array’s (ARRY) internal, broad based drug discovery and research technological capabilities is behind the creation of its small molecule therapeutics. Array’s know-how and expertise led it to build a library of therapeutics for advanced cancers and other diseases. Array’s library’s therapeutic molecules are expected …

The U.S. Food and Drug Administration (FDA) has removed the partial clinical hold it put on Adaptiimmune’s (ADAP) planned study of its NY‑ESO SPEAR™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS). The move cleared Adaptimmune to start enrolling patients with the MRCLS cancer in a trial of NY‑ESO T-cell therapy partnered with GlaxoSmithKline (GSK) Adaptimmune will initiate a study …

The media failure to forecast the results of the Presidential election has become the talk of the town and of the failed media itself. The New York Times’ article about this forecast fiasco titled “How Data Failed Us In Calling An Election” was great, showing that forecasting science is still immature to bring accurate results. The article stated that the failure in predicting the winner …

Biogen (BIIB) and Ionis (IONS) announced that Spinraza (nusinersen), an antisense drug designed and developed by Ionis met its primary endpoint in Phase 3 trial of the CHERISH Study in later-onset spinal muscular atrophy (SMA). This was the second positive Phase 3 study that provides evidence of Spinraza’s efficacy and favorable safety. The data demonstrate statistically significant and clinically meaningful results.   Children receiving Spinraza …

Ariad Pharmaceuticals (ARIA): Good news from the U.S. Food and Drug Administration (FDA) affirmed that the agency accepted for review Ariad’s New Drug Application (NDA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed after being treated with crizotinib. The NDA submission includes clinical data from its Phase 1/2 and …

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 …

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 …

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 …

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 …

EXELIXIS (EXEL) Friends and subscribers are asking the following question for more than two weeks now: Why EXEL stock has rallied? Most of those who asked the question owned the stock and made a lot of profit on it. The truth is that those investors wanted to know whether it was time for them to take their profit and enjoy it elsewhere. In other words; …

The FDA approval of Sarepta’s (SRPT) Duchenne muscular dystrophy (DMD) product, Exondys 51 (eteplirsen), surprised many analysts. Nonetheless, it doubled SRPT's price after the stock had already multiplied everal folds since the stock had been cremated. Good for those who dared to bet on SRPT in spite of the FDA’s independent advisory committee’s voting against the approval and the FDA hesitation to listen to the …

The FDA announced what made Clovis Oncology (CLVS) shareholders believe that the bad times might have ended for the firm and a new era is beginning. The announcement was about the FDA decision not to hold an advisory committee meeting to discuss the company’s New Drug Application (NDA) for drug rucaparib aimed at treating advanced ovarian cancer. The regulatory agency had already granted rucaparib a …

Xoma’s (XOMA) webcast and conference call scheduled for September 15, 2016, at 1:30 p.m. PDT (4:30 p.m. EDT) is important and should be interesting to the firm’s shareholders. The conference call will provide an update on what’s going on in the Phase 2 trial of XOMA 358, the firm’s drug, which aims at treating congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBS). The Drug and …

At the European Society of Cardiology Congress 2016 in Rome, Italy, Array Biopharma (ARRY) presented good results from a Phase 2 study of its drug ARRY-797 - an oral, selective p38 mitogen-activated protein kinase inhibitor for patients with a rare degenerative cardiovascular disease. The disease, is known as lamin A/C-related dilated cardiomyopathy (LMNA-related DCM) and is caused by mutations in the LMNA gene and is …