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 …

Prohost Letter #401 SYNOPSIS PART 1 In this Letter CONTENTS Duchenne Muscular Dystrophy (DMD) FDA Compassionate Approval of Eteplirsen! PART 2 In The Letter Issue #402 CONTENTS EYE ON IONIS (IONS) Antisense Proof of Concept and Feasibility EYE ON INVIVA (INVA) AND THERAVANCE BIOPHARMA (TBPH) Sales of The Ellipta Inhalers Started to Pick up Before an expected Boom Not Losing . . . This content …

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 …

The nature the Presidential Election this time is weighing on investors’ chests and minds and mood and decisions. The stocks are typically reflecting investors’ inability to reason or make rational selection. Many are waiting for the election results to see whether they sell their portfolios or add to them. Negativity is the outcome fuelled by pessimism and by the simultaneous surfacing of articles and biographies …

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 …

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 …

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 …

As we expected in our previous articles, Today, Aerie Pharmaceuticals (AERI) came up with great news about its glaucoma treatment. The stock surged ….   On February 18, 2016, Under News & Comments, we wrote an article titled “Aerie Pharmaceuticals: Novel Glaucoma Eye Drops Confirm their Superiority”. The article also referred to a Prohost previous article written on February 4, 2015 and tittled “Aerie Pharmaceuticals …