MANUFACTURING ISSUES?!  Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …

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. …

Prohost Letter #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …

ProhostLetter #403 Part 1 On December 8, 2016 under News & Comments Prohost commented on President Elect Trump’s statement that he is going to bring down the exorbitant drug prices. The Skyrocketing Prices of Drugs Like everybody else we happen to talk to, we agree that the prices of drugs have skyrocketed to a level that made them unaffordable. It is a serious problem that …

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 …

President Elect Trump was quoted in a Time person of the year as saying “I am going to bring down drug prices.” The President Elect did not say he is going to bring down the drug producing and developing firms. Mr. Trump did not say he will bring down medical research, which is mostly conducted by the biotech and pharmaceutical firms. He did not say …

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 Letter #402 Antisense Proof of Concept and Feasibility EYE ON INVIVA (INVA) Sales of The Ellipta Inhalers Started to Pick up AND ON THERAVANCE BIOPHARMA (TBPH) See Below AND WE WILL NOT LOSE FOCUS ON ARIAD (ARIA), EXELIXIS (EXEL), ARRAY (ARRY), PORTOLA (PTLA), NEKTAR (NKTR), THERAVANCE BIOPHARMA (TBPH), INVIVA (INVA), MERCK (MRK) AND SEE THE TABLES IONIS (IONS) The . . . This content is for paid …

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 …