Illumina Showing 6% revenue increase over the same quarter last year, Q1 2016, was not enough as Illumina (ILMN) missed analysts’ expectations and its own projections regarding its revenues. Prior to the announcement of its Q1 results, the giant gene sequencing firm offered investors a comprehensive explanation of the origin of the miss and the actions it has already begun to take to avoid future misses. Illumina pinpointed …

Meaningful Presentations at the Annual Meeting of the American Association for Cancer Research (AACR) NEKTAR THERAPEUTICS NKTR-214 Drug Improves Survival and Extends Immunity in cancer Immunotherapy Nektar Therapeutics (NKTR) investigational immune-stimulatory cytokine therapy NKTR-214 is in Phase 1/2 trial. At the Annual Meeting of the American Association for Cancer Research (AACR) meeting, Nektar announced new preclinical data for NKTR-214, which demonstrate both its activity as a single-agent and its synergistic activity with checkpoint blockade. …

In the biotech sector, daily stories (news) are not just announced, but mostly edited in ways that project the narrators’ tendencies and wishes rather than the original news. Last week’s headlines comprised positive news from a firm’s drug aimed at treating a chronic progressive disease, muscular dystrophy, which disables children’s by weakening their voluntary and involuntary muscles, while threatening their hearts and lungs and lives. Other headlines …

Pursuing its goal in treating hepatitis, Gilead Sciences (GILD) is at the finish line of clinical trials on another virus, this time the Hepatitis B virus. HBV not HCV. Two large Phase 3 trials evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met the primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate (TDF) 300 mg.  …

Juno Therapeutics (JUNO) is due to receive a fee payment of $50 million from Celgene. The reason for this compensation is that Celgene has exercised its option to develop and commercialize Juno CD19 program outside North America and China. From now on, Juno will share with Celgene the global development expenses for products in the CD19 program outside the U.S. and china and Celgene will have pay …

Regeneron and Intellia to Discover and Develop CRISPR/Cas Therapeutics Moving forward is Regeneron Pharmaceuticals’ (REGN) strategy based on strong scientific and technological capability that needs no validation by external validators. The quality, i.e., safety and efficacy, of Regeneron’s approved products and the clinical trial outcomes of the firm’s drugs in late phase trials speak for themselves. Good news from the firm is flooding the media. The most recent …

Dealing With Bacterial Resistance To Antibiotics    In the NEWS THERAVANCE BIOPHARMA At the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Theravance Biopharma (TBPH) demonstrated that its drug Vibativ® (televancin) possesses a potent in vitro activity against broad range of Staphylococcus aureus (S. aureus) clinical isolates. These isolates included Methicillin-resistant S. aureus (MRSA). The antibiotic activity for VIBATIV was seen in 100% of the evaluated S. aureus clinical isolates regardless of their type or resistance …

Another day, another badly needed treatment for a dangerous disease is on its way to be FDA approved. The day was yesterday, Thursday, April 7, 2016. The company is Intercept (ICPT), the disease is primary biliary cirrhosis renamed primary biliary cholangitis (PBC), the drug is called Ocaliva™ (obeticholic acid). The good news came from the FDA's Gastrointestinal Drugs Advisory Committee, which voted 17 to 0to recommend accelerated approval of Ocaliva™.    Now …

Years ago, a friend who is a highly regarded Immunologist lectured us during one of our visits to his home city Milano in Italy about the important role well written press releases play in highlighting the prominence of unknown, yet, capable biotech firms. “If not for its announced news, millions of interested people around the world, including myself, wouldn’t have heard on time about Genentech …

Pfizer (PF) terminated its acquisition agreement with Allergan Plc (AGN) The new set of rules released by the U.S. Treasury Department to make it difficult for U.S. companies to conduct tax inversions contributed Pfizer’s decision. Analysts noted that the new regulations seem almost directly aimed at Pfizer-Allergan. In one of two major parts of the new rules, the U.S. government would not consider the assets acquired …

PFIZER Pfizer (PF) announced that its oral drug tofacitinib in doses of 5 mg and 10 mg twice daily  met Phase 3 endpoints on psoriatic arthritis. The trial was conducted on adult patients with active psoriatic arthritis (PsA). The recruited patients had an inadequate response to at least one conventional anti-rheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve. Patients enrolled in the study were …

Prohost Letter #394 Part 2 PART 2 - Part 1 of the Prohost letter issue #394 posted on March 31,2016 ended with the review of Ariad Pharmaceuticals (ARIA), one of the biotech firms that have at least one marketed product that we believe have the chance to boost their revenues in the near-future. In this part 2 of the same Prohost Letter, we add other firms …

Many in Wall Street have been anxious, sitting on fire while waiting to learn, which biotech company Gilead Sciences (GILD) would decide upon acquiring that would deepen and enhance its pipeline. In Today’s news, a firm called Nimbus Therapeutics, LLC today announced that it has signed a definitive agreement under which terms Gilead will acquire Nimbus Apollo, Inc., a Nimbus Therapeutics wholly-owned subsidiary. Important is that the acquisition …

Prohost Letter #394 Part 1 Gilead - Some people sold Gilead’s (GILD) stock on Wednesday, March 23 after news announced on Tuesday that a jury decided that Gilead has infringed on two HCV molecules patents that Ionis (IONS), formerly Isis, and Merck had secured from their research. Ionis CEO said in a press release that his firm and Merck used their expertise during their collaboration in …

Incyte (INCY) and Eli Lilly (LLY): The New England Journal of Medicine published detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA). The study met its primary endpoint of ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 response rates were (P≤0.001 for each baricitinib dose versus placebo): 55 percent for baricitinib 4 mg; 49 percent …

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits outweigh the risks of Acadia’s (ACAD) drug Nuplazid™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. The Prescription Drug User Fee Act (PDUFA) action date for the FDA decision is May 1, 2016.  Nuplazid’s NDA was granted a breakthrough designation and Priority Review status for the treatment …

Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine Alder Also Reports Positive Phase 1 Data Supporting Quarterly Single Injection Dosing Strategy for ALD403 Alder BioPharmaceuticals (ALDR) announced positive rrsults from two clinical trials evaluating its preventive chronic migraine monoclonal antibody drug ALD403. The drugtargets calcitonin gene-related peptide (CGRP). ALD403 acted rapidly and prevented migraine over …

It is an ingenuous decision made by investors who rushed to consider betrixaban Phase 3 APEX study a failure. Betrixaban is a once-daily orally administered Factor Xa inhibitor anticoagulant.  The Phase 3 AREX study was evaluating the superiority of oral betrixaban’s extended-duration anticoagulation vs. the injectable standard-of-care anticoagulation for the prevention of venous thromboembolism (VTE) in acute medically ill patients. The 7,513-subject study designed to assess the relative risk …

Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced positive results from the BRIDGE pivotal Phase 3 placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis.  The study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine in men with osteoporosis treated with romosozumab compared with placebo at 12 months. All secondary endpoints comparing romosozumab with placebo …

Published articles in peer review journals cited that pharmacologic inhibition of RORγt regulates Th17 signature gene expression and suppresses cutaneous inflammation in vivo. Here we are, a clinical stage small company called Vitae Pharmaceuticals (VTAE) has just announced positive results from its Phase 2a proof-of-concept clinical trial of its RORyt inhibitor drug VTP-43742 in psoriatic patients. VTP-43742 is wholly owned by Vitae. It is an orally active RORyt inhibitor said to …