Portola Pharmaceuticals and the CHMP’s Oral Explanations for Andexanet Alfa and Betrixaban Portola (PTLA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorization Application (MAA) for Portola’s factor Xa inhibitor antidote andexanet alfa. The agency has also communicated a negative trend vote for betrixaban, the firm’s oral, Factor Xa inhibitor. Andexanet Alfa Bill Lis, the chief executive officer …

The Week in Review #18 The Market - The stock market recuperated most of its losses while analysts preferred to abstain from forecasting and remain bystanders during the market volatility.  Although the causes of volatility have yet to be delineated, some philosophers in the field dared to attribute it as a market’s own mind’s judgment . . . This content is for paid subscribers. Please …

Seattle Genetics and Pieris pharmaceutical Collaboration Agreement Pieris Pharmaceuticals (PIRS) and Seattle Genetics (SGEN) signed a multi-program immuno-oncology collaboration agreement intended to evaluate novel bi-specific immuno-oncology agents. These agents would combine Pieris’ Anticalin proteins drugs with Seattle Genetics’ targeted antibodies to develop multiple targeted bi-specific immuno-oncology treatments for both solid and blood cancers. The Story Pieris Pharmaceuticals created recombinant engineered Anticalin protein-based therapeutics. These proteins are versions of the human protein lipocalin, which naturally bind, …

Expected or not, we believe that the news announcing that the U.S. Food and Drug Administration (FDA) approval Vertex’s (VRTX) cystic fibrosis combo product Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is good news. It is indeed excellent news for the many cystic fibrosis people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis trans-membrane conductance regulator (CFTR) gene or who have at least one mutation that …

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) Announce Global Development & Commercialization Collaboration for Nektar’s Product NKTR-214 The Collaboration is to evaluate the full-potential of NKTR-214 plus Obdivo (nivolumab) across numerous tumors, based on promising early data from ongoing Phase 1/2 PIVOT clinical study. Establishes a broad joint clinical development plan combining NKTR-214 with Opdivo and Opdivo plus Yervoy (ipilmumab) in registration-enabling trials in more than 20 indications across 9 …

The Week in Review #17 A Wild Wild Week - The stock market looked as if it rejected all analysts’ opinions about the stocks they believed were “undervalued” and adopted only their opinion on what they believed are overvalued. As a result, the market decided to dive,... &nbsp . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #417 Private Lessons - These lessons are overdue and we had to do this homework before we go into further evaluations of our picks and introduction of new companies as we promised in the past issue. We believe that the Prohost readers, the fans and the critics should know how and why we pick our biotech stocks . . . This content is …

A Stanford research team investigating a new immunotherapy approach, which consists of injecting tiny amounts of two immuno-stimulating molecules directly into the cancers themselves, announced good news. The first of the two injections contained a CpG oligonucleotide a short stretch of DNA that promotes the expression of OX40, a protein that resides on the surface of the immune system’s T cells. The second injection comprised an antibody that binds …

We postponed the Prohost Letter we planned to post this past Monday until the market’s fits come to an end, which we believe they will. Indeed, the market unexpectedly acted as if it is suffering from petit mal without being diagnosed with epilepsy. The sudden market switch from rallying to tumbling is unexplainable considering that the usual criteria for a stock market suppression are nonexistent. We remembered, …

Vertex (VRTX) announced the selection of two next-generation correctors, VX-659 and VX-445, to advance into Phase 3 development as part of two different triple combination regimens for people with cystic fibrosis (CF). The decision was based on data from initial Phase 2 trials, including new data from ongoing Phase 2 studies demonstrating mean absolute improvements in percent predicted forced expiratory volume in one second from baseline through four weeks of treatment …

Yes, the title is real and correct and the condition is ASD. The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Roche’s (RHHBY) drug balovaptan developed for ASD. Balovaptan has shown the potential to improve social interaction and communication in people with ASD. Balovaptan is an investigational small molecule drug that acts as a vasopressin (V1a) receptor antagonist. Evidence from both human and animal studies implicate …

ChemoCentryx (CCXI) develops new drugs for inflammatory, autoimmune diseases and cancers. The firm’s approach comprises targeting the chemokine and chemoattractant systems with the aim of discovering, developing and commercializing orally-administered therapies for inflammation and malignancy and maybe other disease conditions. In the News A few days ago, ChemoCentryx announced positive overall survival (OS) results from Phase Ib clinical trial of its second CCR2 inhibitor drug CCX872 designed for the treatment of locally advanced/metastatic pancreatic cancer and …

Amgen (AMGN): Phase 3b results from LIBERTY study assessing the safety and efficacy of Aimovig™(erenumab) 140 mg in patients with an episodic migraine who had experienced two to four previous preventive treatment failures demonstrate that the study met its primary and secondary endpoints.    With regard to meeting the primary endpoint, the results demonstrate that patients on Aimovig experienced at least a 50 percent reduction from baseline in …

Celgene (CELG) and Juno (JUNO) announced the signing of a definitive merger agreement upon which Celgene has agreed to acquire Juno. Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies. Juno …

Acorda (ACOR) stock was up around 10% reaching over $28 in premarket trading. The stock is trading now around $27 with its gains oscillating between $2 – $2.20. The enthusiasm for ACOR seems to be about rumors that Biogen (BIIB) or possibly other Asian drug makers might have demonstrated the interest in Acorda. What’s going on with Acorda? In June 2017, the stock rallied on news about positive clinical trial …

Juno Therapeutics’ (JUNO) stock price orbited the moon after-hours trading yesterday, rising 45%, following a wall street journal report stating that Celgene (CELG) was in discussions to take over Juno and that the negotiations could result in a deal in the coming weeks. Juno was established to create cellular immuno-oncology products- chimeric antigen receptor T cell (CAR T) to treat cancer. Neither Juno nor Celgene would …

The Week in Review #16 More Exciting Rallies in Prohost Picks - The past week and for several week fascinating outperformances have been seen for many of the Prohost Portfolio stocks. We continue to articulate that the good news is not only in the stocks’ rallies, but also in the outstanding stories behind them . . . This content is for paid subscribers. Please click here …

Checkpoint inhibitors approved for a few firms as immunotherapy for cancer are increasingly demonstrating their superiority in extending the lives of patients when given as first-line treatments. In the news, Merck’s (MRK) anti-PD-1 therapy, pembrolizumab (Keytruda®) in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival …

VERTEX From Europe, Vertex (VRTX) was informed that the European Commission has granted an extension of the Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor). Orkambi is for cystic fibrosis (CF) in people with two copies of the F508del mutation, including children ages 6 through 11 Reimbursement: In countries such as Ireland, reimbursement agreements will lead to rapid access to ORKAMBI. In other countries across the European Union, Vertex will begin a country-by-country reimbursement process. Clinical trial Results …

Prohost Letter #416 Part 2 2017 - A YEAR OF BREAKTHROUGH TECHNOLOGIES, BREAKTHROUGH PRODUCTS, IMPROVEMENTS ON PROMISING BREAKTHROUGH TREATMENTS, DECIPHERING IMPORTANT LIFE SCIENCE MYSTERIES, PINPOINTING BIOLOGICAL PATHWAYS FOR TREATMENT RESISTANCE, MIRACLE CURES, AND… A LOT OF DISTORTED NEGATIVE INTERPRETATIONS - Prioritizing our choices of breakthroughs has been a dilemma . . . This content is for paid subscribers. Please click here to subscribe or here to log …