On Nov. 21, 2017, Portola Pharmaceuticals (PTLA) announced that the U.S. Food and Drug Administration (FDA) has informed it that it will respond to the Prior Approval Supplement (PAS) request to change the current manufacturing release specification within the standard 60-day extension period. No additional information was requested at this time. The new action date is January 30, 2018. Bill Lis, chief executive officer of Portola said, “As …

Portola Portola Pharmaceuticals (PTLA) announced that it will host a webcast and conference call to provide an update on its anticoagulant Factor Xa inhibitor Bevyxxa® (betrixaban) launch plans, the validation of the commercial manufacturing process and drug release timing. Conference Call Details: The live conference call will be held today, Tuesday, September 5, 2017, at 4:30 p.m. Eastern Time (1:30 p.m. PT). It can be accessed by …

Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the …

The Week in Review #2 The Fairest Upgrades of the Week - Some analysts gave a generous and well measured dose of fairness evaluating biotech firms’ accomplishments. Credit Swiss upgrades Portola Pharmaceuticals (PTLA) from neutral to outperform while maintaining its $70 target . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

AFTER MANY OF THE PROHOST PICKED STOCKS NEARED REACHING THE PROHOST NEAR-TERM TARGETS, recently, external circumstances and exaggerated delaying news, some of our rallied stocks gave back some of their gains. Two reasons were behind the decline in some precious picked stocks, which occurred one after the other in a very short period of time. The first reason for the declines came through traders’ practice …

Prohost Letter #412 Part 1 Updating Our Targets - This Letter will be of three parts. The first part (today’s  issue)aims at presenting our adjusted targets based on current news and updates related to the Prohost picks. A Case in Point - PORTOLA - For example, Portola (PTLA) has recently been granted FDA approval for its Factor 10 (FX) inhibitor anticoagulant drug Bevyxxa (betrixaban . …

The most important last barrier to cross or dismantle for drug developers is the approval of novel products that amplify the improvement of previous drugs. The approvals of drugs in the U.S. and Europe open the door for the same drugs to be approved and marketed in the rest of the world. For the revenue-generating firms, each and every approval helps grow their revenues. With …

Portola (PTLA) announced that the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Bevyxxa’s approval is on …

Prohost Letter #411 SOME STOCK RALLYING NEWS - Under normal conditions, some good news should rally the stocks of the firms that the news belong to them. During the past six months, Amgen (AMGN) announced a series of good news that seem to have fallen on deaf ears. Yesterday Amgen announced some positive results from three approved and one experimental products – all the news …

Prohost Letter #410 JUNE PDUFA DAYS This month, the FDA will decide on the approvals of drugs belonging to companies that Prohost has picked for investment. Usually, granting approvals rallies the stocks of the drugs’ developing firms. Sending Complete Response Letters for demands that might delay approvals would cut a substantial percentage of the stocks’ values, while rejections would cause the stocks to falter. Let’s …

Prohost Letter #406 A Special Prohost Issue SYNOPSIS REASONS FOR THE FOLLOWING PROHOST PICKS RALLIES VERTEX Vertex (VRTX): Great news about 2016 revenues & earnings Growth and pipeline. FROM YESTERDAY: Tremendous Revenues Growth. Cystic fibrosis (CF) revenues grew up around 75%. FOR TOMORROW:  Boosting  the  pipeline  value  by Advancing CF novel correctors into Phase 2 trials while Producing and advancing new CF correctors. PROJECTIONS: Continued …

The FDA’s Center for Drug Evaluation and Research (CDER) informed Portola (PTLA) that it does not plan to hold an Advisory Committee meeting for its Product betrixaban. What is betrixapan? Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway. Why it is used? Betrixapan …

Prohost Letter #404 Part 2 Synthetic Biology (2) A Brief History DNA is the software of life. This is how Synthetic Genomics firm, which we believe is now is the leading biotech firm for applied synthetic biology. Synthetic Genomics is still a private firm in spite of that thousands of investors are impatiently waiting for it to turn public and it will. So stay tuned. …

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 …

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 Letter #400 NEAR-­TERM INVESTING The Prohost Letter #399 Part 3 has Promised to Des

What’s Going on the Morning of Thursday, August 18, 2016? PORTOLA Portola Pharmaceuticals (PTLA) announced the receipt of a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is …

Notwithstanding the unrelenting improvements being constantly made in managing blood coagulation’s problems, conventional anticoagulants still have thrombotic incidents (clots) in patients taking anticoagulants (blood thinners) and bleeding remained the most feared side effect of these indispensable life-saving drugs. In recent years, several novel anticoagulants demonstrating obvious advantages over conventional anticoagulants have been created, developed and marketed. Their advantages over conventional anticoagulants have been validated through …

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 …

Prohost Letter #392 February 28, 2016 - How could it be possible for any genius to make intelligent guesses about the market's next moves when highly regarded experts, including Nobel Prize winners in economics, remained quizzical about the recent horrifying performances of publicly traded stocks? Since the beginning of 2016, the stock market has been made to look as if a runaway train with many passengers …