The Week in Review #21 Part 1 THE MARKET - Like symphonic orchestras that bring to the listeners’ ears, minds and souls melodies composed by legendary authors, the stock market reflects what’s going on in the world, which would positively or negatively impact the lives and well being of the earth’s residents . . . This content is for paid subscribers. Please click here to subscribe or here to …

Prohost Letter #420 REAL BREAKTHROUGHS - One Has Already Been Used and the Other Has Extraordinary Promises In  the  NEWS - THE POWER OF CHECKPOINT INHIBITOR IMMUNOTHERAPY WOW It is about the checkpoint inhibitors immunotherapy, which is bringing to the world of cancer a stunning revelation of a combination treatment offering an almost cure for a lung cancer...

In today’s news, Incyte’s (INCY) immuno-oncology IDO1 inhibitor product Epacadostat in combination with Merck’s immuno-oncology product Keytruda® did not meet the endpoints of the trial in patients with unresectable or metastatic melanoma. The stock was subjected to a selloff – a market’s reaction pattern that occurs whenever negative news comes out of experimentation without consideration of the extent of their impact. A serious question to ask now would …

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of …

AstraZeneca’s (AZN) checkpoint PD-L1 inhibitor Imfinzi and NewLink Genetics’ (NLNK) IDO inhibitor indoximod will be combined and tested in Phase 2 randomized, placebo-controlled clinical trials together with the standard of care chemotherapy treatment for metastatic pancreatic cancer. AstraZeneca and NewLink Genetics will jointly fund the phase 2 trial of the combination that  NewLink will be sponsoring  It is a Phase 2  trial that will be …

Agenus (AGEN) announced that the U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously, recommending the approval of GlaxoSmithKline’s (GSK) shingles vaccine candidate, Shingrix, containing Agenus’ proprietary immune adjuvant, QS-21 Stimulon®. This is good news for Agenus. As Garo Armen, Ph.D., Agenus CEO and Chairman of the Board said, “The Advisory Committee’s recommendation for the approval of Shingrix marks the first for a product …

Indeed, updated data from the ongoing Phase 2 NLG2103 study of NewLink Genetics (NLNK) IDO inhibitor immunotherapy product indoximod in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab) demonstrate positive results in advanced melanoma. The news rallied the stock that has been cremated following news that the same drug Indoximoll has failed to meet the endpoint in mid-phase trials on breast cancer in combination with …

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.

EXELIXIS Exelixis’ (EXEL) shareholders know well how good are the firm’s announced financial results for the second quarter of 2017. They also know well how good is the update presented by the firm about the progress made towards fulfilling its commercial and clinical development milestones. Exelixis report left no reason for complaining, criticizing or downgrading the firm’s stock. As a matter of fact, the presentation …

It took only a few months after the dosing stages of NKTR-358 in in a Phase I trial for Eli Lilly to strike a deal worth $400 million with the ascending firm Nektar (NKTR) related to the drug. Eli Lilly seemed impressed with NeKtar’s drug, which was designed to treat autoimmune and other chronic inflammatory conditions. NKTR-358 targets interleukin (IL-2) receptor complex. Nektar and Lilly …

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 …

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer a successful treatment. Checkpoint inhibitors have reached the market at the hands of Merck, Bristo-Myers Squibb and Roche, with other firms coming forward with products …

Prohost Letter #409 ASCO The American Society of Clinical Oncology (ASCO) meeting is around the corner. The Meeting, which will begin on Friday June 2, 2017 and will end on Monday 5, 2017 will be different than the past years for many reasons, including the following: -­ Checkpoint inhibition as Immunotherapy for cancer treatment moved from wishful thinking a decade ago, to promising cancer treatments …

As a matter of fact, we consider Incyte’s (INCY) drug epacadostat’s good results extremely important. The reason? Two facts are currently settled in researchers’ and oncologists’ minds. These are: 1. Checkpoint inhibitors require effective combination therapy to boost their limited efficacy, or at least to improve their efficacy, especially in solid tumors. 2. IDO inhibition is recognized as central for immunotherapy success. Both facts have been proven …

Prohost Letter #408 AT A GLANCE - Continued from the Previous Prohost Letter #408 In the Past issue #407, we picked the following firms: NEUROCRINE BIOSCIENCES (NBIX) Treating Tardive Dyskinesia CYTOMX Improving On Cancer Immunotherapy CELYAD SA (CYAD) Bringing Solutions To Immunotherapy Problems Please Read the articles written about these firms in the Issue #407 In This Issue We Add  NEW LINK GENETICS...

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

CANCER IMMUNOTHERAPY Nonstop Improvements and Nonstop Discoveries Checkpoint inhibitors and CAR-T immunotherapy are created to stay and succeed and change the way cancer has been treated for decades. The reason is that the successful results from some early attempts to enable the immune system to attack and fight cancers through these new immunotherapy approaches were unmatched in the history of cancer treatments. These successes, though, …

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 …

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …