The Week in Review #29 PROHOST AGGRESSIVE PORTFOLIO  - The aggressive portfolio hosts biotech firms with solid scientific fundamentals and prominent scientists whose stocks have plummeted following some setbacks. A setback could be a failure of an investigational product to meet the endpoints of its clinical trial or that the small biotech firm has taken long to achieve its goals . . . This content …

The Week in Review #28 The approval of revolutionary products created by biotech firms with solid scientific fundamentals, superior scientists and advanced technologies is what motivates us to pick for investment biotech and biopharmaceutical firms. So, let’s see what has been approved in the parting week  from firms that we picked for investment.       IMPORTANT APPROVALS       Prohost Picked Firm     …

The FDA Approves Regeneron’s Product EyLea® (aflibercept) sBLA in Wet Age-Related Macular Degeneration Regeneron (REGN) has two good news. The first is from one of its approved products, EYLEA® announcing that the U.S. Food and Drug Administration(FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the …

Exciting are the Q2 2018 reported results by Exelixis’ (EXEL) including the firm’s revenues and earnings, compared to 2017. Impressive were Cabometyx’ (cabozantinib) revenues, in addition to the milestone payments from collaborating companies and ex-USA marketing agent. Inspiring also are the efforts the firm is spending on research and development with the aim of further boosting its revenues. Of the Results Revenues and Incomes – …

The Week in Review #23  ASCO  2018 - Small  publicly-­traded  oncology  biotech  firms,  large  oncology  biotech  firms,  and  giant  biopharmaceutical  firms,  in  addition  to  some  private  biotech  companies,  all  presented  results  and  observations  about  their  cancer  drugs  at  the  2018  American  Society  of  Clinical  Oncology  (ASCO)   meeting.  Most  presentations  were  useful,...

The U.S. Food and Drug Administration (FDA) has approved Agilent Technologies’ (NYSE: A) Dako PD-L1 IHC 22C3 pharmDx assay for an expanded use. The expended use is expected to help physicians to identify cervical cancer patients who are most likely to benefit from treatment with Merck’s (MRK) checkpoint inhibitor lmmuno-oncology product Keytruda PD-L1 IHC 22C3 pharmDx assay was FDA approved for non-small cell lung cancer and subsequently expanded approval for gastric …

– Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA granted Merck (MRK) approval for its immuno-oncology checkpoint inhibitor Keytruda® for adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or for those who relapsed after two …

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 …

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 …

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 …

The Week in Review #9 KNOCKING DOWN THE BIOTECH STOCKS - Knocking down the biotech companies’ stocks during the announcement of the quarterly reports is no news. Most investors in the stock market, especially those who invest in the biotech sector have become familiar with this pattern . . . This content is for paid subscribers. Please click here to subscribe or log in.

The Week in Review #8 Potential biotech winners inspired through COLLABORATION - When successful top-­tier drug developing firms such as Amgen (AMGN) or Merck (MRK) sign strategic collaborating agreements with small development-­stage biotech firms,...   &nbsp . . . This content is for paid subscribers. Please click here to subscribe or log in.

–The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) – Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million – Merck Acquires 9.9% Stake in KalVista in Private Placement.    -Phase 2 Clinical Trial for the Investigational Intravitreal DME Candidate KVD001 Still Planned to Initiate in 2017. Surprise? Indeed, it is. KalVista Pharmaceuticals …

Prohost Letter #413 FROM BIOTECH TO BIOPHARMA - New research, new findings, new discoveries of trustworthy and doubtful biomarkers more understanding of genomics and proteomics, in addition to more breakthrough diagnostic procedures, are all gifts of the life-science revolution. This revolution started with molecular biology, the discovery of the DNA and its functions, which was the prelude to genomic understanding, gene sequencing, and genetic engineering and …

The Week in Review #4 AMAZING STOCK REBOUNDING - We have already witnessed and wrote about the fierce rebounding of some of our selected stocks comprising: Exelixis (EXEL), Sangamo (SGMO), Array (ARRY), ImmunoGen (IMGN) and others . . . This content is for paid subscribers. Please click here to subscribe or log in.

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 …

Prohost Letter #412 Part 3 GLIOBLASTOMA - Is There Hope? Senator John McCain was diagnosed with a malignant brain tumor, glioblastoma – the most common and aggressive form of brain cancer. The cancer is so aggressive that most surgeries did not provide survival. This brain cancer affects around 3 people out of 100,000 in the U.S., with men more than women and whites more than other …

FROM ARRAY Array’s Drug Binimetinib in Combination Therapy with Merck’s Drug Keytruda for METASTATIC FOR COLORECTAL CANCER   On May 8, 2017, Array BioPharma and Merck announced entering into a clinical trial collaboration to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The decision on this …

Merck’s (MRK) anti-PD-1 drug Keytruda® (pembrolizumab) is approved for many, many cancers. Yet, it is fair to say that this checkpoint inhibitor drug will not be effective in all cancers. This is especially true now that yesterday, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of Keytruda® with Celgene’s products Pomalyst Pomalidomide and …