Category: Today’s Highlights

Amgen Is Still the Biotech King. Nektar Forms a Subsidiary Firm to Market Its Pain Product NKTR-181, When Approved

Amgen Is Still the Biotech King. Nektar Forms a Subsidiary Firm to Market Its Pain Product NKTR-181, When Approved

Amgen Is Still the Biotech King Amgen (AMGN), the biotech king, wanted to buy all of the Denmark biotech firm Nuevolution's drug discovery platform. This platform attracted Amgen in 2016 as well as many other large pharma firms including Merck, Johnson and Johnson, GlaxoSmithKline and Novartis. Nuevolution built impressive pipeline products based on its drug discovery technology, against important targets, which include: RORyt, BET, IL-17A.   …
Array BioPharma: Great News and a Learning Experience

Array BioPharma: Great News and a Learning Experience

Array BioPharma Great News and a Learning Experience Great News for Array BioPharma  Array BioPharma (ARRY) announced positive results from the interim analysis of the Phase 3 BEACON CRC trial. The trial evaluates the combination of: Braftovi® (encorafenib), a BRAF inhibitor, Mektovi® (binimetinib), an MEK inhibitor, and Erbitux® (cetuximab), an anti-EGFR antibody (BRAFTOVI Triplet), in patients with BRAFV600E- mutant metastatic colorectal cancer (mCRC) following one or two prior lines …
The Medicines Company: Are Inclisiran’s Clinical Trial Results Impressive?

The Medicines Company: Are Inclisiran’s Clinical Trial Results Impressive?

The Medicines Company Are Inclisiran's Clinical Trial Results Impressive? Our answer is YES. The trial results came out with several, not just one, good news.  Inclisiran's Good News The first good news came from the ORION-3 study, conducted by The Medicines Company (MDCO), and its siRNA product Inclisiran. The data from this trial demonstrated that Inclisiran lowers the LDL - Cholesterol (the bad cholesterol) by more than …
Another Late-Stage Firm with Impressive Technology and Promising Products

Another Late-Stage Firm with Impressive Technology and Promising Products

Iovance Biotherapeutics' Impressive Technology and Promising Products About Iovance Biotherapeutics Iovance Biotherapeutics (IOVA) is a late-stage biotechnology company developing novel cancer immunotherapies based on its tumor-infiltrating lymphocyte (TIL) technology. Iovance announced promising updates from ongoing clinical trials in advanced cervical cancer and advanced melanoma. The data will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) between May 31, 2019 …
Regeneron: Why the FDA Approval of EYLEA for Diabetic Retinopathy is Extremely Important.

Regeneron: Why the FDA Approval of EYLEA for Diabetic Retinopathy is Extremely Important.

The FDA Approval of Regeneron's EYLEA Is Important The PANORAMA Trial of EYLEA for Diabetic Retinopathy The United States Food and Drug Administration (FDA) has approved Regeneron’s (REGN) product EYLEA® (aflibercept) Injection for all stages of diabetic retinopathy. This approval is important. The data demonstrated from the PANORAMA trial showed EYLEA’s capability of reducing the risk of blindness in millions of people with diabetic retinopathy. That is the …
Exelixis’ and Daiichi Sankyo’s Novel Antihypertensive Drug Minnebro® Hits the Japanese Market

Exelixis’ and Daiichi Sankyo’s Novel Antihypertensive Drug Minnebro® Hits the Japanese Market

Minnebro® Hits the Japanese Market Exelixis and Daiichi Sankyo launched their novel anitihypertension product Minnebro® in Japan Exelixis (EXEL) and Daiichi Sankyo (DSNKY) Limited informed that Daiichi has launched their novel antihypertension product Minnebro® (esaxerenone) tablets in Japan. Exelixis is expected to receive a $20 million milestone payment following Daiichi Sankyo’s first sale in Japan, as dictated under the . . . This content is for paid subscribers. Please click here to subscribe …
A Firm That Defied the Fierce Unwarranted Bear Market Day

A Firm That Defied the Fierce Unwarranted Bear Market Day

Why GW Pharmaceuticals Survived the Bear Market Day The DOW Today Sinking for disputed and unfathomed reasons; watching and listening to analysts with antagonistic opinions on the TV screen; the stock market has taken down with it all the DOW companies; and probably all the other companies, in all the other industries; especially those in the drug industry. GW Pharmaceuticals plc Today Attracting our attention …
Vertex Has Good News and Exelixis Is Reinforcing Its Outperformance

Vertex Has Good News and Exelixis Is Reinforcing Its Outperformance

Vertex Product Kalydeco Has Good News Vertex Pharmaceuticals' Product Kalydeco for CF in Young Children Good news for Vertex (VRTX) product Kalydeco® (ivacaftor) is the first cystic fibrosis (CF) product to be prescribed for children ages six months to less than 12 months. Beneficiary children are those who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco, based …
The FDA Approval of Regeneron’s/Sanofi’s Praluent Is A Big Deal. Will the FDA Approve Nabriva Therapeutics’ Antibiotic Contepo Today?

The FDA Approval of Regeneron’s/Sanofi’s Praluent Is A Big Deal. Will the FDA Approve Nabriva Therapeutics’ Antibiotic Contepo Today?

FDA Approval of Regeneron's/Sanofi's Praluent Will Nabriva's Antibiotic Product Contepo Also Get FDA Approval? Praluent's Approval Is a Big Deal The approval of Regeneron’s (REGN) and Sanofi’s (SNY) supplemental biological license application (sBLA) aimed at updating Praluent’s (alirocumab) prescribing information is, indeed, a big deal. Proven life-saving benefits are confirmed. Comprising reducing the overall risk of major adverse . . . This content is for paid subscribers. Please click here …
Trick or Trade?

Trick or Trade?

Trick or Trade? The Misleading Market? The biotech stocks continue to begin their daily trading relying on opinionated articles implanted by bloggers on the Internet rather than on the firms’ voiced news.  It is unfortunate that we continue to observe many investors incapable of pinpointing the differences between the fake and the real in interpreting the news. We do not blame them; however, as those …
Trovagene’s News Is Encouraging

Trovagene’s News Is Encouraging

Trovagene's News Is Encouraging About Trovagene Trovagene (TROV) is still a clinical-stage company.  The precision cancer medicine approach is practicing what it preaches right now in order to develop drugs that target cell division (mitosis) for: leukemias, lymphomas and solid tumor cancers. In March 2017, Trovagene licensed global development and commercialization rights for Onvansertib (PCM-075); a Polo-like Kinase 1 (PLK1) Inhibitor from Nerviano Medical Sciences; the largest research …
Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal Cell Carcinoma. RegenxBio and Exelixis Are in Great Shape.   Novartis' Gene Therpay Product Zolgensma The FDA submission of the gene therapy product Zolgensma was based on positive findings from a trial of 15 babies treated with it. Recently; however, at the Orlando meeting of the Muscular Dystrophy Association …
Novartis: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis Has More Promising Data from Their Phase 3 Gene Therapy Trial with AveXis AveXis, a Novartis (NVS) company, announced positive interim data from its Phase 3 STR1VE trial of Zolgensma® (onasemnogene abeparvovec-xio (AVXS-101) gene therapy in spinal muscular atrophy (SMA) Type 1. About Spinal Muscular Atrophy (SMA) SMA is a severe neuromuscular disease characterized by the loss of motor neurons. The symptoms include progressive muscle weakness …
Amgen and UCB granted FDA approval of Evenity for osteoporosis in menopausal women at risk of bone fracture

Amgen and UCB granted FDA approval of Evenity for osteoporosis in menopausal women at risk of bone fracture

Amgen (AMGN) and UCB announced that the U.S. Food and Drug Administration (FDA) has granted approval of Evenity™(romosozumab-aqqg) for osteoporosis in postmenopausal women at high risk for bone fracture. Evenity is different from all other osteoporosis products as it is a bone builder that increases bone formation and, to a lesser extent, reduces bone loss and, consequently, reduces the risk of fracture. A full course of …
The Amgen/Novartis story. A Little Curiosity About Alder Biopharmaceuticals.

The Amgen/Novartis story. A Little Curiosity About Alder Biopharmaceuticals.

The Amgen/Novartis Story In May 2018 Amgen (AMGN)  & Novartis (NVS) announced that their novel migraine drug Aimovig™ was granted FDA approval for adults. Aimovig is the first and only FDA-approved migraine treatment designed to specifically block calcitonin-gene-related peptide receptor (CGRP-R) believed to play a critical role in causing migraines.  Amgen and Novartis both expressed their excitement for the . . . This content is …
Novartis’ Revolution: A new dimension and  Prohost expectations

Novartis’ Revolution: A new dimension and Prohost expectations

The market is outperforming today. There is important news today about Novartis; part of which we are posting now. There is still more news related to this same company as well as other biotech and biopharmaceutical companies, which will be in the upcoming Prohost Letter #430. We believe that the news we are posting will have a positive impact on the firms that announced them. …
Seattle Genetics: Why a selloff following good news

Seattle Genetics: Why a selloff following good news

Following Seattle Genetics' (SGEN) and Astellas Pharma's announcement of positive results, from pivotal trial of the conjugated monoclonal antibody drug Enfortumab Vedotin in locally advanced or metastatic urothelial cancer, the stock experienced a selloff. Prohost Observations   We do not believe that there is anything wrong with the positive results coming out of  EV-201 trial investigating Enfortumab Vedotinfor locally advanced or metastatic urothelial cancer who have received previous …
Why Agios Pharmaceuticals’ product TIBSOVO® was granted FDA Breakthrough Therapy designation. The  FDA approves Jazz Pharmaceuticals’ product Sunosi

Why Agios Pharmaceuticals’ product TIBSOVO® was granted FDA Breakthrough Therapy designation. The FDA approves Jazz Pharmaceuticals’ product Sunosi

The uncontrolled blowing toxic wind contaminates this country’s environment, it brings down the oversold scientifically solid and promising biotech stocks together with the undersold disappointing firms’ stocks. All we want is peace of mind, fairness and well being for America and the rest of the world. We are confident that this wish will materialize when the country’s leaders work together in harmony to make it …
Bluebird bio opens a state-of-the art gene and cell therapy manufacturing facility in Durham, NC

Bluebird bio opens a state-of-the art gene and cell therapy manufacturing facility in Durham, NC

Governor Cooper to cut ribbon on bluebird bio facility Bluebird bio (BLUE) announced today, in its press release, the official opening of its first wholly owned manufacturing facility in Durham, N.C. The new facility will produce the lentiviral vector for the company’s investigational gene and cell therapies, including bb2121 and bb21217 for the treatment of multiple myeloma, and potentially LentiGlobin™ for transfusion-dependent β-thalassemia (TDT) and …
Biogen discontinued its Alzheimer’s disease drug Aducanumab. The usual selloff followed

Biogen discontinued its Alzheimer’s disease drug Aducanumab. The usual selloff followed

Biogen’s (BIIB) decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE which is designed to evaluate the efficacy and safety of its product aducanumab in patients with Alzheimer’s disease, has caused an exaggerated selloff of the stock. The failure to treat Alzheimer’s disease is well explained by Michel Vounatsos, Biogen’s Chief Executive Officer, who stated that the failure of aducanumab drug confirms the …