Tag: Exelixis (EXEL)

Another drug approval for Exelixis. Why Alnylam’s stock is under pressure today

Another drug approval for Exelixis. Why Alnylam’s stock is under pressure today

More good news came  from Exelixis (EXEL). It was expected by many but not by those who ignore the good news in favor of any negative news or lack of news. The announced news is that the FDA approved Exelixis’ Cabometyx® (cabozantinib) for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. More good news is Exelixis’ announcement that the firm is prepared to fully support the …
Why the new approval of Exelixis’ blood pressure drug Minnebro in Japan is important

Why the new approval of Exelixis’ blood pressure drug Minnebro in Japan is important

Exelixis collaborator, Daiichi Sankyo, Receives Regulatory Approval for MINNEBRO™ (Esaxerenone) Tablets for Hypertension in Japan Exelixis (EXEL) and Daiichi Sankyo announced that the the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Minnebro™ (esaxerenone) tablets of ,1.25 mg, 2.5 mg, and 5 mg, for hypertension. Minnebro was identified during a prior research collaboration between Exelixis and Daiichi Sankyo, which was entered into in March 2006. The product has been subsequently developed …
Exelixis initiates a phase 3 trial with cabozantinib combination for previously untreated liver cancer

Exelixis initiates a phase 3 trial with cabozantinib combination for previously untreated liver cancer

Exelixis (EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) announced the initiation of COSMIC-312. A phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus sorafenib, in previously untreated advanced hepatocellular carcinoma (HCC). The co-primary endpoints of the trial are: progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting. COSMIC-312 is a multicenter, randomized, controlled phase 3 pivotal trial that …
A great day for Exelixis

A great day for Exelixis

This is just to inform that Europe has approved Cabometyx® (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma (HCC). As you know, Cabometyx belongs to Exelixis (EXEL). Today Exelixis announced that its partner, Ipsen, received approval of the drug, from the European Commission (EC), to be used in adults who have HCC and have previously been treated with sorafenib. This approval allows for the marketing of Cabometyx in this indication in …
Improving on immunotherapy and preventing one of its serious side effects

Improving on immunotherapy and preventing one of its serious side effects

The Week in Review #34 Improving on Immunotherapy and preventing one of its serious side effects. Removal of glutamine leads to a substantial reduction in cell growth or induces cell death in certain types of cancer cells, indicating that these cells are dependent on, or "addiected" to, glutamine. Normal cells do not depend much on glutamine . . . This content is for paid subscribers. …
The molecule that enhanced the T Cells cancer treatment efficacy while preventing autoimmune diseases

The molecule that enhanced the T Cells cancer treatment efficacy while preventing autoimmune diseases

Yesterday, the Stock Market skyrocketed and with it a significant number of Prohost Picks that we keep reminding ourselves are undervalued. The outperformance unveiled the interred strength of firms such as: Illumina (ILMN), Amgen (AMGN) and Vertex (VRTX), the gene therapy firms: RegenxBio (RGNX) and Spark (ONCE), and the gene editing firms: Crispr (CRSP), Intellia (NTLA) and Editas (EDIT), as well as others in the Prohost Portfolio. The rebounding in the …
About Exelixis

About Exelixis

Exelixis (EXEL) provided an update that testified to its solid fundamentals, the growth of its approved products’ sales, the professionalism and seriousness of its management. Revenues: Exelixis’ total quarter revenues were $225.4 million vs. $152.5 million for the comparable period in 2017. Its net product sales revenues were $162.9 million for the quarter compared to $96.4 million for the comparable period in 2017, which represents a 69 percent increase year-over-year. …
Positive News

Positive News

The Week in Review #32 POSITIVE NEWS PROTEOSTASIS THERAPEUTICS Cystic Fibrosis Two days ago, a clinical-­stage small firm called Proteostasis Therapeutics (PTI) announced positive preliminary results from ongoing Phase 1 cystic fibrosis studies. The trial involved the firm’s proprietary combination therapy doublet, PTI-­808 + PTI-­801...
Exelixis initiates phase 3 trial with Cabometyx in radioiodine-refractory differentiated thyroid cancer (DTC) patients

Exelixis initiates phase 3 trial with Cabometyx in radioiodine-refractory differentiated thyroid cancer (DTC) patients

Exelixis (EXEL) announced its initiation of a phase 3 pivotal trial (COSMIC-311) of Cabometyx (cabozantinib) in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. The co-primary endpoints for the trial are progression-free (PFS) survival and objective response rate (ORR). Why conducting trial on patients with radioiodine-refractory differentiated thyroid cancer.    Differentiated thyroid tumors make up …
Exelixis: Health Canada approves Cabometyx in advanced renal cell carcinoma

Exelixis: Health Canada approves Cabometyx in advanced renal cell carcinoma

Exelixis’ (EXEL) partner Ipsen Biopharmaceuticals Canada Inc. received approval of Cabometyx®(cabozantinib) tablets from Health Canada for adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada had granted Cabometyx priority review status, which resulted in the accelerated review of Ipsen’s new drug submission. Explaining the importance of Cabometyx’s additional approval, Michael M. Morrissey, Ph.D., President and Chief Executive Officer …
What is looking good in the aggressive portfolio

What is looking good in the aggressive portfolio

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 …
Vertex has good news from Australia. Why selling solid firms stocks.

Vertex has good news from Australia. Why selling solid firms stocks.

Vertex Pharmaceuticals (VRTX) announced that the Pharmaceutical Benefits Advisory Committee’s (PBAC) in Australia recommendation the listing of Orkambi® (lumacaftor/ivacaftor) on the Pharmaceutical Benefits Scheme (PBS). The recommendation is for cystic fibrosis people ages six and over who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Many thousands of patients worldwide are already receiving lumacaftor/ivacaftor in countries where it is reimbursed …
Exelixis: Why Q2 results are more than impressive

Exelixis: Why Q2 results are more than impressive

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 – …
Stories about research, clinical trials results and an FDA ruling

Stories about research, clinical trials results and an FDA ruling

The Week in Review #26 IN THE BIOTECH WORLD - RESEARCH - IMPROVING CRISPR GENE EDITING The problem cited with gene editing is that the editing may stay switched on after it succeeded in reaching its goals. To prevent further unwarranted mutations, scientists from the Bath and Cardiff University have invented a switch that aims at controlling protein expression in cultured cells and mouse embryos with the …
Exelixis liver cancer results are gratifying, so do not worry if some pretend they do not like them

Exelixis liver cancer results are gratifying, so do not worry if some pretend they do not like them

The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of Exelixis (EXEL) product Cabometyx® (cabozantinib) in previously treated patients with advanced hepatocellular carcinoma (HCC). The data demonstrate that Cabometyx provided a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. It is important to know that the clinical trial results formed the basis of regulatory …
Our outperforming firms and more

Our outperforming firms and more

The Week in Review #24 Biotech Stocks’ Performances, Products on the Move and Biotech Research Biotechnology stocks’ performance should be based on the firm’s intrinsic news that announces the power of their technologies and the successes or failures of their lead products and, to a lesser extent of their early-phase trials’ products. To be taken in consideration too are their financial statuses, especially of firms …
The FDA accepted Exelixis’ supplemental new drug application of Cabometyx® for previously treated advanced Hepatocellular Carcinoma. The FDA approved Imdexxy developed by TherapeuticsMD for moderate to severe Dyspareunia

The FDA accepted Exelixis’ supplemental new drug application of Cabometyx® for previously treated advanced Hepatocellular Carcinoma. The FDA approved Imdexxy developed by TherapeuticsMD for moderate to severe Dyspareunia

The U.S. Food and Drug Administration (FDA) has accepted for filing Exelixis’ (EXEL) supplemental New Drug Application (sNDA) for Cabometyx® (cabozantinib) tablets for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has determined that the application is sufficiently complete to permit a substantive review. The filing has been assigned a Prescription Drug User Fee Act (PDUFA) action date of January 14, 2019. Commenting on the news, Gisela Schwab, M.D., President, Product Development and …
Exelixis: The European Commission approves Cabometix for first line treatment of poor-risk advanced renal cell carcinoma

Exelixis: The European Commission approves Cabometix for first line treatment of poor-risk advanced renal cell carcinoma

Exelixis (EXEL) announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX®(cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate or poor-risk advanced renal cell carcinoma (RCC) in the European Union. Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in the first quarter …
Cures for Hemophilia A and B? See Also: Why EXEL Was a Loser Yesterday

Cures for Hemophilia A and B? See Also: Why EXEL Was a Loser Yesterday

SPARK THERAPEUTICS, SANGAMO THERAPEUTICS AND SALK INSTITUTE CURING HEMOPHILIA?   Hemophilia is an inherited bleeding disorder that causes abnormal or exaggerated bleeding and poor blood clotting. Hemophilia A and Hemophilia B are inherited in an X-linked recessive genetic pattern, so males are commonly affected while females are usually carriers of the disease. Hemophilia A is caused by clotting Factor VIII deficiency and hemophilia B (Christmas disease) is caused by Factor IX deficiency. A …
A Gratifying Exelixis Quarterly Results

A Gratifying Exelixis Quarterly Results

It is obvious that Exelixis’ (EXEL) first quarter results do not justify the selling of EXEL during the whole quarter, but rather condemn it. It is an undeniable fact that Exelixis is doing a great job squeezing the best out of its approved drugs while conducting persistent research and development regarding its investigational pipeline products. The unveiled facts comprise the following: – Strong commercial performance for CABOMETYX in advanced renal cell …