Exelixis Boxed in on Good News Exelixis (EXEL) is one of the firms boxed in by rule of thumb traders and short-sellers who put enormous pressure on biotech firms regardless of their good news. We sincerely believe that is what's happening to EXEL. We also believe that these firms, especially the achievers . . . This content is for paid subscribers. Please click here to subscribe …

Exelixis: FDA Approval for Cabometyx in Combination with Opdivo  Exelixis (EXEL) announced that the United States FDA has approved CABOMETYX (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma (RCC). RCC is among the 10 most frequently diagnosed cancers in the U.S. annually. Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and The …

Exelixis and Ipsen Received Approval from Health Canada for CABOMETYX® From Exelixis (EXEL) we learned that its partner, Ipsen Biopharmaceuticals Canada, has received approval from Health Canada of CABOMETYX® (cabozantinib) tablets for the treatment of hepatocellular . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis’ (EXEL) financial results for the fourth quarter and full year 2018 are as inspiring as they are outstanding compared to many other small biotech firms that succeeded in putting products on the market. Revenues  Exelixis total revenues for the quarter ended December 31, 2018 were $228.6 million, compared to $120.1 million for the comparable period in 2017. Total revenues for the year ended December 31, 2018 were $853.8 million, compared to $452.5 million for the comparable period in 2017. The …

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 …

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 …

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’ (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 …

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 …

Exelixis: Delightful Overseas Cabozantinib News Ipsen (EPA:IPN) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Exelixis’ (EXEL) product Cabometyx® (cabozantinib) 20, 40, 60 mg regarding the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC). The CHMP positive opinion will be reviewed by the European Commission (EC), which has the …

Exelixis (EXEL) completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabometyx® (cabozantinib) tablets for previously treated patients with advanced hepatocellular carcinoma (HCC). The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial of Cabometyx in patients with advanced HCC who received prior sorafenib. Some History: On October 16, 2017, Exelixis announced that the independent data …

Juno Therapeutics’ (JUNO) stock price orbited the moon after-hours trading yesterday, rising 45%, following a wall street journal report stating that Celgene (CELG) was in discussions to take over Juno and that the negotiations could result in a deal in the coming weeks. Juno was established to create cellular immuno-oncology products- chimeric antigen receptor T cell (CAR T) to treat cancer. Neither Juno nor Celgene would …

Exelixis (EXEL) announced a new collaboration with Roche on a phase 1b dose escalation study of a combination of Exelixis cabozantinib in combination with Roche’s anti-PD-L1 immuno-therapy drug atezolizumab. The study aims at evaluating the safety and tolerability  of the combination in patients with locally advanced or metastatic solid tumors. Enrollment is scheduled to begin mid-year 2017. Exelixis will sponsor the trial, and Roche will …

EXELIXIS (EXEL) Friends and subscribers are asking the following question for more than two weeks now: Why EXEL stock has rallied? Most of those who asked the question owned the stock and made a lot of profit on it. The truth is that those investors wanted to know whether it was time for them to take their profit and enjoy it elsewhere. In other words; …

EXELIXIS AGAIN They said: Sell EXEL, as no partner is interested in the firm’s FDA approved cabozantinib to date. What really happened: It did not take long for IPSEN to come forward and take the responsibility of marketing cabozantinib abroad and pay $200 million upfront payment to Exelixis. They said: Although the FDA approved Cabometyx (cabozantinib) for advanced renal cell carcinoma (RCC), the drug will …

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …

Congratulations.   The FDA approved Exelixis’ (EXEL) drug Cabometyx™ (cabozantinib) tablets for advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometrix is the first drug to demonstrate robust and clinically meaningful improvements in a phase 3 trial in patients with advanced RCC. The drug satisfied all key efficacy parameters — …