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 …

As part of its ongoing strategy to build an innovative pipeline beyond its two internally-discovered, commercially available compounds, cabozantinib and cobimetinib, Exelixis (EXEL) entered into an exclusive collaboration and license agreement with StemSynergy Therapeutics. The aim of the collaboration is discovering and developing novel cancer products. targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key cancer processes. Exelixis and StemSynergy intend to conduct preclinical …

Prohost Letter #416 Part 1 The Year In Review - 2017 Unheard of Programs - AN AWESOME YEAR for the biotech sector regarding its accomplishments. Many of the accomplished programs were unheard of regarding the degree of their positive impact on medical practice. Unfortunately, many of these accomplishments, which included the making of new discoveries, the creation of novel advanced technologies and the design of …

Based on statistically significant results from the randomized phase 2 CABOSUN trial in patients with previously untreated renal cell carcinoma (RCC), the U.S. Food and Drug Administration (FDA) approved Exelixis’ (EXEL)drug Cabometyx® (cabozantinib) for the expanded indication of patients with RCC. The results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care. Today’s label expansion follows the initial FDA approval …

The Week in Review #10 NO CONSPIRACY THEORIES - But this is what’s happening - In the past issue of The Week in Review, we wrote about the irrational pattern of selling the biotech stocks during the announcement of the quarterly results and how some investors are taking advantage of this pattern to sell their stocks before the quarterly results . . . This content …

EXELIXIS For Exelixis’ excellent news, please read our latest article, "Exelixis’ (EXEL) Exceptional Financial Results and Corporate Achievements", under Today’s Highlights NEUROCRINE BIOSCIENCE Prohost Picked this firm on April 24, 2017, at $51 (see the Prohost Portfolio in the Prohost Letter). Today, Thursday, November 2, NBIX closed on  at $72.78 Up $11.85     In its Q3 report, Neurocrine Biosciences (NBIX) announced financial results that beat …

Cabozantinib Net Revenue for Q3 is $96.4 million. Total Revenue of $152.5 million  Net Income of $81.4 million, Diluted EPS $0.26 per Share Have these headlines said it all? Of course not, but what they said was sufficient to appreciate this firm when compared to other firms that were granted approvals more than three to four years ago, yet they are still spending much than what they earn. Exelixis’ (EXEL) drug …

Two game changing news has come together on October 16, 2017, both indicating that  Exelixis (EXEL) is on its way to reach its goal becoming the leader in the current oncology discovery and development field.  THE FIRST GOOD NEWS announced that the U.S. Food and Drug Administration (FDA) determined that Exelixis’ supplemental New Drug Application (sNDA) for the approval of Cabometyx® in patients with previously …

Exelixis (EXEL) announced that Daiichi Sankyo (“Daiichi Sankyo”) reported positive top-line results from a phase 3 pivotal trial of esaxerenone for essential hypertension in Japan. The product is the fruit of the collaboration agreement signed by both firms back in 2006. The Story More than ten years ago, in March 2006, Daiichi Sankyo and Exelixis signed a research collaboration agreement to discover, develop and commercialize …

EXELIXIS Being called overvalued by one analyst does not mean that Exelixis (EXEL) is, indeed, overvalued. We believe it is not and that’s why we decided to accumulate the stock on any weaknesses in EXEL. We do not intend to sell this stock at this time for what we believe are the wrong reasons. Some bloggers tried to interpret the reasons that led to the …

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 here to log in.

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 …

AFTER MANY OF THE PROHOST PICKED STOCKS NEARED REACHING THE PROHOST NEAR-TERM TARGETS, recently, external circumstances and exaggerated delaying news, some of our rallied stocks gave back some of their gains. Two reasons were behind the decline in some precious picked stocks, which occurred one after the other in a very short period of time. The first reason for the declines came through traders’ practice …

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 …

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 …

IMPRESSIVE RESULTS?  Bellicum Pharmaceuticals’ (BLCM) drug BPX-501 is described as a safe and effective product that can offer children with cancer and other serious diseases the opportunity to beat their intractable sicknesses. The drug enables the patients who are in desperate need for a bone marrow stem cell transplant to use unmatched donors’ stem cells through lowering their adverse effects. The most recent clinical trial …

Prohost Letter #411 SOME STOCK RALLYING NEWS - Under normal conditions, some good news should rally the stocks of the firms that the news belong to them. During the past six months, Amgen (AMGN) announced a series of good news that seem to have fallen on deaf ears. Yesterday Amgen announced some positive results from three approved and one experimental products – all the news …

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 …