Exelixis and Bristol-Myers Squibb sNDA and sBLA Accepted by the FDA Exelixis (EXEL) and Bristol-Myers Squibb (

Exelixis Announces Submission of sNDA to US FDA for CABOMETYX® Exelixis (EXEL) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). From Exelixis According to Gisela Schwab, M.D., President, Product Development and Medical . . . This content is for paid subscribers. Please click here …

Prohost Letter #440 Coronavirus The Therapeutics Gilead’s Remdesivir Treating COVID-19 patients requires therapeutic products that can deal with moderate and severe persistent symptoms that are unwilling to ease or completely disappear after weeks of isolation, when following the distancing and wearing masks. The first product proven effective and safe to be granted FDA Emergency Use Approval (EUA) happens to be remdesivir from Gilead Sciences (

Exelixis Rallying from CheckMate-9ER Trial Results Exelixis (EXEL) and Bristol-Myers Squibb (

Exelixis, Takeda and Japanese RCC Patients Today we learned from Exelixis (EXEL) that Takeda Pharmaceutical Company Limited, which is responsible for the clinical development and commercialization of Exelixis' oncology drug  CABOMETYX® (cabozantinib . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis Announced Results from its CABOMETYX® Combination with Roche's TECENTRIQ® News announced by Exelixis (EXEL) about encouraging results from the combination of its product cabozantinib (CABOMETYX®) with Roche’s product atezolizumab (TECENTRIQ . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Coming Soon at Prohost Biotech We have stories to tell about our picked stocks which we believe could deepen the Prohost Biotech readers’ understanding of our strategy regarding the evaluation of the biotech companies. Our strategy has made it possible for us to fairly evaluate both the development-stage firms and the revenues- and incomes-generating firms in the biotech sector.     Most of our stories will …

Exelixis Positive Results from IMspire 150 Exelixis (EXEL) announced positive results from IMspire 150; the phase 3 trial of atezolizumab (TECENTRIQ®), cobimetinib (COTELLIC®) and vemurafenib (ZELBORAF®) in people with previously untreated BRAF V600 mutation-positive advanced melanoma.  The IMspire150 study met its primary endpoint of progression-free survival (PFS). Adding atezolizumab to cobimetinib and vemurafenib helped reduce the risk of disease worsening or death, compared to placebo plus …

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 and Daiichi Sankyo Partner to Prevent and Treat Diabetic Nephropathy Exelixis (EXEL) and Daiichi Sankyo (

The Week in Review #46 The Quarterly Financial Results The quarterly financial results that analysts and investors relied on for years to evaluate biotech firms, including development stage firms, seem to change. Investors have finally realized that development-stage firms have no marketed drugs and no revenues, hence, no incomes and should be evaluated based on the clinical trial results of their pipeline products. They saw …

Prohost Letter #436 What Are We Experiencing Now? The bizarre market underperformance progressing rather than regressing and the good economy and the employment gains are the least utilized factors after being the most influential on the stock market performance. We are witnessing the most bullish analysts being confused, hesitating to give their followers a crystal clear explanation about the market’s skepticism, anger and volatility. The …

The Week in Review #41 We Are Still Witnessing … The bizarre market performance that started in early 2019: In the past couple of months the great enthusiasm and response of the market to the undeniably strong economic indicators and the lowest unemployment figures turned, for mysterious reasons, to a perturbed-looking volatile market beast. The biotech stocks have given back most of their deserved gains …

Regeneron Product REGN-EB3 Saving Lives Regeneron (REGN) announced that an independent monitoring board ended its investigational product REGN-EB3 trial after reviewing interim mortality data from 499 patients. REGN-EB3 was found superior to rival therapy from Mapp Biopharmaceuticals (MAPP) in saving the lives in . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

 The News Prohost Was Waiting for to Post Its Special Letter Prohost has one eye on the development-stage biotech and biopharmaceutical companies' scientific fundamentals and accomplishments as well as the financial results on the revenue-generating firms. Prohost has the second eye on the market performance, its volatility and the possible reasons it sinks every other day, or every other week, in calmer days during a …

Exelixis is Expanding Cohorts for COSMIC-021, the Phase 1b Trial for Cabozantinib  From Exelixis (EXEL) we learned about its decision to expand the two original cohorts, and the addition of four new cohorts, to the protocol for COSMIC-021; the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or . . . This content is for paid subscribers. …

Exelixis and Daiichi Sankyo launched their novel anitihypertension product Minnebro® in Japan Exelixis (EXEL) and Daiichi Sankyo (

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 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis & Aerie Have Good News Exelixis’ Good News about Cabometyx Takeda Pharmaceuticals applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and to sell Exelixis’ (EXEL)product Cabometyx® (cabozantinib) for unresectable and metastatic renal cell carcinoma (RCC) in Japan. The submission brings $10 million in milestone payments to Exelixis from Takeda in the second quarter of 2019. Takeda’s application …

Zolgensma Findings 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 (NVS) presented interim results for 22 babies with Type 1 SMA which is considered the . . . This content is for paid subscribers. Please click here to subscribe …