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.
Praluent's Approval Is a Big Deal The approval of the Regeneron / Sanofi 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 cardiovascular events (MACE), i.e., heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization, would change the lives of …
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 who are misleading …
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 …
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);
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 …
Novartis Has More Promising Data from Their Phase 3 Gene Therapy Trial with AveXis AveXis Inc., 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 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Gilead and insitro Collaborate to Discover and Develop Novel Therapies for NASH using ISH Gilead Sciences (GILD) and insitro entered into a strategic collaboration to discover and develop treatments for nonalcoholic steatohepatitis (NASH). NASH A chronic form of liver disease characterized by excess fat in the liver, inflammation, and liver cell damage. Inflammation and liver cell damage can cause scarring of the liver or fibrosis. Ultimately leading …
Regeneron and Alnylam Agreement Will Benefit Both So Why the Sell-Off? Regeneron Pharmacueticals Founded, and led for 30 years, by physician-scientists Regeneron Pharmaceuticals (REGN) demonstrates an exceptional ability to translate science into medicine. Working diligently Regeneron succeeded in putting seven treatments in the hands of specialists in clinics around the world. Additionally, the firm managed to build a rich pipeline of numerous investigational products; all of …
Sangamo’s Stock Price Soars Sangamo Therapeutics’ (SGMO) stock soared more than 52% in pre-market trading following the announcement with Pfizer (PFE), of interim data from Phase 1/2 Alta study evaluating the firm’s gene therapy product SB-525 for severe hemophilia A. The Product, SB-525 SB-525 comprises a recombinant adeno-associated virus serotype 6 vector (AAV6) encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII. The …
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 Novartis as well as other biotech and biopharmaceutical companies. All 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. Today’s 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 …
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 …
While waiting for Mueller’s report we stopped speculating on the stocks in what we saw as an unreadable market. Following the delivery of the Mueller report we hesitated to prophesy as we waited to see how the market would perform and the reasons for its performance. We usually try to speculate about the performance of biotech firms’ stocks based on their scientific capabilities, including their …
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’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 …
News We Loved to Hear The First and Only Approval of a Specific Product for Postpartum Depression ZULRESSOTM The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). This makes Zulresso the first and only medicine specifically approved by the FDA to treat PPD; the most common medical complication of childbirth. The product …
Atossa Genetics (ATOS) announced that the FDA has issued a “Safe to Proceed” letter under their “expanded access” program permitting the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient. The patient completed a 3-week course of Atossa’s oral Endoxifen prior to her surgery under an FDA-approved expanded access program. Atossa’s stock rallied from under $2 to …
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