Month: April 2019

The FDA Approval of Regeneron/Sanofi Praluent Is A Big Deal. Will the FDA Approve Nabriva Therapeutics’ Antibiotic Contepo Today?

The FDA Approval of Regeneron/Sanofi Praluent Is A Big Deal. Will the FDA Approve Nabriva Therapeutics’ Antibiotic Contepo Today?

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 …
Trick or Trade?

Trick or Trade?

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 and Aerie Have Good News

Exelixis and Aerie Have Good News

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 …
Trovagene’s News Is Encouraging

Trovagene’s News Is Encouraging

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); 
Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

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: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

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 announce strategic collaboration to discover and develop novel therapies for NASH

Gilead and insitro announce strategic collaboration to discover and develop novel therapies for NASH

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 …
The Week in Review #40

The Week in Review #40

  Conquering NASH Gilead and Novo Nordisk Conquering NASH What was Gilead Sciences' (GILD) announcement at EASL? What is Gilead doing to find effective treatments for NASH? Why would Novo Nordisk's (
Regeneron and Alnylam collaborative agreement will benefit these firms so why the selloff of both?

Regeneron and Alnylam collaborative agreement will benefit these firms so why the selloff of both?

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 …
Prohost Letter #430

Prohost Letter #430

Prohost Letter #430 Rheumatoid Arthritis and Gilead The FINCH 1 trial: Has it reached its primary endpoints? How did the drugs respond as compared to placebo; what is the disability index, clinical remission, disease activity rate and safety results? What’s happening with Gilead’s HIV product? Read about Gilead’s collaboration with Galapagos. See how Prohost answers these questions in this issue #430 of the Prohost Letter. …
Sangamo’s stock price Soars 52% in pre-market hours on hemophilia A trial results

Sangamo’s stock price Soars 52% in pre-market hours on hemophilia A trial results

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 …
Novartis’ Revolution: A new dimension and  Prohost expectations

Novartis’ Revolution: A new dimension and Prohost expectations

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 …