Author: Prohost

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 …
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 …
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 …
Seattle Genetics: Why a selloff following good news

Seattle Genetics: Why a selloff following good 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 …
Why Agios Pharmaceuticals’ product TIBSOVO® was granted FDA Breakthrough Therapy designation. The  FDA approves Jazz Pharmaceuticals’ product Sunosi

Why Agios Pharmaceuticals’ product TIBSOVO® was granted FDA Breakthrough Therapy designation. The FDA approves Jazz Pharmaceuticals’ product Sunosi

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 …
Aimmune Therapeutics’ product AR101 for the treatment of peanut allergy confirmed in Europe with previous successful results in the U.S.

Aimmune Therapeutics’ product AR101 for the treatment of peanut allergy confirmed in Europe with previous successful results in the U.S.

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 …
Bluebird bio opens a state-of-the art gene and cell therapy manufacturing facility in Durham, NC

Bluebird bio opens a state-of-the art gene and cell therapy manufacturing facility in Durham, NC

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 discontinued its Alzheimer’s disease drug Aducanumab. The usual selloff followed

Biogen discontinued its Alzheimer’s disease drug Aducanumab. The usual selloff followed

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 …
The FDA approves the first ever postpartum depression product. Positive results from Dermira’s atopic dermatitis product Lebrikizumab

The FDA approves the first ever postpartum depression product. Positive results from Dermira’s atopic dermatitis product Lebrikizumab

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’ news that staged a huge Rally of this small firm’s stock

Atossa Genetics’ news that staged a huge Rally of this small firm’s stock

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 …
Gene therapy: Speeding down the road towards offering cures. A small firm might have some good news

Gene therapy: Speeding down the road towards offering cures. A small firm might have some good news

We love to read news about gene therapy as it is the only possibility for curing diseases that no known treatment can halt or delay their progression. The attempts to use gene therapy failed ambitious researchers for several decades before the revolution that led to understanding the genome and even decades  more after the publishing of the genomic map that actually started the real revolution. …
Exelixis moves more products into clinical trials. Alnylam’s product Givosiran demonstrates efficacy in Acute Hepatic Porphyria (AHP). Why investors have caused a stock selloff.

Exelixis moves more products into clinical trials. Alnylam’s product Givosiran demonstrates efficacy in Acute Hepatic Porphyria (AHP). Why investors have caused a stock selloff.

Thanks to abundant cabozantinib sales’ revenues Exelixis (EXEL) is advancing a new generation of its medicines with its new product XL092 entering clinical trials. The drug is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors & MET and was the subject of an active Investigational New Drug (IND) application the firm had submitted to the U.S. Food and Drug Administration (FDA) in December …
Why CRISPR Therapeutics’ stock gained around $8 today

Why CRISPR Therapeutics’ stock gained around $8 today

CRISPR Therapeutics' (CRSP) stock added around $8 today while reporting financial results for the fourth quarter and full year ended December 31, 2018. Here is what Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics, has stated,“This past year was truly transformational for CRISPR Therapeutics as we achieved milestones across our key programs in β-thalassemia, sickle cell disease and immuno-oncology. We’re pleased with the progress we’ve made in …
Spark Therapeutics to be acquired by Roche at $113.47 UP $61.91 

Spark Therapeutics to be acquired by Roche at $113.47 UP $61.91 

We congratulate our subscribers who kept Spark Therapeutics (ONCE) in spite of the stock’s kind of paralysis for no serious reasons. Spark, a fully integrated, commercial gene therapy company, announced today that it has entered into a definitive merger agreement with Roche (RHHBY). The firm is to fully acquire Spark Therapeutics at a price of $114.50 per share, in an all-cash transaction. This move represents  a total equity value …
Cytokinetics’ heart failure drug omecamtiv mecarbil advancing into late phase trials

Cytokinetics’ heart failure drug omecamtiv mecarbil advancing into late phase trials

Cytokinetics’ (CYTK) investigational product omecamtiv mecarbil, the firm’s potential treatment for heart failure with reduced ejection fraction, is advancing in a late phase clinical trial. Cytokinetics is conducting METEORIC-HF clinical trial, in collaboration with Amgen (AMGN), with funding and strategic support from Servier. The trial aims at evaluating the effect of omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) in patients …
Merck’s product Keytruda and Exelixis’ product Cabometyx are both winners

Merck’s product Keytruda and Exelixis’ product Cabometyx are both winners

Keytruda and Cabometyx Are Both Winners Keytruda failed to meet co-primary endpoints in Pivotal Phase 3 trial The pivotal Phase 3 KEYNOTE-240 trial evaluating Keytruda, Merck’s (MRK) checkpoint inhibitor anti-PD-1 therapy plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival …