Tag: Novartis (NVS)

About RegenxBio’s Agreement with Clearside Biomedical and More

About RegenxBio’s Agreement with Clearside Biomedical and More

Diseases of the Back of the Eye Diseases of the back of the eye, such as: age-related wet macular degeneration, diabetic retinopathy and diabetic macular edema, are currently managed with injections of anti-vascular endothelial growth factor (anti-VEGF) drugs into the gel-like substance (the vitreous humor) that fills the eye between the lens and the retina. The currently used age-related wet macular degeneration injections are: Lucentis, which belongs …
Gene Therapy and Other Treatments That Work at the Genetic Level

Gene Therapy and Other Treatments That Work at the Genetic Level

Gene Therapy Stocks Experiencing Selloffs  Every investor in the biotech sector must have experienced selloffs of the stocks from companies specialized in gene therapy, gene editing, antisense, RNAi and mRNA therapies. Recently, bluebird bio’s (BLUE) stock was devastated. The selloffs occurred for many reasons, most of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
The Bizarre Market

The Bizarre Market

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 …
Rhythm Pharmaceuticals Has Good News. See Also: The Novartis News Story

Rhythm Pharmaceuticals Has Good News. See Also: The Novartis News Story

Rhythm Pharmaceuticals From Rhythm Pharmaceuticals (RYTM) we learned that positive, top-line results from two pivotal Phase 3 clinical trials evaluating setmelanotide, for pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities, have met their primary endpoints and all key secondary endpoints. The product demonstrated a statistically significant and clinically meaningful effect on weight loss and reductions in insatiable hunger, or hyperphagia, in patients with POMC and LEPR deficiency …
Gilead Sciences Activities Are Exceeding Its All Time High. Celgene Demonstrates How Valuable It Could be for Bristol-Myers Squibb.

Gilead Sciences Activities Are Exceeding Its All Time High. Celgene Demonstrates How Valuable It Could be for Bristol-Myers Squibb.

Gilead Sciences Activities There is no doubt that Gilead Sciences (GILD) is doing whatever it takes to expand, improve and upgrade its pipeline products. For the last couple of months, each and every week, we heard news about collaborations with some companies and investment in others as well as licensing products from large, medium-sized and small firms. In less than ten . . . This content is for …
Novartis: Psoriatic Arthritis Patients on Cosentyx Had No Radiologic Progression After 2 Years of Treatment

Novartis: Psoriatic Arthritis Patients on Cosentyx Had No Radiologic Progression After 2 Years of Treatment

Good News about Novartis’ Cosentyx® for Psoriatic Arthritis Novartis (NVS) has good news for Cosentyx®. Data emerging out 0f the FUTURE 5 clinical trial on patients with psoriatic arthritis (PsA) showed that there was no radiographic progression in around 90% of PsA patients who were treated with Cosentyx® (secukinumab) 300 mg, over 2 years. These data are being presented at the Annual European Congress of Rheumatology (EULAR) on 12-15, June, in …
bluebird bio Announces a European Conditional Approval of Its Gene Therapy ZYNTEGLO™ for Transfusion-Dependent β-Thalassemia  

bluebird bio Announces a European Conditional Approval of Its Gene Therapy ZYNTEGLO™ for Transfusion-Dependent β-Thalassemia  

Zynteglo™ from bluebird bio Gets European Conditional Approval European marketing authorization for Zynteglo follows the fastest assessment of an advanced therapy medicinal product (ATMP) as part of the European Medicines Agency’s Priority Medicines (PRIME) program. Zynteglo is bluebird bio’s first gene therapy to gain regulatory approval. Gene therapy is, indeed, moving towards the clinic to provide cures; to save people from an early death from …
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.
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. …
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 …
During the Departed Week

During the Departed Week

The Week in Review #39 During the Departed Week Three Prohost Portfolio Picks Hit Their 52-Week Highs The three picks referred to in the above title are, Novartis (NVS), Array (AARY) and Ionis (IONS). Previous Prohost Letters discussed Novartis and Array and continued to remind that they are Prohost favorites. The time has come to take a deeper look at Ionis; starting with the reasons …
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 …
Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

The United States FDA granted Breakthrough Therapy Designation to AMT-061. The European Medicines Agency gave it access to the Priority Medicine (PRIME) regulatory initiative. Gene therapy firm, uniQure (QURE), announced updated clinical data in patients treated in the ongoing Phase 2b study of AMT-061; an investigational AAV5-based gene therapy containing a patent-protected  FIX9-Padua (Factor 9) for the treatment of patients with severe and moderately severe hemophilia B. The announced data, which …
Now You See It, Now You Don’t

Now You See It, Now You Don’t

Now You See it, Now You Don’t Deliberate Omissions of Real Facts Real facts might be displayed or concealed depending on the news announcers’ or bloggers’ self-interests. The following contains cases of deliberate or unintentional omission of facts that led to the decline of fundamentally sound biotech and biopharmaceutical firms in bullish market during the departed trading week . . . This content is for paid subscribers. Please …
When common sense fails to explain market performance

When common sense fails to explain market performance

Prohost Letter #425 When Common Sense Fails to Explain the Market Performance It is not unusual for the stock market to be in a selloff mood for a few days. However, in the last couple of months, the market unexpectedly plunged deep into the ocean of the unknown. The exaggerated volatility was nerve-wracking for professional analysts. This is especially true for candid analysts who base …
Improving on immunotherapy and preventing one of its serious side effects

Improving on immunotherapy and preventing one of its serious side effects

The Week in Review #34 Improving on Immunotherapy and preventing one of its serious side effects. Removal of glutamine leads to a substantial reduction in cell growth or induces cell death in certain types of cancer cells, indicating that these cells are dependent on, or "addiected" to, glutamine. Normal cells do not depend much on glutamine . . . This content is for paid subscribers. …
Immunotherapy and some other results from ESMO 2018

Immunotherapy and some other results from ESMO 2018

IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …
Following the Stars. Less Science and More Logic

Following the Stars. Less Science and More Logic

Prohost Letter #424 Following the Stars Less Science and More Logic We reiterate that while a human star is born every once in a while on Earth, several stars born daily in research labs may be designated every other day by the FDA and other health regulatory agencies around the world. These agencies call these potential stars’ breakthrough drugs, but not all the molecules designated …