Tag: Regeneron (REGN)

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 The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). Zulresso became the first and only medicine specifically approved to treat PPD; the most common medical complication of childbirth. The product is expected to be available …
Politics and the Market

Politics and the Market

The Week in Review #35 Politics and the Market The market tumbled today as Theresa May, the Prime Minister of England, delayed the Brexit vote!  The question becomes, what will be put forth next as a legitimate reason for bringing the market down and eroding investors’ gains? The weather? A war among gangs in a fourth-world country? Maybe the resignation of the chairman of a …
There are no reasons for the Market’s tumbling. The value of the Biotech Revolution.

There are no reasons for the Market’s tumbling. The value of the Biotech Revolution.

Today, the market took another beating as a result of either an intentional or an unintentional lack of clearance by professionals in describing correctly the standing of employment and other current economic realities. They pinpointed irrelevant reasons in an effort to justify the Stock Market's tumbling.  One big headline was that 150,000 added jobs did not meet expectations. They never explained whether those jobs were all …
Alleviating osteoarthritis pain without the need for opioid drugs

Alleviating osteoarthritis pain without the need for opioid drugs

Tanezumab, an investigational humanized monoclonal antibody developed by Pfizer (PFE) and Eli Lilly (LLY), met all three co-primary endpoints in patients with osteoarthritis (OA). The 16-week Phase 3 study, which evaluated subcutaneous administration of tanezumab in patients with OA, demonstrated that the patients who received two doses of tanezumab, separated by eight weeks, experienced a statistically significant improvement in pain, physical function and patients’ overall assessment …
Positive News

Positive News

The Week in Review #32 POSITIVE NEWS PROTEOSTASIS THERAPEUTICS Cystic Fibrosis Two days ago, a clinical-­stage small firm called Proteostasis Therapeutics (PTI) announced positive preliminary results from ongoing Phase 1 cystic fibrosis studies. The trial involved the firm’s proprietary combination therapy doublet, PTI-­808 + PTI-­801...
After being approved for Eczema, Regeneron’s and Sanofi’s product, Dupixent, succeeded in treating chronic rhinosinusitis, nasal polyps and asthma.

After being approved for Eczema, Regeneron’s and Sanofi’s product, Dupixent, succeeded in treating chronic rhinosinusitis, nasal polyps and asthma.

In two pivotal Phase 3 placebo-controlled trials Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) drug, Dupixent® (dupilumab), demonstrated a significant reduction in nasal polyp size, nasal congestion’s severity and the need for systemic corticosteroids and/or surgery. Both trials were evaluating Dupixent® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP). They both met met all their primary and secondary endpoints. Dupixent is a monoclonal antibody designed to …
Regeneron: Two good news and a rebound on the road

Regeneron: Two good news and a rebound on the road

The FDA Approves Regeneron’s Product EyLea® (aflibercept) sBLA in Wet Age-Related Macular Degeneration Regeneron (REGN) has two good news. The first is from one of its approved products, EYLEA® announcing that the U.S. Food and Drug Administration(FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the …
Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron Pharmaceuticals (REGN) and bluebird bio, Inc. (BLUE) announced a collaboration to apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery of human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and …
Bull or Bear

Bull or Bear

The Week in Review #20 THE MARKET - My friend asked: “Are  you  scared?” “Of  what?” I asked “The  market?” The  market? No,” I  said.  We are afraid of those who are rendering the market nervous and  temporarily confused, as we observed while monitoring its volatility.  The market has never been chronically confused . . . This content is for paid subscribers. Please click here to …
Regeneron Discovers the Therapeutic Target for Non-Viral Chronic Liver Diseases. Alnylam is Assigned to Discover and Create the Targeted RNAi Therapeutic

Regeneron Discovers the Therapeutic Target for Non-Viral Chronic Liver Diseases. Alnylam is Assigned to Discover and Create the Targeted RNAi Therapeutic

Regeneron (REGN) and Alnylam (ALNY) announced a collaborative agreement aimed at identifying RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The agreement is not the first between the two firms, but it would not have occurred if not for Regeneron’s identification of an important and unique therapeutic target that influences the liver debilitating and life-threatening nonviral hepatitis diseases, which affect thousands …
Heron Therapeutics’ Product HTX-011: Helping in the War Against Opioids. Why Regeneron Could Fiercely Rebound

Heron Therapeutics’ Product HTX-011: Helping in the War Against Opioids. Why Regeneron Could Fiercely Rebound

What Do We Make of the Following Good News? HERON THERAPEUTICS Will HTX-011 Help in the War Against Opioids?  Heron Therapeutics (HRTX), a commercial-stage biotechnology company announced positive results from its completed Phase 3 studies of the investigational agent HTX-011 in people undergoing bunionectomy and hernia repair. HTX-011 is described as the first and only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain …
Alnylam Reaches Prohost 2018 Target. Regeneron Negotiates a Lower Price for Praluent

Alnylam Reaches Prohost 2018 Target. Regeneron Negotiates a Lower Price for Praluent

Alnylam (ALNY) announced that Sanofi Genzyme declined its opt-in for the development and commercialization of the RNAi product lumasiran, an investigational RNAi therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1). Based on this decision, Alnylam intends to rapidly advance lumasiran into a Phase 3 pivotal study in late 2018, and to commercialize lumasiran globally, assuming product approval. Alnylam has also announced that the FDA has granted lumasiran …
Regeneron’s Product Dupixant is Shown to Improve the Management of Asthma

Regeneron’s Product Dupixant is Shown to Improve the Management of Asthma

Regeneron’s (REGN) pipeline products have still a lot of good news to announce. The latest is about its product Dupixant (dupilumab) which has already been FDA approved for atopic dermatitis. Now, there are reasons to believe that this drug could be also approved as an add-on maintenance for people with moderate to severe Asthma. The news has come from both Regeneron and its partner Sanofi (SNY), stating that …
The Week in Review #9

The Week in Review #9

The Week in Review #9 KNOCKING DOWN THE BIOTECH STOCKS - Knocking down the biotech companies’ stocks during the announcement of the quarterly reports is no news. Most investors in the stock market, especially those who invest in the biotech sector have become familiar with this pattern . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Data From ASCO and Data from the Internet

Data From ASCO and Data from the Internet

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer a successful treatment. Checkpoint inhibitors have reached the market at the hands of Merck, Bristo-Myers Squibb and Roche, with other firms coming forward with products …
Prohost Letter #405

Prohost Letter #405

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …
Prohost Letter #404 Part 2

Prohost Letter #404 Part 2

Prohost Letter #404 Part 2 Synthetic Biology (2) A Brief History DNA is the software of life. This is how Synthetic Genomics firm, which we believe is now is the leading biotech firm for applied synthetic biology. Synthetic Genomics is still a private firm in spite of that thousands of investors are impatiently waiting for it to turn public and it will. So stay tuned. …
Prohost Letter #403 Part 2

Prohost Letter #403 Part 2

Prohost Letter #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …
Ophthotech Bad News Adds to Regeneron Good News

Ophthotech Bad News Adds to Regeneron Good News

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …
Prohost Letter #401

Prohost Letter #401

Prohost Letter #401 SYNOPSIS PART 1 In this Letter CONTENTS Duchenne Muscular Dystrophy (DMD) FDA Compassionate Approval of Eteplirsen! PART 2 In The Letter Issue #402 CONTENTS EYE ON IONIS (IONS) Antisense Proof of Concept and Feasibility EYE ON INVIVA (INVA) AND THERAVANCE BIOPHARMA (TBPH) Sales of The Ellipta Inhalers Started to Pick up Before an expected Boom Not Losing . . . This content …