Tag: Sanofi (SNY)

Denali Therapeutics: Positive Clinical Results and Regulatory Progress for Development Programs in ALS. See Also: NTLA Tumbling Today

Denali Therapeutics News Denali Therapeutics (DNLI) -  a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases.  Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San . . . This content is for …

Regeneron Has Much Good News. Is the Market Paying Attention?

Regeneron Pharmaceuticals Approval of EvkeezaTM for HoFH Regeneron Pharmaceuticals (REGN) has a series of good news that the market does not seem to be aware of as the stock price has yet to react.   On February 11, 2021 Regeneron announced that the U.S. FDA has approved the firm’s product EvkeezaTM (evinacumab-dgnb) as an adjunct to . . . This content is for paid subscribers. Please …

Why Gilead Sciences Product Lenacapavir Deserves the FDA Granted Breakthrough Therapy Designation. See Also: Cellectis and Sanofi

Gilead Sciences News Results from Phase 2/3 CAPELLA trial evaluating Gilead Sciences (GILD) lenacapavir achieved the primary endpoint in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. The study showed that 88% of participants receiving lenacapavir experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as . . . This content is for paid subscribers. Please click here …

Sanofi and GlaxoSmithKLine COVID-19 Vaccines are Advancing in Clinical Trial

Sanofi and GlaxoSmithKline Have COVID-19 Vaccines Advancing in Clinical Trial Sanofi (SNY) and GlaxoSmithKline (GSK) started Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate developed by both firms uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology. The Phase 1/2 clinical trial is a randomized, double-blind and placebo-controlled trial. It is …

The Impacting News of the Day

Impacting News from Novavax, CymaBay Therapeutics and Sanofi SA Novavax  The Grant That Rallied the Stock Novavax (NVAX) stock jumped sky-high following the announcement that the firm has been granted up to $384 million by the coalition for Epidemic Preparedness innovation. The grant is to help the advancement in the clinical development of the firm’s SARS-CoV-2 (COVID . . . This content is for paid …
This Past Week

This Past Week

The Week in Review #43 This Past Week After hearing hints about the trade war between China and the United States being avoided the market reversed course from faltering to flying at the speed of light. This trade war replaced all important factors that would usually affect the market performances. Unemployment is the lowest since 1969 and is expected to cause a bullish market, but …
Regeneron’s Product Libtayo is Unique and Expected to Become a Best-Seller

Regeneron’s Product Libtayo is Unique and Expected to Become a Best-Seller

The EC Granted Conditional Approval for Regeneron and Sanofi Product Libtayo for CSCC The European Commission (EC) conditional approval for Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) product Libtayo® (cemiplimab) is a historical event and a game changer in the prognosis of metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC).   Before the approval of Libtayo patients with advanced CSCC , who are not candidates for curative surgery or curative radiation, had …
The ASCO 2019 Special Edition

The ASCO 2019 Special Edition

Prohost Letter #432 The ASCO 2019 Special Edition SPRAYING FEAR The Victims Are The most disturbed victim of the instigated and irrelevant fear against investing in the stock market is the market itself. Indeed, baseless fear campaigns frighten positive investors while encouraging short-selling investors to maximize their selling which intensifies the markets volatility. We have been experiencing this phenomenon since the beginning of 2019. Market …
From ASCO: Amgen, Nektar, Sanofi, GRAIL and Others. A Biotech to Keep an Eye on

From ASCO: Amgen, Nektar, Sanofi, GRAIL and Others. A Biotech to Keep an Eye on

What Everyone Wants to Hear from ASCO The American Society of Clinical Oncology (ASCO) meeting is ongoing. What the oncologists, the analysts, the researchers and investors and other interested observers are anxious to hear this year is mostly about the improvements in the immune-oncology approaches. The Oncologists Want to Hear About: Up-to-date information from clinical trials on immunotherapies in order to practice the safest and …
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 …
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 …
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 …