Category: News & Comments

Halozyme and argenx Most Recent News

Halozyme and argenx Most Recent News

Halozyme and argenx Collaboration argenx (ARGX) dosed the first subject in phase 1 clinical trial for the safety, pharmacokinetics, and pharmacodynamics of its product efgartigimod plus Halozyme’s (HALO) drug delivery technology ENHANZE®. The drug aims at treating severe autoimmune diseases including myasthenia gravis (MG), immune thrombocytopenia (ITP)and skin blistering diseases.    We find it good news that this first clinical trial has been initiated in a …
The Gilead and Galapagos Agreement Is a Big Win for Both Firms and Their Shareholders

The Gilead and Galapagos Agreement Is a Big Win for Both Firms and Their Shareholders

Gilead and Galapagos Global Research Collaboration Gilead Sciences (GILD) and Galapagos NV (GLPG) entered into a 10-year global research and development collaboration. Gilead will gain access to innovative compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform. Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the …
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 …
Gilead to File NDA for Rheumatoid Arthritis Drug Filgotinib. Karyopharm Stock Gained 36% in Today’s Trading

Gilead to File NDA for Rheumatoid Arthritis Drug Filgotinib. Karyopharm Stock Gained 36% in Today’s Trading

Gilead to File NDA for Filgotinib for Rheumatoid Arthritis Meeting with the U.S. Food and Drug Administration (FDA) Gilead (GILD) announced it discussed with the agency the Phase 3 FINCH studies; as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with its filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion a path forward has …
ImmunoGen: Experiencing Big Internal Changes

ImmunoGen: Experiencing Big Internal Changes

ImmunoGen’s Big Internal Changes ImmunoGen (IMGN) announced a radical impacting decision following the completion of an in-depth operational review aimed at extending the Company’s cash runway; delivering on its promises to continue developing a promising antibody drug conjugate (ADC) product and moving into the clinic what it believes will be next-generation ADCs.   Based on the outcomes of its review, ImmunoGen prioritized continuing the development of mirvetuximab and …
The FDA Approved AMAG Pharmaceuticals’ Product Vyleesi™ for Premenopausal Women with Acquired Generalized Hypoactive Sexual Desire Disorder

The FDA Approved AMAG Pharmaceuticals’ Product Vyleesi™ for Premenopausal Women with Acquired Generalized Hypoactive Sexual Desire Disorder

AMAG Pharmaceuticals’ Vyleesi™ was Approved The U.S. Food and Drug Administration (FDA) approved AMAG Pharmaceuticals’ (AMAG) product Vyleesi (bremelanotide injection); a melanocortin receptor agonist for premenopausal women having acquired, generalized hypoactive sexual desire disorder (HSDD)   To be a candidate for Vyleesi a woman’s low sexual desire must not be the outcome of a co-existing medical or psychiatric condition, problems within the relationship or the side …
Pfizer to Acquire Array Biopharma at $48 a Share

Pfizer to Acquire Array Biopharma at $48 a Share

Pfizer to Acquire Array Pfizer (PFE) announced that it has agreed to acquire Array Biopharma (ARRY) in a deal valued at $11.4 billion.  The Terms of the Agreement Under the terms of the agreement, Pfizer will pay $48 in cash for each Array share. That is around 62% above the $29.59 stock price as it closed on Friday. The price paid represents around $10.64 billion …
bluebird bio: Why This Firm’s Stock Gained $6.37 Yesterday

bluebird bio: Why This Firm’s Stock Gained $6.37 Yesterday

Why has bluebird bio Been Hammered in the Market Recently? Investors should be asking why bluebird bio (BLUE) has been hammered in the market recently before asking why the stock gained $6.37 in trading yesterday. Why was it subjected to a selloff a few days ago? Why? When you consider the announcement of conditional marketing authorization, granted from the European Commission (EC), for the firm’s …
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 …
Cara Therapeutics: More Positive Results from the Korsuva Product Trial for Hemodialysis Patients’ Pruritis

Cara Therapeutics: More Positive Results from the Korsuva Product Trial for Hemodialysis Patients’ Pruritis

Positive Results from Korsuva for Pruritis Cara Therapeutics Postive Results from Korsuva Trial On May 29, 2019 Cara Therapeutics (CARA) announced positive topline data from the KALM-1 pivotal Phase 3 trial of its Korsuva in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (itching) (CKD-aP). Chronic kidney disease-associated pruritus is an intractable frequent systemic intense itch that occurs in patients undergoing hemodialysis and peritoneal dialysis. …
Vertex: Good News and Good Decisions

Vertex: Good News and Good Decisions

Vertex’s Good News Vertex and Kymera Therapeutics Collaboration Last week Vertex Pharmaceuticals (VRTX) and Kymera Therapeutics entered into a four-year strategic research and development collaboration to advance small molecule protein degraders against multiple targets. Kymera is an expert in targeted protein degradation and has its own drug discovery program known as Pegasus™. The collaboration will benefit from this program and from Vertex’s scientific, clinical and regulatory capabilities …
Advaxis: Why This Small Firm’s Stock Outperformed on a Negative Market Day

Advaxis: Why This Small Firm’s Stock Outperformed on a Negative Market Day

Advaxis Outperformed on a Negative Market Day ADXS Outperformed Advaxis’ (ADXS) stock rallied today as the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its product AIM2CERV (axalimogene filolisbac). The product is in a Phase 3 clinical trial on patients with high-risk locally advanced cervical cancer. In its letter the FDA acknowledged that the Company has satisfactorily addressed all hold questions.  The Story …
Will the Bear Escape Tonight from the Market? Regeneron and Severe Asthma Patients Good News

Will the Bear Escape Tonight from the Market? Regeneron and Severe Asthma Patients Good News

The Stock Market The Confused and Confusing Stock Market The stock market is confused and confusing. No analysts’ speculations are materializing and no satisfactory explanations for the market’s agitation and selloff. Although not an unprecedented situation, what makes it strange and more puzzling than previous market’s selloffs is that it is happening at a time when all the prerequisites of a healthy economy exist. Historically …
Bluebird bio and Celgene: Encouraging Clinical Trial Results for Last Resort Multiple Myeloma Treatment

Bluebird bio and Celgene: Encouraging Clinical Trial Results for Last Resort Multiple Myeloma Treatment

A Great Day for Bluebird bio and Celgene Read the Clinical Trial Results for Myeloma What a Great Day! Jobs reaching the moon. Inflation not yet showing any concerning signs. A fiercely rebounding stock market. Those who are still listening to pessimistic opinions are missing the fact that technologies and biotechnology are standing at the starting line. They are not at the finish line. For …
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 …
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 …
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 …