Vitiligo Vitiligo is a chronic autoimmune disease. The immune system attacks the pigment-producing melanocyte cells causing loss of skin pigmentation. This causes a skin discoloration condition known as vitiligo. The immune system’s attack affects around 0.2% to 2.0% of the world’s population. There are currently no U.S. FDA or European EMA approved products for this condition. Initial vitiligo symptoms start before age 20 and remain …

Moderna Therapeutics Trial Results Moderna Therapeutics (MRNA) trial results mark the first systemic mRNA therapeutic to show the production of a secreted protein in humans.  Moderna’s Product mRNA-1944 successfully encoded for functional antibody (CHKV-24) in humans at all dose levels tested (0.1, 0.3 and 0.6 mg/kg). The antibody level reached is predicted to protect against chikungunya infection achieved within hours. It is projected to be …

Outperforming Biotechs On August 27, 2019 we posted “The Medicines Company Has Agreeable News” under Today’s Highlights.  The Medicines Company We described The Medicines Company (MDCO) as a firm focused on cardiovascular diseases with a goal of halting the progression of atherosclerosis and lowering the cardiovascular risk caused by high levels of LDL Cholesterol (LDL-C). The Medicines Company’s good news emanated from the results of …

Amgen Agreement with Celgene for Otezla® In the News Amgen (AMGN) entered into an agreement with Celgene (CELG) to acquire worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities for $13.4 billion in cash. Amgen cited the benefits of this agreement as follows: A strong fit with Amgen’s long-standing expertise in inflammation and …

AstraZeneca: Farxiga for Heart Failure with Reduced Ejection Fraction  AstraZeneca (AZN) has good news. Many of them are extremely positive. However, the firm’s stock is still struggling to get this pharmaceutical company out of the oversold territory where it has been living since the beginning of the year.    Among the recent good news came the results from a Phase 3 trial using AstraZeneca’s SGLT2 inhibitor …

Akari Therapeutics Stock Rallied Autoimmune and inflammatory disease treatments are works in progress with some approved products demonstrating remarkable efficacy. Still there are untreated inflammatory diseases, among them are those where the complement (C5) and/or leukotriene (LTB4) systems are implicated. Akari Therapeutics (AKTX) is a small biopharmaceutical company focused on therapeutics for the orphan autoimmune and inflammatory diseases.The Company announced that the U.S. Food and …

Amgen’s Stock Is Up Amgen (AMGN) is speeding towards reaching its true, fair value. In the Q2 financial results Amgen has beaten the most optimistic analysts’ expectations and negative investors who keep mourning the firm’s 35 years old products’ sales’ decline while ignoring the many newly approved breakthrough products with their large markets and the capability to treat diseases that had no treatments. They continued selling …

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 …

RegenxBio License Agreement with Pfizer RegenxBio (RGNX) announced a license agreement with Pfizer (PFE). Under the terms of the agreement RegenxBio has granted Pfizer a non-exclusive worldwide license, with rights to sublicense, to RegenxBio’s NAV AAV9 vector for the development and commercialization of gene therapies for Friedreich’s ataxia (FA). The most common hereditary ataxia (neurological lack of muscle coordination). RegenxBio will receive an upfront payment and has …

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 …

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 …

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 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’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 …

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 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 …

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 …

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 …

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 …

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. …