Category: News & Comments

Another Approval for Celgene and the First for Acceleron

Another Approval for Celgene and the First for Acceleron

FDA Approval for Celgene and Acceleron Drug REBLOZYL® The U.S. Food and Drug Administration (FDA) has approved Celgene’s (CELG) and Acceleron Pharma’s (XLRN) drug REBLOZYL® (luspatercept-aamt) for anemia only in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.  REBLOZYL® is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy that works by regulating late-stage red blood cell maturation …
The Bad News That Might Save the Life of Halozyme Therapeutics

The Bad News That Might Save the Life of Halozyme Therapeutics

Halozyme Therapeutics is Focusing on ENHANZE® Technology Halozyme Therapeutics (HALO) decides to focus on its ENHANZE® drug delivery technology, halt the development activities for PEGPH20 and close its oncology operations. These decisions were made after the failure of HALO-301 Phase 3 clinical study evaluating PEGPH20 as a first-line therapy for patients with metastatic pancreas cancer to reach the primary endpoint of overall survival. The PEGPH20 failure …
The FDA Approves Compugen’s IND for Its Oncology Product COM902

The FDA Approves Compugen’s IND for Its Oncology Product COM902

Compugen FDA Approval for COM902 Compugen Announces FDA Clearance of IND Application for COM902 Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020 Clinical development of COM902 will enable testing the combination treatment with COM701, Compugen’s anti-PVRIG inhibitor  Compugen (CGEN) is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel …
When Negative Reactions to Biotechnology News Mislead. The Case of Regenxbio.

When Negative Reactions to Biotechnology News Mislead. The Case of Regenxbio.

Regenxbio Misleading Selloff A selloff of Regenxbio (RGNX) stock, following the FDA’s partial hold on the intrathecal administration of AVXS-101, is unwarranted and totally misleading.   Why? Because the selloff of RGNX gave the impression that the gene therapy Zolgensma, using the adeno-associated virus (AAV) vector , developed by Regenxbio, has failed, which is not true. The partial hold was put only on the product …
Can the Combination of Inarigivir from Spring Bank Pharmaceuticals and Vemlidy from Gilead Sciences Succeed in Treating Chronic Hepatitis B Viral Infection

Can the Combination of Inarigivir from Spring Bank Pharmaceuticals and Vemlidy from Gilead Sciences Succeed in Treating Chronic Hepatitis B Viral Infection

Spring Bank Pharmaceuticals, Gilead Sciences and HBV If Spring Bank Pharmaceuticals’ (SBPH) product inarigivir in combination with Gilead Sciences’ (GILD) Vemlidy® could validate the current encouraging results of the ongoing trials on chronic hepatitis B virus (HBV) infection, then the small underestimated firm would hand the giant biotech firm a valuable gift that could increase its sales revenues of its liver disease franchise.    The …
Reata Pharmaceuticals’ Product Omaveloxolone Met the Trial Primary Endpoints in Treating Friedreich’s Ataxia

Reata Pharmaceuticals’ Product Omaveloxolone Met the Trial Primary Endpoints in Treating Friedreich’s Ataxia

Reata Pharmaceuticals Omaveloxolone for Friedreich’s Ataxia On October 14, 2019 Reata Pharmaceuticals (RETA) announced the Part 2 portion of its Phase 2 MOXIe trial, with its product omaveloxolone, met its primary endpoint in modifying Friedreich’s ataxia (FA). The largest change occurred in the modified Friedreich’s Ataxia Rating Scale (mFARS) after 48 weeks of treatment.  Patients treated with omaveloxolone 150 mg/day demonstrated a statistically significant, 2.40 point …
More News for Nektar Therapeutics

More News for Nektar Therapeutics

Nektar Therapeutics Announces Two Studies of NKTR-358 Nektar Therapeutics (NKTR) announced the initiation of two Phase 1b studies of NKTR-358 (LY3471851*), a novel T regulatory (Treg) cell stimulator, one for psoriasis and one for atopic dermatitis. NKTR-358 for Autoimmune and Inflammatory Conditions NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of …
Could Incyte’s Ruxolitinib Cream Effectively Treat Vitiligo?

Could Incyte’s Ruxolitinib Cream Effectively Treat Vitiligo?

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: A Big Day Filled with Good News

Moderna Therapeutics: A Big Day Filled with Good News

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 In a Bad Market Day

Outperforming Biotechs In a Bad Market Day

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 to Acquire Celgene’s Product Otezla at $13.4 Billion

Amgen to Acquire Celgene’s Product Otezla at $13.4 Billion

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 and Vertex Both Have Good News

AstraZeneca and Vertex Both Have Good News

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 …
Why Akari Therapeutics Stock Price Rallied Today

Why Akari Therapeutics Stock Price Rallied Today

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 …
Why Amgen’s Stock Is Up Over $11 Today

Why Amgen’s Stock Is Up Over $11 Today

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 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 …
RegenxBio Has Good News

RegenxBio Has Good News

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 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 …