At the European Society of Cardiology Congress 2016 in Rome, Italy, Array Biopharma (ARRY) presented good results from a Phase 2 study of its drug ARRY-797 - an oral, selective p38 mitogen-activated protein kinase inhibitor for patients with a rare degenerative cardiovascular disease. The disease, is known as lamin A/C-related dilated cardiomyopathy (LMNA-related DCM) and is caused by mutations in the LMNA gene and is …

Benign Prostate Hypertrophy (BPH) Is Fexapotide the Safest and Effective Prostate Cancer Preventative? That’s what Nymox Pharmaceutical (NYMX) announced in its recent press release stating that results from from 7-year prospective placebo controlled double blind studies of treatment of 995 U.S. men with its lead drug fexapotide were positive. According to the press release, men who received fexapotide showed a major reduction in the incidence …

Pfizer accepted to pay $14 billion in cash to acquire Medivation. It is important for investors to know what Pfizer is after with regard to this acquisition so that investors could sense the current deep-pocketed biopharmaceutical firms’ preferences in selecting their takeover targets. Recognizing the facts behind Pfizer’s decision could also protect investors from being mislead by negative bloggers who, while serving their own agendas, …

AMA Publishes Positive Phase 3 Data for Abaloparatide in Postmenopausal Women with Osteoporosis The Company is Radius Health (RDUS) and the new expected to be soon approved drug, abaloparatide, is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. It is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for …

Advaxis (ADXS) is a small clinical-stage biotech producing and developing cancer immunotherapy products based on its proprietary Lm Technology. The technology uses bioengineered live attenuated Listeria monocytogenes (Lm) bacteria. It is said that Adraxis therapeutics cancer immunotherapy agents are the first to generate cancer fighting T cells against cancer antigens in early testing. They could also neutralize myeloid-derived suppressor cells (MDSCs), which protect the tumor …

JAMA Publishes Positive Phase 3 Data for Abaloparatide in Postmenopausal Women with Osteoporosis The Company is Radius Health (RDUS) and the new expected to be soon approved drug, abaloparatide, is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. It is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) …

What’s Going on the Morning of Thursday, August 18, 2016? PORTOLA Portola Pharmaceuticals (PTLA) announced the receipt of a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is …

GILEAD & GENMAB To Access Genmab’s (GEN) bispecific antibody technology, Gilead (GILD) signed a new agreement with Genmab. The King of HIV treatment objective is to use its exclusive license from Genmab to produce an HIV bispecific monoclonal antibody therapeutic. Gilead is paying around $5 million in upfront payment and up to $277 million in milestones. Genmab will also be entitled to one-digit royalty of …

Gene Editing EDITAS MEDICINE CRISPR gene editing firm Editas Medicine (EDIT) signed a collaboration agreement with a   small cap gene therapy firm called Adverum Biotechnologies (ADVM). The collaboration aims at exploring the delivery of Editas’ genome editing approach with Adverum’s next-generation adeno-associated viral (AAV) vectors to treat up to five inherited retinal diseases that have yet to find treatments or have poor existing remedies. According …

Sequenom (SQNM) is no more there as a separate biotech company, as it is on its way to becoming part of Laboratory Corporation of America® Holdings (LH), which might help it create breakthrough diagnostics without the pain of struggling to survive. LabCorp Holding (LH) announced the commencement of its cash tender offer for all outstanding shares of the common stock of Sequenom for $2.40 per …

Immunotherapy Engineered T-Cell Therapy Is Here to Stay Articles aimed at undermining the value of the firms’ chimeric antigen receptor T (CAR T) cells as immunotherapy for cancer are less and less convincing to savvy investors. Most of the bloggers who attack the procedure admit at the end of their articles that the approach is promising, but still needs this or that for the sake of perfection, …

We do expect some selling of Array today after AstraZeneca’s announced negative results from Phase 3 SELECT-1 trial of the MEK inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment for KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). The results did not meet the trial’s primary endpoint of progression-free survival (PFS), and did not demonstrate overall survival (OS). These results, …

ANOTHER MISLEADING STORY  This article was corrected after being posted. Read our apology at the end of the article. Forecasting exaggerated impact of negative-looking news has stricken GlaxoSmithKline (GSK) shareholders today, while enchanting Merck’s (MRK) shareholders. GSK said that: “Used as a single therapy”, its checkpoint immunotherapy drug Opdivo has failed a trial for newly diagnosed lung cancer patients. GSK said that the Checkmate-026 study has not met its primary …

Investors in the stock market know that stocks yo-yo all the time. Sometimes, the yo-yoing becomes so severe it could trigger the soaring of some stocks and the tumbling of others. This article is about the plummeting of the biotech stocks.  Small development-stage biotech stocks, more than stocks belonging to other industries are subjected to a shredding of their values. Some would lose more than …

EMA’s created Priority Medicines (PRIME) regulatory initiative for products which the European agency rules they are of unmet needs. PRIME makes them eligible for support, possible regulatory applications and potential accelerated reviews. PRIME has accepted Adaptimmune’s (ADAP) drug NY-ESO-targeting T-cell therapy. The drug became the 8th accepted for EMA’s PRIME program. The PRIME status has been awarded to Adaptimmune’s NY-ESO-targeting T-cell therapy for the treatment …