Biogen (BIIB) and Ionis (IONS) announced that Spinraza (nusinersen), an antisense drug designed and developed by Ionis met its primary endpoint in Phase 3 trial of the CHERISH Study in later-onset spinal muscular atrophy (SMA). This was the second positive Phase 3 study that provides evidence of Spinraza’s efficacy and favorable safety. The data demonstrate statistically significant and clinically meaningful results.   Children receiving Spinraza …

Ariad Pharmaceuticals (ARIA): Good news from the U.S. Food and Drug Administration (FDA) affirmed that the agency accepted for review Ariad’s New Drug Application (NDA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed after being treated with crizotinib. The NDA submission includes clinical data from its Phase 1/2 and …

Results from trials were negative in two phase 2 studies for Gilead (GILD) experimental drug GS-4997 (selonsertib) intended to treat pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). But the same drug selonsertib showed it might hit the jackpot when results demonstrated it succeeded in treating nonalcoholic steatohepatitis (NASH), which is also known as non-alcoholic fatty liver disease, where, according to Gilead, it showed …

At the Annual European Congress of Rheumatology (EULAR 2016) in London, Eli Lilly and Company (LLY) and Incyte (INCY) presented data from RA-BEYOND study, demonstrating that their drug baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA). A key goal of rheumatoid arthritis treatment is to impede the structural damage that this disease usually causes to the …

EXELIXIS APPROVED PRODUCTS 1. CABOMETYX™(CABOZANTINIB) For Exelixis (EXEL) the two approved oncology products cabozantinib and cobimetinib and its pipeline of promising investigational products are considered now by more analysts a wealth that will be reflected in the firm’s future growth. The results emanating from the clinical trials of two approved products should not be underestimated. The latest of the good news emanated from the firm’s …

News about investigational drugs, which are expected to make big differences in the lives of people with chronic diseases and deadly diseases does not always materialize. Predicting drugs becoming breakthroughs has proven extremely difficult in the early phases of drugs’ development. Some products keep doing well, going from the preclinical testing into several phases of trials then all of a sudden they unexpectedly fail. They …

EXELIXIS (EXEL) Friends and subscribers are asking the following question for more than two weeks now: Why EXEL stock has rallied? Most of those who asked the question owned the stock and made a lot of profit on it. The truth is that those investors wanted to know whether it was time for them to take their profit and enjoy it elsewhere. In other words; …

The FDA approval of Sarepta’s (SRPT) Duchenne muscular dystrophy (DMD) product, Exondys 51 (eteplirsen), surprised many analysts. Nonetheless, it doubled SRPT's price after the stock had already multiplied everal folds since the stock had been cremated. Good for those who dared to bet on SRPT in spite of the FDA’s independent advisory committee’s voting against the approval and the FDA hesitation to listen to the …

The FDA announced what made Clovis Oncology (CLVS) shareholders believe that the bad times might have ended for the firm and a new era is beginning. The announcement was about the FDA decision not to hold an advisory committee meeting to discuss the company’s New Drug Application (NDA) for drug rucaparib aimed at treating advanced ovarian cancer. The regulatory agency had already granted rucaparib a …

Xoma’s (XOMA) webcast and conference call scheduled for September 15, 2016, at 1:30 p.m. PDT (4:30 p.m. EDT) is important and should be interesting to the firm’s shareholders. The conference call will provide an update on what’s going on in the Phase 2 trial of XOMA 358, the firm’s drug, which aims at treating congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBS). The Drug and …

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, …

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 …

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, …

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 …