Following recent reports of new onset or worsening peripheral neuropathy in patients with ATTR amyloidosis with cardiomyopathy (hATTR-CM) treated with Alnylam’s (ALNY) RNAi –based drug revusiran, The firm requested that the Data Monitoring Committee (DMC) review the reports and the Clinical trial data on an unblinded basis. After reviewing the reports, the DMC advised suspending the dosing of revusiran. However, the DMC stated that It …

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 …

As we expected in our previous articles, Today, Aerie Pharmaceuticals (AERI) came up with great news about its glaucoma treatment. The stock surged ….   On February 18, 2016, Under News & Comments, we wrote an article titled “Aerie Pharmaceuticals: Novel Glaucoma Eye Drops Confirm their Superiority”. The article also referred to a Prohost previous article written on February 4, 2015 and tittled “Aerie Pharmaceuticals …

Another gene editing firm, CRISPR Therapeutics decided to become publicly traded. On Friday, the private firm filed with the SEC planning for a $90 million initial public offering (IPO). CRISPR Therapeutics is headquartered in Switzerland, but also exists in Cambridge. It was cofounded by Emmanuelle Charpentier, who, together with Jennifer Doudna claim discovering CRISPR/Cas9 gene editing recipe. The firm aim is to use CRISPR/Cas9 genome-editing …

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 …

Filled with high hopes and great enthusiasm, we are following up on Nektar’s (NKTR) immunotherapy product NKTR-214, which is in trials by Mayo Clinic and MD Anderson cancer center. The product is a CD122-biased agonist designed to stimulate the patient’s own immune system to kill tumor cells. The technology behind the molecule “targeted polymer conjugate technology” has been validated time and time again in clinical …

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, …