News - Part 9

RedHill Biopharma’s RHB-104: A Potential Game Changer for Crohn’s Disease?

Last week I wrote an article on Immune Pharmaceuticals (IMNP) and its first-in-class fully human IgG4 monoclonal antibody, bertilimumab, for the treatment of inflammatory bowel disease (IBD). Immune’s drug is currently in a Phase 2 trial targeting patients with moderate-to-severe ulcerative colitis (UC). Investors can view that article here >> LINK I spent a lot…

Why Immune Pharma Is So Excited About Bertilimumab In Ulcerative Colitis

A Quick Look At IBD Inflammatory Bowel Disease (IBD), which includes ulcerative colitis and Crohn’s disease, is a chronic, lifelong condition with serious quality of life implications. According to the Crohn’s & Colitis Foundation of America (CCFA), IBD affects as many as 1.4 million Americans, most of which are diagnosed before the age of 30….

Immune Pharma’s R&D; Day Highlights Potential For Bertilimumab In Dermatology

On Tuesday, September 8, 2015, I attended the Immune Pharmaceuticals (IMNP) R&D Day at the company’s U.S. headquarters at the Alexandria Center for Life Science, in New York City. The majority of the event was spent talking about Immune’s lead pipeline candidate, bertilimumab, for the treatment of immune-inflammatory diseases of the skin and gastrointestinal tract….

ADMA Biologics Shares Possibly Worth A Triple On FDA Approval Of RI-002

We are initiating coverage of ADMA Biologics, Inc. (ADMA) with a “Buy” rating and a $20 price target. ADMA recently announced positive Phase 3 data for lead product candidate RI-002, a plasma-derived intravenous immunoglobulin (IVIG) for the treatment and prevention of certain infectious diseases in Primary Immunodeficiency Disease (PIDD) patients. RI-002 contains high levels of…

Why Newly Nasdaq-listed Cynapsus Offers Big Upside

Cynapsus Therapeutics Inc. (CYNA) long-awaited U.S. initial public offering is set to close early next week. The company recently announced that it plans to offer 4.5 million shares of common stock at a price of $14.00 per share. Gross proceeds from the offering total $63.0 million. The company has granted to the underwriters (sole book-runner…

Enumeral Biomedical – Platform Validation On Multiple Fronts

Enumeral Biomedical Holdings, Inc. (ENUM) is a development stage biotech company with a focus on immunotherapy for cancer and inflammatory disease. The company has developed a proprietary platform technology with the ability to screen antibodies at a single cell level, which holds multiple advantages over existing technologies. Based on this platform technology, Enumeral is currently…

Avoid Osiris Therapeutics

I recommend avoiding shares of Osiris Therapeutics (OSIR). I believe the stock is meaningfully over-valued at this price, and I see potential clinical failures, the dissolution of the development partnership with Sanofi Aventis, and subsequent dilutive cash raises as catalysts to drive the shares significantly lower. Osiris Therapeutics is a stem cell company focused on…

Will Third Time Be A Charm For Acadia Pharmaceuticals?

Investors familiar with Acadia Pharmaceuticals (ACAD, $1.28/share) know the company’s lead pipeline candidate, pimavanserin, a potent and selective 5-HT2A inverse agonist, failed the first phase 3 trial (Study -012) based on unusually high placebo response. When -012 failed, management discontinued the second phase 3 trial, Study-014, early. What Went Wrong? Upon detailed analysis of the…