BOSTON (TheStreet) -- Listed below are 14 biotech and drug stock catalysts for the remainder of 2014. Healthcare investors (and traders) have had a lot to work with so far this year, and the next six months promises to be equally action packed.
Why are these 14 biopharma stock events more important than others? They may not be. Admittedly, my list is subjective, but I tried to highlight the most significant biotech and drug catalysts remaining for 2014. If you think I'm missing something crucial, let me know in the comments section below.
Biogen Idec (BIIB - Get Report)
Anti-LINGO-1 phase II study results in optic neuritis
Biogen's anti-LINGO-1 antibody is a potential therapeutic game changer for chronic neuro-degenerative diseases like multiple sclerosis. The drug is designed to block the production of a protein known as LINGO-1, which when expressed in the central nervous system, leads to the degradation of the protective myelin sheath around nerve fibers. The breakdown or "demyelination" of nerve fibers interferes with the transmission of nerve impulses, leading to physical and cognitive disability.
If anti-LINGO-1 antibody can prevent the destructive LINGO-1 protein from being produced, nerve fibers in multiple sclerosis patients might be "remyelinated" and the damage caused by the disease reversed or eradicated altogether. No wonder anti-LINGO-1 is considered a crucial, if not the most important, compound in Biogen's research pipeline.
Biogen is running two phase II studies of anti-LINGO-1. Top-line results from the first study in patients with optic neuritis will be announced before the end of the year. These optic neuritis data are highly anticipated by investors as substantial proof of concept for the entire remyelination thesis and as a signal for what may come from the second, more important phase II study of anti-LINGO-1 in multiple sclerosis patients. Results from that study are expected next year.
Gilead Sciences (GILD)
FDA approval of sofusbivir/ledipasvir fixed-dose combination pill to treat hepatitis C.
This is the single-pill, once-daily hepatitis C cure everyone -- doctors, patients, investors -- has been waiting for. The approval decision is expected on (or before) Oct. 10. Gilead's sofusbivir (brand name: Sovaldi) has already broken records for the best, fastest, most amazing drug launch in bio-pharmaceutical history. Once the combination pill is approved (no more interferon or ribavirin necessary for most patients!), investors will watch to see whether Gilead can re-accelerate revenue and profits.
On a related note: Also mark Dec. 19 on your biotech catalyst calendar. That's when Abbvie (along with partner Enanta Pharmaceuticals) expects an FDA approval decision on its competing, all-oral hepatitis C therapy.
Results from two follow-on studies of Kyprolis in multiple myeloma
The jury is still out on the wisdom of Amgen spending $10 billion to acquire Onyx Pharmaceuticals. The verdict may rest in the outcome of two Kyprolis multiple myeloma studies expected this quarter. The "ASPIRE" study investigates the benefit of adding Kyprolis to Revlimid and dexamethasone in "first relapse" multiple myeloma patients. The ASPIRE study, with a progression-free survival primary endpoint -- was designed to confirm the accelerated approval of Kyprolis in the U.S. and to support the approval of the drug in Europe. The second study -- dubbed "FOCUS" -- compares Kyprolis to best supportive care in relapsed/refractory multiple myeloma patient and has an overall survival primary endpoint.