The internet has brought a lot of great tools to shareholders over the past decade. This is especially true for intrepid biotech investors where trial milestones and FDA actions can trigger huge rallies or implosions. There is no need to be in the dark around timelines for potential milestone for prospective investments as the information is easy to find these days. There are lots of good and free FDA calendars available around the internet. Here is the one I prefer.
So, what are potential catalysts and milestones on the horizon that could impact some of the small biotech and biopharma stocks we discuss frequently on these pages in the months ahead? Here are a few key events I will be watching closely for in the months ahead on stocks I think are buys at current levels.
Let's start with Dynavax Technologies (DVAX) . In November, the FDA approved its hepatitis B vaccine 'Heplisav-B'. This is the first new hepatitis B vaccine approved in a quarter century and is clearly superior to the current standard 'Entergis-B' in both protection and compliance. The biologic could easily see at least $500 million in peak sales just in the U.S. The vaccine is already in the marketing stage. On February 21st, the company goes before the Centers of Disease Control's (CDC) Advisory Committee on Immunization Practices. An expected nod before this committee should provide a nice boost to Dynavax's initial marketing effort and could buoy the stock as well.
At the end of April, the FDA is scheduled to render a decision on Azedra from Progenics Pharmaceuticals (PGNX) , although the approval could come weeks earlier given recent early renderings. This drug is aimed at two rare adrenal tumors and has Orphan Drug status. The compound met all criteria in trials under that criteria and I expect the drug candidate to be approved. Given that most individuals with these rare indications are largely known and serviced by a small amount of specialists, rollout should happen relatively quickly. Azedra should have peak sales of approximately $150 million to $250 million, and should cause a sharp reevaluation of the stock of Progrenics which currently carries an approximate $400 million market capitalization.
Around the same time in late April, Neurocrine's (NBIX) Elagolix will be coming up for potential approval for treating women with endometriosis and its associated pain. This drug was developed with partner AbbVie (ABBV) . Upon approval, Neurocrine would be entitled to regulatory and sales milestones potential worth north of $200 million as well as royalties on sales. AbbVie is also conducting a Phase 3 trial using elagolix for the treatment of heavy menstrual bleeding associated with uterine fibroids. Initial sales of Ingrezza for tardive dyskinesia also have been much better than expected since that wholly owned compound was approved last year. Elagolix approval would open another revenue stream for the company and could also mean the stock's recent rally could continue.