Many biotech players have slated 2014 as the year to accomplish goals, ranging from announcement of results from clinical trials to submitting their drug candidates to the FDA for review and possible approval. These sorts of developments will give investors an idea regarding the direction biotech companies are headed. Therefore, I thought I should bring you three biotech companies to watch for these developments this year. The choices here are companies that I covered in 2013.
Array Biopharma Inc. (NASDAQ: ARRY)
I wrote about how Selumetinib could begin an era for Array just before 2013 ended. One of the things that's interesting about Array is that big drug makers, like AstraZeneca (NYSE: AZN) believe in its pipeline. In 2014, however, the progress of Selumetinib being developed for the treatment of a number of cancer types, is what investors should monitor.
Selumetinib is believed to be as effective as, or even more effective than, existing top cancer treatments. If this is anywhere near the truth, then Selumetinib has the potential of generating up to $6 billion in global sales annually. The drug candidate is currently in Phase III clinical trials and we should have a clearer idea of where it's headed this year.
Ampio Pharmaceuticals Inc. (NYSEMKT: AMPE)
Ampio is a clinical stage biotech company that institutional investors seem to have faith in. The company has been doing a good job with investors' money. In 2014, investors should keep close tabs on the progress of its drug candidates, Ampion and Optina.
The clinical trials for Optina, being developed to treat macular edema, are expected to be completed during the first quarter of this year. If the results from the trials have no major concerns, the drug could get direct FDA approval, as per the 505 (b) 2 pathway. That shows how much potential this drug has.
Ampion, being developed for the treatment of a variety of chronic inflammatory and immune-mediated diseases, is also expected to complete clinical trials this year. Successful completion of clinical trials for both drugs and, in the end, getting the FDA's approval would definitely change Ampio's status, from which investors would benefit.
Geron Corporation (NASDAQ: GERN)
In a previous article, I explained that investors should not be too excited about Geron (NASDAQ: GERN) just yet. The company has two drugs in its pipeline, with one of them, Imetelstat, being the one that the investment community is positive about. So far, reports from the clinical trials of this drug have been positive, which is a good indication. But then, Geron has had controversial issues in the past. One with a stem-cell asset it once owned and the other with liver biochemistry abnormalities with this same drug candidate.
Therefore, in 2014, investors should monitor the progress of this drug, which is still in Phase II. Any report about the candidate bringing safety disquiets should make investors ask if this company will be capable of making drugs that most people can use safely.