Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Repros Therapeutics (NASDAQ: RPRX), a clinical-stage company developing therapies to treat hormonal and reproductive system disorders, plunged as much as 32% after delaying the filing of its new drug application for Androxal for several months.
So what: According to this morning's press release from Repros, it is planning to forgo filing a new drug application for its hypogonadism treatment Andorxal, which was expected by mid-2014, and will hold off until the fourth quarter of 2014. The reason for the move is that the Food and Drug Administration wants a year's worth of safety data on the highest dosage of Androxal, which will require Repros to run two additional trials. But, it wasn't all negative news, either. The press release also noted that if Androxal proved markedly superior to competing testosterone treatments in these two trials, that the FDA would consider an expedited NDA review.
Now what: Today is nothing more than traders hoping for a quick approval getting the shaft. Nothing has materially changed in the underlying data of Androxal other than Repros' need to run two additional trials utilizing the highest dosage. In other words, until there's a fire, you don't need to call the fire department!
Despite the several month delay, I feel today's move is based more on emotion than on logic given the success of Androxal in trials to date. As such, I would certainly suggest biotech-savvy investors give a closer look to Repros after today's drop.
