What happened
BioCryst Pharmaceuticals (BCRX 0.12%) stock defied the market's gravity on Wednesday by rising incrementally. Although it was a challenging day for stocks in general, with the S&P 500 index sinking by over 1%, BioCryst landed in the black thanks to some encouraging regulatory news.
So what
Before market open, BioCryst announced that the Food and Drug Administration (FDA) has granted its BCX9250 investigational drug fast-track designation. As the name implies, when a product receives such a designation, it is placed to move more quickly through the regulatory process. Its maker also becomes eligible for a clutch of benefits, including more frequent meetings with the FDA.
BioCryst aims to win approval for BCX9250 to treat heterotopic ossification (HO), or the formation of bone in muscle and other soft tissue, in patients afflicted with fibrodysplasia ossificans progressiva (FOP). This is a rare genetic disorder in which HO develops and can lead to an advanced degree of disability in the patient.
BCX9250 is one of several BioCryst pipeline programs. It is advancing well through the regulatory environment; in late April, the European Medicines Agency (EMA) granted the experimental drug access to its Priority Medicines (PRIME) initiative. That program is similar to the FDA's fast-track status.
Now what
Although BCX9250 did quite well in phase 1 clinical trials, we should bear in mind that it still has to go through much more testing before BioCryst can even think about bringing it to market. That said, this is indisputably an encouraging development for the biotech, and it portends well for the FOP drug's future.
