BioCryst Pharmaceuticals, Inc (NASDAQ:BCRX)’s unending tryst with the FDA
Over the past two weeks BioCryst Pharmaceuticals, Inc (NASDAQ:BCRX) rose 183%. However, there may be a reversal in the trend primarily due to the fact that there was an imbalance in the supply of BCRX stock a couple of days ago. The impressive 183% run-up had been largely driven by the open-label data from a BCX4161 safety study in which 87 patients were being tested.
BioCryst Pharmaceuticals, Inc (NASDAQ:BCRX) says that BCX4161 will be a game changer in the treatment of chronic angioedema. But there is one question that crops up naturally. The dosage of this drug is 4 pills that have to be taken every 8 hours. The question is will this kind of dosage lead to robust sales? Another company, Virophrama is in the process of developing a subcutaneous-version of Cinryze, its extremely popular product.
The company is a frontrunner in this space in the U.S and this new version of its drug might eventually replace the IV-administered version of Cinryze (that already has approval). This might mean that the company’s dominance in the market will remain unscathed.
Influenza treatment has no influence?
Apart from this, at the start of the month, BCRX announced its plans of submitting an NDA to the Food Drug Administration for peramivir, its developmental influenza treatment. To a certain degree, this news was also a catalyst in the stupendous rise of the stock over the last fortnight. Patients who had been treated with this drug in the PhaseIII trail saw just a small benefit in comparison to patients who had received the placebo.
Last November, an independent data-monitoring committee had stalled this study, claiming that the effort was a futile one. There is a distinct possibility that the peramivir NDA will be rejected by the FDA. What the company lacks is a commercial partner and capital. For now, BCRX seems to have a struggle-riddled path before it.