Months after the beleaguered BioCryst Pharmaceuticals ($BCRX) started reading the last rites for its long-running Phase III program for the flu drug peramivir i.v., citing a weak response and the need to add more patients to the study, the biotech has tried to cheer up its battered investors with the news that the therapy may not be completely dead after all. BioCryst put out a release today noting that regulators have "laid out a pathway" by which peramivir could be approved. And then the company noted that BARDA, which has been footing much of the bill for this R&D project, has issued a stop-work order on peramivir covering everything "except for certain activities primarily related to the upcoming FDA Type C meeting which is scheduled."
BioCryst's shares jumped 25% on the news that the company saw some hope yet.
Hope, though, has been in short supply at BioCryst, which announced last November that any further development of peramivir would likely end after a preliminary analysis concluded that the whole effort had become futile. BioCryst then tried to reorganize, only to scuttle a proposed merger with Presidio when its hep C program proved too toxic for regulators to allow in the clinic. And in December BioCryst laid off half of its staff.
"We are encouraged by these recent communications, and we look forward to advancing our peramivir discussions with the FDA and BARDA/HHS. Our ultimate objective is the approval of peramivir as an intravenous treatment option that could benefit patients in the United States," said CEO Jon P. Stonehouse. "The Stop--Work Order is understandable, as it focuses the scope of reimbursable activities to those that are essential and supportive to continuing regulatory communications, with the objective of preparing an NDA submission. If the conversations with theFDA and BARDA/HHS are successful, BioCryst stands ready to file an NDA for peramivir as soon as feasible."
- here's the press release