BioCryst Pharmaceuticals won its first-ever FDA approval for a new treatment and subsequently saw its shares ($BCRX) slide as analysts yawned over its sales potential.
The Research Triangle Park, NC-based biotech spread word of the approval early Monday, saying that the FDA had OK'd an IV formation of peramivir for acute influenza. The treatment will be sold as Rapivab.
Some analysts weren't overly enthusiastic about the drug's immediate market potential, though, saying it is largely limited to the government's interest in stockpiling the antiviral. Roth Capital Partners analyst Ed Arce told Reuters that an estimated $120 million stockpiling order is likely to arrive in 2015.
That modest expectation also limited investors' interest in the company. BioCryst's shares spiked early on today, but were trading down 2% in midmorning trading.
Back in late 2012, though, BioCryst was ready to write off the whole program after looking at unimpressive Phase III data. Then the biotech announced that BARDA had released funds for an NDA after officials at the FDA laid out a possible pathway to an approval.
"The approval of Rapivab provides a new choice to immediately deliver an effective treatment in one dose to adult patients with influenza," said BioCryst CEO Jon Stonehouse. "This is the first U.S. approval of a BioCryst discovered drug and represents an important milestone for our company. We thank our funding partner BARDA/HHS; the development and approval of Rapivab."
- here's the release
CORRECTION: This story was changed to take out a reference related to the drug's potential. A spokesperson for BioCryst says that the drug is not limited to hospital use. Also, Ed Arce's name was misspelled.