Biotech investors have a busy FDA schedule to ponder for the month ahead. Adam Feuerstein at TheStreet highlights four big drug decisions in the weeks to come, and he's bullish about the chances of some closely-watched drugs.
At the top of the list is Vivus ($VVUS), which will hear the formal regulatory word on Qnexa. After Arena's ($ARNA) big win on lorcaserin, Qnexa is given great odds for an approval. Analysts are already looking past the July 17 PDUFA date to try and visualize how Vivus will compete against the Arena/Eisai drug. But Vivus is also a frequently mentioned candidate for a buyout. You can expect to hear a lot more about that this month as well. Feuerstein's big concern here: Possible restrictions on Qnexa's use to mitigate potential side effects.
AMR101, Amarin's ($AMRN) fish oil drug, is finally coming down to the wire. And Feuerstein--who's followed this drug for years--is giving this one a solid shot at an OK, citing strong Phase III data and the FDA's willingness to dispense with a panel review. Amarin, he adds, is also a frequently mentioned takeover target. Given the heated M&A chatter following the big Amylin ($AMLN) buyout, this company is also going to be much discussed.
The analyst considers Onyx's ($ONXX) carfilzomib a shoe-in for multiple myeloma after a positive panel vote. Need we mention that Onyx can't be mentioned without triggering a takeover rumor, particularly given its close relationship with the asset-hungry folks at Bayer? Horizon Pharma also warrants positive odds for an RA therapy.
- here's the story from TheStreet