What happened
Shares of Progenics Pharmaceuticals (PGNX +0.00%) jumped 15.2% on Thursday after the company released fourth-quarter earnings and laid out its plans for the year ahead.
So what
Sales of Relistor, the opioid-induced-constipation drug sold by partner Valeant Pharmaceuticals (VRX 1.96%), came in at $24.6 million in Q4, up 44% from the prior quarter. While the increase was nice, it only translated into $3.7 million in royalty revenue, certainly nothing to get too excited about.
Progenics only lost $2.7 million during the quarter, but that result was bolstered by an $11.7 million tax benefit from the recent tax overhaul.
Image source: Getty Images.
Rather than sales of Relistor -- or any of the numbers in the earnings release, for that matter -- Thursday's share price move more likely had to do with investors piling in ahead of an expected FDA decision on its marketing application for Azedra, a treatment for malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, which are rare types of neuroendocrine tumors.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a goal than a deadline, and an approval can come earlier or later (if it comes at all). Over the last few years, the oncology division of the FDA has approved many drugs well ahead of their PDUFA dates, and their doing so in this case wouldn't be surprising, given the lack of treatment options for patients with late-stage pheochromocytoma and paraganglioma.
Progenics management noted that it's readying its commercial organization so it can launch upon approval. While that's what you'd expect management to say, reading between the lines, that's good news since management has some insight into how the review by the FDA is going based on questions it has received from the agency about its marketing application (or lack thereof).
Now what
Without anything concrete to go on, there isn't much long-term investors need to do but twiddle their thumbs waiting for a potential approval this month or next. Looking a little further ahead, data from a phase 3 trial testing on Progenics' imaging agent 1404 is expected in the third quarter.
