The Most Important FDA Decision We're Watching This Quarter

By Markets Fool.com

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Investing in biotechs is often seen as a feast-or-famine business. In fact, shorts and longs tend to convergeon a stock as a key FDA date approaches, knowing it can send thestock soaring (or tanking) in the blink of an eye.

We're not advising that you follow their lead. In fact, here are a couple of surprising lessons you can profit from. First,research shows that negative FDA decisions hurt share prices more than the positive decisions help them. In addition, positive FDA decisions tend to influence share price long after they're made. In other words, even after a stock has popped from a regulatory thumbs up, there'sstill room for that stock to run.

With that in mind, our contributors are currently closely watching thesethree key FDA decisions.It can be incredibly helpful to know what'sahead, so you can be prepared. Knowing ahead of time what a company is facing can keep you from being surprised by the volatile trading that often surrounds an FDA decision.

So, let's get to it!

Todd Campbell: While not quite "this quarter," the FDA will issue a go-no-go verdict on Insys Therapeutics' oral marinol on April 1, and in my book, that's close enough!

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Marinol is a marijuana-derived drug that has been approved for use as a treatment for anorexia in AIDS patients and to relieve nausea and vomiting in chemotherapy patients. Insys Therapeutics' reformulated variation of marinol, which would be sold under the brand name Syndros, is dosed orally as a liquid, rather than swallowed as a pill, and because liquid dosing has a faster onset of action and dosing is more easily adjusted, management thinks Syndros can win significant market share.

If so, then Syndros has nine-figure annual sales potential, because the market for marinol products is worth $150 million per year and growing.

A successful launch of Syndros is also important because Insys Therapeutics' revenue is made up almost entirely of Subsys, a fentanyl pain killer approved to treat breakthrough cancer pain. Last year, Subsys' sales totaled $330 million, up 49% from 2014.

However, Insys Therapeutics has been under investigation for improper off-label marketing of Subsys, and that has caused Insys Therapeutics to lose its CEO and more than half its value in the past year. Therefore, an approval of a second drug that could diversify the company away from Subsys would be welcome.

Brian Feroldi: One FDA decision I'll be watching closely towards the end of March is for Rayaldee, a drug owned byOpko Health. Rayaldeeis an oral vitamin D prohormone designed to help patients with stage 3 or 4 chronic kidney disease, or CKD, better regulate their vitamin D levels. In phase 3 clinical trials, Rayaldee was able to correct vitamin D insufficiency levels in 96% of patients who used the drug, versus only 8% of patients who took a placebo.

CKD is a huge problem in the U.S.; the National Kidney Foundation estimates that 26 million Americans have the disease, and 20 million of them are in stage 3 or later. It is estimated that more than 70% of patients with CKD have vitamin D insufficiency. Left untreated, this can lead to bone diseases or secondary hyperparathyroidism, and it's associated with increased mortality rates.

Approval would be a big deal for Opko Health's investors, as the drug would compete in a market that rings up an estimated $12 billion in annual sales.

There's at least one big believer that Rayaldee will make its way to market: Opko Health's billionaire CEO Philip Frost, who has been aggressively adding to his huge position in the company recently. Frost purchased more than 47 million additional shares since December alone. That's a big boost of confidence from an accomplished executive, making Opko Health a stock to watch in 2016.

Cheryl Swanson: Jazz Pharmaceuticals has a tiger by its tail with life-saving drug defibrotide, up for the FDA nod on March 31. Assuming defibrotide is approved, doctors shouldfinally be able to reverse a complication of stem cell transplantation so devastating it causes mortality four out of five times.

Jazz gambled big on defibrotide back in 2013, picking up the therapy by buying out rare disease drug developer Gentium for $1 billion. Defibrotide had won European approval before that, but the FDA rejected Italian company Gentium's pitch for approval -- with regulators strongly questioning the monitoring of clinical trials.

Jazz believes it has now satisfied the FDA's requests. And with solid data from three clinical studies, and a priority review treatment designation, it seems likely that Jazz's gamble will soon pay off. That will be none too soon for Jazz investors, since right now, thelion's share of Jazz's revenues comes from sales of Xyrem, Jazz's narcolepsy medicine.

So, is there more investment upside in Jazz? Despite the compelling need for a treatment like defibrotide, approval isn't in the bag. Still, orphan drugs historically produce higher margins than those that treat common diseases, and defibrotide has potential for other rare diseases. The bottom line is thatJazz beat earnings and revenue expectations this quarter, and its growth and success thus far lend plenty of reason for optimism -- assuming of course that defibrotide nails the expected approval.

The article The Most Important FDA Decision We're Watching This Quarter originally appeared on Fool.com.

Brian Feroldi has no position in any stocks mentioned. Cheryl Swanson has no position in any stocks mentioned. Todd Campbell owns shares of Insys. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.