Good morning, fellow Fools! Let's check in on the top stories in health care this morning.
Intercept continues to soar
Intercept Pharmaceuticals (NASDAQ:ICPT) is up big again this morning after Citigroup set a $400-a-share price target on the company today, despite the 281% jump yesterday. This upgrade represents a potential 60% upside remaining in the stock.
To recap yesterday's events, shares of Intercept soared after the company's experimental liver disease drug, obeticholic acid, showed such a strong benefit to patients compared to placebo that the trial was stopped early. Experts believe the drug could see peak sales of around $5 billion a year as a treatment for nonalcoholic steatohepatitis, or NASH, if approved by the U.S. Food and Drug Administration. Currently, there are no approved drugs for the disease, even though it is a leading cause of liver transplants in the U.S.
Should you take a closer look at Intercept? It's important to remember that these are midstage results, meaning the drug is about two-thirds of the way through the normal clinical trial process. That said, the results were so impressive and there is such an unmet medical need with NASH that it's highly likely Intercept will seek accelerated approval.
My take is that the market believes that accelerated approval is forthcoming based on these stellar results. Nonetheless, you need to realize that there is a real risk of a rejection from the FDA for accelerated approval, if the company goes that route. Just ask Sarepta Therapeutics. Put simply, nothing is a given with the FDA.
Even so, there is a better than average chance that Intercept's drug is approved sooner rather than later. In that case, today's share price could look cheap if the drug lives up to the hype. So my take is that Intercept does warrant a closer look, even after yesterday's monstrous rally.
Immunomedics continues to rally on clinical progress
Monoclonal antibody specialist Immunomedics (NASDAQ:IMMU) is up big in premarket this morning after announcing the start of a late-stage trial for its experimental pancreatic cancer therapy clivatuzumab. The trial will enroll up to 440 patients with metastatic pancreatic cancer, with enrollment expected to be completed by mid-2015.
Is this story worth checking out? I believe so. The company's approach is similar to Seattle Genetics and Roche's approved antibody drug conjugates that are top-line cancer therapies, and clivatuzumab would be the first such therapy for pancreatic cancer. What's key to understand is that pancreatic cancer is notoriously difficult to treat, especially when patients fail frontline treatments. So there is an unmet medical need in this area that clivatuzumab could help to fill.
With that said, you need to understand that Immunomedics is a developmental-stage company that relies mostly on dilution for funding, and this trial won't be completed anytime soon. So you might want to wait to see how this plays out before jumping in right now.
MannKind falling back to Earth
Shares of MannKind (NASDAQ:56400P706) are pulling back a fair amount in premarket this morning after yesterday's 18% jump. MannKind soared yesterday after word leaked that an FDA Advisory Committee would possibly review the company's lead clinical candidate Afrezza on April 1 of this year. The review is expected to be completed no later than April 15.
Afrezza is an inhalable, ultra-fast-acting insulin product that could dominate the insulin delivery market if approved. Last year, Afrezza completed two late-stage trials requested by the FDA that will be the main focus of the upcoming regulatory review.
So, what's my take? I think Afrezza will get approved this time around based on the strength of its late-stage trial results. In my view, the real question is whether or not the drug can gain market share against the likes of Novo Nordisk's and Eli Lilly's injectable pens that deliver fast-acting insulin. Overall, I am cautiously optimistic that MannKind will finally deliver on the promise of an inhalable insulin product that customers actually want to use. So you might want to keep tabs on this compelling story going forward.