VIVUS Inc. (NASDAQ: VVUS) investors have a lot to be disappointed about these days. America’s ballooning waistline is reaching a critical level, yet VIVUS did not even manage to close up one penny on a day that Orexigen Therapeutics, Inc. (NASDAQ: OREX) disclosed that the Food and Drug Administration has decided to delay its decision on the company’s own weight-loss drug. The delay is for another three months, and this only highlights the risks of investing in biotech.
It was expected that Orexigen was going to get approval. The FDA and the company supposedly need to work out post-marketing safety monitoring.
The troubles for Orexigen investors may have only grown more complicated. All sidebar analysis aside, the FDA just hates the current weight loss drug regimes on the market and up for approval. In some cases for good reason. The approval for the pill Contrave has now been punted down the road to September 11.
Shares of competitors Arena Pharmaceuticals and VIVUS hardly even budged. Arena Pharmaceuticals Inc. (NASDAQ: ARNA) has Belviq and VIVUS has Qsymia, both of which are on the market now and both are undergoing post-marketing safety studies. The problem is that sales have been atrocious compared to the opportunity here.
Here is how the stocks performed on Wednesday. Ariad shares were up a mere 2.9% at $7.02, with a $1.3 billion market cap. VIVUS closed flat at $5.21, with a 52-week range of $4.56 to $15.40.
Orexigen was the big loser with a drop of almost 15% to $5.81 on the day with over 20 million shares trading hands, down from a high of $7.84 this year. Its market cap is now $675 million.
Investors need to understand that the FDA is no friend of these companies right now. That being said, doctors are not great friends of these companies either as they are taking a wait and see attitude on the post-marketing safety results before they get more patients on the drugs.