3 Key FDA Decisions Expected in February

Companies in the pharmaceutical industry are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, as with biotech companies, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside. U.S. Food and Drug Administration (FDA) rulings can make or break these companies. A single failed clinical trial can mean disaster for a stock.

24/7 Wall St. has collected three big FDA decisions coming up in February and added some color, along with the trading range and price target. Note that, due to many outside and internal factors, there are no assurances that the dates will not change.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) recently had its cystic fibrosis treatment Kalydeco (ivacaftor), accepted for review of a supplemental New Drug Application (sNDA). The FDA granted Vertex’s request for Priority Review of this sNDA and a target review date of February 6. This could be a turning point for Vertex, as the stock has gotten beaten up over the past couple of weeks. Shares ended last week at $90.75, with a consensus analyst price target of $140.25 and a 52-week trading range of $81.98 to $143.45.
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Regulus Therapeutics Inc. (NASDAQ: RGLS) has been pushing new lows recently, but an FDA announcement coming in mid-February could put the wind back in this company’s sails. Regulus recently completed enrollment for its Phase 2 study of RG-101 indicated in the treatment of hepatitis C. The company is planning to report interim results from this study in mid-February 2016, in time for submission for potential publication at the European Association for the Study of the Liver (EASL) annual meeting. Primary endpoint results from this study are expected late in the second quarter. Shares of Regulus closed on Friday at $5.78, within a 52-week range of $5.24 to $21.22. The consensus price target is $29.00.

Sarepta Therapeutics Inc. (NASDAQ: SRPT) was absolutely crushed when the FDA turned down a NDA for BioMarin’s Kyndrisa for the treatment of Duchenne muscular dystrophy earlier in January. Although this had little to do with Sarepta, the company is developing a similar drug, eteplirsen, for the same indication, and investors were spooked when they saw that BioMarin failed. Sarepta’s eteplirsen has a target PDUFA date set for February 26. Shares of Sarepta were trading at $11.88 on Friday’s close. The consensus price target is $35.25, and the 52-week range is $11.10 to $41.97.