Healthcare Business

5 Big FDA Decisions Expected in September

Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, similar to that of 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 several big FDA decisions coming up on the calendar for the month of September and added some color, along with the 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.

Opko Health Inc. (NYSE: OPK) announced in its first-quarter operating results in May and is expecting a rolapitant PDUFA action date on September 5. Opko will receive up to $110 million of milestone payments upon the approval and commercialization. Rolapitant is involved in the prevention of chemotherapy induced nausea and vomiting. Shares of Opko were trading at $11.42 on Friday’s close. The stock has a consensus analyst price target of $18.00 and a 52-week trading range of $8.02 to $19.20.

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Tesaro Inc. (NASDAQ: TSRO), to tag along with Opko, has a New Drug Application (NDA) for oral rolapitant under review by the FDA with the same PDUFA goal date. The company is continuing its commercial preparations in support of the potential product launch in the fourth quarter of 2015. Tesaro shares closed at $53.36, in its 52-week trading range of $23.00 to $66.95. The stock has a consensus price target of $67.40.

Zosano Pharma Corp. (NASDAQ: ZSAN) recently completed its enrollment for the Phase 2 trial for ZP-Glucagon. If it is approved by the FDA, it has the potential to be a significant improvement over the currently marketed products for treatment of severe hypoglycemia, which often require a lay person to deliver an injection after a cumbersome preparation process. The company anticipates announcing top-line data from the trial around September. Shares of Zosano ended the week at $8.10, in its 52-week range of $7.01 to $12.40. The consensus analyst price target is $21.00.

Xenoport Inc. (NASDAQ: XNPT) completed enrollment in its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis and reiterated its plans to disclose top-line data from this trial by the end of the third quarter, meaning September. Xenoport shares were at $6.67 on Friday’s close. The consensus price target is $11.50, and the 52-week trading range is $4.85 to $9.60.

Apricus Biosciences Inc. (NASDAQ: APRI) enrolled its last patient in its RayVa Phase 2a proof-of-concept study, back in June. The top-line data from this study is expected to be released in the third quarter. At that time it will report safety and proof-of-concept data from its RayVa Phase 2a clinical trial in patients with Raynaud’s phenomenon secondary to scleroderma. Shares of Apricus closed most recently at $1.35, in a 52-week trading range of $0.92 to $2.75. The stock has a consensus price target of $4.63.

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