Healthcare Business

5 Big Upcoming FDA Decisions Expected in July

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. 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 July 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 remain not change.

Eli Lilly & Co. (NYSE: LLY) will have an advisory committee meeting on July 9 to discuss the Biologics License Application (BLA) filing of necitumumab injection in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

Shares of Eli Lilly closed Monday relatively flat at $86.35. The stock has a consensus analyst price target of $85.61 and a 52-week trading range of $60.14 to $87.24.

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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has a prescription drug user free act (PDUFA) priority review. The date is set for July 24 for Praluent in patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 Odyssey trials. This was previously projected to have mega-blockbuster potential.

Regeneron shares closed Monday relatively flat at $512.24, in a 52-week trading range of $295.76 to $544.00. The consensus analyst price target is $511.71.

Alkermes PLC (NASDAQ: ALKS) has a PDUFA priority review as well with partner Johnson & Johnson (see below). It is also expected to be on July 24. This review is for three-month invega sustenna (paliperidone palmitate) for schizophrenia. Alkermes has been touted as a potential buyout candidate before. Alkermes shares did not move wildly around its last drug update.

Shares of Alkermes closed Monday up 1.2%, at $63.84 on a 52-week range of $38.49 to $75.17. The consensus price target is $70.82.

Johnson & Johnson (NYSE: JNJ) is facing a PDUFA priority review with an estimated date of July 24. As mentioned above, three-month invega sustenna (paliperidone palmitate) for schizophrenia will be under review. If approved, the company believes that this three-month formulation adds an unprecedented treatment option to help address the needs of people living with schizophrenia by providing a new, less frequently dosed treatment choice.

J&J shares closed Monday relatively flat at $98.20, in a 52-week range of $95.10 to $109.49. The consensus price target is $109.59.

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Amgen Inc. (NASDAQ: AMGN) is scheduled for a PDUFA priority review on July 26. Kyprolis for relapsed multiple myeloma will be under review. According to the company, the FDA’s priority review designation for Kyprolis underscores the need for new treatment options for patients with relapsed multiple myeloma.

Amgen shares closed Monday up 0.8% to $154.50. The consensus price target is $179.47, and the 52-week range is $114.93 to $173.60.