Healthcare Business

5 Big FDA Decisions Expected in August

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 August 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.

Exelixis Inc. (NASDAQ: EXEL) is scheduled for a PDUFA review on November 11 for its cobimetinib. Specifically,  cobimetinib is used in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation. Shares of Exelixis were down 5.1% at $5.96 Thursday afternoon. The stock has a consensus analyst price target of $5.89.

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Alkermes PLC (NASDAQ: ALKS) is scheduled for a PDUFA review on August 22 for its aripiprazole lauroxil, the company’s investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia. CEO Richard Pops noted that if this is approved it could be a significant new entrant in the increasingly important category of long-acting injectable medicines for schizophrenia. Alkermes shares were down 4.9%, at $68.62 in its 52-week trading range of $38.49 to $75.17. The stock has a consensus price target of $70.60.

Amgen Inc. (NASDAQ: AMGN) is scheduled for a PDUFA target action date for August 27 for its evolovumab application. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol, or “bad” cholesterol, from the blood. Shares of Amgen were down 3.5%, at $170.24 in its 52-week range of $124.81 to $181.81. The consensus analyst price target is $183.25.

Bristol-Myers Squibb Co. (NYSE: BMY) was granted its supplemental Biologics License Application for Opdivo (nivolumab) back in April. The projected FDA action date is August 27. Opdivo is involved in the treatment of previously untreated patients with unresectable or metastatic melanoma. Bristol-Myers shares were down 2.2% at $63.63. The consensus price target is $70.56, and the 52-week trading range is $47.55 to $70.54.

Clovis Oncology Inc. (NASDAQ: CLVS) has a rolling New Drug Application (NDA) submission to the FDA for advanced (epidermal growth factor receptor) EGFR-mutant non-small cell lung cancer, which is expected to be completed by August 31. Rociletinib is an oral, potent, mutant-selective inhibitor of EGFR. Shares of Clovis were down 4.1%, at $83.00 in its 52-week trading range of $36.31 to $102.28. The stock has a consensus price target of $103.14.

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