Health and Healthcare

7 Key FDA Decisions and Catalysts Expected in January and February

Chris Lange

Published: December 30, 2016 7:45 am

Last Updated: January 12, 2020 4:17 pm

Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a great amount of risk involved, 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 massive upside.

The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.

24/7 Wall St. has collected several catalysts that are coming up in the first two months of 2017 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 remain static. Some date changes are positive developments, and some can be disasters if a company is not deeply financed.

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.

Synergy Pharmaceuticals

Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) is scheduled to have its PDUFA target action date on January 29, 2017, where the FDA will review its New Drug Application for plecanatide in the treatment of chronic idiopathic constipation.

Shares of Synergy were closed trading on Thursday at $5.92, with a consensus analyst price target of $10.80 and a 52-week trading range of $2.50 to $6.29.

Protalix BioTherapeutics

Protalix BioTherapeutics Inc. (NYSEMKT: PLX) just finished its final patient enrollment for its Phase 2 clinical trial of AIR DNase (PRX-110) for the treatment of cystic fibrosis. Interim results are expected in the first week of January 2017, with the full results from this mid-stage trial coming before the end of the first quarter of 2017.

Protalix shares were last trading at $0.46 apiece. The stock has a consensus price target of $2.40 and a 52-week trading range of $0.26 to $1.04.

Tesaro

Back in July, Tesaro Inc. (NASDAQ: TSRO) announced that the FDA has accepted its NDA for review for its intravenous (IV) formulation of rolapitant. The agency set a PDUFA target action date for January 11, 2017. Rolapitant is a treatment for chemotherapy-induced nausea and vomiting.

Last seen trading at $135.06, Tesaro shares have a consensus price target of $130.64 and a 52-week range of $29.51 to $148.74.

Ocular Therapeutix

After receiving a Complete Response Letter (CRL) from the FDA back in July in regards to its NDA for Dextenza, Ocular Therapeutix Inc. (NASDAQ: OCUL) expects to resubmit its NDA in the first quarter of 2017, following the completion of testing of its commercial batches. Dextenza is used for the treatment of post-surgical ocular pain.

The stock closed most recently at $8.33 a share. The consensus price target is $29.40, and the 52-week range is $4.04 to $14.50.

Neurocrine Biosciences

In January 2017, Neurocrine Biosciences Inc. (NASDAQ: NBIX) is expecting to report top-line results from its Phase 2 study of Ingrezza in the treatment of moderate to severe Tourette’s. Other trials for slightly different indications of Ingrezza are expected in early 2017 as well. The NDA for Ingrezza for the treatment of tardive dyskinesia has a PDUFA target date of April 11, 2017.

Shares of Neurocrine were last seen at $37.90, with a consensus price target of $68.27 and a 52-week range of $31.25 to $57.49.

Lexicon Pharmaceuticals

Back in September, Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) announced that the FDA needed additional time to complete its NDA review for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. Ultimately this additional time extended the PDUFA goal date to February 28, 2017.

Lexicon was last closed at $13.83 per share, with a consensus price target of $24.67 and a 52-week range of $7.65 to $19.62.

FibroGen

FibroGen Inc. (NASDAQ: FGEN) has data from multiple studies coming out in early 2017. First, the company is expecting to announce top-line Phase 3 data in “early 2017” for Roxadustat (FG-4592) in the treatment of anemia in chronic kidney disease. Also Phase 2 interim results for Pamrevlumab (FG-3019) in the treatment of pancreatic cancer are expected in January 2017.

Shares of FibroGen were last trading at $21.75, with a consensus analyst target of $36.20 and a 52-week trading range of $14.38 to $31.90.