6 Major FDA Decisions and Biopharma Catalysts Coming in January and February

Health and Healthcare

Published: January 6, 2017 10:25 am

Last Updated: January 12, 2020 4:06 pm

Companies that reside within the biotech and pharmaceutical industries are subject to a sizable amount of risk in regards to their drug candidates passing clinical trials and gaining regulatory approval. But with the risk of failure, which could spell disaster for a stock, comes great reward as well. Some companies can see a massive upside just from winning a single mid-stage trial or even achieving as much as a Fast Track designation from the U.S. Food and Drug Administration (FDA).

In simpler terms, these updates within the industry have the potential to make or break biopharma companies.

24/7 Wall St. has included a calendar of a few of the biggest companies expecting clinical trial and FDA updates within the next two months. We have added some color, a recent trading history and a consensus analyst price target.

It’s worth mentioning that these dates may be subject to change due to various outside and internal factors. Some of these date changes are positive developments, and some can be disasters if a company is 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.

Tesaro

Back in July, Tesaro Inc. (NASDAQ: TSRO) reported that the FDA has accepted its New Drug Application (NDA) for review for its intravenous 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.

Shares of Tesaro were last seen at $138.59, with a consensus price target of $130.64 and a 52-week trading range of $29.51 to $148.74.

Synergy Pharmaceuticals

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

Last seen trading at $6.59, Synergy shares have a consensus price target of $10.67 and a 52-week range of $2.50 to $6.97.

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. In fact, the company recently announced successful results from its Phase 3 clinical trial of Dextenza, which could play a role in overturning this CRL. Dextenza is used for the treatment of post-surgical ocular pain.

Ocular was trading at $8.18 per share, with a consensus price target of $29.40 and a 52-week range of $4.04 to $14.50.

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 seen at $22.75, with a consensus price target of $35.75 and a 52-week range of $14.38 to $27.47.

Amphastar Pharma

Back in April 2016, Amphastar Pharmaceuticals Inc. (NASDAQ: AMPH) filed the NDA for its less invasive intranasal Naloxone treatment of opioid addiction. But now the company has a set PDUFA target date of February 19, 2017. Sales of its injectable Naloxone treatment totaled $39 million in 2015.

Shares of Amphastar were trading at $18.70, with a consensus price target of $21.00 and a 52-week range of $10.50 to $21.75.

Lexicon Pharmaceuticals

Last 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.

The stock closed most recently at $14.42 a share. The consensus price target is $24.67, and the 52-week range is $7.65 to $19.62.

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