4 Key FDA Decisions Expected By Year End

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Pharmaceutical companies generally are 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, as with 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 massive upside.

The long and short of the matter in biotech is that Food and Drug Administration (FDA) rulings can make or break these companies.

24/7 Wall St. has collected several big FDA decisions coming up on the calendar in the month of December 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.

ACHILLION PHARMA

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) is working on the development of a hepatitis C vaccine (HCV) or treatment. So far the company has been relatively successful and just initiated a phase 2a trial. Top-line results from this trial are expected this quarter.

Shares of Achillion were recently trading around $10.00, with a consensus analyst price target of $11.36 and a 52-week trading range of $6.41 to $16.87.

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BIOCRYST PHARMA

The OPuS-2 (Oral ProphylaxiS-2) clinical trial of BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) has been proceeding as planned in 2015, and the company expects to report results in late 2015. OPuS-2 is a 12-week, three-arm, parallel cohort design trial to evaluate the efficacy and safety of two doses of BCX4161, administered three-times daily, compared with placebo.

Approximately 100 hereditary angioedema patients will be enrolled in the United States and other selected countries. BioCryst shares were last trading just over $10.00, with a consensus analyst price target of $16.22 and a 52-week trading range of $7.85 to $16.83.

TETRAPHASE PHARMA

Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) is in the process of developing its lead antibiotic candidate to treat bacterial infections including those caused by MDR Gram-negative bacteria. The company is looking for to submitting a New Drug Application (NDA) by the end of the year. Shares of Tetraphse were recently trading at nearly $11, with a consensus analyst price target of $14.60 and a 52-week trading range of $7.20 to $52.90.

CLOVIS ONCOLOGY

Clovis Oncology, Inc. (NASDAQ: CLVS) has an ongoing phase 2 program exploring lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced lung cancer with FGFR1 amplification.

In parallel with these Clovis-sponsored studies, a Servier-sponsored phase 2 study of lucitanib in patients with advanced breast cancer is underway to identify the population of patients most likely to benefit from lucitanib therapy. Initial results from this study is expected by the end of 2015.  Shares of Clovis were recently trading around $28, with a consensus analyst price target of $49.67 and a 52-week trading range of $24.50 to $116.75.

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