4 New Big FDA Decisions Expected in September

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Pharmaceutical companies usually are involved in a lengthy process of 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. U.S. Food and Drug Administration (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 September 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 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.

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Tetraphase Pharmaceuticals Inc. (NASDAQ: TTPH) is a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant infections. Following the requisite protocol-specified follow-up visits and database lock activities, the company expects top-line data from its IGNITE2 to be available in the third quarter, and it is targeting a submission of its New Drug Application (NDA) for both IV and oral formulations in complicated intra-abdominal infection and complicated urinary tract infection by year-end 2015. Shares of Tetraphase were trading at $43.25 on Friday’s close. The stock has a consensus analyst price target of $53.20 and a 52-week trading range of $14.75 to $52.90.

Vital Therapies Inc. (NASDAQ: VTL) is a biotherapeutic company that focuses on developing a cell-based therapy for the treatment of acute liver failure in the United States. It is on track for database lock and release of top-line results for the VTI208 clinical trial in the third quarter of 2015. VTI208 is a Phase 3 randomized, controlled, open-label trial, evaluating the ELAD System in subjects with alcohol-induced liver decompensation. Enrollment was completed in January with 203 subjects. Vital shares were at $3.36, in its 52-week trading range of $2.81 to $29.67. The consensus analyst price target is $12.00.

Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) is a biotechnology company that focuses on the development and commercialization of novel medicines to treat liver diseases in the United States. In September 2014, the company initiated an exploratory, open-label Phase 2 clinical trial in patients with LC of mixed etiologies and PH confirmed by hepatic venous pressure gradient (HVPG) procedure prior to enrollment. Patients will receive 25 mg of emricasan orally twice daily for 28 days. The co-primary endpoints are the changes from baseline in HVPG and cleaved Cytokeratin-18 (cCK18), a mechanism-specific biomarker that increases with liver disease severity. Secondary endpoints include changes from baseline in MELD score and CPT score. Top-line results from this trial are expected to be available in the third quarter of 2015. Shares of Conatus ended the week at $3.84, in its 52-week range of $3.44 to $11.74. The consensus price target is $13.00.

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Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) is a biopharmaceutical company focused on developing breakthrough treatments for human disease. It completed enrollment in Telestar, its pivotal Phase 3 clinical trial of telotristat etiprate for patients with carcinoid syndrome. The company expects to announce top-line data from the Telestar trial in the third quarter of 2015. Telotristat etiprate is an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels. Lexicon shares were at $12.21 on Friday’s close. The consensus price target is $20.00, and the 52-week range is $5.60 to $13.88.