4 Key FDA Decisions Expected in November and December

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 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 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 in the month of November 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.

Repros Therapeutics

Repros Therapeutics Inc. (NASDAQ: RPRX) previously announced that the Division of Bone, Reproductive and Urologic Products of the FDA has scheduled the advisory committee to review its New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal, on November 3. However, this was cancelled due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain study data. On this news shares tanked over 60% to the current price level.

Separately, Repros has a PDUFA goal date set on November 30 for the substantive review of its NDA for the enclomiphene citrate product candidate. Additionally, the FDA has informed Repros that it is currently planning to hold an advisory committee meeting on the NDA during this review.

Shares of Repros closed trading at $1.71 on Friday. The stock has a consensus analyst price target of $9.00 and a 52-week trading range of $1.75 to $10.72.

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Gilead Sciences

On November 6, 2014, Gilead Sciences Inc. (NASDAQ: GILD) filed an NDA for its single tablet treatment that contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (TAF) for the treatment of HIV. No PDUFA date was mentioned in the original release; however, it is expected that this review will take place on November 6, 2015. The TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety.

Gilead shares ended last week at $108.13, in its 52-week trading range of $85.95 to $123.37. The consensus analyst price target is $124.07.

BioCryst Pharmaceuticals

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 changing hands at $8.99 on Friday’s close. The consensus price target is $16.67, and the 52-week range is $7.85 to $16.83.

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Synergy Pharmaceuticals

Back in January, Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) completed patient enrollment in the first and second of two pivotal Phase 3 CIC trials. These are evaluating the safety and efficacy of two plecanatide doses. Synergy announced top-line data results from the both the first and second Phase 3 CIC trials earlier in the year. Now the company plans to file its first NDA with the FDA for plecanatide in the CIC indication in December 2015.

The share price ended the week at $6.41, in its 52-week range of $2.75 to $10.15. The consensus price target on Synergy is $13.58.