Healthcare Business

8 Major FDA Decisions and Trial Results to Watch for in September

Pharmaceutical and biotech companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount to a great amount of risk involved, should a study come back negative or 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 U.S. Food and Drug Administration (FDA) rulings and results from clinical trials can make or break these companies.

24/7 Wall St. has collected several big FDA decisions and mid-to-late-stage trials that should be coming up in 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 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 Pharmaceuticals

In mid-August, Achillion Pharmaceuticals Inc. (NASDAQ: ACHN) announced that interim results from its ongoing Phase 2a clinical trial evaluating all-oral combination regimens, containing odalasvir, AL-335 and simeprevir, which were accepted for presentation at the EASL — American Association for the Study of Liver Diseases (AASLD) Special Conference being hosted in Paris, France.

This study is being conducted in conjunction with Alios BioPharma, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ). The data will be presented on Friday September 23. This Phase 2a study is aiming to establish the safety, pharmacokinetics and efficacy of doublet and triplet regimens, consisting of odalasvir and AL-335, with or without simeprevir, in treatment naïve patients with genotype 1 hepatitis C virus (HCV) infection for treatment durations of eight weeks or less.

Shares of Achillion closed trading at $8.23 on Thursday, with a consensus analyst price target of $9.71 and a 52-week trading range of $5.57 to $10.95.

Johnson & Johnson was last seen at $119.08. The consensus price target is $126.72, and a 52-week range is $89.90 to $126.07.


Amarin Corp. PLC (NASDAQ: AMRN) announced that it completed the randomization of patients in the REDUCE-IT cardiovascular outcomes study with 8,175 patients. The study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors. Amarin closed enrollment at all global clinical sites in June 2016.

The company continues to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with publication of trial results likely in 2018. An independent Data Monitoring Committee is expected to complete a protocol pre-specified interim efficacy and safety analysis after approximately 60% of the target aggregate primary cardiovascular events have occurred within the study. This interim analysis most likely will occur in September 2016. A second interim efficacy and safety analysis with approximately 80% of the primary cardiovascular events is expected in mid-2017.

Shares of Amarin closed most recently at $2.79, with a consensus analyst price target of $6.83 and a 52-week trading range of $1.24 to $3.46.