Revance Therapeutics (NASDAQ:RVNC)
On Tuesday June 14, 2016 shares of Revance Therapeutics went down in after-hours trading by 24% after the company stated that it had failed to meet the primary endpoint of its phase 3 clinical trial. The phase 3 trial was testing patients with lateral catheral lines or Crows Feet. The trial used Revance’s drug known as RT001, which is a topical gel. This gel would have been easier for these patients to use, because it is able to be used in areas of the body which are deemed very sensitive.
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Failing the primary endpoint of the phase 3 clinical trial was a huge blow for the company. The failure of the primary endpoint was calculated using two different scales. One scale is known as the Global Assessment of lateral Catheral lines and the other one is known as Patient Severity Assessment. This failure really hurts the company greatly, but the good news out of all this is that the company still has a pretty big pipeline in place.
For example, Revance is gearing up to begin a phase 3 trial that would treat patients with Glabellar lines. It would use its injectable proprietary drug known as RT002. As soon as this trial is completed it will be a good catalyst to potentially drive the share price higher. The company even states that it has another phase 2 clinical trial treating patients with cervical dystonia, which is expected to report interim results within this year.
Along with these other potential indications it is nice to see that the company has a split in the amount of risk in its pipeline. For instance, the company has both a therapeutic and cosmetic pipeline. This is good for Revance as it allows them breathing room in case any of the trials fail yet again.
Marinus Pharmaceuticals (NASDAQ:MRNS)
On Monday June 13, 2016 shares of Marinus Pharmaceuticals tumbled by 70% after the company announced that its phase 3 trial in patients with drug-resistant epilepsy had failed. The company’s drug, known as ganaxalone failed to beat out a placebo compound in the study. The trial failed to meet the primary endpoint of the study, which was the 28-day seizure frequency from baseline as a median percentage.
The percent reduction of focal onset seizures in the ganaxalone group was 21.28% compared to 10.25% in the placebo group. Patients were evaluated over a 12-week period to determine if the drug could perform better than its placebo counterpart. While the drug showed a small improvement, it still failed to reach statistical significance over the placebo. With this in mind Marinus has chosen to completely cut this program out of its pipeline.
Instead Marinus will put more focus to other indications in its pipeline. That’s the good news for investors is that Marinus has the ability to to use ganaxalone in other potential indications, and this provides a cushion for investors. The other two programs that it is targeting are patients with epilepticus, and pediatric orphan indications. The CEO sounded upbeat about the other programs and had this to say:
“We are committed to building our ganaxolone franchise and are confident in the potential of ganaxolone in the treatment of status epilepticus and pediatric orphan seizure and behavior disorders. We will provide an update in the upcoming weeks on our clinical programs in these indications.”
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Whether these other trials pan out or not remains to be seen, but at least the CEO indicated that the company will update investors in the coming weeks. This will allow investors to make a decision on whether or not they should hold onto the stock, or sell it. At least the company is making an efforts to boost shareholder value, and keep its programs running.
[Image Courtesy of Wikimedia]