A couple of companies have had a tough twenty-four hours in the biotech space. One discontinuation, and another primary endpoint miss, has served up double digit losses in the companies in question, and both look set for further losses as we close in on the end of the week.
Here’s what happened.
The companies in question are Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) and Tenax Therapeutics Inc (NASDAQ:TENX). We’ll kick things off with Alnylam, as this is the major news of the day.
The company has been developing what looks like a pretty robust pipeline of what are called RNAi therapeutics, or RNA interference drugs. This class of drugs was hailed as being a potential game changer across a variety of target indications as near term as just a couple of years ago. Some big names picked up programs, however they subsequently dropped these programs and moved on. Alnylam was one of the few that stuck with the drug class, and the biggest of the bunch, and it pretty much gambled its future on RNAi.
Fats forward to last night, and the company announced that it was dropping one of its lead programs, a phase III trial investigating the efficacy of a drug called revusiran in a rare disease target called hereditary transthyretin-related amyloidosis (hATTR) with cardiomyopathy (hATTR-CM).
Right now, we don’t know much. All we know is that the data monitoring committee that was tasked with keeping an eye on the study brought to light some concerning death rates (and recommended halting dosing), and that on analysis of these rates, the company has decided to discontinue the study entirely. Reportedly, eighteen deaths out of a total of a little over 200 patients occurred, and there was some unusually high level of nerve pain in patients in the active arm.
On the news, markets have traded down on Alnylam, and the company is currently trading close to 50% down on its Wednesday evening close. How this is going to play out, nobody is quite sure. The company still has a number of RNAi programs ongoing, and there looks to be some promise in these. If this turns out to be the case, the 50% hit will probably turn out to be an oversell. It’s a real gamble right now, however. It’s another in the long list of failures already racked up in RNAi, and the number of potential positive plays is dwindling
So, let’s put that on hold for now until (if) we get some more information on the situation, and move on to Tenax.
This has taken second fiddle to the Alnylam discontinuation, but for shareholders of Tenax, it’s just as important. The latter’s lead septic shock trial just failed to meet its primary endpoint, and the company is set to discontinue its investigation.
It’s an already approved drug, and Tenax was looking to expand its use into the above mentioned septic shock indication. In a double blind trial, however, the drug (active) arm did not meet the primary endpoint of reducing the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as a bunch of pre-specified secondary endpoints.
It’s not great news, and the company has taken around a 10% hit on the news (although during today’s session, it has stages a slight recovery on a bounce). Having said this, the septic shock indication is secondary to the company’s lead trial, which is investigating the same drug in a condition called low cardiac output syndrome (LCOS). The company is just shy of an 880 patient enrollment target in a phase 3 on this one, and an independent monitoring board has already recommended approval based on the available safety data from a little over 600 patients.
This is going to be the company’s primary focus going forward, and it’s what we are watching from a catalyst perspective near term.
So there we go. As these two play out we are going to be watching for any indication that either of the two declines might become a buy opportunity. Of the two, the first (Alnylam) is our key focus right now. A 50% hit on a company that size (although it’s yet to prove this worth with revenues) is always potentially an oversell if it’s just one catalyst, and this hints at a medium term recovery on any positive data going forward.