As the markets take a break for Thanksgiving, things settled down a little bit late Wednesday, but not before some sharp shocks in the biotech sector. These sorts of shocks present something of a unique opportunity around this time of year. Markets open half day on Friday, and sentiment at Wednesday close often carries into the early morning out of the US as traders and investors look to load up on/reduce their exposure ahead of the weekend.
With this in mind, here are some of biotech’s biggest movers from yesterday, and in turn, some of the companies we expect to move considerably early Friday. The two companies in focus are Eli Lilly and Co (NYSE:LLY) and Juno Therapeutics Inc (NASDAQ:JUNO).
We’ll start with Juno.
This one’s a tough one. The company is developing a drug called JCAR15, which it is aiming to commercialize as a treatment for relapsed or refractory B cell acute lymphoblastic leukemia. It’s one of the leading assets in the CART space, a hot space in biotech right now, but it’s been dogged with setbacks. The first major setback came earlier this year, when the FDA put a clinical hold on a phase II trial of the drug. The hold came on the back of two patients, which at the time, Juno blamed on the inclusion of a chemotherapy agent called fludarabine in the regimen. The company said that the deaths weren’t based on the fludarabine alone, but that the combination of the chemo agent and the JCAR15 regimen caused them.
The FDA accepted this, and the trial restarted.
Fats forward to yesterday, and the trial is again on hold, after the company reported two more deaths to the agency. These aren’t fludarabine related, as the agent is now removed from the combo regimen, so there must be some underlying issue with JCAR15 – or that’s the assumption that markets are running with.
Nothing is confirmed yet, and it’s still early days, but markets aren’t willing to gamble on the potential for a full trial shut down (and that’s looking pretty likely, especially if Juno is unable to come up with some mitigating factor related to the two deaths that get JCAR15 of the hook). As such, the company is down close to 25% heading into its Friday morning US open.
Next up, Eli.
Eli also took a hit on Wednesday, and this one is again trial related. The company was developing a drug called solanezumab in patients with mild dementia due to Alzheimer’s disease, and investigating the efficacy drug in a phase III trial that closed out recently. The company just announced that the trial failed to meet its primary endpoint. The endpoint in question was a statistically significant slowing of cognitive decline across the study sample, as measured across a host of industry standard scales designed to assess neuro-activity in these sorts of degenerative conditions.
The trial also investigated the drug against a host of secondary endpoints, and there was some degree of benefit when measured against said points, but not to the degree required to warrant further investigation in this indication (or at least, that’s the impression we get right now from Eli.
On the back of the development, Eli is down a little more than 10% on a spike in volume.
Looking at wider markets, there has been some fallout from both of these scenarios, but the degree to which this fallout will carry forward isn’t entirely clear. A few CART companies are down on the Juno release, most notably Kite Pharma Inc (NASDAQ:KITE) and bluebird bio Inc (NASDAQ:BLUE). AC Immune Ltd (NASDAQ:ACIU) took a hit on the Eli news, since its lead development asset in Alzheimer’s has a similar MOA as that of Eli’s solanezumab.