Here’s a look at what happened during the latter half of this week in the biotech sector – which companies moved, why they moved, and what we are looking for next from each.
The companies in focus are Vericel Corporation (NASDAQ:VCEL), Alcobra Ltd. (NASDAQ:ADHD) and vTv Therapeutics Inc (NASDAQ:VTVT).
So, let’s kick things off with Vericel.
This is one we looked at a little earlier on this month. The company was trying to get its MACI therapy approved or the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. It’s a pretty neat treatment, and in the registration submission that supported the application to the FDA, the company proved it was equivalent (and better, in some cases) to what’s called microfracture therapy – a current SOC in the space. PDUFA was set for midweek, but the FDA released a press release late on Tuesday, reporting it had approved MACI in the target indication. Markets went in to overdrive (uncertain overdrive, as Vericel hadn’t confirmed or denied the approval) and the company started to gain strength. On Wednesday, Vericel put out a release confirming the approval, and the company took off. The company gained 70% on the approval, and currently sits just off these highs.
OK, next up, Alcobra.
This one is a little less clear cut. The company is developing a drug called Metadoxine Extended Release (MDX), which as the name of the drug suggests, is an extended release formulation of the currently approved, and widely used as SOC, drug Metadoxine. It’s used to treat chronic and acute alcohol intoxication, through improving the clinical signs of acute alcohol intoxication and accelerating alcohol clearance from the blood. In this instance, however, Alcobra is looking to use the ER version to treat Attention-deficit/hyperactivity disorder (ADHD). Well, the company previously reported that the FDA has put the drug on clinical hold, and mid week announced that it met with the FDA to discuss the hold. Meeting minutes will hit press over the coming weeks, and when they hit, Alcobra will provide further details regarding the MDX regulatory path. Markets interpreted the report as negative for the company, and it lost more than 11% of its market cap during Wednesday’s session. Throughout the early session on Thursday, however, markets traded back up on Alcobra, and the company is now pretty much flat on its weekly open.
Finally, vTv. This one is a drug related move. The company is developing an oral version of GLP-1 drug for a diabetes type 2 target indication. Patients that suffer from this type of diabetes (it’s by far the most common, accounting for 95% of all diabetes cases globally) generally use injectable GLP-1 drugs to control their condition. vTv is trying to develop an oral version, targeting improved regimen following, and moved this week on the back of a data release from a phase II study of the drug. It’s called TTP273, and in the study, vTv was able to show that it demonstrated a statistically significant reduction in HbA1c (the industry standard measurement for this sort of thing). On the back of this stat sig efficacy, vTv gained strength, and reached a 20% premium at its intraday highs. Throughout the day this tapered off, however, and the company now sits around flat on its pre-announcement valuation.