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Company Run By 30-Year-Old Former Hedge Fund Manager Starts Study To Get Its Alzheimer's Drug Approved

This article is more than 8 years old.

Axovant Sciences, the Alzheimer's startup founded by former hedge fund manager Vivek Ramaswamy, announced this morning that it has begun a 1,150-patient study aimed at getting RVT-101, the Alzheimer's drug that the company purchased from GlaxoSmithKline , approved by the Food and Drug Administration.

In another positive step for the company, Axovant announced that the FDA has granted it a special protocol assessment, or SPA, an agreement that means the agency agrees that the study, if successful, would provide adequate evidence for an approval of the drug.

Axovant had said that the study would start in the fourth quarter. The SPA should also ease any worries about whether a single new study would be enough to garner FDA approval.

This isn't going to end the controversy about Axovant, which has a market capitalization of $1.3 billion. Skeptics argue Glaxo wouldn't have sold a valuable asset for just $5 million upfront, large milestone payments, and a 12.5% royalty, point out that Axovant employs both Ramaswamy's mother and brother, and that the drug has technically failed its previous study. Ramaswamy counters that aside from a single badly picked measure of how well patients functioned, the study showed statistically significant improvements for Alzheimer's disease. Alzheimer's researchers are generally positive about the medicine's odds.

RVT-101 does not slow or reverse the underlying causes of Alzheimer's disease, but does improve symptoms. I caught up with Ramaswamy yesterday at the Forbes 30 Under 30 Summit, where he spoke with a panel of young tech CEOs about how to found a company with a billion-dollar valuation. Our conversation about this new study and the FDA agreement is embedded in this post.