By ADAM FEUERSTEIN @adamfeuerstein

MARCH 19, 2019

Vivek Ramaswamy, the hedge fund manager turned biotech entrepreneur, has raised billions of dollars to create a constellation of “Vant” companies that license and develop drugs from other firms. Five years and one spectacular Alzheimer’s drug blowup later, Ramaswamy finally notched a late-stage clinical trial win.

It comes courtesy of Urovant, the urology-focused spinout from his Roivant Sciences mothership. On Tuesday, Urovant said its lead pipeline drug, vibregon, achieved all the treatment goals in a Phase 3 clinical trial involving patients with overactive bladder.

With these new overactive bladder data in hand, Urovant intends to file a marketing application for vibregon with the Food and DrugAdministration in “early 2020,” the company said.

Until Tuesday, Ramaswamy was best known for his worst failure. His first company, Axovant Sciences, managed a record-breaking initial public offering before crashing in spectacular fashion on the negative clinical trial of an Alzheimer’s disease drug licensed from GlaxoSmithKline.

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Achieving his first big drug-development win — and likely first regulatory approval — with a new overactive bladder treatment may seem like a consolation prize for Ramaswamy. But there’s good money to be made in taming the excessive urge to urinate: Myrbetriq, marketed by Astellas, delivered $750 million in sales last year and is still growing.

Vibregon is a superior version of Myrbetriq — providing faster relief for patients and with fewer side effects, Urovant believes. The company acquired vibregron from Merck in 2017 after the pharma giant made a strategic decision to get out of the urology business. Vibregon had already demonstrated positive efficacy in two previously conducted overactive bladder clinical trials.

In Tuesday’s Phase 3 study, vibregon, taken as a once-daily pill, significantly lowered the number of times patients urinated over the course of a day. The drug also significantly dampened muscle spasms in the bladder that cause involuntary urine leaks. The benefit of vibregon over a placebo was first observed at two weeks and continued until the end of the 12-week study. The study enrolled 1,500 patients diagnosed with overactive bladder. Urovant withheld more detailed results from the study so they could be presented at a medical meeting.

Some patients in the study were treated with tolterodine, an overactive bladder drug that is already available, as an active control. Vibregon performed only marginally better than tolterodine at all measured points, Urovant said. This isn’t likely to hurt vibregron’s chance for approval, but insurance companies might push back against reimbursement since the drug isn’t much better than a cheap generic.

The rate of reported side effects was equal between vibregon and placebo and higher with tolterodine, the company said.

Urovant went public last September, raising $140 million at $14 per share. The stock ran into immediate trouble, falling to $4 per share in December. It’s since rebounded, closing Monday at just under $14 in anticipation of positive Phase 3 study results.

In early Tuesday trading, Urovant shares fell 13 percent, as some investors sold the expected clinical trial win while also raising concerns about the commercial potential for Ramaswamy’s overactive bladder drug.

This story was updated at with more information about the clinical trial and the early stock reaction.