Regado's CEO steps down as the biotech limps forward

Regado CEO David Mazzo

David Mazzo is out at Regado Biosciences ($RGDO), resigning from the CEO post as the company he led into Phase III works to move on from a disastrous clinical roadblock.

Mazzo's exit caps 12 months of escalating disappointment for the New Jersey biotech, which tried to go it alone on a late-stage anticoagulant. When that drug, Revolixys, ran into serious safety issues in its Phase III study, Regado had no choice but to halt the trial, torpedoing the company's share price and likely sealing Mazzo's fate.

But Regado is pressing on, appointing former COO Michael Metzger to lead the process of "evaluating strategic alternatives to optimize value for shareholders," as Chairman Dennis Podlesak put it in a statement.

Value has been hard to come by for Regado's shareholders since the company pulled off a massively discounted IPO last year. Initially expecting to price at $14 to $16 a share, Regado went public at just $4, raising $47 million to fund its costly Phase III ambitions for Revolixys.

And then things began to go awry. In July, the company paused its trial to allow a safety monitoring committee to investigate some potentially dangerous allergic reactions among subjects. A week later, the FDA stepped in and placed a full clinical hold on the Revolixys study, and, in August, the biotech confirmed what investors feared: Seriously allergic reactions made it impossible to continue the trial.

Now the company is working to save as much money as it can, last month laying off 60% of its staff and setting out in search of strategic alternatives.

Metzger's appointment suggests Regado isn't planning to just call it quits and return its leftover cash to shareholders, as many would prefer. But the company doesn't have much with which to move forward: Regado's remaining assets are the Phase I REG2, a subcutaneous treatment using the same active ingredients as Revolixys, and the preclinical antiplatelet therapy REG3.

- read the statement

Sponsored by GenScript

Accelerate Biologics, Gene and Cell Therapy Product Development partnering with GenScript ProBio

GenScript ProBio is the bio-pharmaceutical CDMO segment of the world’s leading biotech company GenScript, proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.

Suggested Articles

Janssen is tapping little-known and privately held Hemera Biosciences for a new gene therapy aimed at reversing a severe disease.

Merck is clearly still buzzing about its two-year Dragonfly Therapeutics pact, as it has snapped up a cancer program.

The platform is intended to enable Bayer to make its expertise and resources available to its partners while preserving their autonomy and culture.