* Stops enrollment in trial after safety concerns
* Pipeline includes another drug with same ingredients
* Don't see clear path forward - Deutsche Bank analyst
* Stock hits record low at $1.11
(Adds analyst comment; updates shares)
By Natalie Grover
Aug 25 Regado Biosciences Inc lost more
than half its market value on Monday after saying it terminated
enrollment in a late-stage trial of its lead drug over safety
concerns, creating uncertainty over the company's strategy and
The ingredients comprising the lead drug, Revolixys or REG1,
are also present in Regado's second experimental drug, REG2.
"Given the safety issues associated with REG1, we are
uncertain if REG2 will move forward in the clinic," Deutsche
Bank analyst Robyn Karnauskas said, slashing her price target on
the stock to $2 from $14.
Regado's shares had plummeted early July, after it was
revealed that a data safety monitoring board (DSMB) had
initiated an unplanned review of the Revolixys trial.
The U.S. Food and Drug Administration had imposed a clinical
hold on the trial last month.
The DSMB raised serious concerns of allergic reactions and
recommended that Regado suspends enrollment in the trial, the
company said on Monday.
"Given the swift and unequivocal halting of the trial (the
safety review was expected to last into September) we expect the
program will be terminated," Needham & co analyst Chad Messer
wrote in a note.
Regado will review the trial data, Chief Executive David
Mazzo said, but it is expected to take several months.
The company will have to reengineer its product pipeline and
rethink its overall strategy, Liana Moussatos, an analyst at
Wedbush Securities, said.
Regado has another experimental anti-platelet drug, REG3, in
preclinical development. It consists of a different active
Revolixys was being evaluated against the anticoagulant
bivalirudin in patients undergoing percutaneous coronary
intervention, a procedure to mechanically open or widen
obstructed coronary arteries.
The drug comprises pegnivacogin, which binds to blood
coagulation Factor IXa to prevent blood clotting, and
anivamersen, an active control agent which rapidly reverses the
anticoagulant effect, helping patients' blood return to normal.
Blood coagulation or clotting is initiated and maintained by
a set of proteins in the blood, called coagulation factors, and
Regado shares, which debuted a year ago, were Monday's
biggest percentage loser on the Nasdaq. They were down about 60
percent at $1.15 in afternoon trading, after touching a record
low of $1.11.
Nearly 6.5 million shares of the Basking Ridge, New
Jersey-based company changed hands by 12.20 p.m. ET, more than
five times their 10-day average volume.
(Editing by Joyjeet Das)