(Adds details, shares)
May 8 Women's healthcare company TherapeuticsMD
Inc said the U.S. Food and Drug Administration had
rejected its application to market its drug to treat vaginal
pain, sending its shares down about 13 percent in premarket
trading on Monday.
The FDA had identified issues related to long-term safety
data, the company said.
"We... respectfully disagree with the FDA's decision,"
TherapeuticsMD's Chief Executive Robert Finizio said, adding
that there are multiple paths forward to address the concerns.
The drug, TX-004HR, is being developed to treat
moderate-to-severe vaginal pain during sexual intercourse in
Last month, the company said it received a letter from the
FDA identifying deficiencies in the drug's application, but did
not mention them.
Shares of the Boca Raton, Florida-based company were down
13.3 percent at $4.05 before the bell. Up to Friday's close, the
stock had fallen 41 percent in the last 12 months.
(Reporting by Divya Grover in Bengaluru; Editing by Sai Sachin
Ravikumar and Martina D'Couto)