Shares of Chiasma Inc. lost more than half their value in premarket trade Monday, after the Food and Drug Administration said the new drug application (NDA) for its treatment of a rare ailment related to the pituitary gland was not ready for approval in its present form. The stock was recently down 55% at $4.61, or less than a third of its initial public offering price of $16; the company went public on July 16. The FDA said Chiasma would need to conduct another clinical trial, as its NDA didn’t provide enough evidence of efficacy to warrant approval. “We are surprised, disappointed and respectfully disagree with the FDA’s decision,” said Chiasma Chief Executive Mark Leuchtenberger. “The FDA has encouraged us to request an end of review meeting with the agency to discuss the path forward, and we will do so.”
Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
From:: Stock Market News