OvaScience slumps 38% on disappointing Augment update

US fertility treatment specialist OvaScience (Nasdaq: OVAS) saw its shares plummet 38.4% to $8.80 in pre-market trading, when the company  provided a regulatory, manufacturing and international strategy update on Augment, the company’s product candidate designed to improve egg quality and increase the success of in vitro fertilization (IVF).

OvaScience has chosen to suspend enrollment of Augment in the USA, while moving forward with its plans for enrollment outside of the USA. On September 6, 2013, the company received an “untitled” letter from the Food and Drug Administration questioning the status of Augment as a 361 HCT/P and advising it to file an Investigational New Drug application. OvaScience anticipates having further discussions with the FDA to present details on Augment and its qualifications as a 361 HCT/P, and to determine the appropriate path forward. OvaScience continues to believe that Augment qualifies as a 361 HCT/P.

OvaScience plans to initiate sites for an Augment study in select countries outside the USA in 2014. In preparation for the launch of Augment, OvaScience has expanded its manufacturing capabilities with a global supplier, which has extensive commercial experience in cell therapy manufacturing. This will enable OvaScience to increase capacity for the launch. The company says it is making steady progress in preparation for the study and launch of its product.