Innocoll Holdings (NASDAQ: INNL) shares soared as much as 43% this morning – currently up 14% – after the company said it received formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL. This clarifies the data that the company will need in order to address the questions raised in the Refusal to File (RTF) Letter the company received from the FDA in December 2016. During the Type A meeting, representatives of the FDA provided guidance which was confirmed in the formal FDA meeting minutes. The company intends to resubmit the NDA at the end of 2017. “I am pleased that we have clarified the data needed to address the questions raised in the RTF letter. With the official minutes from the FDA now in hand, we believe that we have a path forward for a possible resubmission of the XARACOLL NDA by the end of 2017, assuming adequate financing to commence the proposed studies, and further assuming positive results,” CEO Tony Zook stated in the news release.
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About Innocoll Holdings plc
Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application. For more information, visit www.innocoll.com.
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